The key facts about biosimilars and biologics in Ukraine. Prepared in association with Sayenko Kharenko, a leading law firm in Ukraine, this is an extract from The Pharma Legal Handbook: Ukraine, available to purchase here for GBP 99.

 

1. Are biosimilar medicines considered the same as generic medicines in your country?

No, in Ukraine, biosimilar medicines are not considered the same as generic medicines. According to the Order of the Ministry of Health of Ukraine “On Approval of the Procedure to Examining Registration Materials for Medicinal Products Submitted for State Registration (Re-registration) and also to Examining Materials on Amendments to Registration Materials during the Validity of the Registration Certificate” (the “Procedure on Examining Registration”)¹ No. 426 dated 26 August 2005, biosimilar medicines must be similar in its quality, efficiency, and safety to the referent biologic medicines. Meanwhile, generic medicines must have the same quality and quantity of the active substance and be of the same form as the referent medicine. The Ministry of Health of Ukraine (the “Ministry of Health”) in its Guidelines ² states that since bioequivalence cannot be established for biosimilar medicines, such medicines must undergo more detailed comparison.

 

2. Are all biologic medicines, including biosimilar medicines, patentable in your country?

The Law of Ukraine “On the Protection of Rights to Inventions and Utility Models” No.3687-XII dated 15 December 1993 (the “Law on inventions”)³ does not provide for the separate rules governing the patentability of any biologic medicines, including biosimilar medicines. Thus, the issue of patentability will be determined on a case-by-case basis according to three general criteria in the course of the qualification examination.

The National Intellectual Property Authority conducting the qualification examination examines the following criteria:

• Novelty;
• Inventive step;
• Industrial applicability.

Meeting the above criteria, the biologic medicines, including the biosimilar medicines, will receive a patent.

 

3. Is there a specific regulatory framework for the marketing authorization of biosimilar medicines in your country? If yes, what is the regulatory framework for the authorization of biosimilar medicines?

No, Ukrainian legislation does not envisage a specific regulatory framework for the marketing authorisation of biosimilar medicines, and the general procedure shall apply.

In Ukraine, the marketing authorisation of medicines is governed by:

• the Law of Ukraine “On Medicinal Products “No. 123/96-VR dated 4 April 1996 ⁴ (the “Law on Medicinal Products”), Art. 9 and Art. 91;
• the Resolution of the Cabinet of Ministers of Ukraine (the “CMU”) “On Approval of the Procedure of State Registration (Re-registration) of Medicinal Products and Fees for Their State Registration (Re-registration)” ⁵ (the “Procedure for State Registration of Medicinal Products”) No. 376 dated 26 May 2005;
• the Procedure on Examining Registration etc.

According to the Procedure for State Registration of Medicinal Products, biosimilar medicines must be registered with the Ministry of Health to be placed on the market in Ukraine. The registration is conducted based on the application and results of the examination of registration materials for medicines. Furthermore, the Procedure on Examining Registration establishes specific requirements for the content of the registration dossier of biosimilar medicines.

Upon completing registration, the applicant receives a registration certificate for the medicinal product with a validity period of five years. Medicines placed on the market during the five-year validity period are allowed for use until their expiry term indicated on the packaging. After the expiry of the five-year initial registration term, medicines shall be re-registered. After re-registration the medicines may be placed on the market for an unlimited period.

 

4. What kind of data package is needed to obtain approval for a biosimilar drug? Is this any different to the requirements for the original Biologics drug?

The data package needed to obtain the approval is the same for biosimilar drugs and original Biologics drugs and comprise:

• registration dossier materials;
• materials regarding the control methods of medicine product quality;
• information regarding the production technology and a copy of the official production certificate issued by the authorized body of the state of production;
• text of package labelling;
• a certified copy of the State Service of Ukraine on Medicines and Drugs Control (the “SSM”) document conforming that production conditions meet the GMP requirements;
• confirmation of the registration fee payment.

Although the above data package is uniform required for approval for all medicines, the Procedure on examining registration establishes specific requirements for the content of the registration dossier of biosimilar medicines, since resalts of comparability examinations of biosimilar and original medicines must be reflected in the biosimilars registration dossier.

 

5. What are the requirements for the choice of the reference comparator product?

No specific requirements for the choice of the reference comparator product are envisaged in the Ukrainian legislation. According to the Procedure on Examining Registration, the selected reference comparator product must be a medicinal product registered in the world for the first time based on the full dossier, as an innovative product. The referent product used for all forms of comparability analysis must be of the same source majorly registered in the country with a tough regulatory system.

 

6. Can the comparator product be sourced from another regulatory jurisdiction? If yes, what are the data needed to support this approach?

Yes, the reference comparator product can be sourced from another regulatory jurisdiction as long as it meets the above description of the comparator product. The Procedure on Examining Registration specifies that if the reference product is sourced from another country additional information such as the maintenance of the cold chain during the transportation is required.

However, the exact scope of the required additional data is not established. According to the general rule prescribed for biosimilar medicines, the type and scope of the additional data are defined on a case-by-case basis under the principles laid down in the EMA Guidelines and the Ministry of Health Guidelines.

 

7. How are the prices of biosimilar medicines regulated? Is this any different from the requirements for the original Biologics drug?

Prices on biosimilars and original Biologics drugs are covered by the general regulation of pricing of medicinal products. The following acts are applicable:

• The Law of Ukraine “On Prices and Pricing” No. 5007-VI dated 21 June 2012;⁶
• The CMU Resolution “On Measures to Stabilise the Prices for Medicinal Products and Medical Devices” No. 955 dated 17 October 2008;⁷
• The CMU Resolution “On Certain Issues of State Regulation of Prices for Medicines and Medical Devices” No. 333 dated 25 March 2009;⁸
• The CMU Resolution “The Issues of Declaration of the Change of the Wholesale Prices for the Medicinal Products” No. 240 dated 2 July 2014;⁹
• The CMU Resolution “On Certain Issues of Reimbursement of Medicinal Products under the Program of State Guarantees of Medical Care of the Population” No.854 dated 28 July 2021;¹⁰
• The CMU Resolution “On Governmental Regulation of Prices for Medicinal Products” No. 862 dated 9th November 2016;¹¹
• The CMU Resolution “On Certain Issues of Reimbursement of Medicinal Products” No. 135 dated 27 February 2019;¹²
• The Order of the Ministry of Health “On Adoption of the Rules on the Register of Wholesale Prices for Medicinal Products and Medical Devices, the Rules of its Change and the Forms of Declaration of the Change of the Wholesale Prices for Medicinal Products and Medical Devices” No. 574 dated 18 August 2014;¹³
• The Order of the Ministry of Health “On Adoption of the Rules of Calculation of Marginal Wholesale Prices for Medicinal Products Based on the Reference Prices” No. 1423 dated 29 December 2016.¹⁴

In general, the medicines are traded at free-market prices. Nevertheless, the state price regulation in form of marginal wholesale prices is introduced for medicinal products procured and/or reimbursed for the budgetary funds.

Moreover, the CMU Resolution “On Measures to Stabilise the Prices for Medicinal Products and Medical Devices” establishes marginal sales mark-ups for:

• medicinal products (except for narcotic drugs, psychotropic drugs, precursors and medical gases, as well as drugs to be purchased under controlled access agreements), which are included on the national list of essential medicinal products (such list is available at https://zakon.rada.gov.ua/laws/show/333-2009-%D0%BF#n15);
• medicinal products (except for narcotic drugs, psychotropic drugs, precursors and medical gases, as well as drugs to be purchased under controlled access agreements) purchased wholly or partly for budgetary funds;
• medicinal products (except for insulin drugs), which are reimbursed according to legislature;
• insulin drugs, which are reimbursed according to legislation.

 

8. What is the reimbursement policy for biosimilar medicine? Is this any different from the requirements for the original Biologic drug?

Ukrainian legislation does not envisage a specific reimbursement policy for biosimilar medicine and original Biologics drugs. Therefore, such medicines are covered by the general reimbursement procedure.

In Ukraine, the reimbursement mechanism covers cardiovascular diseases, particularly primary and secondary prevention of heart attacks and strokes, type II diabetes and bronchial asthma. The reimbursement is also envisaged for insulin.

According to the CMU Resolution “On Certain Issues of Reimbursement of Medicinal Products under the Program of State Guarantees of Medical Care of the Population”, the reimbursement is conducted for the medicines registered in Ukraine and included in the Register of medicinal products reimbursable under the program of medical guarantees (the “Register “). The Register is approved by the Order of the Ministry of Health and is updated bi-annually (in August and February).

 

9. Does biosimilar competition impact the reimbursement policy of the originator reference products?

Ukrainian legislation does not provide any impact of biosimilar competition on the reimbursement policy of the originator reference products. Medicine is included in the Register independently from others based on the submitted application.

 

10. What is the legal framework for biosimilar medicines prescribing (clinical decision maker) and dispensing (pharmacy level, hospital or retail)? Is this any different to the requirements for the original Biologics drug?

The general procedure of medicines prescribing and dispensing is applicable to biosimilar medicines and original Biologics drugs. Legal framework for prescribing and dispensing comprises:

• The Law of Ukraine “Fundamentals of the Legislation of Ukraine on Healthcare” ¹⁵  (the “Legislature on healthcare”), establishing general grounds for medicines prescribing and dispensing;
• The Law on Medicinal Products, Chapter IV, regulating the medicines sales;
• The Rules for prescribing medicines and medical devices,¹⁶ regulating both general prescribing procedure and prescribing procedure for certain categories of citizens (the “Rules for prescribing medicines”);
• The Procedure for dispensing medicines and medical devices from pharmacies and their structural units.¹⁷

According to the Rules for prescribing medicines, prescription medicines can be prescribed to patients only by physicians of business entities practicing medicine according to medical specialties under the obtained licenses and in accordance with medical posts.

As to dispensing, it is conducted by the pharmacies, their structural subdivisions and pharmacy warehouses (bases) holding respective licenses.

 

11. Is the system considering physician-led switching and/ or pharmacy-level substitution (without involvement of the clinical decision maker)?

The legislation does not address physician-led switching. Nevertheless, Ukrainian physicians are guided by the clinical protocols approved by the Ministry of Health. Such protocols may expressly prohibit switching between the original biological medicines and biosimilar medicines in cases where such switching is dangerous. In other cases, the clinical protocols allow the prescription of biosimilar medicines.

In practice, physicians can prescribe biosimilar medicines in cases where it is not prohibited by clinical protocols. However, such prescription must be made with the consent of a patient according to the general rule of Art.43 of the Legislature on healthcare.

As to the pharmacy-level substitution, this issue is not regulated by the Ukrainian legislation as well. Art. 781 of the Legislature on healthcare obliges pharmaceutical professionals to inform customers at their request about the available medicines with the same active substance. However, due to the biosimilars complexity, they may contain an active substance different from the original biological medicine and, thus, will not be covered by the above requirement.

 

12. What are the post-authorisation requirements (including pharmacovigilance, risk management plans, post-approval studies) for biosimilar medicines? Is this any different to the requirements for the original Biologics drug?

Ukrainian legislation does not prescribe any specialised post-authorisation procedure for original biological drugs and for biosimilar drugs. Both types of drugs are covered by the general procedures.

In general, the pharmacovigilance system in Ukraine involves both manufacturers of medicinal products (applicants) and regulatory authorities. The Order of the Ministry of Health “On Approval of Procedure for pharmacovigilance” No. 898 dated 27 December 2006,¹⁸ requires applicants to appoint a person responsible for pharmacovigilance matters and establishes the following post-authorisation procedures:

• reporting on all recorded and proven cases of serious and non-serious adverse reactions to medicines;
• submitting a periodic safety report regarding the medicines 
• conducting the post-authorisation studies on either voluntary or mandatory basis if risk management plan envisages such studies;
• submitting the updated risk management plan if such update took place due to the available new information.

Moreover, the Procedure for State Registration of Medicinal Products requires the entity to inform the Ministry of Health on any facts requiring updating registration materials.

The applicant must submit the above information to the State Expert Centre of the Ministry of Health (the “Centre”), which is the state enterprise authorised to conduct pharmacovigilance.

The Centre is responsible for:

• analysis of the available information on adverse effects, lack of efficiency etc;
• audit of the pharmacovigilance system of applicants;
• analysis of periodic safety reports, risk management plans.

Based on such analysis, the Centre may propose the Ministry of Health prohibit in full or temporarily or restrict the use of the medicine.

 

13. Are there specific policies and requirements for labelling biosimilar medicines in the event of second medical use patents? Is this any different from the requirements for the original Biologic drug?

There are no specific policies and requirements in terms of medicines labelling in the event of second medical use patents is provided in Ukrainian legislation. All requirements regarding labelling are laid down in Art. 12 of the Law on Medicinal Products.

 

14. Have there been any significant legal/judicial developments in relation to biosimilars in your country? (Including but not limited to IP, procurement, competition, misleading information campaign, access to reference comparator product)

No, there have been no significant legal/judicial developments in relation to biosimilars in Ukraine.

 

15. Are there proposals for reform or significant change to the legal, regulatory, procurement of biosimilars? If yes, when are they likely to come into force?

There are no draft laws addressing the procurement or significantly changing the legal regulation of biosimilars.

Nevertheless, the Draft Law “On Medicinal Products” No. 5547,¹⁹ registered on 21 May 2021, with the Parliament of Ukraine, defines in detail the notion of “biological medicinal product”, which is not introduced by the implemented laws.

Since the given Draft Law has only been taken as a basis as and is to be considered at the second reading, it is hard to predict when it will be adopted and enter into force.

 

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1.  The Order of the Ministry “On Approval of the Procedure to Examining Registration Materials for Medicinal Products Submitted for State Registration (Re-registration) and also to Examining Materials on Amendments to Registration Materials during the Validity of the Registration Certificate “ No. 426 dated 26 August 2005, available at: https://zakon.rada.gov.ua/laws/show/z1069-05#n4645
2.  The Guidelines “Medical products. Similar biological medicinal products containing biotechnology-derived proteins as active substance” available at: https://zakon.rada.gov.ua/rada/show/v0582282-13#n425
3.  The Law of Ukraine “On the Protection of Rights to Inventions and Utility Models” No. 3687-XII dated 15 December 1993, available at: https://zakon.rada.gov.ua/laws/show/3687-12#Text 
4.  The Law of Ukraine “On Medicinal Products” No. 123/96-VR dated 4 April 1996, available at: https://zakon.rada.gov.ua/laws/show/123/96-%D0%B2%D1%80#Text 
5.  The CMU Resolution “On Approval of the Procedure of State Registration (Re-registration) of Medicinal Products and Fees for Their State Registration (Re-registration)” No. 376 dated 26 May 2005, available at: https://zakon.rada.gov.ua/laws/show/376-2005-%D0%BF/ 
6.  The Law of Ukraine “On Prices and Pricing” No. 5007-VI dated 21 June 2012, available at: https://zakon.rada.gov.ua/laws/show/5007-17#Text 
7.  The CMU Resolution “On Measures to Stabilise the Prices for Medicinal Products and Medical Devices” No. 955 dated 17 October 2008, available at: https://zakon.rada.gov.ua/laws/show/955-2008-%D0%BF#Text 
8.  The CMU Resolution “On Certain Issues of State Regulation of Prices for Medicines and Medical Devices” No. 333 dated 25 March 2009, available at: https://zakon.rada.gov.ua/laws/show/333-2009-%D0%BF#Text 
9.  The CMU Resolution “The Issues of Declaration of the Change of the Wholesale Prices for the Medicinal Products” No. 240 dated 2 July 2014, available at: https://zakon.rada.gov.ua/laws/show/240-2014-%D0%BF#Text 
10.  The CMU Resolution “On Certain Issues of Reimbursement of Medicinal Products under the Program of State Guarantees of Medical Care of the Population” No.854 dated 28 July 2021, available at: https://zakon.rada.gov.ua/laws/show/854-2021-%D0%BF#Text 
11.  The CMU Resolution “On Governmental Regulation of Prices for Medicinal Products” No. 862 dated 9 November 2016, available at: https://zakon.rada.gov.ua/laws/show/862-2016-%D0%BF#Text 
12.  The CMU Resolution “On Certain Issues of Reimbursement of Medicinal Products” No. 135 dated 27 February 2019, available at: https://zakon.rada.gov.ua/laws/show/135-2019-%D0%BF#Text 
13.  The Order of the Ministry of Health “On Adoption of the Rules on the Register of Wholesale Prices for Medicinal Products and Medical Devices, the Rules of its Change and the Forms of Declaration of the Change of the Wholesale Prices for Medicinal Products and Medical Devices” No. 574 dated 18 August 2014, available at: https://zakon.rada.gov.ua/laws/show/z1097-14#Text 
14.  The Order of the Ministry of Health “On Adoption of the Rules of Calculation of Marginal Wholesale Prices for Medicinal Products Based on the Reference Prices” No. 1423 dated 29 December 2016, available at: https://zakon.rada.gov.ua/laws/show/z0012-17#Text 
15.  The Law of Ukraine “Fundamentals of the Legislation of Ukraine on Healthcare”, available at: https://zakon.rada.gov.ua/laws/show/2801-12#n348 
16.  The Rules for prescribing medicines and medical devices, available at: https://zakon.rada.gov.ua/laws/show/z0782-05#n37 
17.  The Procedure for dispensing medicines and medicine devices from pharmacies and their structural units, available at: https://zakon.rada.gov.ua/laws/show/z0783-05#Text 
18.  The Order of the Ministry of Health “On Approval of Procedure for Pharmacovigilance” No. 898 dated 27 December 2006, available at: https://zakon.rada.gov.ua/laws/show/z0073-07#Text 
19.   The Draft Law “On Medicinal Products “ No. 5547 dated 21 May 2021, available at: http://w1.c1.rada.gov.ua/pls/zweb2/webproc4_1?pf3511=72012

Also from this Legal Handbook

Want to know more about localization in Ukraine? Prepared in association with Sayenko Kharenko, a leading law firm in Ukraine, this is an extract from The Pharma Legal Handbook: Ukraine, available to purchase here for GBP 99.

 

 

1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies?

No, there are no rules or regulations requiring localisation with respect to medicinal products.

 

2. Have there been any recent significant changes involving localization rules? If yes, when did they take place and what did they involve?

Since there are no rules or regulations requiring localisation with respect to medicinal products, there were no such changes.

 

3. Is the process of obtaining a marketing authorization impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?

Since there are no rules or regulations requiring localisation with respect to medicinal products, no such policies exist.

 

4. Is the pricing process for pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?

Since there are no rules or regulations requiring localisation with respect to medicinal products, localisation does not impact the pricing of medicinal products. 

 

5. Is the reimbursement of pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?

Since there are no rules or regulations requiring localisation regarding medicinal products, such reimbursement does not occur.

 

6. Is the access to public or public tenders of pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?

Since there are no rules or regulations requiring localisation with respect to medicinal products, such policies do not affect tenders. 

 

7. Are import tariffs, importation and/or exportation permits, trade and/or taxation of pharmaceutical products impacted by localization policies in your country ? If yes, how so?

Since there are no rules or regulations requiring localisation with respect to medicinal products, import tariffs, importation and/or exportation permits, trade and/or taxation of pharmaceutical products are not impacted by such policies.

 

8. Are there any other incentives or advantages offered by the current local localization rules in your country? If yes, what are they?

Since there are no rules or regulations requiring localisation regarding medicinal products, there are no other incentives or advantages.

 

9. Are there discussions about the possibility of implementing localization policies in your country? If yes, what are the proposed reforms and when should they come into place?

Yes, there have been discussions and initiatives about the possibility of implementing localisation policies concerning the production of pharmaceutical products in Ukraine among different stakeholders at different events. 

For instance, the President’s Decree “On Approval of the Decision of the Council on National Security and Defence of Ukraine ‘On the State of National Healthcare System and Urgent Measures to Provide Ukrainian Citizens with Medical Care”¹  No. 369/2021 dated 18 August 2021, entrusts government to develop projects on localisation of vaccine production and immunobiological drugs within an international consortium formed among foreign and domestic pharmaceutical manufacturers. Moreover, the stated decree also entrusts the government to take measures to stimulate the development of domestic production of immunobiological drugs (vaccines, toxoids, immunoglobulins, sera, bacteriophages, other drugs for the specific prevention of infectious diseases) to prevent the most common infectious diseases in Ukraine and the world. Please note that the stated decree provides only for general approaches to localisation. Thus, implementations act shall be expected in future.  

The President’s Decree “On Approval of the Decision of the Council on National Security and Defence of Ukraine Dated 11 August 2021 ‘On the Strategy of Economic Security of Ukraine for the Period to 2025’”²  No. 347/2021 dated 11 August 2021, among other things, entrusts the government to develop a legal framework stimulating domestic production and approve economic support mechanism for domestic production irrespective of product kinds. Since the stated decree does not necessarily target the pharmaceutical production, it is expected that subsequent governmental acts will clarify its content and provide for more detailed ways of localisation initiatives implementation. 

Furthermore, on 09 June 2020, the Ministry of Health published the Draft Order of the Cabinet of Ministers of Ukraine “On Approval of the Concept of the State Target Program for the Creation and Development of Domestic Production of High-Guality Drugs for the Prevention and Treatment of Particularly Dangerous Infectious and Other Diseases…” ³ (the “Concept”). The Concept provides plans of ensuring domestic productions of necessary medicinal products to be procured by the state by attracting domestic and foreign investments into the development of new production capacities. Among medicinal products, it aims at domestic production of immunobiological drugs and medicines necessary to prevent and treat particularly dangerous infectious diseases. 

However, this Concept has not been approved. Therefore, it is hard to predict when it can be approved and whether it will be approved in the future. 

Also, the latest Draft Law “On Medicinal Products” (the “Draft Law”)⁴  No. 5547 dated 21 May 2021, currently does not contain any rules on localisation. Although since the Parliament has only been accepted the Draft Law as a basis on 9 September 2021, it might be amended in the future during first or second hearing prior to its adoption. However, the exact amendments cannot be foreseen and shall be monitored.

 

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1.  The President’s Decree “On Approval of the Decision of the Council on National Security and Defence of Ukraine ‘On the State of National Healthcare System and Urgent Measures to Provide Ukrainian Citizens with Medical Care” No. 369/2021 dated 18 August 2021, available at: https://www.president.gov.ua/documents/3692021-39713
2.  The President’s Decree “On Approval of the Decision of the Council on National Security and Defence of Ukraine Dated 11 August 2021 ‘On the Strategy of Economic Security of Ukraine for the Period to 2025’” No. 347/2021 dated 11 August 2021, available at: https://www.president.gov.ua/documents/3472021-39613?fbclid=IwAR3HfA9pFwDo8S_rPj4eRfCoP2vkkSjSMAc9GaqNG8ElSegFhBkXvmgEOTA
3.  The Concept available at: https://bit.ly/3nhht9d
4.  The Draft Law available at: http://w1.c1.rada.gov.ua/pls/zweb2/webproc4_1?pf3511=72012

Also from this Legal Handbook

An intro to the legal situation for orphan drugs and rare diseases in Ukraine. Prepared in association with Sayenko Kharenko, a leading law firm in Ukraine, this is an extract from The Pharma Legal Handbook: Ukraine, available to purchase here for GBP 99.

 

1. What is the definition of Rare Diseases in your country?

Art. 3 of the Law of Ukraine “Fundamentals of the Legislation of Ukraine on Healthcare” (“Legislature on healthcare”)¹ defines rare (orphan) disease as a disease that threatens human life or chronically progresses, leads to shortening of citizen’s life duration or to their disablement, the prevalence of which among the population is not more than 1:2,000.

Art. 531 of the Legislature on healthcare provides for frameworks of state involvement in free medical treatment of rare diseases, which are further elaborated by the subsequent orders of the Ministry of Health of Ukraine (the “Ministry of Health”). The Ministry of Health annually renews the list of rare diseases adopted by the Order of the Ministry of Health No. 778 dated 27 October 2014, the diseases in which are enlisted with reference to WHO ICD-10 classification and Orphan rare disease nomenclature.

The Cabinet of Ministers of Ukraine (the “CMU”) Resolution No. 160 dated 31 March 2021 “On the approval of the Procedure of Provision to the Citizens Suffering from Rare (Orphan) Diseases, of Medicines and the Corresponding Foodstuff for Special Dietary Consumption”²  provides for financing mechanisms to ensure free treatment of patients suffering from rare diseases, including, providing of medicinal products (drugs) for free. 

 

2. Does the designation of ‘Orphan Drug’ exist in your country? (Does it correspond with the definition of Rare Diseases?)

The definition of orphan drug closely corelates to the definition of rare diseases. 

Under the Order of the Ministry of Health No. 426 dated 26 August 2005 “On Approval of the Procedure to Examining Registration Materials for Medicinal Products Submitted for State Registration (Re-registration) and also to Examining Materials on Amendments to Registration Materials during the Validity of the Registration Certificate”³  (the “Procedure on examining registration”) orphan drug in Ukraine is named as “medicine of limited use (orphan drug)” – a drug intended for the diagnosis, prevention or treatment of a rare disease, namely, a disease that threatens the life or causes disability of not more than five people out of every 10,000 inhabitants on the date of application for state registration.

 

3. What is the regulatory framework for the authorization of an Orphan Drug? (Is this regulatory framework based on Rare Disease status or can it alternatively be based on Orphan Drug foreign status?)

The regulatory framework for authorisation of orphan drugs in Ukraine is the same as the regulatory framework for authorisation of any other medicinal product in Ukraine, except there may apply some exception for import of unauthorised orphan drugs based on the decision of the Ministry of Health.

Like any other medicinal product in Ukraine, orphan drugs must be registered with the Ministry of Health to be placed on the market in Ukraine. Upon completion of registration, the applicant receives a registration certificate for the medicinal product with a validity period of five years. Medicinal products placed on the market during a five-year validity period are allowed for use until they reach the expiry term indicated on the packaging. Upon the expiry of the five-year initial registration term, medicinal products shall be re-registered. After re-registration, the medicinal products may be placed on the market for an unlimited period.⁴

The following regulatory framework applies to the authorisation of orphan drugs in Ukraine: 

1. The Law of Ukraine “On Medicinal Products” No. 123/96-VR dated 4 April 1996⁵ (the “Law on Medicinal Products”) provides detailed criteria for medicinal products authorisation, including peculiarities of medicinal products registration by persons authorised for healthcare procurement. 
2. The CMU Resolution “On Approval of the Procedure of State Registration (Re-registration)⁶ of Medicinal Products and Fees for Their State Registration (Re-registration)”   No. 376 dated 26 May 2005, further elaborates the procedure of state authorisation of medicinal products.
3. The Procedure on examining registration, besides general requirements to all medicinal products, provides separate requirements for medicines of limited use (orphan drugs) and their registration dossiers. 
4. The CMU Resolution “On Approval of the Licensing Terms on Economic Activity on Manufacturing of Medicinal Products, Wholesale and Retail Sale of Medicinal Products, Import of Medicinal Products (except for Active Pharmaceutical Ingredients)” ⁷ No. 929 dated 30 November 2016 provides for general licensing requirements applicable to orphan drugs in Ukraine.

As for cases of import of unauthorised orphan drugs, Art. 17 of the Law on Medicinal Products provides for import procedure of unregistered medicinal products, only developed for treatment of rare (orphan) diseases that were duly authorised for use in the USA or the EU irrespective of their registration by authorised bodies of the USA and the EU. 

According to the Order of the Ministry of Health “On Approval of the Procedure of Import into the Territory of Ukraine of Unregistered Medicinal Products, Standard Samples and Reagents”⁸  No. 237 dated 26 April 2011 import of unregistered orphan drugs is allowed only upon receiving a separate decision of the Ministry of Health based on the information submitted to the Ministry of Health that shall include:

• The request to the Ministry of Health (central or territorial authorities), which consists of information on the medicinal product, its name, manufacturer, release form, dosage, the total number of packages, batch number, expiration date;
• Copies of documents confirming registration of the medicinal product in the country of export;
• Copies of quality certificates issued by the manufacturer for each batch stating expiration date (at least six months at the time of drugs receipt);
• Instructions for the use of the drug with a translation into Ukrainian.

 

4. Does your country have pro- visions for relaxed clinical trial/ scientific evidence requirements in respect of Orphan Drugs as compared to other drugs?

Under the Procedure of examining registration, the applicant is allowed in the summary of pre-clinical and clinical data to provide a justification for the reasons why it is not possible to provide complete information and a justification of the benefit/risk balance for the declared orphan drugs in cases of absence of the complete data on the efficacy and safety of the medicinal product under normal conditions when submitting registration dossier materials for medicinal products of limited use (orphan drugs) to the State Expert Centre of the Ministry of Health.

Furthermore, the registration certificate of such orphan drug may be issued subject to certain obligations. One of them could be prescription-only dispensing and/or usage of the drug under strict medical supervision. 

 

5. Is there an expedited pathway for Orphan Drugs?

Yes, there is. Although the expedited pathway applies only for orphan drugs already registered in a number of counties. 

For instance, under the Procedure of examining registration, examination of materials on medicinal products intended exclusively for the treatment of tuberculosis, HIV/AIDS, viral hepatitis, cancer and rare (orphan) diseases that are registered by the competent authorities of the United States, Switzerland, Japan, Australia, Canada, or the European Union, is held for a reduced period of 45 days (for other drugs it takes up to 210 days). Moreover, laboratory tests during the registration of such drugs are not conducted, which significantly speeds up and reduces the cost of registration.

Also, to apply for registration of medicinal products intended exclusively for the treatment of tuberculosis, HIV/AIDS, viral hepatitis, cancer and rare (orphan) diseases that are registered by the competent authorities of the United States, Switzerland, Japan, Australia, Canada or the European Union, it is allowed to provide only materials on methods of quality control of the medicinal product together with packaging samples of the medicinal product with the labelling stated in the language used for the labelling of medicinal products. 

 

6. Are foreign marketing authorizations recognized in your jurisdiction for Orphan Drugs? If yes, marketing authorizations from which countries are recognized?

Foreign marketing authorisations of orphan drugs are not valid in Ukraine, and local authorisation is required. However, obtaining marketing authorisation (state registration) for the medicinal products already authorised by competent authorities of the United States, Switzerland, Japan, Australia, Canada, and the European Union is subject to special rules. In particular, instead of submitting the materials from pre-clinical and clinical studies to the State Expert Centre of the Ministry of Health (the “Centre”), an applicant shall attach the materials of the foreign registration dossier to the application, and such materials are not subject to expert examination by the Centre.

 

7. Can Orphan Drugs be reimbursed? If so, is there a specific reimbursement procedure for Orphan Drugs?

Yes, orphan drugs can be reimbursed if they are included in the Register of medicinal products reimbursable under the program of medical guarantees (the “Register”) that is regularly updated by the orders of the Ministry of Health. The last edition of the Register was approved by Order of the Ministry of Health No. 2077 dated 27 September 2021 and includes new drugs for treating rare diseases. The Register itself neither distinguishes between orphan drugs and other medicinal products nor provides the list of orphan diseases related to treatment of orphan drugs.

Furthermore, there are no specific reimbursement procedures for orphan drugs and, thus, general provisions established by the CMU Resolution “On certain issues of reimbursement of medicinal products under the program of state guarantees of medical care of the population” ⁹ No. 854 dated 28 July 2021, shall apply.

The costs for orphan drugs included in the Register can be fully or partly reimbursed to the retail sellers of medicinal products through contracts with officials responsible for budgetary funds. The retail seller (e.g. pharmacy) shall release medicinal products subject to reimbursement to end-users only upon the prescription from the authorised doctor (either working in a medical institution or a specially licensed entity). 

 

8. How are the prices of Orphan Drugs regulated?

There are no separate requirements for the orphan drugs pricing. The regulatory framework regarding the pricing of medicinal products applicable to orphan drugs in Ukraine derives from:

• The Law of Ukraine “On Prices and Pricing” No. 5007-VI dated 21 June 2012¹⁰ 
• The CMU Resolution “On Measures to Stabilise the Prices for Medicinal Products and Medical Devices” No. 955 dated 17 October 2008 (last time amended on 28 July 2021)¹¹ ;
• The CMU Resolution “The Issues of Declaration of the Change of the Wholesale Prices for the Medicinal Products “ No. 240 dated 2 July 2014 (last time amended on 28 July 2021)¹² ;
• The CMU Resolution “On Certain Issues of Reimbursement of Medicinal Products under the Program of State Guarantees of Medical Care of the Population” No. 854 dated 28 July 2021¹³ ;
• The CMU Resolution “On Governmental Regulation of Prices for Medicinal Products” No. 862 dated 9 November 2016 (last time amended on 28 July 2021)¹⁴ ;
• The CMU Resolution “On Certain Issues of Reimbursement of Medicinal Products” No. 135 dated 27 February 2019 (last time amended on 28 July 2021)¹⁵ ;
• The Order of the Ministry of Health “On Adoption of the Rules on the Register of Wholesale Prices for Medicinal Products and Medical Devices, the Rules of its Change and the Forms of Declaration of the Change of the Wholesale Prices for Medicinal Products and Medical Devices” No. 574 dated 18 August 2014¹⁶ ;
• The Order of the Ministry of Health “On Adoption of the Rules of Calculation of Marginal Wholesale Prices for Medicinal Products Based on the Reference Prices” No. 1423 dated 29 December 2016 (last time amended on 16 June 2021)¹⁷ .

Medicinal products (except for narcotic drugs, psychotropic drugs, precursors and medical gases, as well as drugs to be purchased under controlled access agreements), which are included on the national list of essential medicinal products shall be limited to 10% marginal wholesale mark-ups, accrued to the wholesale price, including taxes and fees, and marginal trade (retail) surcharges, based on the purchase price including taxes, from 10 to 25% based on the purchase price in UAH. 

For medicinal products (except for narcotic drugs, psychotropic drugs, precursors and medical gases, as well as drugs to be purchased under controlled access agreements) purchased wholly or partly for budgetary funds, sales mark-ups must not exceed 10% of the declared change in wholesale price, including tax, and marginal commercial (retail) mark-ups must not exceed 10% of the purchase price, including taxes. 

For medicinal products (except for insulin drugs) which shall be reimbursed according to legislature, sales mark-ups must not exceed 10% of the marginal wholesale price including taxes, and marginal commercial (retail) mark-ups must not exceed 15% of the purchase price including taxes. 

For insulin drugs, which shall be reimbursed according to legislature, sales mark-ups must not exceed 10% of the marginal wholesale price, including taxes, and marginal commercial (retail) mark-ups must not exceed 10% of the purchase price, including taxes. 

 

9. In case of reference price based on a basket of countries, what countries are included?

Reference prices for medicinal products are determined based on the latest published information on registered prices obtained from the authorised state bodies of the reference countries. The reference countries include the Republic of Poland, the Slovak Republic, the Czech Republic, the Republic of Latvia, Hungary for all kinds of medicinal products, and the Republic of Bulgaria, Greece, Romania only for insulin drugs. 

 

10. Have there been any significant legal/judicial developments in relation to Orphan Drugs in your country?

No, there have been no significant legal/judicial developments in relation to orphan drugs. 

 

11. Are there proposals for reform or significant change to the regulation of Orphan Drugs? If yes, when are they likely to come into force?

On 21 May 2021, the Draft Law “On Medicinal Products” No.5547¹⁸  (the “Draft Law”) was registered by the Parliament of Ukraine. Among other things, this provides for a few clarifications to the definition of orphan drugs and regulation in terms of special requirements to state registration with reference to EU legislation, including expedited registration procedure for no more than 30 days after the submission of application for registration of orphan drug irrespective of country of origin.

The Draft Law has only been approved as a basis and has not yet been considered at any of the sessions of the Ukrainian Parliament. Therefore, it is hard to predict when it is likely to come into force. For instance, for the most recent draft law regarding procurement of medicinal products, it took about eight months to be approved by the Parliament and signed by the President. Furthermore, the current text of the Draft Law provides for a six month transition period. 

 

 

—————————-

1. The Law of Ukraine “Fundamentals of the Legislation of Ukraine on Health Care”, available at: https://zakon.rada.gov.ua/laws/show/2801-12#n348
2. The CMU Resolution “On the approval of the Procedure of Provision to the Citizens Suffering from Rare (Orphan) Diseases, of Medicines and the Corresponding Foodstuff for Special Dietary Consumption” No. 160 dated 31 March 2021, available at: https://zakon.rada.gov.ua/laws/show/160-2015-%D0%BF#Text
3. The Order of the Ministry of Health “On Approval of the Procedure to Examining Registration Materials for Medicinal Products Submitted for State Registration (Re-registration) and also to Examining Materials on Amendments to Registration Materials During the Validity of the Registration Certificate” No. 426 dated 26 August 2005, available at: https://zakon.rada.gov.ua/laws/show/z1069-05#n4645
4. According to Art. 9 of the Law of Ukraine “On Medicinal Products” No. 124/96-VR dated 4 April 1996, available at: https://zakon.rada.gov.ua/laws/show/123/96-%D0%B2%D1%80#Text; the CMU Resolution “On Approval of the Procedure of State Registration (Re-registration) of Medicinal Products and the Amount of Fees for State Registration (Re-registration)” No. 376 dated 26 May 2005, available at: https://zakon.rada.gov.ua/laws/show/376-2005-%D0%BF/; the Procedure on examining registration
5. Law of Ukraine “On Medicinal Products” No. 123/96-VR dated 4 April 1996, available at: https://zakon.rada.gov.ua/laws/show/123/96-%D0%B2%D1%80#Text
6. The CMU Resolution “On Approval of the Procedure of State Registration (Re-registration) of Medicinal Products and the Amount of Fees for State Registration (Re-registration)” No. 376 dated 26 May 2005, available at: https://zakon.rada.gov.ua/laws/show/376-2005-%D0%BF/
7. The CMU Resolution “On Approval of the Licensing Terms on Economic Activity on Manufacturing of Medicinal Products, Wholesale and Retail Sale of Medicinal Products, Import of Medicinal Products (except for Active Pharmaceutical Ingredients)” No. 929 dated 30 November 2016, available at: https://zakon.rada.gov.ua/laws/show/929-2016-%D0%BF#Text 
8. The Order of the Ministry of Health “On Approval of the Procedure of Import into the Territory of Ukraine of Unregistered Medicinal Products, Standard Samples and Reagents” No. 237 dated 26 April 2011, available at: https://zakon.rada.gov.ua/laws/show/z0965-11#Text
9. The CMU Resolution “On Certain Issues of Reimbursement of Medicinal Products under the Program of State Guarantees of Medical Care of the Population “ No. 854 dated 28 July 2021, available at: https://zakon.rada.gov.ua/laws/show/854-2021-%D0%BF#Text
10.  The Law of Ukraine “On Prices and Pricing” No. 5007-VI dated 21 June 2012, available at: https://zakon.rada.gov.ua/laws/show/5007-17#Text
11.  The CMU Resolution “On Measures to Stabilise the Prices for Medicinal Products and Medical Devices” No. 955 dated 17 October 2008, available at: https://zakon.rada.gov.ua/laws/show/955-2008-%D0%BF#Text
12.  The CMU Resolution “The Issues of Declaration of the Change of the Wholesale Prices for the Medicinal Products” No. 240 dated 2 July 2014, available at: https://zakon.rada.gov.ua/laws/show/240-2014-%D0%BF#Text
13.  CMU Resolution “On Certain Issues of Reimbursement of Medicinal Products under the Program of State Guarantees of Medical Care of the Population” No.854 dated 28 July 2021, available at: https://zakon.rada.gov.ua/laws/show/854-2021-%D0%BF#Text
14.  The CMU Resolution “On Governmental Regulation of Prices for Medicinal Products” No. 862 dated 9 November 2016, available at: https://zakon.rada.gov.ua/laws/show/862-2016-%D0%BF#Text
15.  The CMU Resolution “On Certain Issues of Reimbursement of Medicinal Products” No. 135 dated 27 February 2019, available at: https://zakon.rada.gov.ua/laws/show/135-2019-%D0%BF#Text
16.  The Order of the Ministry of Health “On Adoption of the Rules on the Register of Wholesale Prices for Medicinal Products and Medical Devices, the Rules of its Change and the Forms of Declaration of the Change of the Wholesale Prices for Medicinal Products and Medical Devices” No. 574 dated 18 August 2014, available at: https://zakon.rada.gov.ua/laws/show/z1097-14#Text
17.  The Order of the Ministry of Health “On Adoption of the Rules of Calculation of Marginal Wholesale Prices for Medicinal Products Based on the Reference Prices” No. 1423 dated 29 December 2016, available at: https://zakon.rada.gov.ua/laws/show/z0012-17#Text
18.  The Draft Law “On Medicinal Products” No.5547 dated 21 May 2021, available at: http://w1.c1.rada.gov.ua/pls/zweb2/webproc4_1?pf3511=72012

Also from this Legal Handbook

Cannabinoid drugs, medicinal cannabis and opioid drugs in Ukraine – a comprehensive legal overview.. Prepared in association with Sayenko Kharenko, a leading law firm in Ukraine, this is an extract from The Pharma Legal Handbook: Ukraine, available to purchase here for GBP 99.

 

Cannabinoid Drugs

1. Are Cannabinoid Drugs authorized in your country?

Ukrainian legislation¹, namely Resolution No.770 of the Cabinet of Ministers of Ukraine (the ‘CMU’) dated 6 May 2000, establishes the ‘List of Narcotic Drugs, Psychotropic Substances and Precursors’ (hereinafter – the ‘List of Narcotic Drugs’), which provides a list of narcotic substances, psychotropic substances and precursors, separated into 4 categories:

• Prohibited narcotic substances and psychotropic substances (Table I);
  • Especially dangerous narcotic substances which turnover is prohibited (Schedule 1);
  • Especially dangerous psychotropic substances which turnover is prohibited (Schedule 2);
  • Plants, containing narcotic and psychotropic substances, which turnover is allowed for manufacturing purposes (Schedule 3);
• Narcotic substances and psychotropic substances with limited turnover (Table II):
  • Narcotic substances with limited turnover (Schedule 1);
  • Psychotropic substances with limited turnover (Schedule 2);
• Narcotic substances and psychotropic substances with limited turnover and exclusion of certain control measures (Table III):
  • Narcotic substances with limited turnover and exclusion from certain control measures (Schedule 1);
  • Psychotropic substances with limited turnover and exclusion from certain control measures (Schedule 2);
• •Precursors (Table IV):
  • Precursors with limited turnover subject to control measures (Schedule 1);
  • Precursors subject to control measures (Schedule 2).

The notion of ‘turnover’ includes development, production, growing of plants, manufacturing, storage, transportation, sending, sale, purchase, importation, exportation, transit, use and utilization. 

Turnover of narcotic and psychotropic substances listed in Table I of the List of Narcotic Drugs is prohibited (except for expert, investigation or training activity)², which means that such substances can’t be used for production of medicinal products. Analogues of narcotic and psychotropic substances, i.e. substances which are not included in the List of Narcotic Drugs but which possess chemical structure and characteristics resembling those of narcotic and psychotropic substances, are also prohibited in Ukraine. Substances, included in Tables II, III and IV may be used for medical purposes under certain conditions. 

Cannabinoids (e.g. tetrahydrocannabinol including its isomers and their stereochemical variants) are defined as ‘especially dangerous psychotropic substances, which turnover is prohibited’ and are enlisted in Schedule 2, Table I, which means that turnover of such substances is prohibited in Ukraine.

Notably, Dronabinol ((-) – trans delta-9-tetrahydrocannabinol) is the cannabinoid substance which is currently included in Schedule 2 Table II of the List of Narcotic Drugs, which means that it can be used for production of medicinal products in Ukraine. Therefore, Dronabinol is the substance which may be used in Cannabinoid Drugs in Ukraine. The List of Narcotic Drugs may be subject to amendments, therefore the current status of each particular substance shall be checked separately.

Ukrainian law differentiates between narcotic and psychotropic substances and precursors as such, and medicinal products produced from such substances. According to Ukrainian legislation, medicinal products can be placed on the market only after state registration. For instance, Dronabinol or medicinal products containing Dronabinol have not yet been registered in Ukraine and therefore cannot be placed on the Ukrainian market.³

Dronabinol was added to Schedule 2, Table II of the List of Narcotic Drugs by the CMU Resolution of 2011.⁴ However, the effectiveness of this CMU Resolution (by means of which dronabinol was added to ‘psychotropic substances, the turnover of which is restricted’, listed in Schedule 2, Table II of the List of Narcotic Drugs) has been suspended numerous times (for the last time until 1 June 2012⁵).

 

2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?

The State Service of Ukraine on Medicinal Products and Drugs Control (hereinafter – the ‘SSM’) is a state body controlling the turnover of narcotic drugs, psychotropic substances and precursors, and combating its illegal trafficking. The SSM is responsible for the licensing of commercial activities connected with the production and import of medicinal products, wholesale and retail of medicinal products, and the turnover of narcotic drugs, psychotropic substances and precursors.⁶

Registration of medicinal products in Ukraine is carried out by the Ministry of Health of Ukraine.

Combating the illegal turnover of narcotic drugs, psychotropic substances and precursors is the responsibility of the National Police, the Security Service of Ukraine, the General Prosecutor’s Office, the State Fiscal Service, the State Border Service, and other bodies within their authority.

 

3. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Cannabinoid Drugs?

As indicated above, the only cannabinoid psychotropic substance which can be used for production of medicinal products in Ukraine is dronabinol. Since dronabinol is considered a psychotropic drug, the general regulatory framework for medicinal products and the specific one for narcotic drugs, psychotropic substances and precursors shall apply to dronabinol and medicinal products containing it. 

Medicinal products containing cannabinoid substances allowed for use in Ukraine (for instance, dronabinol), like any other medicinal product in Ukraine, must be registered with the Ministry of Health of Ukraine in order to be placed on the market in Ukraine. Upon completion of registration, the applicant receives a registration certificate for the medicinal product with a validity period of five years. Medicinal products which are placed on the market during the five-year validity period are allowed for use until their expiry term indicated on the packaging. After expiry of the five-year initial registration term, medicinal products shall be re-registered. After re-registration the medicinal products may be placed on the market for an unlimited period.⁷

Moreover, general licensing requirements applicable to medicinal products and special licensing requirements for the development, manufacture, production, storage, transportation, purchase, sale, import into Ukraine, export from Ukraine, usage and utilization of restricted narcotic drugs, psychotropic substances and precursors included in the Tables II-IV of the List of Narcotic Drugs⁸ are applicable to Cannabinoid Drugs. 

Pricing or reimbursement for narcotic drugs, psychotropic substances and precursors, included in the Tables II-IV of the List of Narcotic Drugs, as well as medicinal products containing such substances, is not regulated by the state.

Dronabinol (as well as other narcotic drugs, psychotropic substances and precursors) is not enlisted in the Register of medicinal products, the price of which is subject to reimbursement. Therefore, dronabinol or any medicinal product containing it cannot be placed on the market or be reimbursed to retail sellers of medicinal products.

 

4. Which are the cannabinoid drugs that have received market approval to date?

No Cannabinoid Drugs have received market approval (registration) to date.

 

5. Who can prescribe Cannabinoid Drugs?

In general, all narcotic or psychotropic medicinal products can be prescribed by doctors licensed for medical practice according to their medical specialties and working at business entities (medical establishments, hospitals, individual entrepreneurs or other entities authorized for medical practice).⁹ Prescription of narcotic or psychotropic medicinal products is via specially designed prescription form 3.

In order to prescribe this category of medicinal products, medical establishments or other entities authorized for medical practice are additionally required to receive a special license for production, storage, purchase or sale (release), usage and utilization of restricted narcotic drugs, psychotropic substances and precursors included in the List of Narcotic Drugs.¹⁰ The license is issued to a particular entity for the particular schedule of the particular table of the List of Narcotic Drugs.

Feldshers (Physician Assistant or Nurse Practitioners) working at medical establishments are entitled to prescribe narcotic or psychotropic medicinal products for patients with protracted and chronic diseases for the purpose of continuing the treatment provided by the doctor by stating their position, placing their signature and the stamp of the medical establishment. 

Medical practitioners (doctors or feldshers) are not authorized to prescribe narcotic or psychotropic medicinal products unless the respective business entity has a license for the production, storage, purchase or sale (release), usage and utilization of restricted narcotic drugs, psychotropic substances and precursors.

 

6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?

There is a register of entities (including medical establishments, pharmaceutical stores, etc.)¹¹ entitled to conduct economic activity related to the production, storage, transportation, purchase, sale, import, export, usage and utilization of narcotic drugs, psychotropic drugs and precursors included in the List of Narcotic Drugs according to special Licensing terms.

As a general rule, any doctor working at a medical establishment or other entity authorized for medical practice and licensed for production, storage, purchase or sale (release), usage and utilization of narcotic drugs, psychotropic substances and precursors included in Tables II-IV of the List of Narcotic Drugs can prescribe narcotic or psychotropic medicinal products. A license is issued to a particular entity for the particular schedule of the particular table of the List of Narcotic Drugs, including all substances of the respective Schedule (not a single medical product).

 

7. What approvals or notifications are required to prescribe Cannabinoid Drugs?

Any doctor working at a medical establishment or other entity authori-zed for medical practice and licensed for production, storage, purchase or sale (release), usage and utilization of psychotropic substances included in Schedules 2, Table II of the List of Narcotic Drugs can prescribe narcotic or psychotropic medicinal products.

 

8. Which organizations are authorized to sell/distribute Cannabinoid Drugs available?

Since no medicinal products containing cannabinoids have been registered in Ukraine to date, there are no organizations authorized to sell/distribute them.

However, any medicinal product (narcotic or psychotropic medicinal products) shall only be sold for wholesale in pharmaceutical warehouses and for retail in pharmacies or their branches. Trade in medicinal products can be conducted exclusively through pharmaceutical establishments and shall not be conducted through any electronic commercial means, by post or by establishments other than pharmaceutical ones (some exclusions are envisaged for rural areas where medicinal products may be sold by certain healthcare institutions). 

Moreover, pharmaceutical warehouses, pharmacies and their branches shall receive a special license for production, storage, transportation, purchase, sale, import, export, usage and utilization of narcotic drugs, psychotropic substances and precursors included in the List of Narcotic Drugs. 

Narcotic or psychotropic medicinal products like any other medicinal product subject to state procurement procedure can be provided to patients in the course of treatment in state medical establishments which have received a special license for this purpose.

 

9. Is there a list of retailers/distributors authorized to sell Cannabinoid Drugs?

There is no special list of retailer/distributors authorized to sell Cannabinoid Drugs. 

There is a register of entities, including pharmacies and their branches, authorized to sell narcotic or psychotropic medicinal products that have received special license for this purpose.¹² The license is issued to a particular entity for the particular schedule of the particular table of the List of Narcotic Drugs, including all substances of the respective schedule and table (not a single medical product).

Please note that medicinal products (including narcotic or psychotropic medicinal products), shall only be sold for wholesale in pharmaceutical warehouses and for retail in pharmacies or their branches. Trade in medicinal products can be made exclusively through pharmaceutical establishments and shall not be made through any electronic commercial means, by post or by establishments other than pharmaceutical ones (some exclusions are envisaged for rural areas where medicinal products may be sold by certain healthcare institutions).

 

10. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?

There have been numerous discussions and petitions to the parliament, although no legislative proposals for reform or significant change to the regulation of Cannabinoid Drugs has been introduced to date. 

The Strategy of State Policy on Narcotics for the period up to 2020 (approved by Ruling of the Cabinet of Ministers of Ukraine (hereinafter – the ‘CMU’) No. 735-p dated 28 August 2013) includes certain provisions on scientific research of medical usage prospective of Cannabinoid Drugs as pain killers and other medical drugs.

 

11. When are they likely to come into force?

Since there were no proposals for reform or significant change to the regulation of Cannabinoid Drugs, it is impossible to predict whether they will occur in the nearest future.

 

 

Medicinal Cannabis

12. Is Medicinal Cannabis authorized in the country?

No, Medical Cannabis is not authorized in Ukraine. 

Cannabis, cannabis resins, cannabis extracts and cannabis tinctures are considered ‘especially dangerous narcotic drugs, the turnover of which is prohibited’, enlisted in Schedule 1, Table I of the List of Narcotic Drugs.

Cultivation of cannabis plants for industrial purposes is not prohibited provided that contents of tetrahydrocannabinol in the dried straw of cannabis plants, originating cannabis seeds for such cultivation, does not exceed 0.08 percent. The cultivation of cannabis plants requires a special license according to the licensing terms, approved by the CMU Resolution No. 282 dated 6 April 2016.¹³ Cultivation of cannabis is subject to a number of requirements applicable to such activity.

Under Ukrainian law, the illegal production, purchase, storage, transportation, transmission or turnover of narcotic drugs, psychotropic substances and their analogies as well as illegal cultivation of cannabis plants may entail administrative or criminal liability.¹⁴

Ukraine also fulfills its international obligation in the field of control over narcotic and psychotropic drugs turnover. Notably, Ukraine is a participant of the Single Convention on Narcotic Drugs of 1961 as amended by the 1972 Protocol, the Convention on Psychotropic Substances of 1971 and the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, which together set the framework for international drug control regulation. 

 

13. What are the regulatory authorities with jurisdiction over Medicinal Cannabis?

Since Medical Cannabis is not authorized in Ukraine, there are no regulatory authorities over it. 

Combating the illegal turnover of narcotic drugs, psychotropic substances and precursors is the responsibility of the National Police, the Security Service of Ukraine, the General Prosecutor’s Office, the State Fiscal Service, the State Border Service, and other bodies within their authority. 

 

14. What is the regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis?

Since Medicinal Cannabis is not authorized in Ukraine, there is no specific regulatory framework for authorization, pricing, and reimbursement.

 

15. How is the production and import of Medicinal Cannabis regulated and by which agencies/authorities?

The production and import of Medicinal Cannabis are prohibited in Ukraine.

 

16. What approval or notifications are necessary to produce or import Medicinal Cannabis?

The production and import of Medicinal Cannabis are prohibited in Ukraine.

 

17. What is the regulatory framework for the marketing and distribution of Medicinal Cannabis?

Since Medicinal Cannabis is prohibited in Ukraine, there is no regulatory framework for the marketing and distribution of Medicinal Cannabis.

 

18. How can patients obtain Medicinal Cannabis?

Since Medicinal Cannabis is prohibited in Ukraine, patients cannot obtain Medicinal Cannabis.

 

19. Who can prescribe Medicinal Cannabis?

Since Medicinal Cannabis is prohibited in Ukraine, there are no persons authorized to prescribe Medicinal Cannabis.

 

20. Is there a list of doctors authorized to prescribe Medicinal Cannabis?

Since Medicinal Cannabis is prohibited in Ukraine, there are no doctors authorized to prescribe Medicinal Cannabis.

 

21. What approvals or notifications are required to prescribe Medicinal Cannabis?

Since Medicinal Cannabis is prohibited in Ukraine, there are no specific requirements for approvals or notifications to prescribe Medicinal Cannabis.

 

22. Where is Medicinal Cannabis available?

Since Medicinal Cannabis is prohibited in Ukraine, it not available.

 

23. Is there a list of retailers authorized to sell Medicinal Cannabis?

Since Medicinal Cannabis is prohibited in Ukraine, there is no list of retailers authorized to sell Medicinal Cannabis.

 

24. Are there proposals for reform or significant change to the regulation of Medicinal Cannabis?

The Draft Law No. 4533 dated 27.04.2016 ‘On amending the Law of Ukraine ‘On Narcotic Drugs, Psychotropic Substances and Precursors’ (On the Turnover Procedure of Substances under Control)’ (hereinafter – the ‘Draft Law No.4533’) has been introduced to the Verkhovna Rada (Ukrainian Parliament). 

The Draft Law No.4533 offers to allow cultivation of cannabis for the purposes of scientific research and medical usage. 

It suggests to displace Schedule 3 (Plants, containing narcotic and psychotropic substances, which turnover is allowed for manufacturing purposes) from Table I (Prohibited narcotic substances and psychotropic substances) to Table II (Narcotic substances and psychotropic substances with limited turnover), thus allowing the restricted cultivation of cannabis plants. 

Notably, Draft Law No. 4533 has not been through a first hearing in parliament yet. The parliamentary procedure provides that a draft law shall pass two to three hearings before adoption by parliament.

 

 

Opioid Drugs

25. Are Opioid Drugs authorized in your country?

Ukrainian legislation has no definition and special regulatory framework for Opioid Drugs. Ukrainian law differentiates between narcotic and psychotropic substances and precursors (including opioids) as such, and medicinal products, produced from such substances. Medicinal products authorized for medical use shall be duly registered before their market placement.

Opioid substances are considered within the general legislative framework applied to narcotic and psychotropic substances and precursors and fall under one of the categories indicated in Chapter 8 above (according to the tables and schedules indicated in the List of Narcotic Drugs).

There are different regimes for different kinds of opioid substances in Ukraine. The turnover of opioid substances indicated in Table I of the List of Narcotic Drugs is prohibited in Ukraine. Such substances cannot be used for the production of medicinal products. The turnover of opioid substances indicated in Tables II and III of the List of Narcotic Drugs is restricted.¹⁵

For instance, some opioids like acetorphine, etorphine, heroin, and opium are considered ‘especially dangerous narcotic drugs, the turnover of which is prohibited’, enlisted in the Schedule 1, Table I of the List of Narcotic Drugs, which turnover is prohibited in Ukraine. Such substances cannot be used for production of medicinal products. 

In turn, certain Opioid Drugs, for instance morphine, codeine, tramadol are considered as ‘narcotic drugs, the turnover of which is restricted’, enlisted in Schedule 1, Table II of the List of Narcotic Drugs, which turnover in Ukraine is restricted, but which can be used for the production of medicinal products. 

 

26. What are the regulatory authorities with jurisdiction over Opioid Drugs?

The State Service of Ukraine on Medicinal products and Drugs Control (hereinafter – the ‘SSM’) is a state body controlling the turnover of narcotic drugs, psychotropic substances and precursors and combating illegal trafficking. The SSM is also responsible for the licensing of commercial activities connected with production and import of medicinal products, wholesale and retail of medicinal products, and turnover of narcotic drugs, psychotropic substances and precursors.¹⁶

Registration of medicinal products in Ukraine is exercised by the Ministry of Health of Ukraine.

Combatting the illegal turnover of narcotic drugs, psychotropic substances and precursors is the responsibility of the National Police, the Security Service of Ukraine, the General Prosecutor’s Office, the State Fiscal Service, the State Border Service, and other bodies within their authority.

 

27. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Opioid Drugs?

There is no specific framework for authorization of Opioid Drugs. 

The general regulatory framework for medicinal products and the specific framework for narcotic drugs, psychotropic substances and precursors shall be applicable to medicinal products containing opioids. 

Medicinal products containing opioids allowed for use in Ukraine (Tables II-III of List of Narcotic Drugs), like any other medicinal product in Ukraine, must be registered with the Ministry of Health of Ukraine in order to be placed on the market of Ukraine. Upon completion of registration, the applicant receives a registration certificate for the medicinal product with a validity period of five years. Medicinal products which are placed on the market during the five-year validity period are allowed for use until the expiry term indicated on the packaging. After expiry of the five-year initial registration term, medicinal products shall be re-registered. After re-registration, medicinal products may be placed on market for an unlimited period.¹⁷

Moreover, special licenses are required for development, manufacture, production, storage, transportation, purchase, sale, import into Ukraine, export from Ukraine, usage and utilization of restricted narcotic drugs, psychotropic substances and precursors included in the Tables II-IV of List of Narcotic Drugs.¹⁸

Medicinal products containing narcotic drugs, psychotropic substances and precursors are subject to control measures (e.g. import quotas, reporting, etc.). Medicinal products with small amounts of narcotic drugs, psychotropic substances and precursors, which cannot be easily extracted therefrom, can be exempted from certain control measures. 

Pricing for narcotic drugs, psychotropic substances and precursors, included in the Tables II-IV of the List of Narcotic Drugs, as well as medicinal products containing such substances, is not regulated by the state. Medicinal products containing opioids are not enlisted in the Register of medicinal products, price of which is subject to reimbursement (regularly reviewed),¹⁹ thus, they cannot be reimbursed to retail sellers of medicinal products.

 

28. Which are the Opioid drugs that have received market approval to date?

Medicinal products containing opioids that have received market approval and have been duly registered can be found in the Register of medicinal products.²⁰

 

29. Who can prescribe Opioid Drugs?

In general, all narcotic and psychotropic medicinal products can be prescribed by doctors in specially designed prescription form 3, licensed for medical practice according to their medical specialties and working at business entities (medical establishments, hospitals, individual entrepreneurs or other entities authorized for medical practice).²¹ 

In order to prescribe this category of medicinal products, medical establishments or other entities authorized for medical practice are additionally required to receive a special license for production, storage, purchase or sale (release), usage and utilization of restricted narcotic drugs, psychotropic substances and precursors included in the List of Narcotic Drugs.

The license is issued to a particular entity for the particular schedule of the particular table of the List of Narcotic Drugs.²²

Feldshers (Physician Assistant or Nurse Practitioners) working at medical establishments are entitled to prescribe narcotic and psychotropic medicinal products for patients with protracted and chronic diseases for the purpose of continuing the treatment provided by the doctor by stating their position, placing their signature and the stamp of the medical establishment. 

Medical practitioners (doctors or feldshers) are not authorized to prescribe narcotic and psychotropic medicinal products unless the respective business entity has a license for production, storage, purchase or sale (release), usage and utilization of restricted narcotic drugs, psychotropic substances and precursors.

Please note that certain narcotic and psychotropic medicinal products can be prescribed by any doctor according to simplified prescription form 1 (regardless of whether they work at the respective entity being licensed for the particular schedule of the particular table of the List of Narcotic Drugs or not) unless they contain more than the marginal quantity of narcotic drugs, psychotropic substances or precursors established by the CMU.²³ In regard to opioids, the CMU establishes marginal quantity for codeine, dextropropoxyphene and tramadol. Medicinal products which contain more than the marginal quantity of narcotic drugs, psychotropic substances and precursors shall be prescribed according to prescription form 3 generally applicable for all narcotic and psychotropic medicinal products. 

 

30. Is there a list of doctors authorized to prescribe Opioid Drugs?

There is a register of entities (including medical establishments, pharmaceutical stores, etc.),²⁴ entitled to conduct economic activity related to the production, storage, transportation, purchase, sale, import, export, usage and utilization of narcotic drugs, psychotropic drugs and precursors included in the List of Narcotic Drugs according to special Licensing terms.

As a general rule, any doctor working at a medical establishment or other entity authorized for medical practice and licensed for production, storage, purchase or sale (release), usage and utilization of narcotic drugs, psychotropic substances and precursors included in Tables II-IV of the List of Narcotic Drugs can prescribe narcotic and psychotropic medicinal products. The license is issued to a particular entity for the particular schedule of the particular table of the List of Narcotic Drugs, including all substances of the respective Schedule (not a single medicinal product).

 

31. What approvals or notifications are required to prescribe Opioid Drugs?

Any doctor working at a medical establishment or other entity authorized for medical practice and licensed for production, storage, purchase or sale (release), usage and utilization of narcotic drugs, psychotropic substances and precursors included in Tables II-IV the List of Narcotic Drugs can prescribe medicinal products containing opioids.

 

32. Which organizations are authorized to sell/distribute Opioid Drugs available?

As a general rule, any medicinal product (including narcotic and psychotropic medicinal products) shall only be sold for wholesale in pharmaceutical warehouses and for retail in pharmacies or their branches. Trade in medicinal products can be made exclusively through pharmaceutical establishments and shall not be made through any electronic commercial means, by post or by establishments other than pharmaceutical ones (some exclusions are envisaged for rural areas where medicinal products may be sold by certain healthcare institutions).

Moreover, pharmaceutical warehouses, pharmacies and their branches shall receive a special license for production, storage, transportation, purchase, sale, import, export, usage and utilization of narcotic drugs, psychotropic substances and precursors included in the List of Narcotic Drugs. 

Narcotic or psychotropic medicinal products as any other medicinal product subject to state procurement procedure can be provided to patients in the course of treatment in state medical establishments which have received a special license for this purpose.

 

33. Is there a list of retailers/distributors authorized to sell Opioid Drugs?

There is no special list of retailer/distributors authorized to sell Opioid Drugs. 

There is a register of entities including pharmacies and their branches authorized to sell narcotic and psychotropic medicinal products that have received a special license for this purpose.²⁵ The license is issued to a particular entity for the particular schedule of the particular table of the List of Narcotic Drugs, including all substances of the respective schedule and table (not a single medical product).

Please note that medicinal products (including narcotic and psychotropic medicinal products), shall only be sold for wholesale in pharmaceutical warehouses and for retail in pharmacies or their branches. Trade in medicinal products can be made exclusively through pharmaceutical establishments and shall not be made through any electronic commercial means, by post or by establishments other than pharmaceutical ones (some exclusions are envisaged for rural areas where medicinal products may be sold by certain healthcare institutions).

 

34. Are there proposals for reform or significant change to the regulation of Opioid Drugs?

There have been no proposals for reform or significant change to the regulation of Opioid Drugs.

 

35. When are they likely to come into force?

Since there were no proposals for reform or significant change to the regulation of Opioid Drugs, it is impossible to predict whether they will occur in the near future.

 

 

————————-

 1) According to the Law of Ukraine ‘On Narcotic Drugs, Psychotropic Substances and Precursors’ No. 61/95-VR dated 15 February 1995, the Resolution of the Cabinet of Ministers of Ukraine (hereinafter – the ‘CMU’) No.770 dated 6 May 2000 ‘On Approval of the List of Narcotic Drugs, Psychotropic Substances and Precursors’, the CMU Resolution No.589 dated 3 June 2009 ‘On Approval of the Procedure of Conducting Activity Connected with the Turnover of Narcotic Drugs, Psychotropic Substances and Precursors, and Control Over their Turnover’

2) According to Articles 12, 13 of the Law of Ukraine ‘On Narcotic Drugs, Psychotropic Substances and Precursors’ No. 61/95-VR dated 15 February 1995

 3) The list of registered medicinal products in Ukraine can be found at: http://www.drlz.com.ua/ 

 4) According to CMU Resolution No. 4 dated 5 January 2011 ‘On amending CMU Resolutions dated 6 May 2000 No.770 and dated 10 October 2007 No. 1203’.

 5) According to the CMU Resolution No. 248 dated 29 February 2012, suspending the CMU Resolution No. 4 dated 5 January 2011

 6) According to the CMU Resolution No.647 dated 12 August 2015 ‘On Approval of Regulation on the State Service of Ukraine on Medicinal Products and Drugs Control’

 7) According to Art. 9 of the Law of Ukraine ‘On medicinal products’ No. 124/96-VR dated 04 April 1996; the CMU Resolution No. 376 dated 26th May 2005 ‘On Approval of the Procedure of State Registration (Reregistration) of Medicinal Products and the Amount of Fees for State Registration (Reregistration)’; the Order of the Ministry of Health of Ukraine No. 426 dated 26th August 2005 ‘On Approval of the Procedure of Examination of Registration Data Necessary for State Registration (Reregistration) of Medicinal Products, and Also Examination of the Data on Amending the Registration Data During the Validity of the Registration Certificate’

 8) According to CMU Resolution No. 282 dated 6 April 2016 ‘Certain Questions on Licensing Business Activity Connected with Cultivation of Plants, Included in Table I of the List of Narcotic Drugs, Psychotropic Substances and Precursors, Approved by the Cabinet of Ministers of Ukraine, on Development, Manufacturing, Storage, Transportation, Purchase, Sale (Release), Import into the Territory of Ukraine, Export from the Territory of Ukraine, Usage, Utilization of Narcotic Drugs, Psychotropic Substances and Precursors, Included in the Stated List’ and the CMU Resolution No. 929 dated 30 November 2016 ‘On Approval of the Licensing Terms on Economic Activity On Manufacturing of Medicinal Products, Wholesale and Retail Sale of Medicinal Products, Import of Medicinal Products (except for active pharmaceutical ingredients)’

 9) According to the Order of the Ministry of Health of Ukraine No. 360 dated 19 July 2005 ‘On Approval of Rules of Prescribing Medicinal Products and Medical Products, Procedure of Release of Medicinal Products and Medical Products from Pharmacies and their Branches, Instruction on Storage, Accounting and Destruction of Prescription Forms’ 

 10) According to CMU Resolution No. 282 dated 6 April 2016 ‘Certain Questions on Licensing Business Activity Connected with Cultivation of Plants, Included in Table I of the List of Narcotic Drugs, Psychotropic Substances and Precursors, Approved by the Cabinet of Ministers of Ukraine, on Development, Manufacturing, Storage, Transportation, Purchase, Sale (Release), Import into the Territory of Ukraine, Export from the Territory of Ukraine, Usage, Utilization of Narcotic Drugs, Psychotropic Substances and Precursors, Included in the Stated List’

 11) The webpage of the Register of licensed entities entitled to conduct economic activity connected with narcotic drugs, psychotropic drugs and precursors is available at: http://usuan.dls.gov.ua/ 

 12) Register of licensed entities entitled to conduct economic activity connected with narcotic drugs, psychotropic drugs and precursors is available at: http://usuan.dls.gov.ua/

 13) According to CMU Resolution No. 282 dated 6 April 2016 ‘Certain Questions on Licensing Business Activity Connected with Cultivation of Plants, Included in Table I of the List of Narcotic Drugs, Psychotropic Substances and Precursors, Approved by the Cabinet of Ministers of Ukraine, on Development, Manufacturing, Storage, Transportation, Purchase, Sale (Release), Import into the Territory of Ukraine, Export from the Territory of Ukraine, Usage, Utilization of Narcotic Drugs, Psychotropic Substances and Precursors, Included in the Stated List’

 14) Articles 307, 309 of the Criminal Code of Ukraine No. 2341-III dated 5 April 2001; Articles 1061, 1062 of the Code of Ukraine on Administrative Offences No. 8073-X dated 1 June 1985.  

 15) According to the Law of Ukraine No. 61/95-VR dated 15 February 1995 ‘On Narcotic Drugs, Psychotropic Substances and Precursors’, the CMU Resolution No.770 dated 6 May 2000 ‘On Approval of the List of Narcotic Drugs, Psychotropic Substances and Precursors’, the CMU Resolution No.589 dated 3 June 2009 ‘On Approval of the Procedure of Conducting Activity Connected with the Turnover of Narcotic Drugs, Psychotropic Substances and Precursors, and Control Over their Turnover’

 16) According to the CMU Resolution No.647 dated 12 August 2015 ‘On Approval of Regulation on the State Service of Ukraine on Medicinal Products and Drugs Control’

 17) According to Art. 9 of the Law of Ukraine ‘On medicinal products’ No. 124/96-VR dated 04 April 1996; the CMU Resolution No. 376 dated 26th May 2005 ‘On Approval of the Procedure of State Registration (Reregistration) of Medicinal Products and the Amount of Fees for State Registration (Reregistration)’; the Order of the Ministry of Health of Ukraine No. 426 dated 26th August 2005 ‘On Approval of the Procedure of Examination of Registration Data Necessary for State Registration (Reregistration) of Medicinal Products, and Also Examination of the Data on Amending the Registration Data During the Validity of the Registration Certificate’ 

 18) According to CMU Resolution No. 282 dated 6 April 2016 ‘Certain Questions on Licensing Business Activity Connected with Cultivation of Plants, Included in Table I of the List of Narcotic Drugs, Psychotropic Substances and Precursors, Approved by the Cabinet of Ministers of Ukraine, on Development, Manufacturing, Storage, Transportation, Purchase, Sale (Release), Import into the Territory of Ukraine, Export from the Territory of Ukraine, Usage, Utilization of Narcotic Drugs, Psychotropic Substances and Precursors, Included in the Stated List’ the CMU Resolution No. 929 dated 30 November 2016 ‘On Approval of the Licensing Terms on Economic Activity On Manufacturing of Medicinal Products, Wholesale and Retail Sale of Medicinal Products, Import of Medicinal Products (except for active pharmaceutical ingredients)’

 19) According to the Order of the Ministry of Health of Ukraine No. 148 dated 19 January 2019 ‘On Approval of the Register of medicinal products, price of which is subject to reimbursement as of 21 January 2019’

 20) The list of registered medicinal products in Ukraine can be found at: http://www.drlz.com.ua/ 

 21) According to the Order of the Ministry of Health of Ukraine No. 360 dated 19 July 2005 ‘On Approval of Rules of Prescribing Medicinal Products and Medical Products, Procedure of Release of Medicinal Products and Medical Products from Pharmacies and their Branches, Instruction on Storage, Accounting and Destruction of Prescription Forms’ 

 22) According to CMU Resolution No. 282 dated 6 April 2016 ‘Certain Questions on Licensing Business Activity Connected with Cultivation of Plants, Included in Table I of the List of Narcotic Drugs, Psychotropic Substances and Precursors, Approved by the Cabinet of Ministers of Ukraine, on Development, Manufacturing, Storage, Transportation, Purchase, Sale (Release), Import into the Territory of Ukraine, Export from the Territory of Ukraine, Usage, Utilization of Narcotic Drugs, Psychotropic Substances and Precursors, Included in the Stated List’

 23) According to the CMU Resolution No.1203 dated 10 October 2007 ‘On Approval of the Marginal Quantity of Narcotic Drugs, Psychotropic Substances and Precursors Permissible in the Medicinal Products’ 

 24) The webpage of the Register of licensed entities entitled to conduct economic activity connected with narcotic drugs, psychotropic drugs and precursors is available at: http://usuan.dls.gov.ua/ 

 25) The webpage of the Register of licensed entities entitled to conduct economic activity connected with narcotic drugs, psychotropic drugs and precursors is available at: http://usuan.dls.gov.ua/

Also from this Legal Handbook

An insight into regulatory reforms in Ukrainian pharma. Prepared in association with Sayenko Kharenko, a leading law firm in Ukraine, this is an extract from The Pharma Legal Handbook: Ukraine, available to purchase here for GBP 99.

 

1. Are there proposals for reform or significant change to
the healthcare system?

N/A

 

2. When are they likely to come into force?

N/A

 

Also from this Legal Handbook

The low-down on the situation regarding patents and trademarks in Ukrainian pharma. Prepared in association with Sayenko Kharenko, a leading law firm in Ukraine, this is an extract from The Pharma Legal Handbook: Ukraine, available to purchase here for GBP 99.

 

1. What are the basic requirements to obtain patent and trademark protection?

In order to obtain an invention/utility model/design patent or trademark protection for an object in the field of medicine, it is required to file a trademark or an invention/utility model/design patent application to the State Enterprise “Ukrainian Intellectual Property Institute (Ukrpatent)” (“UAPTO”).

A well-known trademark is protected irrespective of its registration in Ukraine under Article 6bis of the Paris Convention, provided it has been recognized as such either by the Appeal Board of the Ministry of Economic Development and Trade of Ukraine (“MEDT”) or by a competent court. Both authorities will determine the date on which the trademark is deemed to be well-known.

 

2. What agencies or bodies regulate patents and trademarks?

The MEDT is responsible for the development of general legal frameworks for patents and trademarks, implementing state policy in the field of intellectual property, organizing examination of patent and trademark applications, as well as issuing patents and trademark certificates. The MEDT also maintains state registers with respect to patents and trademarks.

The MEDT’s functions with respect to the examination of applications for inventions/utility models/designs and trademarks, as well as technical administration of state registers with respect to patents and trademarks are delegated to the UAPTO.

 

3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?

Trademarks 

According to Ukrainian law a sign or a combination of signs may be registered as a trademark. Such signs may represent words (including people’s names, if consented), letters, numbers, pictures, colors, 3D objects or any combination of the foregoing. Further to traditional signs, the UAPTO also accepts registration of sounds as a trademark in Ukraine if they can be graphically represented by audio notation. Other non-traditional trademarks (tastes, smells, etc.) are not prohibited for registration in Ukraine but the respective trademark applications are not accepted by the UAPTO due to the technical incapacity to record such trademarks in the trademark register and make them available to the public. 

 

Patents 

Patent protection concerns inventions, utility models, and designs.

An invention/utility model patent protects new and inventive technical features of products (e.g. a new active ingredient in a medicinal product) and processes (e.g. a manufacturing technique) or advanced use of already known products or processes.

To qualify for patent protection, an invention must be new, involve an inventive step, be industrially applicable, should not be specifically excluded from protection (e.g. methods of medical treatment or diagnostic methods but not the products used in such methods), and should not contravene public order as well as the principles of humanity or morality. 

In the framework of patenting inventions, pharmaceuticals, chemical compounds, treatment of the human or animal body are patentable. In its turn, no patent protection shall be granted for processes for:

• Cloning a human being, 
• processes for modifying the germ line genetic identity of human beings, 
• use of human embryos for industrial or commercial purposes, 
• processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man oranimal, and also animals resulting from such processes; 
• discoveries, 
• scientific theories and mathematical methods, 
• solutions relating only to an external appearance of products, rules, and methods of games, intellectual or business methods, computer programs and solutions relating to the presentation of information.

The protection of utility models, as well as industrial designs in the field of medicine, is also available. However, such objects are rarely employed in Ukraine to protect medical solutions.

 

4. How can patents and trademarks be revoked?

Invalidation and revocation actions should be brought to the court. There are no administrative proceedings including the specific board of the UAPTO/MEDT for invalidation or revocation of patent or trademark.

Trademarks

I. INVALIDATION ACTION:

A registered trademark may be invalidated partially or in full by the court if the trademark:

• fails to meet the registration requirements (e.g. the trademark was registered in spite of the existence of absolute grounds for refusal or the trademark is confusingly similar to the trademark previously registered in the name of a third person for the same goods/services);
• a trademark certificate contains elements or goods/services which were not claimed in the trademark application; and/or
• infringes the rights of third parties at the trademark application date.

An invalidation claim may be lodged to the court by any interested party within three years of the date on which that party learned about or could have learned about violation of their own rights arising out of disputed trademark registration.

 

II. REVOCATION ACTION:

A trademark may be revoked partially or in full by the court in cases involving the existence of at least one of the following circumstances:

• non-use of a trademark during three consecutive years.

The most recent court practice in this regard suggests use of the five-year term stipulated by the EU-Ukraine Association Agreement instead of the three-year term stipulated by Ukrainian Trademark Law.• a trademark has become a generic name for a product or service for which it is registered and the owner has not taken sufficient measures to prevent this.

 

Patents

Ukrainian Patent Law envisages the following grounds for invalidating an invention patent partially or in full:

• a patented solution does not meet the patentability requirements as prescribed by the law (e.g. lacks novelty, inventive step or industrial applicability);
• a claim of the patent extends beyond the content of the filed application;
• it infringes the rights of third parties at the invention patent application date; and;
• an applicant has failed to file an international patent application for a Ukrainian invention with the UAPTO first.

Although there are specialized chambers within the commercial courts and specialized judges within the civil courts for IP cases who have been additionally trained and usually hear IP disputes, most of IP disputes regarding trademarks and patents still tend to fall under the category of disputes which require special knowledge.

 

5. Are foreign patents and trademarks recognized and under what circumstances?

Trademarks

When applying for trademark registration, an applicant may rely on foreign trademark application to claim a priority in Ukraine. Priority may be claimed within six months from the prior application submission date with the trademark authority of a member state of the Paris Convention provided that the priority on the prior application was not claimed. A copy of the priority document certified by registration body of the prior trademark shall be submitted to the UAPTO within three months from the date of filing a Ukrainian trademark application.

The priority of the trademark that was initially shown at an official or officially recognized international exhibition in the territory of the Paris Convention member state may be determined by the date of opening of the exhibition if the application is filed within six months from the respective date.

 

Patents

An applicant may claim priority of the prior application relating to the same invention within the 12 months that follow the filing date of the prior application with the patent authority of a member state of the Paris Convention provided that no priority has been claimed with regard to the prior application. In order to claim priority, the applicant should submit the respective motion to the UAPTO accompanied by a copy of the priority materials within three months from the date of filing the Ukrainian patent application for the invention. The respective three-month term may be extended upon the applicant’s motion in certain cases.

Where the UAPTO decides it to be necessary, it may request the applicant to furnish a translation of the previous materials into Ukrainian. The translation shall be furnished to the UAPTO within a period of two months. 

The applicant may claim priority for the whole application or for one of the claims of the invention or the priority of several earlier applications.

Priority shall apply only to those claims which have been mentioned in the prior application for which priority is claimed.

 

6. Are there any non-patent/trademark barriers to competition to protect medicines or devices?

Apart from patent/trademark barriers, Ukrainian legislation envisages data exclusivity as an instrument to protect medicines. In this context, Ukrainian laws prescribe that if an original medicine is registered for the first time in Ukraine then the registration of another medicine containing the same active pharmaceutical ingredients may be performed in 5 years from the date of the original medicine registration. The 5-year data exclusivity period may be extended to 6 years when a state body governing healthcare in Ukraine will determine such medicine as one having particular advantages compared to other medicines within three years upon registration of the original medicine.

 

7. Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?

The relevant Ukrainian law does not stipulate limitations on obtaining patent or trademark protection for any types of medicines or devices.

 

8. Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?

Generally, Ukrainian laws do not impose an obligation to approve or accept a license agreement with a foreign licensor by any government or regulatory body. The parties to a license agreement may voluntarily submit it for registration with the MEDT. In practice, the parties usually apply for license agreement registration.

As a party to the TRIPS Agreement, Ukraine has undertaken to introduce compulsory licensing of medical inventions aimed at therapy of socially dangerous diseases. More specifically, Ukrainian law stipulates that the Ukrainian government may grant a license (approval) to a third party to use medical invention with mandatory royalty payments to a patent holder if the latter fails to serve a demand of patented medicines and refuses to grant a license to the third party willing to use the invention.

 

Also from this Legal Handbook

All about product liability in Ukrainian pharma. Prepared in association with Sayenko Kharenko, a leading law firm in Ukraine, this is an extract from The Pharma Legal Handbook: Ukraine, available to purchase here for GBP 99.

 

1. What types of liability are recognized in your jurisdiction?

A breach of laws and regulations on medicines may result in disciplinary, administrative, civil and criminal liability. Liability claims in general are regulated by laws and not by court precedents. 

 

2. How do these types of liabilities apply to the manufacturers of medicines and devices?

Civil liability 

The Civil Сode of Ukraine envisages the general principle that the property damages inflicted by unlawful actions or omissions shall be recovered in full by the person who inflicted such damages. Civil liability comprises both claims for damages according to the Civil Сode and civil claims under other laws (e.g. consumer claims). For example, the Law of Ukraine “On Protection of Comsumers’ Rights” entitles consumers to request from the manufacturer or seller termination of the contract and return of the paid amount in cases of sufficient deficiencies or falsification of the purchased goods. Consumers are entitled to damages inflicted due to misleading, incomplete, untimely or incomprehensible information on the product. Damages inflicted due to unfair commercial practices are also subject to compensation. The general period of limitation for civil claims is 3 years, the special period of limitations for claims arising from product deficiencies is 1 year.

 

Administrative liability

Ukrainian legislation envisages administrative liability for various types of administrative offences which are envisaged both by the Code of Administrative Offences of Ukraine and sectoral laws. Administrative offences may include breach of licensing or advertising requirements, marketing and sale of unsafe or non-compliant products, breach of legislation in the sphere of customs clearance, competition or consumer protection, breach of requirements on the sale of the products (violation of pricing requirements, sale of prescription medicine without prescription). Medical devices are also subject to product safety legislation. Violation of its provisions entails a range of administrative penalties (mostly in the form of fines), as well as administrative aftermaths in the form of corrective measures: obligation to bring the products in line with legislative requirements, limitation of sale of the product, withdrawal of the product from turnover or recall.

 

Criminal liability 

Criminal liability is applied for certain offences in the sphere of commercial activity, e.g. market placement of unsafe products in large volumes, falsification of medicinal products or their illegal traffic, illegal production, transportation or sale of dangerous medicinal products, violation of the rules of clinical trials and state registration of medicinal products, etc.

 

Disciplinary liability

Disciplinary liability is applied for violations by an employee of obligations in the sphere of labour relations and labour discipline. The Code of Labour Laws defines two types of disciplinary liability: admonition and dismissal. 

Disciplinary liability is applied by the employer to the employee.

 

3. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?

Ukrainian law envisages liability for both legal entities and individuals. Penalties envisaged by the Code of Administrative Offences and the Customs Code of Ukraine may be applied exclusively to individuals, whereas, penalties under the Criminal Code may be applied either exclusively to individuals, or to individuals and legal entities depending on the violation.

Penalties envisaged by sectoral laws (e.g. penalties for violation of the licensing, advertising, consumer protection or competition requirements, marketing and sale of unsafe products) are applied to the commercial entity, enterprise or individual entrepreneur. Each sectoral law may envisage its own procedure for bringing the the guilty party to liability and the entity subject to such liability. 

Therefore, manufacturers, corporate executives, employees and representatives involved in producing, selling, advertising and distributing of medicines and medical devices can be brought to liability depending on the circumstances of the case. 

 

4. How can a liability claim be brought?

Civil claims (including consumer and third party claims for damages) are considered by the court. Any person, in case of violation of his/her rights and interests, has the right to bring a claim to the court. 

Investigations in criminal cases are initiated and carried out by law enforcement bodies which have the powers to exercise certain procedural actions in such investigations. Criminal cases are considered by the courts on a mandatory basis. Based on such considerations, the courts designate the criminal penalty or designate the accused person not guilty.

Administrative cases are considered either by the courts or by the governmental bodies within their competence, depending on the type of violation. Ukrainian legislation provides for different procedural rules of consideration of administrative cases by government authorities. As a rule, government authorities may initiate administrative proceedings based on the information about the violation which might be obtained upon the results of an inspection or at the request of the interested person (e.g. the consumer). Upon consideration of the case the governmental body may order the commercial entity to eliminate violation and bring its activity into line with the legislation, to take actions to prevent negative results of the violation, and to impose an administrative sanction on the commercial entity. Administrative sanctions in most cases take the form of a fine. In case the commercial entity does not agree with the decision of the governmental body, it has the right to challenge it before the court.

 

5. What defences are available?

Liability and potential defences are designated on a case-by-case basis. Manufacturers, importers, distributors and other authorized persons shall strictly comply with all the requirements provided in Ukrainian laws and regulations, including GMP standards. In case of violation of any legislatory requirements, the violators shall take due measures to eliminate such violations and to prevent any negative consequences. 

 

 

————————–

1) According to Art .27 of the Law of Ukraine “On Medicinal Products”.

 

Also from this Legal Handbook

A brief overview of the situation regarding traditional medicines and OTC products in Ukraine. Prepared in association with Sayenko Kharenko, a leading law firm in Ukraine, this is an extract from The Pharma Legal Handbook: Ukraine, available to purchase here for GBP 99.

 

1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?

Ukkrainian legislation distinguishes between traditional and herbal medicines; furthermore, homeopathic preparations are as well recognized as medicines in Ukraine. There is no definition of complementary or alternative medicines and devices in Ukrainian legislation. However, it defines traditional (folk) medicine, which means the therapeutic, prevention, diagnostic methods based on the experience of many human generations, fixed in folk traditions, which do not require state registration. Practicing traditional (folk) medicine requires a license issued upon attestation.

Ukrainian legislation provided for certain differences regarding registration and marketing of different types of medicines. However, the general requirements on mandatory registration, licensing of manufacturing, import and whole and retail sales, and the special regime of advertising remain the same irrespective of the category of medicinal product.

Traditional medicines include medicinal products simultaneously qualifying
for five criteria:

• Having therapeutic indications applied exclusively for traditional medicines which are designed for application without medical supervision for diagnostic and treatment purposes;
• Intended for use strictly according to the indicated strength and dosage;
• Intended for oral, external or inhalational application;
• The period of their traditional application (over 30 years abroad and over 15 years in EU and/or Ukraine) has expired;
• There is enough data on traditional use of the preparation (safety, pharmaceutical effects, efficiency, etc.).

 

State registration of traditional medicinal products is carried out in a simplified way. The list of certain traditional preparations and their manufacturing prescriptions is designated by order of the Ministry and includes the list of simple medicinal products (e.g. ethanol, aqua ammonia, etc.).

Medicinal products made exclusively from herbal substances or herbal preparations are considered as herbal medicinal products. Such medicinal products may be originally made from whole, granulated or sliced plants, parts of plants, seaweed, mushrooms, raw dried or fresh fungi. GMP standards are applied to the quality of herbal substances and herbal preparations in Ukraine. Herbal medicines are subject to state registration by the Ministry on a general basis (with certain additional requirements).

Homeopathic medicinal products (produced from homeopathic raw materials) are also subject to state registration and shall be manufactured according to State Pharmacopoeia. Ukrainian legislation provides for simplified registration requirements for homeopathic medicinal products without therapeutic effect. 

Dietary supplements, medicinal food products, and weight control food products are considered not as medicinal products and are not subject to the respective requirements, but as food products under Ukrainian legislation. However, such products are allowed for sale in pharmacies. 

Medical devices are not considered as medicinal products and are not subject to the respective regulations. Such devices shall comply with requirements defined in technical regulations. 

 

2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?

All medicinal products (including traditional and herbal) are subject to common general and sectoral advertising regulations, defined in the Law of Ukraine “On advertising”.

Advertising of prescription medicines is prohibited. Only non-prescription medicines allowed for use in Ukraine can be advertised directly to the public. The list of non-prescription medicines is established by the order of the Ministry. Furthermore, the Law “On advertising” prohibits advertising of certain non-prescription medicines listed in the special order of the Ministry. Such prohibitions, however, do not apply to advertising in special periodicals for healthcare institutions and doctors, as well as for advertising disseminated at medical seminars and conferences.

Ukrainian legislation prohibits advertising of traditional (folk) medical practices applied to mass audience.

Advertising of dietary supplements to the public is allowed. However, it is subject to certain restrictions. Advertising of such supplements can not refer to any therapeutic effect, pain relief effect, contain letters of thanks, etc.

 

3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?

Legislatory requirements and restrictions for claims which may or shall be made for marketing and advertising, are uniform for all medicinal products. Advertising of medicinal products must contain:

• objective information about the medicine which makes it clear that the information is an advertisement and that the advertised product is a medicine; 
• the requirement to receive a doctor’s advice before using the medicine;
• a recommendation to read the instructions on the use of the medicine; 
• a warning: “self-treatment may be dangerous to your health” which must take up at least 15% of the advertising area.

It is prohibited to produce any advertisement which implies that a medicinal product is a food, cosmetic or other consumer product, or that its safety or efficiency is due to its natural origin. At the same time, advertisement of goods or food products which do not belong to medicinal products shall not refer to any therapeutic effect of such products.

Advertising of traditional (folk) medical practice (as well as conventional) is allowed depending on the relevant certification.

 

4. What are the regulatory requirements for over-the-counter (non-prescription) medications?

The sale category of medicinal products (prescription or non-prescription) is established during the state registration based on criteria established by order of the Ministry. The sale category is fixed in the registration certificate. The criteria used to determine the sale category of medicinal products includes the risk to health, the potential effects, the content (e.g. narcotic drugs, precursors), the method of consumption, etc. The list of non-prescription medicinal products is additionally fixed by the Ministry in a separate order.

The legislatory requirements to registration, importation, distribution (wholesale) and retail sale are the same both for prescription and non-prescription medicinal products. However, non-prescription medicinal products may be sold to consumers without prescription and may be advertised, unless they are included in the list of medicinal products prohibited for advertising. Furthemore, non-prescription medicinal products may be placed in pharmacies at counters or shop windows with free access for consumers, whereas prescription medicines shall be stored in separate cabinets without access for consumers.

 

5. Are there any limitations on locations or channels through which OTC products may be sold?

There is no difference in the sale channels for prescription and non-prescription medicinal products. Non-prescription medicines, as well as prescription ones, shall only be sold for wholesale in pharmaceutical warehouses and for retail in pharmacies or pharmacy branches (some exclusions are envisaged for rural areas, where medicines may be sold by certain healthcare institutions). 

Trade in medicines can be made exclusively through pharmaceutical establishments and shall not be made through any electronic commercial means, by post, or by establishments other than pharmaceutical stores.  

 

6. What health, advertising, and marketing claims may be made for OTC products?

Ukrainian legislation does not establish any special health, advertising, and marketing claims for OTC products. Such requirements are uniform for all medicinal products, as specified in question 3 of this chapter.

 

7. Can OTC products be marketed or advertised directly to the public?

Only non-prescription medicines allowed for use in Ukraine and not included in the special list of medicines prohibited from advertising may be advertised directly to the general public in Ukraine subject to requirements and restrictions as described in question 3 of this chapter and question 17 Marketing, Manufacturing, Packaging and Labeling, Advertising Overview.

 

8. What is the mechanism by which a prescription-only product can be converted to an OTC product?

There is no established procedure for conversion of a prescription-only product to an OTC product.

Changes of the API, medicinal form, dosage, etc, which might potentially affect the status of the medicinal product, will require new registration. In case of such changes to the product, which change its status from prescription to non-prescription, its owner shall apply for changes to the registration materials. Expert examination of such changes is made according to the producedure for registration of any new medicinal product. The owner receives the new registration certificate or extra sheet to the existing certificate depending on the nature of the changes.

 

9. What are the requirements for the importation of either traditional medicines or OTC products?

Ukrainian legislation provides for uniform rules of importation of medicinal products in Ukraine, irrespectively of their status or category. Only registered medicinal products are allowed for importation for the purpose of sale.

In order to import medicinal products to Ukraine, the importer shall comply with the licensing requirements and obtain an import license. An annex to the import license shall contain the list of medicines allowed for importation and the conditions for implementation of activities.

 

——————————

 

 1) The Guidelines for Good Manufacturing Practice of Medicinal Products were adopted according to the Decree of the Ministry No.95 as of 16.02.2009 “On the approval of documents on procuring medicinal products quality”

2) According to Art. 17 of the Law of Ukraine “On Medicinal Products”

 

Also from this Legal Handbook

Key info on marketing, manufacturing, packaging and labeling and advertising in Ukrainian pharma. Prepared in association with Sayenko Kharenko, a leading law firm in Ukraine, this is an extract from The Pharma Legal Handbook: Ukraine, available to purchase here for GBP 99.

 

1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products?

With respect to the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products, please refer to question 3 in Regulatory, Pricing, and Reimbursement Overview.

 

2. What is the authorization process for the marketing of generic versions of these products?

Obtaining marketing authorization for generic versions of innovator medicinal products has certain peculiarities. In particular, an applicant must prove that the generic product is equivalent to the innovator/reference product. The applicant shall provide, inter alia, 

• brief information on the generic medicinal product (quantitative and  qualitative indicators of active substances, dosage form, security and safety profile of its active substances in comparison with active substances of the  reference product, information on bioavailability and bioequivalence of the generic product); 
• evaluation of bioequivalence investigations or justification of the absence  of such either according to the EMA Guideline on the Investigation of the  Bioequivalence (CPMP/QWP/EWP/1401/98 Rev. 1) or Regulation СТ-Н МОЗУ 42-7.1:2014; and
• results of the respective bioequivalence investigations.

The applicant must not violate the exclusivity and intellectual property rights related to the innovator\reference medicinal product.

 

3. What are the typical fees for marketing approval?

Ukrainian Healthcare Laws provide for the following state duties for state registration (re-registration) of medicinal products:

1. For state registration (re-registration) of medicinal products (except  for radioactive medicinal products, diagnostic products, simple or complex  (galenicals) products of herbal materials) — EUR 100 for each pharmaceutical form; EUR 10 for each subsequent strength; EUR 10 for each subsequent package of a medicinal product;
2. For state registration (re-registration) of radioactive medicinal products, diagnostic products, simple and complex (galenicals) products of herbal materials, preparations of limited use and those produced according to the specifications approved by the Ministry (information on composition, production technology (manufacture), quality control and use of a medicinal product) and donor blood or plasma products — EUR 25 for each item; EUR 5 for each subsequent strength; EUR 5 for each subsequent package of a medicinal product.

The above state duties can be also paid in Ukrainian hryvnia currency. 

In addition to the above state duties, the applicant shall also pay official fees for examination of the registration materials by the Center. The fee depends on the type of application for marketing authorization and the type of medicinal product or materials to be assessed and may range from UAH 14,250 (approximately US$ 540) to UAH 117,900 (approximately US$ 4,530).

 

4. What is the period of authorization and the renewal process?

Pursuant to the Law of Ukraine “On Medicinal Products”, marketing authorization is granted for a five-year term. This initial term can be renewed (re-registration of the medicinal product). As soon as marketing authorization is promptly renewed, the period of respective marketing authorization becomes generally unlimited (with a few exceptions). 

For the purpose of said renewal, an applicant must submit a respective application to the Ministry. The application must be filed not earlier than a year but not later than 90 calendar days prior to the expiry date of the medicinal product registration certificate. In addition to the application, the applicant must submit a set of required supporting documents including, inter alia, updates on clinical data overview focusing on critical analysis of medicinal product risk/benefit ratio. On the basis of the Center’s examination of the provided documents and conclusion of the latter, the Ministry may either re-register the medicinal product or refuse to renew the marketing authorization.

 

5. What are the requirements, if any, for post-approval pharmacovigilance?

The pharmacovigilance system in Ukraine involves both manufacturers of medicinal products (applicants) and regulatory authorities (e.g. the Ministry, the Center). The existing pharmacovigilance system is mainly focused on ensuring the safety of medicinal products, detecting any changes in their risk/benefit ratio, and developing measures to minimize or prevent risks associated with the medicinal products. 

The obligations of the applicant include, inter alia, (i) appointment of a person responsible for pharmacovigilance matters; (ii) reporting to the Center on all recorded and proven cases of serious adverse reactions as well as any cases of unexpected non-serious adverse reactions to medicinal products; (iii) submitting a periodic safety report regarding the medicinal product to the Center.

Post-registration Surveillance Board of the Center (“Board”) and the Board’s regional divisions acting in all regions of Ukraine play the key role in pharmacovigilance system. According to the Procedure for Surveillance over Adverse Reactions to Medicinal Products Permitted for Medical Use approved by Order No. 898 of the Ministry dated 27 December 2006, the Center collects information on adverse reactions to medicinal products by means of unscheduled reporting, active hospital-based monitoring, monitoring of prescriptions, meta-analysis and other methods such as involving of applicants, medical officers, legal and natural persons, performing medical practice, as well as patients and/or their representatives.

Based on analysis of the safety and efficacy of medicinal products as well as information on safety studies conducted by the parties engaged in pharmacovigilance in the post-registration period, the Center may propose the Ministry to prohibit in full or temporarily the medical use of the medicinal product.

 

6. Are foreign marketing authorizations recognized?

Foreign marketing authorizations are not valid in Ukraine and local authorization is required. 

However, obtaining marketing authorization (state registration) for those medicinal products which are already authorized by competent authorities of the United States, Switzerland, Japan, Australia, Canada and the European Union is subject to special rules. In particular, instead of submitting the materials from preclinical and clinical studies to the Center, an applicant shall attach the materials of the foreign registration dossier to the application and such materials are not subject to expert examination by the Center.

 

7. Are parallel imports of medicines or devices allowed?

Medicinal products can only be imported to Ukraine after their registration save for the cases when they are imported for the purpose of conducting preclinical or clinical trials, obtaining market authorization, etc. 

In addition to proper local registration, an import license should be issued by the SSM for the purpose of importing medicinal products which are manufactured outside Ukraine.

When it comes to prohibition or allowance of parallel import, no clear-cut statutory regulation is in place. 

However, in relation to intellectual property, relevant provisions of Ukrainian laws may be interpreted as such that establish the principle of international exhaustion of intellectual property rights in copyright, trademarks as well as patented designs, utility models, and inventions. International exhaustion means that, once a medicinal product is legally brought to market anywhere in the world, a trademark or patent owner\licensor may not prohibit the further import of such medicines into Ukraine.

 

8. What are the restrictions on marketing practices such as gifts, sponsorships, consultancy agreements, travel and entertainment, or other incentives for healthcare organizations and individual medical practitioners?

Ukrainian Healthcare Laws envisage prohibition for HCPs to:

• obtain unjustified benefits from producers of medicines/medical devices and/or their distributors within their professional activity;
• obtain samples of medicines/medical devices from producers of medicines/medical devices and/or their distributors for use in professional activity, unless to be used for clinical trials with respect to medicines/medical devices; 
• advertise medicines/medical devices within their professional activity,  including by way of writing prescriptions on the papers which contain information of an advertising nature or specify producers of medicines/medical devices (trademarks).

In addition to healthcare law restrictions, HCPs are also bound by prohibitions prescribed by anticorruption regulations if they serve as officials at healthcare organizations.

As a matter of practice, certain limitations for HCPs – which mainly duplicates the described statutory prohibitions – might be included in the internal regulations (policies) of the healthcare organization.

 

9. How is the manufacturing of medicines and devices regulated and by which agencies?

Ukrainian regulations pertaining to manufacturing and distribution of medicinal products and medical devices consist of a number of legal acts issued by state authorities of different levels.

The Law of Ukraine “On Medicinal Products” provides for general regulation for medicinal products. Foregoing regulation is further developed and extended in the Licensing Terms for Manufacturing, Wholesale and Retail, Import of the Medicinal Products, Regulations approved by the Ministry (e.g. GMP Regulation No. 42-4.0:2016, Operation Area Dossier Regulation No. 42-4.1:2011); regulations approved by the Ministry, the SSM, and other local regulators.

The regulatory framework described above involves requirements for the manufacturing process and distribution in relation to:

• Production facilities;
• Workforce engaged;
• Safety rules;
• Equipment;
• Packaging; and
• Labelling.

The manufacturing and distribution of medical devices is mainly regulated by the Law of Ukraine “On General Safety of Non-Food Products”, the Law of Ukraine “On State Market Supervision and Control over Non-Food Products”, and the Law of Ukraine “On Technical Requirements for Products and Conformity Assessment”. The respective legal landscape is amplified in technical regulations (e.g. Technical Regulation for Medical Devices of 2013 and Technical Regulation for In-Vitro Diagnostics Medical Devices of 2013) and various state standards.

The Ministry is a governmental body that develops and establishes the general regulatory framework for medicinal products and medical devices, while the SSM is responsible for implementation and enforcement of the established framework. In particular, the SSM grants licenses for the manufacture of medicinal products; conducts checks of manufacturers for compliance with licensing terms; confirms compliance of the manufacturing to GMP standards; and observes compliance to GMP standards.

 

10. Are local manufacturing requirements compatible with Good Manufacturing Practices (GMPs) as defined by the U.S. Food & Drug Administration and/or the European Medicines Agency?

Ukrainian manufacturing requirements are compatible with the GMPs established by the European Medicines Agency. Ukraine recognizes and accepts GMP certificates issued by authorities of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) members.

 

11. What is the inspection regime for manufacturing facilities?

The SSM is authorized to perform inspections of manufacturing facilities to observe compliance with the respective licensing terms. Such inspections can be both scheduled and unscheduled. The manufacturer is included in the inspection schedule on the basis of risk ratings assigned to the manufacturer. 

An unscheduled inspection may be conducted at the request of the manufacturer or on the basis of specific grounds, such as: 

• detection of discrepancies in manufacturer’s reports; 
• checking on whether previously discovered violations were cured; 
• respective order (assignment) of the Prime Minister of  Ukraine; 
• complaints of individuals as regards to violations of their rights by the  manufacturer;
• failure to submit reporting documents for two consecutive reporting periods; and 
• individual’s personal injury or death related to manufacturing of the producer.

The SMM may also decide on revocation of the manufacturing license.

 

12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?

Yes, manufacturing facilities are open for on-site inspection by foreign inspectors or third-party inspectors. Ukrainian legislation provides no restrictions or conditions for such inspections. Additionally, Ukraine is a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), which shall facilitate the inspections.

 

13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?

Storage, packaging and handling of medicines is comprehensively regulated by special requirements of Licensing Terms¹, Good Distribution Practice and Good Storage Practice².

Among others, warehouse storage requirements include: 

• the size of pharmaceutical warehouse shall not be less than 250 sq. meters;
• pharmaceutical warehouses shall consist of manufacturing premises, personnel facilities, household and additional premises;  
• the walls, ceiling and floor of manufacturing premises of pharmaceutical warehouses shall be made of materials resistant to disinfection;
• •access to manufacturing pharmaceutical premises shall be restricted, etc. 

In the retail trade the size of pharmaceutical warehouse shall not be less than 10 sq. meters. Retailers shall comply with the specific requirements for storage of medicines and the Good Storage Practice.

Transportation of medicines shall be made in packages protected from spilling, polluting and mixing with other medicines or substances. If certain medicine requires certain temperature conditions, transportation facilities for such medicine shall be equipped with the corresponding refrigerator and temperature monitoring system.  

Medicines shall not be transported:

• with other products, except for related products;
• by means of public transportation, post or in luggage compartments.³

Requirements for packaging of medicines include the requirements for its labelling, as described below. Packaging of medicine is submitted for approval in the process of medicine registration. The manufacturer is obliged to pack medicinal products in packaging approved during state registration. Detailed requirements for packaging are contained in the GMP.

Requirements for storage, packaging and handling of medical devices are envisaged by the respective technical regulations. In particular, medical devices shall be stored and transported in a way not to hamper their characteristics. Packaging of sterile medical devices shall ensure their sterility and packaging of non-sterile medical devices shall keep them clean. Packaging of medical devices shall contain information, the full list of which is envisaged by the technical regulations.

 

14. What information must be included in medicine and device labeling?

The labelling of medicine or medical devices shall be provided in Ukrainian. 

1. The labelling of any medicine on its packaging shall include the following information:

• Barcode of the medicine;
• Name of the product; 
• Name and address of the manufacturer; 
• Number of registration certificate; 
• Batch number; 
• Method of application; 
• Dose of active substance in each item and its number on the package; 
• Pharmaceutical form;
• List of supplementary substances that the product contains;
• Shelf life (expiry date); 
• Storage conditions; 
• Precaution for storage of the medicine away from children reach;
• Precautions when taking. 

The name of the product, mass, concentration, batch number, expiry date, manufacturer’s name shall be indicated as well on the inner packaging of the medicine. The name of the product, the dose of the active substance and the pharmaceutical form must also be inscribed with braille characters on the outer packaging of the product.

There are some exceptions to labelling of special kinds of medicines, namely medicines containing radionuclides, homeopathic medicines, traditional and herbal medicines, medicines containing one or more narcotic and/or psychotropic substances.

Medicines shall additionally include instructions which provide detailed information regarding the medicine, its application, etc.

 

2. Marketing and labelling of medical devices is governed by different legislation as applied to medicines.Medical devices are subject to conformity assessment procedure according to technical regulations applied to medical devices, active implantable medical devices and medical devices for in vitro diagnostics. Three technical regulations establish separate rules for labelling of each of the three above types of medical devices. In any case, the labelling of all types of medical devices must include the mark of conformity with the technical regulation placed after completion of the procedure of conformity assessment. This conformity mark shall be applied either directly on the medical device, or on its packaging and instructions for use.

The labelling of medical devices shall include the following items:

• Name or trademark and address of the manufacturer and authorized representative;
• Information necessary for consumer to identify medical device and packaging contents;
• If necessary – word “sterile”;
• If necessary – batch number;
• If necessary – shelf-life (date, month and if necessary – day);
• If necessary – single-use mark; 
• For medical devices manufactured on a by-order basis – words “medical device manufactured on a by-order basis”
• For medical devices designed for clinical trials – words “medical device designed for clinical trials”
• information on any special conditions for storage and/or use; 
• information on any special instructions for exploitation; 
• information on any precautions; 
• date of manufacturing (unless it has a limited shelf-life); 
• if necessary – information on sterilisation method; 
• if the medical device contains inseparable human blood derivatives – the corresponding information.⁴

The labelling of medical devices for in vitro diagnosis or active implantable medical devices shall comply with the requirements of the respective technical regulations which might require labelling of additional information.

 

15. What additional information may be included in labelling and packaging?

The labelling of medicine may additionally include the following items:

• other manufacturer’s name (involved in product’s manufacturing) 
• symbols or icons that easily explain mandatory information to the consumer;
• other information which corresponds with the short characteristics of the medicine and is useful for the consumer, except advertisement;
• information translated in the regional language or the minority language, provided that it does not contradict the information in Ukrainian.

 

16. What items may not be included in labelling and packaging?

Labelling or packaging shall not include advertisement of the product and information which misleads the consumer.

 

17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?

Advertisement of medicines and medical devices shall be in line with the general requirements for advertisement (prohibition of discriminatory, hidden or violent advertisement, prohibition of unfair commercial practices, etc.).

Additionally, advertisement of medicines and medical devices shall contain:

• objective information on the medicine or medical device, provided in a manner to understand that such information is advertisement and the advertised product is a medicine or medical device;
• requirement for consultation with a doctor before use of the medicine or medical device;
• recommendation to read the instructions for the medicine;
• it should contain the warning “self-treatment might be harmful for your health”, taking not less than 15% of the space (length) of the advertisement.

 

It is prohibited to place the following information in the advertising of medicines and medical devices:

• references to the therapeutic effect on incurable illnesses or illnesses that do not respond well to treatment;
• information regarding the guaranteed cure;
• information stipulating that use of the advertised medications or medical technologies does not require consultation with a specialist;
• images of the effect of illness or injury to the human body or its parts;
• statements provoking fear of illness or deterioration of one’s health condition as a result of failure to use the advertised products;
• statements supporting self-diagnosis and self-treatment with the use of the advertised products;
• references to medications, medical devices, methods of prevention, diagnostics, treatment and rehabilitation as the most effective, most secure and exclusive because of lack of side effects;
• comparisons to other products intended to increase the impact of the advertised product;
• references to separate cases of successful use of medications, medical equipment, methods of prevention, diagnostics, treatment and rehabilitation;
• recommendations or references to recommendations of medical professionals, scientists, medical institutions and organizations;
• special expressions of gratitude, letters or extracts with recommendations, stories about the use of the advertised goods or services and the results of such use;
• images and references to celebrities, film characters or reputable organizations;
• information which misleads consumers stating that a medicinal product is a food, cosmetic or other product of consumption or that the safety and effectiveness of the product is determined by its natural origin.

Participation of doctors, other healthcare practitioners or persons whose outlook resembles that of the doctors in advertising of medicines or medical devices is prohibited. Advertising of products which do not belong to the medical devices, medicinal products or special foods, shall not contain references to their curative effect. Sponsorship of TV or radio shows by manufacturers or sellers of medicinal products or medical devices is allowed, provided that it does not contain references to prescription-only medicines or medical devices, which use requires special knowledge. TV sales of medicines and medical devices, which use requires special knowledge, is prohibited.

It is prohibited to advertise prescription-only medicines, medicines not allowed for use in Ukraine or prohibited for advertising, doping and methods of its use in sport etc.⁵  Advertisement of medicines and medical devices shall be ordered by persons, having the license (for medicines) or conformity certificate (for medical devices).

 

18. Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?

Medicines shall only be sold for wholesale in pharmaceutical warehouses and for retail in pharmacies or their branches. Trade in medicines can be made exclusively through pharmaceutical establishments and shall not be made through any electronic commercial means, by post or by establishments other than pharmaceutical ones (some exclusions are envisaged for rural areas, where medicines may be sold by certain healthcare institutions). 

At the same time, legislation sets no restrictions on sale of medical devices via the Internet and by post. Generally, medical devices may be sold and delivered by any means (except medical devices which use requires special knowledge and which are prohibited for sale through TV).

 

19. What are the restrictions and requirements for electronic marketing and advertising via email, by Internet, social media, and other channels?

General requirements and restrictions shall apply to any kind of promotion and advertising of medicines or medical devices. Dissemination of commercial information by digital means is governed by the law “On Electronic Commerce”. Commercial digital messages (e-mail) shall include:

• full name of the commercial entity, its registration place and ID or tax code;
• e-mail or domain name of the online shop;
• information on the license (if required);
• information on the delivery price and the taxes. 

 

Sales of medical devices by electronic means shall also comply with the requirements of the Law “On Consumer Protection” for distant transactions. Such requirements include provision of full information on the seller, place, characteristics of the product, warranty obligations, etc. Failure to provide such information entitles the buyer to terminate the contract.

Personal data received and used for such types of advertising and marketing shall be processed and stored according to the requirements of the Law of Ukraine “On Personal Data Protection”.

Ukrainian legislation prohibits healthcare practitioners from receiving from manufacturers or sellers of medicines or medical devices unlawful benefits, samples of such medicines or medical devices for use in professional activity, or advertising medicines or medical devices. 

 

20. May medicines and devices be advertised or sold directly to consumers?

Under Ukrainian law medicines are allowed for sale directly to customers only in pharmacies or their branches.

As for advertising, all requirements and restrictions described in question 17 shall apply even in case of direct communications with customers. Notably, non-prescription medicines and medical devices may be sold directly to consumers. Prescription medicines may be sold directly to consumers upon provision of prescription and according to the rules of such sales. 

As for medical devices, they may be advertised (subject to the above restrictions and requirements as described in answer to question 17) and sold directly to consumers.  

 

21. How is compliance monitored?

Compliance over efficiency of medicines and potential side-effects is monitored by the system of pharmacovigilance, which is exercised by the bodies of the Ministry. Manufacturers are obliged to develop a system of pharmacovigilance and to have an employee responsible for pharmacovigilance. Manufacturers also collect information on the efficiency of the medicine, risks associated with it, and side effects. Manufacturers are obliged to submit notification on discovered side-effects of medicines or its inefficiency. Healthcare institutions submit an annual report on pharmacovigilance and extraordinary reports in case of unusual reactions to vaccination.

Quality of imported medicines is controlled by the SSM. Each lot of imported medicines requires a safety certificate issued by the SSM upon the results of compliance control. Control is performed by analysis of documents submitted by the importer, on-site inspection of the imported medicines and, if necessary, laboratory analysis. Sale of the imported medicine is only allowed after receipt of the certificate. 

Monitoring over compliance of medicines placed on market is controlled by the SSM. Legislation distinguishes between several stages of non-compliance, depending on potential negative effects. Non-compliance may include mistakes in labelling of medicine and doses in the package, falsification of medicine, its contamination, insufficient information in the instructions, etc. Depending on the type of non-compliance, the SSM may impose prohibition on turnover (sale, production, importation, transportation, storage and use) of the medicine; request the Ministry to terminate registration of the medicine; or take measures on recall of the medicine. The legislation provides for criteria used for taking measures, depending on the circumstances. After elimination of the grounds for the prohibition of turnover, the turnover of the medicine may be resumed. Safety control is also performed at the stage of wholesale and retail trade. Wholesalers and retailers are obliged to inform the SSM on any identified problems with the compliance of medicines.

Compliance with requirements in the sphere of safety of medical devices, as well as compliance with the licensing requirements is monitored by the SSM. Compliance of the medical devices with safety requirements is confirmed by conformity assessment procedure and conformity certificate. The manufacturer or its authorized representative is responsible for the conformity of medical devices and any issues regarding their safety. In case of discovered non-compliance of the medical devices, the manufacturer or its authorized representative shall, depending on the risk, take measures to bring the medical devices in line with the legislation, to withdraw or to recall the medical devices.

Compliance with advertisement regulations is monitored by the State Service of Ukraine on Food Safety and Consumer Protection and the Antimonopoly Committee of Ukraine. 

 

22. What are the potential penalties for noncompliance?

Penalties vary depending on the particular type of violation. 

For example, violation of licensing requirements in the sphere of production, import, distribution of medicines entails an administrative fine of UAH 17,000 to 34,000. 

Violation of the requirements regarding advertising entail a fine, which may be applied to advertisers, producers and distributors of the advertisement. The size of the fine for advertisers is five prices the produced advertisement. 

If such advertisement constitutes violation of unfair competition rules, the fine may reach up to 5% of the legal entity’s income of the sale of goods and services for the last fiscal year.

Certain offences, e.g. smuggling drugs or falsified medicines, violation of the rules of turnover of drugs, falsification and turnover of falsified medicines, violation of the rules of clinical trials or state registration of medicines, etc., may entail criminal liability.

Violation of consumer rights (e.g. sale of expired products, sale of the non-compliance (unsafe) products, sale of products prohibited for sale by state bodies, failure to provide the required information to the consumer, etc.) may entail large fines up to 500% of the value of the batch of product received for sale.

Separate penalties are envisaged for violation of the requirements on safety of medical devices, pricing of medicines, market placement of unsafe products, etc.

 

———————

 1) Licensing Terms for Manufacturing, Wholesale and Retail, Import of the Medicinal Products approved by the CMU Resolution No.929 of 30 November 2016 (“Licensing Terms”)

 2) Approved by the Order of the Ministry No. 95 of 16 February 2009 “On the approval of documents on procuring medicinal products quality”.

3) Para. 135-139 of Licensing Terms.

4) According to para. 44 of Annex 1 to Technical regulation for medical devices.

5) According to para.6-14 of Art. 21 of the Law of Ukraine “On Advertising”

Also from this Legal Handbook

All legal aspects surrounding precinical and clinical trials in Ukraine. Prepared in association with Sayenko Kharenko, a leading law firm in Ukraine, this is an extract from The Pharma Legal Handbook: Ukraine, available to purchase here for GBP 99.

 

1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?

For the purpose of obtaining marketing approval, at least part of clinical trials should be conducted in Ukraine. Notably, in relation to medical products with well-established medicinal use within the EU and/or Ukraine, an applicant may provide references to published scientific data instead of conducting clinical trials and submitting their results to the Center for obtaining marketing authorization.

 

2. How are clinical trials funded?

Funding of clinical trials is also regulated by the Procedure on Conducting Clinical Trials of Medicinal Products and Examination of the Materials of the Clinical Trials approved by Order No. 690 of the Ministry dated 23 September 2009 (“Clinical Trials Procedure”).

 

3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?

According to the Procedure on Conducting Preclinical Trials of Medicinal Products and Examination of the Materials of the Preclinical Trials approved by Order No. 944 of the Ministry dated 14 December 2009, preclinical trial protocol determines the objectives and design of the preclinical trial and shall include the following sections:

• General information, including the name of the trial, objectives and characteristics etc.;
• Information regarding the sponsor and executors of the trials, as well as engaged investigators;
• Dates of approval and alignment of the protocol, period of the trial; and
• Trial design.

The above list is not exhaustive. The preclinical trial protocol may be supplemented with other information that the applicant deems reasonable to provide. 

The preclinical trial protocol should be approved (signed, dated) by the clinical trial manager and reviewed for compliance with the Good Laboratory Practice (GLP). The protocol should be further approved by the head of medical institution involved in the trial and by the sponsor.

According to the Clinical Trials Procedure, clinical trial protocol should describe the objectives, methodology, procedures, statistical considerations, and design of the clinical trial, as well as, as a rule, justification for a trial. The Clinical Trials Procedure sets out that the trial protocol shall include information as provided by Section 6 of the Good Clinical Practice (GCP), in particular:

• General information about all participants of a trial (name, address, contact information);
• Background information (name and description of the investigational product, description of the population to be studied, references to nonclinical studies, literature, and data that are relevant to the trial);
• Trial objectives and purpose;
• Trial design; 
• Selection and withdrawal of subjects (subject inclusion/exclusion criteria);
• Treatment of subjects;
• Assessment of efficacy;
• Assessment of safety;
• Statistics;
• Direct access to source data/documents;
• Quality control and quality assurance;
• Ethics;
• Data handling and record keeping;
• Financing and Insurance;
• Publication policy; and
• Supplements.

Clinical trial protocols along with other materials of the clinical trial are subject to expert examination at the Center of the Ministry. Following examination of trial materials, the Center gives either a positive or a negative opinion on conducting the trial. The Center’s opinion must be further approved by the Ministry.

 

4. What are the requirements for consent by participants in clinical trials?

Clinical trials are conducted with an adult patient (volunteer), who is legally capable subject to his written consent to participate in such trials (so-called “informed consent”). Special consent requirements should be met with respect to the participation of minors in clinical trials:

• involving a minor (individual under 18) requires the written consent of both parents and providing the minor with written and oral information regarding the trial in understandable form;
• in cases involving an individual aged between 14 and 18, his/her written consent should be obtained in addition to parents’ consent.

Clinical trials with a person who is recognized as incapable or whose civil capacity is limited due to mental illness can be performed only under the written consent of legal representatives of such person.

The Clinical Trials Procedure provides for mandatory list of written and oral information to be provided to the patient (volunteer) in understandable form for obtaining his/her consent (e.g.  nature of clinical trial, procedures, implications, risks, rights and obligations of the trial subject, compensations, insurance information, etc.). The consent should be dated, signed, evidence of trial subject’s awareness of all information to be provided to him or her under the Clinical Trials Procedure, as well as indicate that it was given freely after receiving the information in full. The consent to participate in the clinical trial must include consent of the patient (volunteer) or, where applicable, their legal representative or close relative, to processing his/her personal data.

If the individual is unable to write, his/her oral consent may be obtained in the presence of at least one witness who confirms the trial subject’s consent in written.

 

5. May participants in clinical trials be compensated?

Generally, it is not prohibited to provide compensation to clinical trial participants. However, the Clinical Trials Procedure prohibits using any encouragement or inducement in relation to engaging minors and incapable persons in clinical trials, except for providing them indemnification against health harm caused by the trial. 

Besides monetary compensation (which is rarely practiced), the participants may be reimbursed for their travel expenses, meals, and compatible expenses.

 

6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?

As a matter of law, participants in clinical trials shall be insured against trial-related injuries. Concluding an insurance agreement between sponsor and insurance company is one of the condition precedents to obtain approval for clinical trials. 

In the event of trial-related injury, the participants shall obtain compensation and/or treatment pursuant to the terms of the respective insurance certificate. Notably, when obtaining a participant’s informed consent for participation in a trial, the sponsor should ensure that the participant is given details of the insurance agreement, as well as provided with details of the insurance company.

 

Also from this Legal Handbook

An intro to the legal situation for regulatory, pricing and reimbursement in Ukraine. Prepared in association with Sayenko Kharenko, a leading law firm in Ukraine, this is an extract from The Pharma Legal Handbook: Ukraine, available to purchase here for GDP 99.

 

1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country?

• the Ministry of Health of Ukraine (“Ministry”)
• the State Service of Ukraine on Medicines and Drugs Control (“SSM”)
• the National Health Service of Ukraine (“NHSU”)
• Quality control authorities accredited by the Ministry of Economic Development and Trade of Ukraine

 

2. What is the regulatory framework for the authorization, pricing, and reimbursement of drugs, biologicals, and medical devices?

The authorization, pricing, and reimbursement of drugs, biologicals, and medical devices is regulated by the following laws and regulations:

1. Laws of Ukraine:

• On Medicinal Products
• On Licensing of Certain Types of Economic Activity
• On Technical Requirements for Products and Conformity Assessment
• On Price and Pricing
• On the Basis of the State Regulation of Economic Activity

 

2. Decrees of the Cabinet of Ministers of Ukraine:  

• “On Approval of the Procedure for State Registration (Re-registration) of Medicinal Products and Amounts of Fees for Their State Registration (Re-Registration)” No. 376 dated 26.05.2005 
• “On the State Register of Medicinal Products” No. 411 dated 31.03.2004
• “On Approval of License Conditions for Conducting Business Activity of Medicinal Products Production, Wholesale and Retail Trade, Import (except active pharmaceutical ingredients)” No. 929 dated 30.11.2016
• “On Approval of the Technical Regulation for Medical Devices”, “On Approval of the Technical Regulation for in vitro Diagnostic Medical Devices”, “On Approval of the Technical Regulation for Active Implantable Medical Devices” No. 753, 754, 755 dated 02.10.2013
• “On Reference Pricing for Medicines and Medical Products, Purchased with Funds of the State and Local Budgets” No. 240 dated 02.07.2014
• “On State Regulation of Prices on Medicines” No. 862 dated 09.11.2016
• “On Introduction Reimbursement of Medicines” No. 863 dated 09.11.2016
• “On Ensuring Access to Medicinal Products” No. 152 dated 17.03.2017
• “On Some Issues of State Regulation of Prices for Medicines and Medicinal Products” (National List of Essential Medicines) No. 333 dated 25.03.2009
• “On the Implementation of Pilot Project on State Regulation of Insulin Products Prices” No 73 dated 05.03.2014
• “On Certain Issues of Insulin Products Costs Reimbursement” No. 239 dated 23.03.2016

3. A number of orders of the Ministry of Health of Ukraine: 

• “On Approval of the Procedure for State Registration (Re-registration) of Medicinal Products” No. 426 dated 26.08.2005
• “On Approval of the Procedure of Maintaining the Register of Persons Responsible for the Introduction of Medical Devices, Active Implanted Medical Devices, and Medical Devices for in vitro Diagnostics in Turnover, Forms of Communication and List of Data Stored therein and Access to Them” No. 122 dated 10.02.2017
• “On Approval of the Register of Margin Wholesale and Trade Prices for Medicinal Products”No. 2 dated 02.01.2018
• “On Approval the Procedure for Calculation of the maximum Wholesale Prices for Medicinal Products Based on Reference Prices” No. 1423 dated 29.12.2016
• “On Approval of Form of the Register of Medicinal Products Subject to Reimbursement” No. 298 dated 21.03.2017
• “On Approval of Regulation on Register of Reference (Reimbursement) Prices for Insulin Products and the Procedure for Calculation of Reference (Reimbursement) Price for Insulin” No. 453 dated 07.03.2018
• “On Approval of Rules of Writing Prescriptions for Medicines and Medicinal Products, the Procedure for the Dispatch of Medicines and Medicinal Products from Pharmacies and their Structural Subdivisions, Rules on Storage, Recording and Disposal of Prescription Forms” No. 360 dated 19.07.2005, etc.

 

3. What are the steps to obtain authorization to develop, test, and market a product?

In cases relating to a finished medicinal product:

Production, market access and distribution: 

1. Undergo the procedure of state registration of medicines (for registration of medical devices, the applicant should submit the necessary documents based on the requirements of the Ministry) 
2. Obtain a state registration certificate for medicinal products (issued by the Ministry)
3. Obtain a license for economic activity on import of medicines/manufacturing of medicines (issued by the SSM) 
4. Receive confirmation of GMP compliance (issued by the SSM)
5. Complete the quality control procedure (controlled by the SSM)
6. Receive a license for wholesale trade of medicinal products (issued by the SSM)
7. Conclude agreement with drug manufacturer (for procurement)
8. Conclude agreement with pharmacy (for sale)

 

Retail

1. Obtain a license for retail trade in medicinal products (for direct sale to patients)
2. Conclude a medicine supply agreement with a distributor 

Economic entities must subsequently undergo, in the terms set by the legislation, a check for the observance of the licensing conditions for medicinal product manufacturing, wholesale and retail trade in medicinal products (carried out by the SSM)

 

4. What are the approximate fees for each authorization?

Medicine state registration:

State registration (re-registration) fee:

1. for state registration (re-registration) of medicinal products, including  medical immunobiological drugs, in addition to radioactive drugs, diagnostic agents, simple or complex (galenical) herbal medicinal products, in the amount equivalent to EUR 100 for each dosage form, EUR 10 for each subsequent dose, and EUR 10 for each subsequent package of a medicinal product.
2. for state registration (re-registration) of radioactive drugs, diagnostic agents, simple or complex (galenical) herbal medicinal products, active  restricted drugs and those produced in accordance with the regulations  approved by the Ministry (information about the composition, formulation (manufacturing technique), quality control, and application of a medicinal product), and donated blood or plasma products equivalent to EUR 25 per item, EUR 5 for each subsequent dose, EUR 5 for each subsequent package of the medicinal product

The registration fee does not include the cost of medicinal product expertise as well as additional expertise.

Information on the cost of expertise procedures for the state registration of medicinal products submitted for state registration (re-registration) is available on the website of the State Expert Center (“Center”) at www.dec.gov.ua/index.php/ua/1

 

Licensing of economic activities:

The license fee is payable once at one minimum subsistence income, based on the minimum subsistence income of able-bodied persons valid on the day the licensing body takes the decision to issue the license.

The procedure for assessing the conformity of medical products/confirmation of conformity of the production conditions of medicinal products with the GMP requirements:

The cost of the specified procedures is specified in the contract between the applicant and the appropriate body depending on the performed works (to determine an estimated cost of the procedures, the applicant must consult the appropriate body).

 

5. For how long are marketing authorizations/registrations valid? How are marketing authorizations/registrations renewed?

The registration certificate for a medicinal product is valid for five years; after re-registration, the validity is unlimited.

The validity of the conformity assessment certificate for medical products according to the decision of the relevant body that assesses for conformity for a period of up to five years, after the re-assessment of medical products for conformity, is unlimited.

The license validity is unlimited.

 

6. How does the authorization process differ between brand-name products and generic products? Are there differences for local manufacturers versus foreign-owned manufacturers?

The original (innovative) medicinal products are patented.

There is a simplified state registration procedure for medicinal products, in particular, those registered by the competent authority of the United States of America, Switzerland, Japan, Australia, Canada, those registered by the competent authorities of the European Union according to the centralized procedure, to be applied in the territories of these countries or member states of the European Union which are subject to procurement on the basis of the procurement procedure conducted by a specialized organization that makes purchases for the Ministry.

 

7. How are combination products (drug + drug, drug + biologic, drug + device, biologic + device, drug + biologic + device) regulated?

Medicinal products (including combination products (drug + drug, drug + biologic, drug + device, biologic + device, drug + biologic + device) are allowed for medical application after they are registered with the state and a registration certificate is obtained for them, for example, a solution for injection in a cartridge within an injection pen.

Medical devices are allowed to apply after they are assessed for conformity and a corresponding certificate is obtained for them. A medical product may be in the form of a device + a product and is allowed for use as a medical product. If an active component contained in a medical product has a therapeutic effect, it must be registered as a medicinal product.

 

8. How is compliance with regulation monitored and evaluated? Is the regulatory regime comparable with the U.S. Food and Drug Administration or the European Medicines Agency expectations and requirements?

For medicinal products:

The Department of Pharmacovigilance of the State Expert Center of the Ministry takes measures to inform the Ministry regarding decisions on market access and registration of medicinal products adopted by the FDA or the European Medicines Agency, in particular, regarding adverse reactions.

Physicians and patients can also fill in a notice of a product’s adverse reaction on the website of the State Register of Medicinal Products.

Based on the relevant recommendations, the Ministry may decide to cancel the state registration of a medicinal product.

Within the terms established by the legislation, business entities are tested for compliance with the license provisions of business activity on the production of medicinal products, wholesale and retail trade in medicines, as well as control of the quality of medicinal products carried out by the SSM.

The Ministry maintains the State Register of Medicinal Products.

The SSM maintains the Register of Licensed Business Entities.

The SSM issues decisions on the prohibition of medicinal product circulation for the duration of their quality control. It supervises the medicinal product market operations and prevents adulterated products from entering circulation.

 

For medical devices:

The SSM carries out market surveillance of medical device circulation, inspections of manufacturers and medical-purpose products.

It maintains a register of persons responsible for introduction of medical devices, active implantable medical devices, and medical devices for in vitro diagnosis.

Control over the circulation of food products on the market does not fall within the competence of the Ministry and the SSM; it is carried out by the State Service of Ukraine on Food Safety and Consumer Protection.

 

9. What is the potential range of penalties for noncompliance?

Administrative or criminal liabilityas established by the current legislation.

 

10. Is there a national healthcare system? If so, how is it administered and funded?

The Law of Ukraine “On State Financial Guarantees for Medical Care of the Population” has recently come into force. In accordance with the law, a program is introduced that determines the list and scope of medical services (including medical products) and medicinal products, the full payment for which the state guarantees patients at the expense of the state budget of Ukraine according to the tariff, for prevention, diagnostics, treatment, and rehabilitation with regard to illnesses, injuries, poisonings, and other health issues, as well as pregnancy and childbearing. An an electronic health-care system is also undergoing trials  featuring  electronic prescriptions in five pilot regions in Ukraine.

The NHSU has now been established, which is a central executive body implementing state policy in the area of state financial guarantees for the population’s medical care and performing the functions of a client of medical services and medicinal products under the program of medical guarantees.

Financing is at the expense of funds allocated from the state budget to pay for medical services for the population.

Medical institutions (those that have undergone automation) which have entered into agreements with the NHSU will receive payments for services rendered.

The NHSU will control the quality of provision of medical services to patients by appropriate health facilities. Patients make, at their own discretion, a declaration with a physician from whom they intend to receive treatement. If a patient is not satisfied with the physician, he can change and make a declaration with another one at another institution, regardless of the place of residence of the patient.

Patients will receive a (benefit) package of guaranteed medical services (under the specified list), the cost of which is compensated from the state budget.

In addition, from the beginning of 2018, medical institutions funded from the state budget should provide in full the needs of patients in medicinal products included in the National List of Essential Medicines. The cost of these drugs is completely compensated from the state budget. If a medical institution did not purchase medicinal products to satisfy the patients’ needs according to the National List, it has no legal grounds to purchase other medicinal products that are not included on the List.

The National List is a guaranteed list of medicinal products reimbursed to patients at the expense of the state budget, which is formed in accordance with the recommendations of the WHO (the 20th Edition of the WHO Model List of Essential Medicines).

 

11. How does the government (or public) healthcare system function with private sector healthcare?

To carry out medical practice, business entities (private or public) must obtain an appropriate license issued by the Ministry.

The difference between a public medical institution and a private one is that public (state) medical institutions provide medical services, treatment to patients on a preferential basis or free of charge and are financed from the budget, while in the private sector, patients get medical services at a tariff established by private medical institutions and pay for the services rendered on their own. Provision of such services is not compensated for from the state budget.

A patient chooses independently a medical institution (private or public) to receive medical care.

In addition, patients who are prescribed medicinal products within the “Affordable Medicines” state program that are reimbursed by the state budget can get them at a public or private pharmacy (participation of pharmacy institutions in the program is voluntary).

 

12. Are prices of drugs and devices regulated and, if so, how?

No, they are not. Prices for medicinal products and medical devices are not regulated by current legislation.

For medical devices purchased in whole or in part at the expense of the state and local budgets, marginal supply and sale mark-ups are set that are no higher than ten percent-charged for medical devices and added to the wholesale factory price, taking into account taxes and duties. Marginal trade (retail) mark-ups are no higher than ten per cent charged to the purchase price, including taxes.

 

13. How are drugs and devices used by patients paid for? What roles do public and private payers play?

To date, patients who, according to legislation, have benefits or a certain illness, receive medicinal products and medical devices free of charge or with an additional payment. There is also a state system of reimbursement of medicinal products for patients with bronchial asthma, type II diabetes, and cardiovascular diseases, as well as the reimbursement of insulin preparations. Patients receive medicinal products under the reimbursement program free of charge or with an additional payment.

In addition, from the beginning of 2018, medical institutions funded from the state budget should provide in full for the needs of patients in medicinal products included in the National List of Essential Medicines. The cost of these medicinal products is completely compensated from the state budget. If a medical institution did not purchase medicinal products to satisfy the patients’ needs according to the National List, it has no legal grounds to purchase other medicinal products that are not included in the List.

Also, medicinal products and medical devices are purchased by specialized organizations under special state programs by order of the Ministry to be supplied to the medical institutions of the regions of Ukraine in accordance with the needs declared by these institutions.

Financing for the purchase of medicinal products and medical devices is done at the expense of the state budget.

Private sector patients receive medical services at tariffs set by private medical institutions and pay the cost of services rendered on their own. Provision of such services is not compensated for from the state budget.

 

14. Who dispenses drugs and devices to patients and how are those dispensers compensated?

Medicinal products and medical devices are prescribed to patients by physicians who work at a medical institution, work for a sole proprietor, or are sole proprietors themselves. Narcotic and psychoactive drugs are prescribed by physicians on a special Form 3 prescription blank.

Medicinal products are delivered to patients by a pharmacy (according to the prescription if they are prescribed) or its structural subdivisions (according to the license obtained).

Patients undergoing inpatient treatment receive medicinal products and medical devices in accordance with the medication administration records prescribed by physicians.

The cost of the medicinal products included in the National List of Essential Medicines purchased by medical institutions financed from the budget and purchased by specialized organizations under special state programs by order of the Ministry is compensated to patients in full at the expense of the state budget.

Medicinal products that are reimbursed by the state under the “Affordable Medicines” and insulin reimbursement programs are prescribed to patients at an outpatient level and delivered free of charge or with additional payment (within the “Affordable Medicines” program, patients decide for themselves whether to obtain the medicinal product for free or get another (alternative) one with additional payment).

In addition, patients who receive care at outpatient level and relate to reimbursement population categories, or have a certain illness in accordance with Resolution No. 1303 of the Cabinet of Ministers of Ukraine dated August 17, 1998, obtain medicinal products either free of charge or with an additional payment (50% reimbursement), which is compensated from the state budget.

 

15. What are the professional and legal responsibilities of those who dispense drugs and devices? What role do they play in providing patient care, information, and safety?

Medicinal products and medical devices are administered and prescribed to patients by physicians in accordance with medical specialties. Physicians must follow the prescription rules established by the Ministry when prescribing medicinal products to patients. They must familiarize patients with the directions for use of a medicinal product and make sure that patients do not have issues with the active ingredients. They must provide qualified medical assistance to patients and maintain medical records (medical histories, patient cards).

In cases provided for by current legislation, medical personnel are administratively and criminally liable while carrying out their professional activities.

Dispensing medicinal products to patients is carried out by pharmaceutical sales representatives (pharmacists) at pharmacies and their structural subdivisions. A pharmaceutical sales representative working at a pharmacy must meet the qualification requirements provided for in the Licensing Conditions for the production of medicinal products and wholesale and retail trade.

When dispensing OTC medicines, a pharmaceutical sales representative must hold a conversation with a patient (pharmaceutical care) in order to find out the causes of his disease and provide guidance on the choice of the medicinal product.

When dispensing prescribed medicines, a pharmaceutical sales representative must make sure that the prescription is written out without violation of the prescription rules and dispense the medicine to the patient. If the prescription is written out in violation of the rules, the pharmaceutical sales representative must refuse to dispense the medicine to the patient (in this case, the prescription is considered invalid and is returned to the patient).

In cases provided for by the current legislation, pharmaceutical sales representatives are administratively and criminally liable while carrying out their professional activities.

 

Also from this Legal Handbook

The legal framework for cannabinoid drugs, medicinal cannabis and opioid drugs in Ukraine. Prepared in association with Sayenko Kharenko, a leading law firm in Ukraine, this is an extract from The Pharma Legal Handbook: Ukraine, available to purchase here for USD 99.

 

Cannabinoid Drugs

1. Are Cannabinoid Drugs authorized in your country?

Ukrainian legislation, namely Resolution No.770 of the Cabinet of Ministers of Ukraine (the ‘CMU’) dated 6 May 2000, establishes the ‘List of Narcotic Drugs, Psychotropic Substances and Precursors’ (hereinafter – the ‘List of Narcotic Drugs’), which provides a list of narcotic substances, psychotropic substances and precursors, separated into 4 categories:

• Prohibited narcotic substances and psychotropic substances (Table I);

• Especially dangerous narcotic substances which turnover is prohibited (Schedule 1);
• Especially dangerous psychotropic substances which turnover is prohibited (Schedule 2);
• Plants, containing narcotic and psychotropic substances, which
  turnover is allowed for manufacturing purposes (Schedule 3);

• Narcotic substances and psychotropic substances with limited turnover (Table II):

• Narcotic substances with limited turnover (Schedule 1);
• Psychotropic substances with limited turnover (Schedule 2);

• Narcotic substances and psychotropic substances with limited turnover and exclusion of certain control measures (Table III):

• Narcotic substances with limited turnover and exclusion from certain control measures (Schedule 1);
• Psychotropic substances with limited turnover and exclusion from certain control measures (Schedule 2);

• Precursors (Table IV):

• Precursors with limited turnover subject to control measures (Schedule 1);
• Precursors subject to control measures (Schedule 2).

The notion of ‘turnover’ includes development, production, growing of plants, manufacturing, storage, transportation, sending, sale, purchase, importation, exportation, transit, use and utilization.

Turnover of narcotic and psychotropic substances listed in Table I of the List of Narcotic Drugs is prohibited (except for expert, investigation or training activity), which means that such substances can’t be used for production of medicinal products. Analogues of narcotic and psychotropic substances, i.e. substances which are not included in the List of Narcotic Drugs but which possess chemical structure and characteristics resembling those of narcotic and psychotropic sub- stances, are also prohibited in Ukraine. Substances, included in Tables II, III and IV may be used for medical purposes under certain conditions.

Cannabinoids (e.g. tetrahydrocannabinol including its isomers and their stereochemical variants) are defined as ‘especially dangerous psychotropic substances, which turnover is prohibited’ and are enlisted in Schedule 2, Table I, which means that turnover of such substances is prohibited in Ukraine.

Notably, Dronabinol ((-) – trans delta-9-tetrahydrocannabinol) is the cannabinoid substance which is currently included in Schedule 2 Table II of the List of Narcotic Drugs, which means that it can be used for production of medicinal products in Ukraine. Therefore, Dronabinol is the substance which may be used in Cannabinoid Drugs in Ukraine. The List of Narcotic Drugs may be subject to amendments, therefore the current status of each particular substance shall be checked separately.

Ukrainian law differentiates between narcotic and psychotropic substances and precursors as such, and medicinal products produced from such sub- stances. According to Ukrainian legislation, medicinal products can be placed on the market only after state registration. For instance, Dronabinol or medicinal products containing Dronabinol have not yet been registered in Ukraine and therefore cannot be placed on the Ukrainian market.

Dronabinol was added to Schedule 2, Table II of the List of Narcotic Drugs by the CMU Resolution of 2011. However, the effectiveness of this CMU Resolution (by means of which dronabinol was added to ‘psychotropic substances, the turnover of which is restricted’, listed in Schedule 2, Table II of the List of Narcotic Drugs) has been suspended numerous times (for the last time until 1 June 2012).

 

2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?

The State Service of Ukraine on Medicinal Products and Drugs Control (hereinafter – the ‘SSM’) is a state body controlling the turnover of narcotic drugs, psychotropic substances and precursors, and combating its illegal trafficking. The SSM is responsible for the licensing of commercial activities connected with the production and import of medicinal products, wholesale and retail of medicinal products, and the turnover of narcotic drugs, psychotropic substances and precursors.

Registration of medicinal products in Ukraine is carried out by the Ministry of Health of Ukraine.

Combating the illegal turnover of narcotic drugs, psychotropic substances and precursors is the responsibility of the National Police, the Security Service of Ukraine, the General Prosecutor’s Office, the State Fiscal Service, the State Border Service, and other bodies within their authority.

 

3. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Cannabinoid Drugs?

As indicated above, the only cannabinoid psychotropic substance which can be used for production of medicinal products in Ukraine is dronabinol. Since dronabinol is considered a psychotropic drug, the general regulatory framework for medicinal products and the specific one for narcotic drugs, psychotropic substances and precursors shall apply to dronabinol and medicinal products containing it.

Medicinal products containing cannabinoid substances allowed for use in Ukraine (for instance, dronabinol), like any other medicinal product in Ukraine, must be registered with the Ministry of Health of Ukraine in order to be placed on the market in Ukraine. Upon completion of registration, the applicant receives a registration certificate for the medicinal product with a validity period of five years. Medicinal products which are placed on the market during the five-year validity period are allowed for use until their expiry term indicated on the packaging. After expiry of the five-year initial registration term, medicinal products shall be re-registered. After re-registration the medicinal products may be placed on the market for an unlimited period.

Moreover, general licensing requirements applicable to medicinal products and special licensing requirements for the development, manufacture, production, storage, transportation, purchase, sale, import into Ukraine, export from Ukraine, usage and utilization of restricted narcotic drugs, psychotropic substances and precursors included in the Tables II-IV of the List of Narcotic Drugs are applicable to Cannabinoid Drugs.

Pricing or reimbursement for narcotic drugs, psychotropic substances and precursors, included in the Tables II-IV of the List of Narcotic Drugs, as well as medicinal products containing such substances, is not regulated by the state.

Dronabinol (as well as other narcotic drugs, psychotropic substances and precursors) is not enlisted in the Register of medicinal products, the price of which is subject to reimbursement. Therefore, dronabinol or any medicinal product containing it cannot be placed on the market or be reimbursed to retail sellers of medicinal products.

 

4. Which are the cannabinoid drugs that have received market approval to date?

No Cannabinoid Drugs have received market approval (registration) to date.

 

5. Who can prescribe Cannabinoid Drugs?

In general, all narcotic or psychotropic medicinal products can be prescribed by doctors licensed for medical practice according to their medical specialties and working at business entities (medical establishments, hospitals, individual entrepreneurs or other entities authorized for medical practice). Prescription of narcotic or psychotropic medicinal products is via specially designed prescription form 3.

In order to prescribe this category of medicinal products, medical establishments or other entities authorized for medical practice are additionally required to receive a special license for production, storage, purchase or sale (release), usage and utilization of restricted narcotic drugs, psychotropic substances and precursors included in the List of Narcotic Drugs. The license is issued to a particular entity for the particular schedule of the particular table of the List of Narcotic Drugs.

Feldshers (Physician Assistant or Nurse Practitioners) working at medical establishments are entitled to prescribe narcotic or psychotropic medicinal products for patients with protracted and chronic diseases for the purpose of continuing the treatment provided by the doctor by stating their position, placing their signature and the stamp of the medical establishment.

Medical practitioners (doctors or feldshers) are not authorized to prescribe narcotic or psychotropic medicinal products unless the respective business entity has a license for the production, storage, purchase or sale (release), usage and utilization of restricted narcotic drugs, psychotropic substances and precursors.

 

6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?

There is a register of entities (including medical establishments, pharmaceutical stores, etc.) entitled to conduct economic activity related to the production, storage, transportation, purchase, sale, import, export, usage and utilization of narcotic drugs, psychotropic drugs and precursors included in the List of Narcotic Drugs according to special Licensing terms.

As a general rule, any doctor working at a medical establishment or other entity authorized for medical practice and licensed for production, storage, purchase or sale (release), usage and utilization of narcotic drugs, psychotropic substances and precursors included in Tables II-IV of the List of Narcotic Drugs can prescribe narcotic or psychotropic medicinal products. A license is issued to a particular entity for the particular schedule of the particular table of the List of Narcotic Drugs, including all substances of the respective Schedule (not a single medical product).

 

7. What approvals or notifications are required to prescribe Cannabinoid Drugs?

Any doctor working at a medical establishment or other entity authorized for medical practice and licensed for production, storage, purchase or sale (release), usage and utilization of psychotropic substances included in Schedules 2, Table II of the List of Narcotic Drugs can prescribe narcotic or psychotropic medicinal products.

 

8. Which organizations are authorized to sell/distribute Cannabinoid Drugs available?

Since no medicinal products containing cannabinoids have been registered in Ukraine to date, there are no organizations authorized to sell/distribute them.

However, any medicinal product (narcotic or psychotropic medicinal products) shall only be sold for wholesale in pharmaceutical warehouses and for retail in pharmacies or their branches. Trade in medicinal products can be conducted exclusively through pharmaceutical establishments and shall not be conducted through any electronic commercial means, by post or by establishments other than pharmaceutical ones (some exclusions are envisaged for rural areas where medicinal products may be sold by certain healthcare institutions).

Moreover, pharmaceutical warehouses, pharmacies and their branches shall receive a special license for production, storage, transportation, purchase, sale, import, export, usage and utilization of narcotic drugs, psychotropic substances and precursors included in the List of Narcotic Drugs.

Narcotic or psychotropic medicinal products like any other medicinal product subject to state procurement procedure can be provided to patients in the course of treatment in state medical establishments which have received a special license for this purpose.

 

9. Is there a list of retailers/ distributors authorized to sell Cannabinoid Drugs?

There is no special list of retailer/distributors authorized to sell Cannabinoid Drugs.

There is a register of entities, including pharmacies and their branches, authorized to sell narcotic or psychotropic medicinal products that have received special license for this purpose. The license is issued to a particular entity for the particular schedule of the particular table of the List of Narcotic Drugs, including all substances of the respective schedule and table (not a single medical product).

Please note that medicinal products (including narcotic or psychotropic medicinal products), shall only be sold for wholesale in pharmaceutical warehouses and for retail in pharmacies or their branches. Trade in medicinal products can be made exclusively through pharmaceutical establishments and shall not be made through any electronic commercial means, by post or by establishments other than pharmaceutical ones (some exclusions are envisaged for rural areas where medicinal products may be sold by certain healthcare institutions).

 

10. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?

There have been numerous discussions and petitions to the parliament, although no legislative proposals for reform or significant change to the regulation of Cannabinoid Drugs has been introduced to date.

The Strategy of State Policy on Narcotics for the period up to 2020 (approved by Ruling of the Cabinet of Ministers of Ukraine (hereinafter – the ‘CMU’) No. 735-p dated 28 August 2013) includes certain provisions on scientific research of medical usage prospective of Cannabinoid Drugs as pain killers and other medical drugs.

 

11. When are they likely to come into force?

Since there were no proposals for reform or significant change to the regulation of Cannabinoid Drugs, it is impossible to predict whether they will occur in the nearest future.

 

Medicinal Cannabis

12. Is Medicinal Cannabis authorized in the country?

No, Medical Cannabis is not authorized in Ukraine.

Cannabis, cannabis resins, cannabis extracts and cannabis tinctures are considered ‘especially dangerous narcotic drugs, the turnover of which is prohibited’, enlisted in Schedule 1, Table I of the List of Narcotic Drugs.

Cultivation of cannabis plants for industrial purposes is not prohibited provided that contents of tetrahydrocannabinol in the dried straw of cannabis plants, originating cannabis seeds for such cultivation, does not exceed 0.08 percent. The cultivation of cannabis plants requires a special license according to the licensing terms, approved by the CMU Resolution No. 282 dated 6 April 2016. Cultivation of cannabis is subject to a number of requirements applicable to such activity.

Under Ukrainian law, the illegal production, purchase, storage, transportation, transmission or turnover of narcotic drugs, psychotropic substances and their analogies as well as illegal cultivation of cannabis plants may entail administrative or criminal liability.

Ukraine also fulfills its international obligation in the field of control over narcotic and psychotropic drugs turnover. Notably, Ukraine is a participant of the Single Convention on Narcotic Drugs of 1961 as amended by the 1972 Protocol, the Convention on Psychotropic Substances of 1971 and the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, which together set the framework for international drug control regulation.

 

13. What are the regulatory authorities with jurisdiction over Medicinal Cannabis?

Since Medical Cannabis is not authorized in Ukraine, there are no regulatory authorities over it.

Combating the illegal turnover of narcotic drugs, psychotropic substances and precursors is the responsibility of the National Police, the Security Service of Ukraine, the General Prosecutor’s Office, the State Fiscal Service, the State Border Service, and other bodies within their authority.

 

14. What is the regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis?

Since Medicinal Cannabis is not authorized in Ukraine, there is no specific regulatory framework for authorization, pricing, and reimbursement.

 

15. How is the production and import of Medicinal Cannabis regulated and by which agencies/authorities?

The production and import of Medicinal Cannabis are prohibited in Ukraine.

 

16. What approval or notifications are necessary to produce or import Medicinal Cannabis?

The production and import of Medicinal Cannabis are prohibited in Ukraine.

 

17. What is the regulatory framework for the marketing and distribution of Medicinal Cannabis?

Since Medicinal Cannabis is prohibited in Ukraine, there is no regulatory framework for the marketing and distribution of Medicinal Cannabis.

 

18. How can patients obtain Medicinal Cannabis?

Since Medicinal Cannabis is prohibited in Ukraine, patients cannot obtain Medicinal Cannabis.

 

19. Who can prescribe Medicinal Cannabis?

Since Medicinal Cannabis is prohibited in Ukraine, there are no persons authorized to prescribe Medicinal Cannabis.

 

20. Is there a list of doctors authorized to prescribe Medicinal Cannabis?

Since Medicinal Cannabis is prohibited in Ukraine, there are no doctors authorized to prescribe Medicinal Cannabis.

 

21. What approvals or notifications are required to prescribe Medicinal Cannabis?

Since Medicinal Cannabis is prohibited in Ukraine, there are no specific requirements for approvals or notifications to prescribe Medicinal Cannabis.

 

22. Where is Medicinal Cannabis available?

Since Medicinal Cannabis is prohibited in Ukraine, it not available.

 

23. Is there a list of retailers authorized to sell Medicinal Cannabis?

Since Medicinal Cannabis is prohibited in Ukraine, there is no list of retailers authorized to sell Medicinal Cannabis.

 

24. Are there proposals for reform or significant change to the regulation of Medicinal Cannabis?

The Draft Law No. 4533 dated 27.04.2016 ‘On amending the Law of Ukraine ‘On Narcotic Drugs, Psychotropic Substances and Precursors’ (On the Turnover Procedure of Substances under Control)’ (hereinafter – the ‘Draft Law No.4533’) has been introduced to the Verkhovna Rada (Ukrainian Parliament).

The Draft Law No.4533 offers to allow cultivation of cannabis for the purposes of scientific research and medical usage.

It suggests to displace Schedule 3 (Plants, containing narcotic and psychotropic substances, which turnover is allowed for manufacturing purposes) from Table I (Prohibited narcotic substances and psychotropic substances) to Table II (Narcotic substances and psychotropic substances with limited turnover), thus allowing the restricted cultivation of cannabis plants.

Notably, Draft Law No. 4533 has not been through a first hearing in parliament yet. The parliamentary procedure provides that a draft law shall pass two to three hearings before adoption by parliament.

 

Opioid Drugs

25. Are Opioid Drugs authorized in your country?

Ukrainian legislation has no definition and special regulatory framework for Opioid Drugs. Ukrainian law differentiates between narcotic and psychotropic substances and precursors (including opioids) as such, and medicinal products, produced from such substances. Medicinal products authorized for medical use shall be duly registered before their market placement.

Opioid substances are considered within the general legislative framework applied to narcotic and psychotropic substances and precursors and fall under one of the categories indicated in Chapter 8 above (according to the tables and schedules indicated in the List of Narcotic Drugs).

There are different regimes for different kinds of opioid substances in Ukraine. The turnover of opioid substances indicated in Table I of the List of Narcotic Drugs is prohibited in Ukraine. Such substances cannot be used for the production of medicinal products. The turnover of opioid substances indicated in Tables II and III of the List of Narcotic Drugs is restricted.

For instance, some opioids like acetorphine, etorphine, heroin, and opium are considered ‘especially dangerous narcotic drugs, the turnover of which is prohibited’, enlisted in the Schedule 1, Table I of the List of Narcotic Drugs, which turnover is prohibited in Ukraine. Such substances cannot be used for production of medicinal products.

In turn, certain Opioid Drugs, for instance morphine, codeine, tramadol are considered as ‘narcotic drugs, the turnover of which is restricted’, enlisted in Schedule 1, Table II of the List of Narcotic Drugs, which turnover in Ukraine is restricted, but which can be used for the production of medicinal products.

 

26. What are the regulatory authorities with jurisdiction over Opioid Drugs?

The State Service of Ukraine on Medicinal products and Drugs Control (hereinafter – the ‘SSM’) is a state body controlling the turnover of narcotic drugs, psychotropic substances and precursors and combating illegal trafficking. The SSM is also responsible for the licensing of commercial activities connected with production and import of medicinal products, wholesale and retail of medicinal products, and turnover of narcotic drugs, psychotropic substances and precursors.

Registration of medicinal products in Ukraine is exercised by the Ministry of Health of Ukraine.

Combatting the illegal turnover of narcotic drugs, psychotropic substances and precursors is the responsibility of the National Police, the Security Service of Ukraine, the General Prosecutor’s Office, the State Fiscal Service, the State Border Service, and other bodies within their authority.

 

27. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Opioid Drugs?

There is no specific framework for authorization of Opioid Drugs.

The general regulatory framework for medicinal products and the specific framework for narcotic drugs, psychotropic substances and precursors shall be applicable to medicinal products containing opioids.
Medicinal products containing opioids allowed for use in Ukraine (Tables II-III of List of Narcotic Drugs), like any other medicinal product in Ukraine, must be registered with the Ministry of Health of Ukraine in order to be placed on the market of Ukraine. Upon completion of registration, the applicant receives a registration certificate for the medicinal product with a validity period of five years. Medicinal products which are placed on the market during the five-year validity period are allowed for use until the expiry term indicated on the packaging. After expiry of the five-year initial registration term, medicinal products shall be re-registered. After re-registration, medicinal products may be placed on market for an unlimited period.

Moreover, special licenses are required for development, manufacture, production, storage, transportation, purchase, sale, import into Ukraine, export from Ukraine, usage and utilization of restricted narcotic drugs, psychotropic substances and precursors included in the Tables II-IV of List of Narcotic Drugs.

Medicinal products containing narcotic drugs, psychotropic substances and precursors are subject to control measures (e.g. import quotas, reporting, etc.). Medicinal products with small amounts of narcotic drugs, psychotropic substances and precursors, which cannot be easily extracted therefrom, can be exempted from certain control measures.

Pricing for narcotic drugs, psychotropic substances and precursors, included in the Tables II-IV of the List of Narcotic Drugs, as well as medicinal products containing such substances, is not regulated by the state. Medicinal products containing opioids are not enlisted in the Register of medicinal products, price of which is subject to reimbursement (regularly reviewed), thus, they cannot be reimbursed to retail sellers of medicinal products.

 

28. Which are the Opioid drugs that have received market approval to date?

Medicinal products containing opioids that have received market approval and have been duly registered can be found in the Register of medicinal products.

 

29. Who can prescribe Opioid Drugs?

In general, all narcotic and psychotropic medicinal products can be prescribed by doctors in specially designed prescription form 3, licensed for medical practice according to their medical specialties and working at business entities (medical establishments, hospitals, individual entrepreneurs or other entities authorized for medical practice).

In order to prescribe this category of medicinal products, medical establishments or other entities authorized for medical practice are additionally required to receive a special license for production, storage, purchase or sale (release), usage and utilization of restricted narcotic drugs, psychotropic substances and precursors included in the List of Narcotic Drugs.

The license is issued to a particular entity for the particular schedule of the particular table of the List of Narcotic Drugs.

Feldshers (Physician Assistant or Nurse Practitioners) working at medical establishments are entitled to prescribe narcotic and psychotropic medicinal products for patients with protracted and chronic diseases for the purpose of continuing the treatment provided by the doctor by stating their position, placing their signature and the stamp of the medical establishment.

Medical practitioners (doctors or feldshers) are not authorized to prescribe narcotic and psychotropic medicinal products unless the respective business entity has a license for production, storage, purchase or sale (release), usage and utilization of restricted narcotic drugs, psychotropic substances and precursors.

Please note that certain narcotic and psychotropic medicinal products can be prescribed by any doctor according to simplified prescription form 1 (regardless of whether they work at the respective entity being licensed for the particular schedule of the particular table of the List of Narcotic Drugs or not) unless they contain more than the marginal quantity of narcotic drugs, psychotropic substances or precursors established by the CMU. In regard to opioids, the CMU establishes marginal quantity for codeine, dextropropoxyphene and tramadol. Medicinal products which contain more than the marginal quantity of narcotic drugs, psychotropic substances and precursors shall be prescribed according to prescription form 3 generally applicable for all narcotic and psychotropic medicinal products.

 

30. Is there a list of doctors authorized to prescribe Opioid Drugs?

There is a register of entities (including medical establishments, pharmaceutical stores, etc.), entitled to conduct economic activity related to the production, storage, transportation, purchase, sale, import, export, usage and utilization of narcotic drugs, psychotropic drugs and precursors included in the List of Narcotic Drugs according to special Licensing terms.

As a general rule, any doctor working at a medical establishment or other entity authorized for medical practice and licensed for production, storage, purchase or sale (release), usage and utilization of narcotic drugs, psychotropic substances and precursors included in Tables II-IV of the List of Narcotic Drugs can prescribe narcotic and psychotropic medicinal products. The license is issued to a particular entity for the particular schedule of the particular table of the List of Narcotic Drugs, including all substances of the respective Schedule (not a single medicinal product).

 

31. What approvals or notifications are required to prescribe Opioid Drugs?

Any doctor working at a medical establishment or other entity authorized for medical practice and licensed for production, storage, purchase or sale (release), usage and utilization of narcotic drugs, psychotropic substances and precursors included in Tables II-IV the List of Narcotic Drugs can prescribe medicinal products containing opioids.

 

32. Which organizations are authorized to sell/distribute Opioid Drugs available?

As a general rule, any medicinal product (including narcotic and psychotropic medicinal products) shall only be sold for wholesale in pharmaceutical warehouses and for retail in pharmacies or their branches. Trade in medicinal products can be made exclusively through pharmaceutical establishments and shall not be made through any electronic commercial means, by post or by establishments other than pharmaceutical ones (some exclusions are envisaged for rural areas where medicinal products may be sold by certain healthcare institutions).

Moreover, pharmaceutical warehouses, pharmacies and their branches shall receive a special license for production, storage, transportation, purchase, sale, import, export, usage and utilization of narcotic drugs, psychotropic substances and precursors included in the List of Narcotic Drugs.

Narcotic or psychotropic medicinal products as any other medicinal product subject to state procurement procedure can be provided to patients in the course of treatment in state medical establishments which have received a special license for this purpose.

 

33. Is there a list of retailers/ distributors authorized to sell Opioid Drugs?

There is no special list of retailer/distributors authorized to sell Opioid Drugs. There is a register of entities including pharmacies and their branches authorized to sell narcotic and psychotropic medicinal products that have received a special license for this purpose. The license is issued to a particular entity for the particular schedule of the particular table of the List of Narcotic Drugs, including all substances of the respective schedule and table (not a single medical product).

Please note that medicinal products (including narcotic and psychotropic medicinal products), shall only be sold for wholesale in pharmaceutical warehouses and for retail in pharmacies or their branches. Trade in medicinal products can be made exclusively through pharmaceutical establishments and shall not be made through any electronic commercial means, by post or by establishments other than pharmaceutical ones (some exclusions are envisaged for rural areas where medicinal products may be sold by certain healthcare institutions).

 

34. Are there proposals for reform or significant change to the regulation of Opioid Drugs?

There have been no proposals for reform or significant change to the regulation of Opioid Drugs.

 

35. When are they likely to come into force?

Since there were no proposals for reform or significant change to the regulation of Opioid Drugs, it is impossible to predict whether they will occur in the near future.