The Pharma Legal Handbook: Ukraine
The Pharma Legal Handbook: Ukraine answers essential questions about the legal and regulatory environment for pharmaceuticals in Ukraine. It is a must-have for any company operating in the country or looking to enter the market.
Prepared in association with Sayenko Kharenko, a leading Ukrainian law firm, it should answer any questions linked to regulation, pricing, clinical and preclinical trials, marketing, manufacturing, trademarks and patents.
If legal handbook content is updated, you will receive a free updated PDF for up to one year after purchase.
October 2018
1. Biosimilars & Biologics: Ukraine
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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- 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
- 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
- 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
- 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
- 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/
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- The Law of Ukraine “Fundamentals of the Legislation of Ukraine on Healthcare”, available at: https://zakon.rada.gov.ua/laws/show/2801-12#n348
- The Rules for prescribing medicines and medical devices, available at: https://zakon.rada.gov.ua/laws/show/z0782-05#n37
- 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
- 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
- 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
2. Localization: Ukraine
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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- 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
- 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
- The Concept available at: https://bit.ly/3nhht9d
- The Draft Law available at: http://w1.c1.rada.gov.ua/pls/zweb2/webproc4_1?pf3511=72012
Also from this Legal Handbook
3. Orphan Drugs & Rare Diseases: Ukraine
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:
- 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.
- 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.
- 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.
- 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.
—————————-
- 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
- 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
- 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
- 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
- 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
- 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 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
4. Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs: Ukraine
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.
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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
5. Regulatory Reforms: Ukraine
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