The Pharma Legal Handbook: Russia

Key legal info on biosimilars & biologics in Russia. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for GBP 99.

 

 

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

Biosimilar drugs are not the same as generic drugs in Russia. A biosimilar drug cannot be a copy of the original biological drug, as in respect of a biosimilar drug it can neither be proved nor confirmed the full similarity of its effect on a human. Biosimilar can only be similar in certain parameters (quality, efficiency and safety) to the original biological drug, whereas a generic drug is considered to be equal to its reference drug.

 

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

In Russia certain criteria of patentability are established that are common for all inventions and do not depend on a specific type of drug. Under the Russian Civil code a technical solution in any area is protected as an invention if it relates to a product (including a device, substance, strain of microorganisms, plant or animal cell culture) or a method (the process of carrying out actions in respect of a material object by material means), including the use of the product or method for a specific purpose. An invention is provided with legal protection if it meets the following criteria:

• Invention is novel (i.e. it is not known from the state of the art);
• Invention has an inventive step (i.e. it does not explicitly follow for a specialist from the state of the art);
• Invention is industrially applicable (i.e. it can be used in industry, agriculture, public health and other branches of the economy or in the social sphere).

Consequently, if a biologic drug (or biosimilar drug) meets the abovementioned criteria it can be patented. However, in practice, the nature of biosimilar drugs makes it hard for them to meet the novelty criterion.

 

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?

The general regulatory framework is applied for biosimilars. In particular, it includes Federal law of 21.11.2011 No. 323-FZ “On fundamental healthcare principles in the Russian Federation” (“Law on fundamental healthcare principles”), Federal law of 12.04.2010 No. 61-FZ “On drugs circulation” (“Law on drug circulation”), which provisions are supplemented with the regulations adopted by the Government of the Russian Federation and Russian Ministry of Healthcare (“Minzdrav”) (including, inter alia, “Administrative regulations of the Russian Ministry of Healthcare on the provision of state services for the state registration of medical drugs”). In addition, some specific rules are applied, e.g. separate features of biosimilar drug’s examination at its registration are governed by “Rules of carrying out examination of medical drugs and features of examination of separate types of medical drugs (reference drugs, generic drugs, biological drugs, biosimilar drugs (biosimilars), homeopathic drugs, medicinal plant preparations, combinations of drugs)”.

Biosimilar drug may be subject to registration upon expiration of 3 years period of registration of its reference biologics drug.

 

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?

Besides the data package required for all biological drugs in general, for the purposes of biosimilar drug registration applicant must specify the following information within the biosimilar drug registration dossiers: identification of drug’s type as a biosimilar drug and data on its reference biologics drug.

Further, during the state registration procedure (during quality examination and examination of correlation between anticipated benefits and possible risks of drug by the state institution) the authorized state institution must establish the biosimilar drug’s interchangeability considering the data obtained following the results of clinical studies on the absence of clinically significant differences in safety, efficacy and immunogenicity compared with the reference drug.

 

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

The reference comparator product must meet the following criteria:

• It is a biological drug registered in Russia;
• It has similar quality, efficiency and safety characteristics.

 

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

Comparator product cannot be sourced from another regulatory jurisdiction since it is only allowed to use reference comparator drug that has Russian marketing authorization.

 

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

General drug price regulating requirements are applied both to biosimilar and to biologics drugs. State regulation of drug prices is executed for drugs that are included in the List of vital essential and necessary drugs (“EDL”). For EDL drugs maximum sale prices must be submitted by the manufacturers or their authorized representatives and must be subject to state registration with Minzdrav. Purchasing price in the public procurement sector must not exceed the price calculated on the basis of such a registered price considering the relevant maximum wholesale mark-up.

In addition, the Russian Federal Antimonopoly Service (“FAS”) supervises the Russian market in general regarding monopolistically high or low prices establishment by manufacturers (including drug manufacturers) which is a violation of Russian antimonopoly laws. In its official Statement of 10.02.2016 (“Statement”) FAS clarified definitions of monopolistically high and low prices:

• Monopolistically low price of goods is the price, which is (1) below the amount necessary for the production and sale of such goods, expenses and profits; and (2) lower the price formed in competitive conditions at the comparable commodity market (if such market exists in Russia or abroad).
• Monopolistically high price of goods is the price, which is (1) above the amount necessary for the production and sale of such goods, expenses and profits; and (2) above the price formed in competitive conditions at the commodity market comparable in composition of buyers or sellers of goods, conditions of goods circulation, conditions of access to the commodity market, state regulation, including taxation and customs and tariff regulation (if such market exists in Russia or abroad).

In order to prevent establishing monopolistically high or low prices FAS developed certain mechanisms so that to identify timely the fact of monopolistically high or low price establishment and to take relevant prevention measures. Due to recent FAS practice, this approach is applied not only to EDL drugs but to all drugs in general.

Thus, for drug manufacturers it is recommended to establish an economically justified price that considers all pricing factors (i.e. purchase volume, forms and terms of payment, the presence of delays and arrears in payment, packing forms, etc.).

 

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

Russian laws do not contain specific rules for reimbursement of expenses for biosimilars. Reimbursement of biosimilars cost for certain categories of the population is the same as for all other drugs.

At the legislative level, there is a list of groups of citizens that are entitled to receive drugs free of charge or with a 50 percent discount.

The List of drugs to provide certain categories of citizens and the EDL are established, reimbursement of the cost of drugs under these lists is at the expense of the Federal budget. Besides, there is a list of high-cost nosologic diseases. The purchase of drugs (including biosimilars) intended for the treatment of such diseases is also compensated at the expense of the Federal budget.

 

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

Biosimilars certainly create some competition for originator reference biologics mainly due to the fact that biosimilars are less expensive and thus their purchase is less expensive for the state.

 

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?

There are no specific requirements defining the procedure for prescribing biosimilar drugs, thus, general rules are applied.

Main laws and statutory instruments governing the procedure for drugs prescribing, including biosimilars, are as follows:

• “Procedure for drugs prescribing” (established by Minzdrav Order of 14.01.2019 No. 4n);
• “Instructions for the procedure for drugs prescribing and executing drug orders and inventory orders” (Annex No. 13 to Minzdrav Order of 12.02.2007 No. 110).

There are no specific rules for biosimilars dispensing as well. Thus, biosimilar drugs are to be dispensed on the basis of the same legal acts and according to the same rules that are established for all drugs in general.

The rules for drugs dispensing are established on the basis of the “Rules for drugs dispensing, including immunobiologicals, by pharmacy institutions, individual entrepreneurs licensed for pharmaceutical activity”, “Rules for drugs dispensing by healthcare institutions having a license for pharmaceutical activity and their separate subdivisions located in rural settlements where pharmacy institutions are absent”, etc.

 

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

The interchangeability of a drug is determined in the process of its state registration on the basis of comparison with a reference drug.

Pursuant to the Law on fundamental healthcare principles the duty to select the appropriate treatment for the patient is imposed on its attending physician. Thus, physician may prescribe a biosimilar drug instead of the original biologic drug after consultation with the patient based on a comprehensive examination of the patient, if the biosimilar drug has passed its registration procedure.

The final decision remains in the competence of the attending physician, who must act in the interests of the patient.

 

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?

General drugs post-authorization requirements are applied to biosimilar drugs. Each marketing authorization holder must carry out the reception, accounting, processing, analysis and storage of all notifications received about side effects, adverse reactions, serious adverse reactions with the use of drugs, about the individual intolerance, lack of efficacy of drugs, as well as about other facts and circumstances that represent a threat to life or health of a human with the use of drugs. All such notifications must be reported to state authorities.

 

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

General drug labeling requirements are applied to biosimilar drugs.

 

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.

 

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?

Starting from 01.03.2020 the amendments on the procedure for determining the interchangeability of drugs came into force. These amendments included, inter alia, that the government will have the right to establish the rules and features of determining the interchangeability of biological drugs. Currently the relevant legislation act is under consideration in Government. It is supposed to be adopted soon.

Also from this Legal Handbook

Want to know more about localization in Russia? Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, 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?

The Strategy of the pharmaceutical industry development until 2020 (“Pharma-2020”) defined localization as one of the main tendencies of pharmaceutical business development in Russia. Pursuant to Pharma-2020 some laws and regulations were adopted to encourage drug manufacturing in the territory of the Russian Federation. At the same time Russia as a member of the EAEU forcing harmonization of its legislation in accordance to the EAEU guidelines as well as to set several limits for drugs manufactured outside of Russia or the EAEU.

 

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

The last significant amendments in the legislation were connected with the conclusion procedure of Special Investing Contracts (“SPIC”).

The changes in the procedure of the SPIC conclusion took place in August 2019. These changes, inter alia, stipulated the following:

• increase of a time period for SPIC conclusion from 10 years up to 15-20 years depending on the amount of the investment;
• cancellation of the minimum amount of the investments;
• new SPIC could be concluded only for progressive technologies manufacturing and the list of such technologies shall be approved by the Russian Government (valid list was approved in the end of November 2020).

 

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)?

No.

 

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)?

The pricing process for pharmaceutical products is impacted by localization policies for EDL drugs only. Drugs that are included in the EDL and produced in Russia have several privileges, including their annual price indexation depending on the inflation level. At the same time, prices of drugs manufactured abroad can be updated annually, including their decreasing, depending on the currency exchange rate to Russian ruble and depending on the price changes at the reference markets. It should be noted, that the Russian Federal Antimonopoly Service does not reveal its sources of information about prices on imported drugs that are to be used during the process of approval of the new price suggested by the manufacturer.

 

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)?

There is no reimbursement of pharmaceutical products in the framework of medical insurance. Certain categories of citizens are entitled to the preferential provision of drugs. Drug procurement for these purposes is carried out in the framework of tenders and auctions held by medical organizations that manage the preferential provision of citizens with drugs.

 

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)?

There are a number of restrictions for foreign-made drugs to gain access to tenders and auctions for the purchase of drugs. Foreign drugs are not allowed for tenders and auctions, provided that applications for participation are submitted in relation to 2 or more drugs of Russian production or the EAEU countries production.

To obtain the appropriate status, sufficient processing of goods on the territory is necessary. Sufficiency criteria are defined in the Resolution of the Russian Government of 02.08.2016 No. 744 and the Resolution of the Russian Government of 30.11.2015 No. 1289. Confirmation of the drug’s local status is made by issuing an ST-1 certificate.

At the same time, the list of 10 INN for several oncology disease is approved as a priority (as of Annex 1 to the Resolution of the Russian Government of 30.11.2015 No. 1289) and restrictions for foreign-made drugs are not applicable for the list. The mentioned regulation is valid till the end of 2021.

 

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?

No. Requirements for quality certification are the same both for drugs produced in Russia and for foreign ones. The procedure for taxation of drugs is the same. Import customs duties are applicable only for drugs of foreign production.

However, there are a number of tax preferences for localization of drug production in the territory of the Russian Federation.

 

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

If the production of drugs involves the use of modern technologies, manufacturers have the opportunity to conclude a Special investment contract (SPIC). Among the features of this contract is to allocate investment from the state, tax incentives, the possibility of obtaining subsidies, and establishing the state’s obligation on the preservation conditions in relation to conditions in force at the date of SPIC conclusion.

 

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?

At the moment, there is a public discussion of the draft strategy for the development of the pharmaceutical industry until 2030 (“Pharma-2030”). The main priority of Pharma-2030 (as opposed to Pharma-2020) is to stimulate the full cycle of new drug development, their production and further exports. To implement these priorities, Pharma-2030 requires special funds to finance the phases of development and research of new drugs, the establishment of special export duties, the possible compensation of import duties in other countries when exporting, as well as the further modernization of the EDL drugs pricing and introduction of differentiated trade allowances to them. However, as Pharma-2030 is still be under discussion due to fact that the Government was focused on COVID pandemic issues within 2020 and is expected to be approved in 2021.

Also from this Legal Handbook

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

 

 

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

The definition of rare diseases is stipulated by Art. 44 of the Federal law dd 21.11.2011 No. 323-FZ “On fundamental healthcare principles in the Russian Federation” (the “Law on fundamental healthcare principles”). Rare (orphan) diseases are diseases that have a prevalence of no more than 10 cases per 100 thousand populations. A list of rare (orphan) diseases is maintained by the Russian Ministry of Healthcare based on statistical data and is placed on its official website on the Internet.

 

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

Orphan drugs are regarded as drugs intended solely for diagnosis or pathogenic treatment (treatment aimed at the mechanism of development of the disease) of rare (orphan) diseases (Clause 6.1 Art. 4 of the Federal Law dd 12.04.2010 No. 61-FZ “On drugs circulation” (the “Law on drug circulation”)).

 

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 authorization of orphan drugs is the same as the regulatory framework for authorization of drugs in general.

Russia, being the member state of the Eurasian Economic Union (“EAEU”), complies with the EAEU provisions regarding the formation of the Common Market of medicines and medical devices under Art. 30 and Art. 31 of the Eurasian Economic Union Treaty dd 29.05.2014. Starting from 2021, authorization (i.e. registration) of new medical drugs in Russia is performed under the regulations of the EAEU that include the Rules of registration and examination of medical drugs approved by the decision of the Council of the Eurasian Economic Commission dd 03.11.2016 No. 78 (the “EAEU Rules”) and other applicable regulations of the EAEU.

 

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

Yes. According to the EAEU Rules, to orphan drugs, the main provisions of Part II (registration on conditions) may be applied. The applicant must justify in the preclinical and clinical summaries the reasons why it is not possible to provide complete information and provide a justification for the balance of benefits and risks for the orphan drugs in question.

Besides, the submission of samples, specific reagents, and other materials is not required if it is impossible to conduct tests in an expert organization due to the inaccessibility of samples of medicinal products (if they are classified as an orphan), the impossibility of observing the conditions for transporting these samples to the territory of the member state and (or) their storage, lack of special equipment and consumables in an expert organization.

 

5. Is there an expedited pathway for Orphan Drugs?

The EAEU Rules do not establish any specifics regarding time period of orphan drug registration.

 

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

Yes, but only those that are issued within the EAEU and recognized under the EAEU Rules.

 

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

Reimbursement procedure for orphan drugs in Russian Federation implies a special procedure for providing citizens with orphan drugs and their purchasing to:

• Some orphan drugs are included in the List of high-cost nosologic diseases and thus are purchased at the expense of the federal budget pursuant to the Law on fundamental healthcare principles;
• Other orphan drugs are purchased at the expense of the relevant regional budget.

To effectively provide citizens suffering from rare (orphan) diseases with drugs and specialized medical food products, the federal register of persons suffering from rare (orphan) diseases is maintained.

Besides, special rules for purchasing drugs (including those that are not registered in Russia) for children with rare diseases are introduced starting from April 20, 2021. The need for drugs for a specific child (or group of children) will be determined by the expert council of the Fund for Support of Children with Severe Life-threatening and Chronic Diseases, including rare (orphan) diseases called “Krug Dobra”. These drugs will be purchased by the Russian Ministry of Healthcare or its subordinate institutions, as well as the Fund itself.

 

8. How are the prices of Orphan Drugs regulated?

State registration of drug prices is executed for those orphan drugs that are included in the List of vital essential and necessary drugs (“EDL”). For EDL drugs maximum sale prices must be submitted by the manufacturers or their authorized representatives and must be subject to state registration with the Russian Ministry of Healthcare. Purchasing prices in the public procurement sector must not exceed the price calculated based on such a registered price considering the relevant maximum wholesale mark-up.

In addition, the Russian Federal Antimonopoly Service (“FAS”) supervises the Russian market in general regarding monopolistically high or low prices establishment by manufacturers (including drug manufacturers) which is a violation of Russian antimonopoly laws. Definitions of monopolistically high and low prices are provided in Art. 6-7 of the Federal law dd 26.07.2006 No. 135-FZ “On protection of competition”. Besides, in its official Statement dd 10.02.2016 (“Statement”) FAS clarifies the definitions of monopolistically high and low prices as follows:

• Monopolistically low price of goods is the price that is (1) below the amount necessary for the production and sale of such goods, expenses, and profits; and (2) lower the price formed in competitive conditions at the comparable commodity market (if such market exists in Russia or abroad).
• Monopolistically high price of goods is the price that is (1) above the amount necessary for the production and sale of such goods, expenses and profits; and (2) above the price formed in competitive conditions at the commodity market comparable in the composition of buyers or sellers of goods, conditions of goods circulation, conditions of access to the commodity market, state regulation, including taxation and customs and tariff regulation (if such market exists in Russia or abroad).

To prevent establishing monopolistically high or low prices FAS developed certain mechanisms so that to identify timely the fact of monopolistically high or low-price establishment and to take relevant prevention measures. Due to recent FAS practice, this approach is applied not only to EDL drugs but to all drugs in general.

Thus, for drug manufacturers, it is recommended to establish an economically justified price that considers all pricing factors (i.e. purchase volume, forms and terms of payment, the presence of delays and arrears in payment, packing forms, etc.).

 

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

Proceeding from the FAS Statement comparable country is to be established based on the following criteria: this country is to be comparable in terms of the composition of drug buyers or sellers, the conditions of drugs circulation, the conditions of access to the market, state regulation, including taxation and customs tariff regulation. At the same time, such a country’s market should be in a state of competition.

 

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

Starting from 2020 the List of high cost nosologic diseases has been expanded and 2 additional diseases have been included in the list. These additional diseases are rare (orphan) diseases.

 

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?

It is proposed to purchase all orphan drugs at the expense of the federal budget only. However, this proposal currently is under public discussions and may not be supported at the legislative level.

Starting from 2021 Fund for Support of Children with Severe Life-threatening and Chronic Diseases, including rare (orphan) diseases called “Krug Dobra” is established. The fund’s founder is the Russian Ministry of Healthcare. The Fund is funded by deductions from the increased personal income tax rate (15%), which is applied for income over RUB 5 million per year. These funds go to the federal budget and then go to the fund in the form of subsidies. Krug Dobra is created to provide medical assistance to seriously ill children who need expensive treatment. This fund will participate in purchasing drugs (including those that are not registered in Russia) for children with rare (orphan) diseases, the rules for the purchasing are in force starting from April 20, 2021. The list of diseases and the list of drugs to be covered by these rules are expected to be approved soon.

Also from this Legal Handbook

All legal aspects surrounding cannabinoid drugs, medicinal cannabis and opioid drugs in Russia. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for GBP 99.

 

 

Cannabinoid Drugs

1. Are Cannabinoid Drugs authorized in your country?

Cannabinoid Drugs are regarded as narcotic drugs of ‘List I’ which circulation within the Russian Federation is prohibited. Cannabinoid Drugs might be imported for scientific and expertise purposes only.

 

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

• Russian Ministry of Internal Affairs – the main authority, which handles matters in connection with Cannabinoid Drugs distribution, import and export;
• Russian Ministry of Health – state authority responsible for establishing requirements as to Cannabinoid Drugs.

 

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

The general rules of drug authorization are applied to Cannabinoid Drugs subject to certain special requirements established by the Federal law of 08.01.1998 No. 3-FZ “On narcotic drugs and psychotropic substances”, namely:

• Producing of expert standards of narcotic substances stipulated in the “List I” can be performed only by state unitary enterprises and state institutions having the relevant license within the established quota-based limits;
• Storage of narcotic substances must be organized in specially equipped rooms given the special rules stipulated for the storage of narcotic substances. License is required for storage of narcotic substances;
• Only state unitary enterprise can import Cannabinoid Drugs pursuant to relevant license for import of narcotic substances.

 

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

There is not any market approval due to the fact Cannabinoid Drugs are regarded as prohibited narcotic drugs.

 

5. Who can prescribe Cannabinoid Drugs?

Cannabinoid Drugs are prohibited to use for medical/treatment purposes.

 

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

No.

 

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

Cannabinoid Drugs are prohibited to be used for medical/treatment purposes.

 

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

The sale of Cannabinoid Drugs is prohibited. Distribution of Cannabinoid drugs for scientific and expertise purposes can be performed only by state unitary enterprises and state institutions with the relevant license.

 

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

No.

 

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

No.

 

11. When are they likely to come into force?

No.

 

 

Medicinal Cannabis

12. Is Medicinal Cannabis authorized in the country?

Cannabis is regarded as a narcotic drug of ‘List I’ which circulation within the Russian Federation is prohibited. Moreover, Cannabis does not divide by Medical and others.

 

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

• Russian Ministry of Internal Affairs – the main authority, which handles matters in connection with Cannabis distribution, import and export;
• Russian Ministry of Health – the state authority responsible for establishing requirements as to Cannabis.

 

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

The general rules of drugs authorization are applied to Cannabis subject to certain special requirements established by the Federal law of 08.01.1998 No. 3-FZ “On narcotic drugs and psychotropic substances”, namely:

• Producing of expert standards of narcotic substances stipulated in the “List I” can be performed only by state unitary enterprises and state institutions having the relevant license within the established quota-based limits;
• Storage of narcotic substances must be organized in specially equipped rooms given the special rules stipulated for the storage of narcotic substances. License is required for storage of narcotic substances;
• Only state unitary enterprise can import Cannabis pursuant to relevant license for import of narcotic substances.

 

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

The production of Cannabis is prohibited. Cannabis might be imported for scientific and expertise purposes only.

 

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

Production of Cannabis, including Medicinal Cannabis, is prohibited. Import of Cannabis for the scientific and expertise purposes can be performed only by state unitary enterprises and state institutions having the relevant license.

 

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

Marketing and distribution of Cannabis, including Medicinal Cannabis, is prohibited.

 

18. How can patients obtain Medicinal Cannabis?

Cannabis is prohibited to be used for medical/treatment purposes. Patients cannot obtain it.

 

19. Who can prescribe Medicinal Cannabis?

Cannabis is prohibited to be used for medical/treatment purposes.

 

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

No.

 

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

Cannabis is prohibited to be used for medical/treatment purposes.

 

22. Where is Medicinal Cannabis available?

Cannabis is not available for medical/treatment use.

 

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

No.

 

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

No.

 

 

Opioid Drugs

25. Are Opioid Drugs authorized in your country?

It depends on the Opioid Drug in question. Opioid Drugs are regarded as narcotic drugs, thus there are several types of them: (a) Opioid Drugs, for which distribution within the Russian Federation is prohibited (prohibited Opioid Drugs); (b) Opioid Drugs, for which distribution within the Russian Federation is allowed, however subject to special limitations and controls (admissible Opioid Drugs).

 

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

• Russian Ministry of Health – state authority responsible for establishing requirements as to admissible Opioid Drugs dispensing;
• Russian Ministry of Internal Affairs – the main authority, which handles matters in connection with the distribution, import and export of opioids.

 

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

General rules of medical drugs authorization are applied to admissible Opioid Drugs as well subject to certain special requirements established by the Federal law of 08.01.1998 No. 3-FZ “On narcotic drugs and psychotropic substances”, namely:

• Producing of narcotic substances (i.e. opioids) can be performed only by state unitary enterprises and state institutions having the relevant license within the established quota-based limits;
• Storage of narcotic substances must be organized in specially equipped rooms given the special rules stipulated for the storage of narcotic substances. License is required for storage of narcotic substances;
• Only state unitary enterprise can import admissible Opioid Drugs pursuant to relevant license for import of narcotic substances;
• Special requirements to admissible Opioid Drug’s package (e.g. marking with a double red stripe).

 

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

At the time of this publication there are 13 Opioid Drugs that have received market approval, 9 of them are included in Vital and Essential Drugs list.

For instance, Opioid Drugs with the following INN (International Non-proprietary Name) have received market approval:

• Papaverine;
• Morphine;
• Codeine;
• Codeine+terpin hydrate, etc.

 

29. Who can prescribe Opioid Drugs?

Admissible Opioid Drugs can be prescribed by:

• an individual physician or physician’s assistant or nurse-midwife
• representative person appointed by the director of a healthcare organization,

The prescription for admissible opioid drug shall contain 2 signatures – 1 from each group mentioned above.

 

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

No.

 

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

Approval of a medical panel is required when admissible Opioid Drugs are assigned to the patient for the first time.

 

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

Sale and distribution of Opioid Drugs can be performed only by state unitary enterprises and state institutions having the relevant license.

 

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

No.

 

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

No.

 

35. When are they likely to come into force?

No.

Also from this Legal Handbook

Upcoming reforms in Russia’s pharma environment. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for GBP 99.

 

 

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

1. Functioning of the EAEU common market for drugs and the EAEU common market for medical devices.
2. The authorization of distance selling of OTC drugs subject to the following requirements:
   • The following types of drugs are excluded: prescription drugs, narcotic and psychotropic drugs, alcohol-containing drugs with a volume fraction of ethyl alcohol of more than 25%;
   • Distance selling can only be performed by pharmacy organizations that have both (1) license to carry out pharmaceutical activities and (2) special distance selling permit issued by RZN;
   • Distance selling of drugs is to be compliant with the applicable regulations (including the rules for distance selling of drugs approved by Resolution of the Government of the Russian Federation dd 16.05.2020 No. 697; rules for the sale of goods under a retail sale agreement approved by the Resolution of the Government of the Russian Federation dd 31.12.2020 No. 2463).
3. The Pharmaceutical Register of the EAPO is available on the official website of the EAPO. The Register contains information on Eurasian patents protecting active substances of drugs. The EAPO specifically indicates that the Pharmaceutical Register shall relate to the patents protecting pharmacologically active products (chemical compounds, including those described by the same structural formula, biotechnological products, compositions, combinations), production methods, and medicinal use of the products.
4. The Government of the Russian Federation granted the first compulsory license “in the interests of public security”. In accordance with the Government Decree, Pharmasintez JSC, a Russian generic company, has been granted a 1-year compulsory license to use the inventions of the US companies Gilead Sciences Inc. and Gilead Pharmasset LLC protecting Remdesivir subject to a “fair compensation”.

 

2. When are they likely to come into force?

1. Starting from 01.01.2021 drugs are to be registered under the EAEU Rules only due to the formation of the EAEU common market for drugs. As for the medical devices, their registration under the EAEU rules and procedures becomes obligatory starting from 01.01.2022.
2. The distance selling of OTC drugs is allowed starting from 03.04.2020.
3. The Pharmaceutical Register of the EAPO is available on the official website of the EAPO starting from 01.03.2021.
4. The Decree of the Government of the Russian Federation dd 31.12.2020 No. 3718-r was published on 01.05.2021.

 

3. Alterations to admission to public procurement

Alterations to admission to public procurement of vital essential and necessary drugs, set forth by Government Decree dd 30.11.2015 No. 1289, are adopted by Government Decree dd 12.05.2018 No. 572. A public customer shall decline applications to supply vital and essential drugs originated from foreign countries, which are not the EAEU members if at least one application to supply vital essential and necessary drugs originated from the EAEU member state is filed. All manufacturing stages of such drug, including molecule synthesis for API, shall be operated within the territory of EAEU member states. Such API shall be included in marketing authorization for the drug. The amendments are effective starting from 01.01.2019.

Also from this Legal Handbook

All about patents and trademarks in Russia. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for GBP 99.

 

 

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

PATENTS

The Russian law provides protection for registered inventions, utility models and industrial designs. Pharmaceutical substance is generally protected as an invention. An invention is a technical solution in any field related to a product (inter alia, to a device, substance, microbial strain, or cell culture of plants and animals) or a method/process.

Patent protection can be granted to a product or a method if it is novel over the prior art, has the necessary degree of inventiveness, and is industrially applicable. The prior art includes any information known to the public in the world before the priority date.

 

TRADEMARKS

Trademarks identify goods and services of Russian and foreign legal entities or entrepreneurs. Russian law does not recognize prior use trademarks. Russia grants protection only for registered trademarks within the territory of Russia, including under the Madrid Treaty and Protocol Relating to the Madrid Treaty.

Any protectable word, design, symbol, etc. could be registered as a trademark if it is distinctive and enjoys priority right before other similar designations. The list of signs and symbols for registration is open, which allows the trademark holder to apply for non-traditional marks.

 

2. What agencies or bodies regulate patents and trademarks?

Patents and trademarks are regulated by Federal Service for Intellectual Property (the “Rospatent”). Patents can be registered under Patent Cooperation Treaty and Eurasian Patent Convention. Eurasian Patents are granted by the Eurasian Patent Office (EAPO) located in Moscow.

 

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

PATENTS

Patent for invention may be granted for products, for instance, individual chemical compounds and composition (i.e. pharmaceutical), microorganism strains, cell culture of plants or animals, and processes inventions and methods for treatment, both with medicines and medical procedures.

The following objects shall not be protected as invention due to ethical reasons:

(1) human cloning technologies; (2) technologies for modifying the genetic integrity of human embryo cells; (3) use of human embryos for industrial and commercial purposes; (4) other solutions inconsistent with public interest and moral principles.

The following shall not be patentable:

(1) discoveries; (2) scientific theories and mathematical methods; (3) proposals concerning solely the outward appearance of manufactured articles and intended to satisfy aesthetic requirements; (4) rules and methods of games for intellectual or business activity; (5) computer programs; (6) ideas on presenting information; (7) varieties of plants and animals and biological methods for producing them, except for microbiological methods and products produced by such methods.

There are recent changes to the patent law restricting evergreen patenting. According to the Order of the Russian Ministry of Economic Development dated 31 March 2021 No 155 “On amendments to the Rules for the preparation, submission, and consideration of documents that are the basis for the performance of legally significant actions for the state registration of inventions, and their forms and Requirements for documents of an application for the grant of a patent for an invention, approved by the Russian Ministry of Economic Development dated 25 May 2016 No. 316” (registered on 28 May 2021 No 63664), a form of the known chemical compound, including an isomer, amorphous or crystalline form, or its derivatives (e.g., salt, solvate, ether, etc.) shall not be patented if such a form or a derivative does not exhibit any new unknown properties.

 

TRADEMARKS

Any sign may be registered as trademarks unless it lacks distinctiveness (absolute ground for refusal), including:

(1) it has fallen into the public domain to indicate the goods of a certain kind; (2) is generally accepted symbol and term; (3) characterizes goods, including an indication of their type, quality, quantity, properties, purpose, etc.; (4) represents the configuration of goods that is determined exclusively or mainly by the properties or purpose of the goods.

The designation shall not be registered if it is false or misleading a consumer in respect of goods or its producer; are contrary to public interests, or to principles of humanity or morality. Designations identical or confusingly similar to a registered geographical indication, or protected designation of origin, or applications for such registration with an earlier priority shall not be registered as trademarks with respect to any goods.

As a relative ground, the designation shall not be registered if it is identical, or confusingly similar to protected trademark and trademark applied for registration with respect to similar goods with an earlier priority.

According to Russian case law, the name of a pharmaceutical substance and international nonproprietary name cannot be registered as a trademark.

 

4. How can patents and trademarks be revoked?

PATENTS

The patent shall be found invalid fully or in part upon the claim of any interested third party on the following grounds:

1. the invention fails to meet the criteria of patentability;
2. the documents of an application on the date of filing are inconsistent with the requirement to disclose the essence of the invention;   
3. the claims of the invention contain features that were missing on the filing date in the description of the invention and in the claims for the invention;
4. a patent was granted in respect of several identical inventions, having the same priority date with incompliance to the procedures of the Russian Civil Code;
5. a patent was granted with a false indication of its author or patent holder.

 

TRADEMARKS

Early termination

The trademark may be early terminated in the Intellectually Property Court upon the claim of the interested party due to the non-use within 3 consecutive years before the date of filing the statement of claim.

Under this category of IP disputes, the claimant shall prove his status of an interested party, the respondent has to prove the trademark use for each disputed goods/service apart from cases when the trademark can be deemed as well-known or famous within Russia.

Invalidation

The trademark shall be found invalid fully or in part on the following grounds:

1. trademark protection has been granted in contravention of the absolute grounds for refusal (e.g., the trademark was generally accepted symbol and term);
2. trademark protection has been granted in contravention of the relative grounds for refusal (e.g., the trademark was identical, or confusingly similar to trademarks applied for registration or protected in Russia with respect to similar goods) within five years from the date of trademark registration;
3. a trademark holder lost the status of entrepreneur or a company was liquidated;
4. trademark registration is recognized by antitrust authorities as an abuse of rights or an act of unfair competition.

 

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

Generally, Russia recognizes only patents and trademarks that are registered in Russia or protected under treaties, that are effective within Russia. A foreign patent or trademark may be recognized in Russia under conventional priority provided they meet certain requirements.

PATENTS

Russia has three patent systems for inventions: national, regional, and international. The regional patent system is based on the Eurasian Patent Convention, which is applied by eight members of the Commonwealth of Independent States. Under Eurasian Patent Convention a patent holder is entitled to obtain a united Eurasian Patent. Moreover, Russia is a signatory member of the Patent Cooperation Treaty which enables foreign companies to adhere to patent protection in Russia.

Any person, who has duly filed the first application for a patent in a member state of the Paris Convention, is entitled to enjoy the priority date of the first application in a subsequent Russian application, filed not later than 12 months after the first application.

 

TRADEMARKS

Russia provides national and international registration systems of trademarks (the Madrid Treaty and Protocol Relating to the Madrid Treaty).

Any person, who has duly filed the first application for a trademark in a member state of the Paris Convention, is entitled to enjoy the priority date of the first application in a subsequent Russian application, filed not later than 6 months after the first application.

 

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

Under data exclusivity provisions, it is prohibited to obtain, disclose and use the data of preclinical and clinical trials without the holder’s consent for commercial purposes within 6 years after marketing authorization. Furthermore, the law prohibits any circulation of the registered medicines passes over this restriction.  An application for generic medicine could be filed with Minzdrav after 4 years from the date of market authorization has been issued in respect of reference medicine.

Courts interpreted the term “the date of the preclinical and clinical trials” too narrowly. The Intellectual Property Court in case No. A40-188378/2014 stipulated that the data exclusivity regime could not be applied to the information published in specialized printed editions and shall cover only those clinical trial data provided to Minzdrav within the registration procedure.

 

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

No, there are no particular restrictions to any types of medicines or devices that can be granted patent and trademark protection except those that were mentioned in Question 3.

 

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

There is no difference between a license agreement with a foreign licensor or a national one. Pursuant to the Russian Civil Code, any license agreement must be registered with Rospatent provided that the exclusive rights themselves are subject to registration requirements (e.g. patents, trademarks) in Rospatent. The absence of such registration does not entail invalidity of the license agreement, but transfer or granting of the exclusive right is deemed to not have taken place for third parties.

Also from this Legal Handbook

The lowdown on the situation regarding the product liability in Russian Pharma. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for GBP 99.

 

 

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

There are several types of liability recognized by the Russian Federation, namely:

• disciplinary liability (for disciplinary offenses);
• civil liability (for civil offenses);
• administrative liability (for administrative offenses);
• criminal liability (for criminal offenses),

depending on the type of the committed violations. Either this or that type of liability is applicable.

 

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

The Constitution of the Russian Federation guarantees everyone the right to life, health protection, and medical care. General rules on liability for causing harm are stipulated in the Civil Code of the Russian Federation. Law on Circulation of Drugs contains separate chapter 15 called “Liability for the violation of the legislation of the Russian Federation in the circulation of drugs and compensation for harm caused to the health of citizens as a result of the use of drugs”.

The Civil Code of the Russian Federation regulates only civil liability, while the Law on Circulation of Drugs in Article 68 refers to other types of liability, i.e.

• disciplinary (e.g. for committing a disciplinary offense, that is, failure to perform or improper performance by an employee due to his fault of the duties assigned to him);
• administrative (e.g. for turnover of falsified, counterfeit, poor-quality and unregistered medicines and medical devices);
• criminal (e.g. for the illegal manufacture of medicines and medical devices).

Therefore, disciplinary, administrative, criminal and civil liability can be applied to manufacturers of medicines and devices.

Administrative and criminal liability are specified by the Criminal and Code of Administrative Offenses of the Russian Federation, respectively.

 

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

 

4. How can a liability claim be brought?

Individuals are entitled to bring a claim before a court of general jurisdiction. The limitation period constitutes 3 years.

A state commercial (arbitrazh) court can hold manufacturers administratively liable if RZN decides that the manufacturer produces medicine with poor quality.

The Investigation Committee of the Russian Federation investigates crimes involving the circulation of falsified and counterfeit medicines.

In April 2019, Minzdrav launched the section on Information related to state registration of medicines on its website. This section discloses information on recently filed applications for registration of drugs currently pending before Minzdrav.

Access to this information is particularly significant in harsh competitive conditions on the market and a significant increase of patent disputes in Russia between originators and generics.

Russian law does not recognize registration of generic drugs during the patent validity term as an act of infringement (Para. 2, Art. 1359 of the Civil Code of the Russian Federation).

However, disclosure of information on filed applications will allow patent holders to keep control of any threat of infringement coming from generic registrations. Under the current jurisprudence, the “threat of infringement” takes place when a generic drug obtains a market authorization in Russia over 3 years before the patent expiry (case No. А41-85807/2016).

Moreover, any company seeking to register a new drug (original or generic) shall indicate all patents and trademarks relevant for this new drug. Another obligation is to warrant that registration of this new drug would not infringe any third party’s intellectual rights, under the risk of penalties.

 

5. What defenses are available?

The consumers have the defenses stipulated in the Civil Code of the Russian Federation and the Law “On Consumer Protection”.

In accordance with the current legislation any injured and aggrieved person is entitled to claim compensation for harm both either from the manufacturer or from the seller (Art. 1095, 1096 of the Civil Code of the Russian Federation, Art. 14, 18, 19 of the Law “On Consumer Protection”). Accordingly, the consumer has the right to choose between contractual and tort claims (Ruling of the Russian Supreme Court dd 22.09.2015 No. 66-КГ 15-10). The harm is subject to compensation in full.

In addition to harm, the consumer has the opportunity to claim compensation for moral damage, the “consumer fine” is calculated as fifty percent of the sum recovered, “consumer forfeit”, the compensation of price difference (the difference in the price established by the sale contract and the price of the goods existing on the market).

Also from this Legal Handbook

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

 

 

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

Traditional medicines are treated as nutrition products (dietary products or health supplements, as the case may be) under Russian law. Thus, the basic regulatory requirements for traditional medicines include:

• mandatory confirmation of compliance with requirements of regulatory documents;
• traditional medicines must satisfy the human physiological needs in necessary substances and energy, comply with mandatory requirements of normative documents to the permissible content of chemical (including radioactive), biological substances and their compounds, microorganisms, and other biological organisms representing health hazard to present and future generations;
• manufacturing is to be carried out in accordance with technical documents, subject to the requirements of regulatory documents;
• for the manufacturing only raw nutrition materials, which quality and safety meet the requirements of regulations, shall be used; it is not allowed to use raw nutrition materials produced with the use of supplementary feeds, animal growth stimulants (including hormonal drugs), separate kinds of medicines, pesticides, agrochemicals, and other substances and connections hazardous to human’s health.

Herbal medicines are considered as drugs, thus, regulatory requirements for herbal medicines are the same as requirements for drugs in general.

 

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

Traditional medicines can be advertised directly to the public given the requirements provided by law for such advertising.

Ground rules for advertising of traditional medicines are envisaged in the Federal Law dd 13.03.2006 No. 38-FZ “On advertising”. Namely, advertising of traditional medicines must not:

• create the idea that they are drugs and/or possess any healing properties;
• contain a reference to specific cases when people have been cured when their condition has improved as the result of using such supplements;
• contain an expression of gratitude by individuals in connection with the use of such supplements;
• incite somebody to refuse to practice healthy nutrition;
• create the impression that such supplements have an advantage by referring to the fact of completion of research that is compulsory for the state registration of the supplements, and also to use the results.

Herbal medicines can be advertised directly to the public considering general drug advertising rules (for more details, please, refer to Question 20 in “Marketing, Manufacturing, Packaging, and Labelling Advertising” Chapter).

 

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

The following information shall be provided in Russian:

• name of the product
• nutritional value (caloric content, protein, fat, carbohydrates, vitamins, macro-and microelements);
• appointment and conditions of application;
• storage conditions (if certain requirements are established);
• date of manufacture and date of packaging;
• exp. date;
• manufacturer.

Herbal medicine must have the inscription “the products have passed radiation control” on its secondary (consumer) package.

 

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

Regulatory requirements for over-the-counter (OTC) drugs are the same as requirements applied to drugs in general.

 

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

OTC drugs can be sold in drug stores, healthcare organizations, or by sole entrepreneurs that have a license to carry out pharmaceutical activities, including retail pharmaceutical trading.

 

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

General labeling rules are applied (please, refer to Question 14 in ‘’Marketing, Manufacturing, Packaging and Labelling Advertising’’ Chapter). The “Over-the-counter use” mark shall be specified in Russian.

 

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

Yes, according to the Federal Law dd 13.03.2006 No. 38-FZ “On advertising” OTC products can be advertised directly to the public. In an advertisement, an announcement of an OTC product’s properties and characteristics is permitted only to the extent of indications contained in instructions for application of such objects of advertising that are approved in the established procedure. Moreover, an advertisement shall be accompanied by a warning of the existence of counter-indications for the application and use thereof, as well as the necessity to be read the instruction or to consult with the specialist.

 

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

Before 2011 there was a list of OTC products kept by Minzdrav. However, lately, it was nullified. As of now, there are no requirements established by Russian laws as for the procedure for the transfer of the drug to non-prescription one and the criteria for classifying the drug in this category.

However, this issue is clarified on the supranational level within the EAEU.

In general, criteria for classifying a drug as prescription-only are the following:

• even when properly used, but without medical supervision can cause direct or indirect harm to human health;
• often used incorrectly and, as a result, can cause direct or indirect harm to human health;
• contain substances or compounds, the effect of which and (or) undesirable reactions to which are not sufficiently studied (subject to further study);
• are administered extrabuccal (usually) (i.e. escaping the gastrointestinal tract, e.g. intravenous injection).

Consequently, if a drug fulfills at least one of the aforementioned criteria, then this drug is to be regarded as prescription-only.

 

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

Importation of traditional medicines is carried out based on a decision of the customs authority, made upon the results of the documentary inspection. At the same time, a contract for the supply of nutrition products, including dietary food, should contain mandatory obligations to comply with the requirements of regulatory documentation about nutrition products. Importation is prohibited if the nutrition product has not passed the procedure of its state registration.

It is possible to import OTC drugs, which quality is confirmed by the certificate of their manufacturer, certifying compliance of imported drugs with the requirements of pharmacopeia monograph or, in its absence, – requirements of regulatory documentation or regulatory document. The importer who intends to import OTC drugs must have the relevant admittance issued by Minzdrav.

Also from this Legal Handbook

Learn more about marketing, manufacturing, packaging & labeling, and advertising in Russian pharma. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, 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?

The authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications has been already covered by Question 3 in Regulatory, Pricing, and Reimbursement Overview.

In addition, biomedical cellular products (the “BCP”), i.e. products containing cultivated living cells of humans, used in various studies and medicine, can be classified as “other medicinal products”.

BCP authorization process includes obligatory receiving of marketing authorization. BCP manufacturers can only distribute them to:

• other BCP manufacturers for BCP manufacturing;
• scientific organizations, education organizations for carrying out scientific research;
• healthcare organizations.

 

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

The authorization process for a generic drug is similar to authorization of the original drug, more simplified though. In particular, no personal preclinical and clinical trials are required from the applicant, bioequivalence trials are required instead.

 

3. What are the typical fees for marketing approval?

The government fees for marketing authorization issuance are the following:

• for a drug: around USD 135 (RUB 10 000);
• for a medical device: around USD 95 (RUB 7 000);
• for a BCP: around USD 70 (RUB 5 000).

Besides, additional fees are incurred before the registration process with governmental authorities (e.g. production fees, expert examination fees, etc.).

 

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

Drugs: marketing authorization validity for a drug to be registered for the first time is 5 years. Upon the expiration of this 5-year term, the marketing authorization can be renewed for an indefinite term subject to confirmation of its registration (re-registration). In some cases (due to pharmacovigilance issues), a renewed marketing authorization can be issued for 5 years.

Marketing authorizations of those drugs that (A) were registered under national rules (under Russian laws) before 2021; and (B) have valid Russian marketing authorization, are valid until their expiration date, but no later than December 31, 2025. For these drugs, the procedures for making changes and confirming their registration in compliance with the EAEU regulations will be available until December 31, 2025.

Medical devices: marketing authorization is granted for an unlimited period.

BCP: the first marketing authorization is issued for 5 years. Upon the marketing authorization’s expiration, the marketing authorization must be renewed every 5 years (the number of renewals is unlimited) subject to confirmation of its registration.

 

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

Marketing authorization for some drugs may be issued subject to the fulfillment of certain obligations if the applicant can confirm (justify) that it is impossible to provide complete data on the effectiveness and safety of the drug under normal conditions of its use for one of the following reasons:

• The drug’s intended indications for use are so rare that the applicant cannot reasonably expect to receive comprehensive confirmation of the evidence of the effectiveness and safety of the drug;
• Complete information about the effectiveness or safety of the drug cannot be provided with the existing scientific methods of research;
• Obtaining information about the efficacy or safety of the drug would be contrary to generally accepted principles of medical ethics.

Registration under the conditions may include the following:

• The applicant must complete, within the time limit set by the authorized body of the member state, a certain safety or effectiveness research program, the results of which should allow for a reassessment of the benefit-risk ratio;
• The drug in question can only be dispensed by prescription and to be used in certain cases only under strict medical supervision, possibly in a hospital, and in the case of radiopharmaceuticals under the supervision of a specially authorized person;
• The instruction for medical use, company core data sheet, marketing authorization, and any medical information must contain information that draws the attention of the medical professional to the fact that the available characteristics of the drug in question are insufficient in terms of confirming certain aspects of the effectiveness or safety of the drug.

If a drug is registered under the conditions, its marketing authorization has an annex specifying these conditions (restrictions for the use, additional obligations that must be fulfilled by the marketing authorization holder).

Besides, each marketing authorization holder must carry out the reception, accounting, processing, analysis, and storage of all notifications received about side effects, adverse reactions, serious adverse reactions (including unexpected) with the use of drugs or medical devices, about the individual intolerance, lack of efficacy of medicinal products, as well as about other facts and circumstances that represent a threat to the life or health of a human with the use of drugs. All such notifications must be reported to state authorities.

 

6. Are foreign marketing authorizations recognized?

Yes, but only those that are issued within the EAEU and recognized under the EAEU Rules.

 

7. Are parallel imports of medicines or devices allowed?

Until 2018 parallel imports of goods were treated similarly to import of counterfeit products and hence prohibited in Russia. Any trademarked goods could be brought into circulation within Russia or members of the Eurasian Economic Union only by the trademark holder or with their consent. Besides, the recent approach of Federal Antimonopoly Service (decisions on cases No. 1-14-163/00-08-18 and 1-14-164/00-08-18) is that the right holder’s ignoring or groundlessly rejecting to permit the import of the goods for the potential importers both constitute an act of unfair competition.

In early 2018, the Constitutional Court checked the validity of the regime of parallel imports and related legal remedies. The Constitutional Court recognized the provisions of the Civil Code of the Russian Federation as valid and compliant with the Constitution. However, the Constitutional Court restricted IP holders’ authority to control the importation of goods into Russia and legalized parallel imports of goods.

According to the Constitutional Court’s approach:

• the court may dismiss the claim of the trademark holder wholly or in part, reduce the amount of compensation if the holder acts in bad faith, i.e. restricts the import of particular goods into the territory of Russia, which results in selling goods at inflated prices;
• the court may not impose the same civil liability on importers of original products and importers of counterfeit products.
• parallel imported original goods cannot be confiscated and destroyed, if only such goods bring inadequate quality or pose a risk of negative influence to human health, nature preservation, or cultural values.

 

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?

Medical practitioners must comply with the following limitations in their interactions with organizations engaged in the development, production, and (or) sale of drugs, medical devices, organizations that have the rights to use the trade name of a drug, organizations that wholesale drugs, pharmacy organizations (their representatives, other individuals and legal entities that carry out their activities on behalf of these organizations) – medical practitioners are not allowed to:

• accept gifts, cash (unless it’s a fee for conducting clinical trials or scientific and(or) pedagogic activities), including payment for entertainment, recreation, travel to the place of rest, as well as participate in sponsored entertainment events;
• agree on the appointment or recommendation of drugs, medical devices to patients*;
• receive samples of drugs, medical devices for further delivery to patients*;
• have appointments with their representatives for the purposes not related to the conduct of clinical trials of drugs and medical devices or participation in activities aimed at improving the professional level or providing information related to the implementation of monitoring the safety of drugs and medical devices.

* Except for cases related to the conduct of clinical trials of drugs and medical devices

 

Besides, medical practitioners are not allowed to:

• when prescribing a course of treatment to a patient, provide false and (or) incomplete information about the used drugs and medical devices, including hiding information about the availability of similar drugs and medical devices;
• issue prescriptions for medicinal drugs, medical devices on forms that contain advertising information.

 

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

The EAEU Good Manufacturing Practice (approved by the decision of the Council of the Eurasian Economic Commission dd 03.11.2016 No. 77) entails basic provisions for the manufacturing of drugs. As for the manufacturing of medical devices, some basic grounds are established by the Law on Fundamental Healthcare Principles, more specific requirements are enumerated in “Rules of State Registration of Medical Devices” approved by Regulation of the Government of the Russian Federation dd 27.12.2012 No. 1416.

Minzdrav is a Russian governmental body responsible for enforcing the regulatory framework concerning drugs and medical devices.

 

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

Provisions of the EAEU Good Manufacturing Practice are similar to GMPs as defined by the U.S. Food & Drug Administration and/or the European Medicines Agency and include a lot of their adopted provisions. However, not all provisions are identical.

 

11. What is the inspection regime for manufacturing facilities?

Manufacturing facilities can be inspected within licensing supervision measures on both scheduled and unscheduled basis. Russian state authority responsible for such inspections is:

• for medical drugs: Russian Ministry of Industry and Trade and its subordinated authorities;
• for veterinary drugs: Federal Service for Veterinary and Phytosanitary Surveillance and its subordinated authorities;
• for medical devices: Minzdrav.

All inspections are aimed at ensuring the manufacturer’s compliance with the requirements of laws for the manufacturing process management and quality control. Negative results of such inspections can entail revocation of the marketing authorization.

In addition, each manufacturer is responsible for conducting self-inspections as well.

 

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

Manufacturing facilities can be examined by foreign inspectors or third-party inspectors only within self-inspection conducted by the manufacturer. Such inspections can involve independent inspectors as well. In other cases, inspections are to be held by employees of the relevant authorized authority with special knowledge and period of service.

 

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

The drug storage rules establish the basic requirements for the premises, equipment, as well as storage management of drugs. Requirements are classified in accordance with the composition and characteristics of drugs: there are requirements for flammable and explosive drugs, drugs that require protection against sunlight, moisture, evaporation, thermal effect, gases, etc. Besides, drugs are also placed indoors considering the requirements that are specified on the package.

Certain requirements are stipulated for medical device storage depending on the material they are made of. Moreover, for each type of product-specific requirements are set as for the premise where the product is stored (e.g. sunlight protection, temperature conditions), the order of products’ placement in storage (chronological, alphabetical). Besides, special conditions are envisaged for some types of products.

Requirements for packaging are covered by Questions 14-15 of this Chapter.

 

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

Drug labeling must include essentially the following information on the secondary (consumer) package:

• medicinal product name (INN or generic name, or chemical and brand name);
• manufacturer’s name;
• batch number;
• marketing authorization number;
• best before date;
• drug route (usage method);
• dosage or concentration;
• volume;
• strength measured in units of the activity or dose number per package;
• pharmaceutical form;
• prescription status;
• storage requirements;
• cautionary warning;
• bar code;
• two-dimensional bar code for track and trace.

 

The general rule is that labeling information must be in Russian and easy to read.

Starting from July 01, 2020, a two-dimensional bar code for track and trace is mandatory for drug circulation. A two-dimensional bar code for track and trace makes it possible to monitor a drug’s movement from manufacturer to end-consumer. Drugs passed to circulation before the specified date keep valid till the expiry.

Additional requirements may be established for the specific type of drug or its production conditions: e.g. for homeopathic drug information “homeopathic” must be included as well; for drugs to be used in clinical trials information “to be used in clinical trials” must be additionally set forth, etc.

Devices labeling must include essentially the following information on the secondary (consumer) package:

• product name (type and/or brand name);
• identification information (designation);
• manufacturer’s information (might be excluded from consumer pack if specified in package leaflet) and representative information for the products manufactured not in the territory of the EAEU;
• information about medical drug or biological materials containing in a device;
• batch and serial number (might contain the date of production);
• best before date;
• storage and/or circulation requirements;
• information on sterility and sterilization method (if applicable for device type);
• cautionary warning.

Additional requirements may be established for a specific type of device or its production conditions: e.g. for single-use devices, individually produced devices, demonstrational devices.

 

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

Additional information may be included in the secondary (consumer) package given its compliance with the drug’s registration dossier.

 

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

The applicable regulations in Russia and the EAEU mainly establish only the list of mandatory information to be included in labeling. The list of prohibited information is not explicitly stated. However, based on the existing regulations, for instance, the following information cannot be included:

• Information that is not compliant with the drug’s registration dossier;
• Selective information specified in “clinical data” and “pharmacodynamic properties” sections of the general characteristics of the drug and the equivalent sections of the instructions for medical use (leaflet) of this drug.

 

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

Firstly, activities on the production of drugs as well as pharmaceutical activities are licensed (Art. 12 of the Federal Law “On licensing of certain types of activities”).

Secondly, state regulation of prices for drugs is carried out in the Russian Federation. Manufacturers set the maximum selling price on drugs from EDL (please, refer to Question 12 in “Regulatory, Pricing, and Reimbursement Overview” Chapter) in accordance with the methodology established by the Government of the Russian Federation. Further, the maximum selling price is subject to registration. The executive bodies of subjects of the Russian Federation establish the maximum amounts of wholesale mark-ups and the maximum amount of retail mark-ups to actual selling prices.

As for the advertising requirements, general advertising rules established by Art. 5 of the Federal Law dd 13.03.2006 No. 38-FZ “On Advertising” are to be applied together with special rules for advertising of drugs and medical devices established by Art. 24 of the said Federal Law.

Special rules for advertising include the following:

The advertising of drugs and medical devices shall not:

• be addressed to minors;
• contain references to specific cases of curing diseases, improving the health of a person as a result of using such a drug;
• express gratitude to individuals in connection with the use of such a drug;
• create an idea of the advantages of such a drug by reference to the fact of carrying out research (pre-clinical and clinical studies) that is mandatory for the state registration;
• contain statements or assumptions about the presence of certain diseases or health disorders with the consumers;
• create an impression with a healthy person of a need to use the advertised drug;
• create an impression of being unnecessary to apply to a doctor;
• guarantee the positive effect of the advertised drug (medical device), its safety, effectiveness, and the absence of side effects.

 

The advertising of drug also shall not:

• represent a drug as a biologically active additive and food supplement or other non-medical product;
• contain statements that the safety and (or) effectiveness of the advertised drug are guaranteed by its natural origin.

 

Posting in advertising about the properties and characteristics of drugs and medical devices shall be permitted only within the indications contained in the duly approved instructions for application and use of the advertised drug (medical device).

Advertising of prescription drugs is prohibited in the Russian Federation as well as advertising of drugs or psychotropic substances permitted for use in medical purposes listed in narcotic drugs and psychotropic substances, the turnover of which is limited in accordance with the Russian legislation.

It is forbidden to conduct advertising campaigns accompanied by a distribution of samples of drugs containing narcotic drugs and psychotropic substances.

Any advertising messages must comply with the instructions for the use of the drug.

Advertisements of drugs and medical devices must generally include information about the presence of contraindications to use drugs (medical devices), the need to review the instructions for use, or consult experts. In advertisements distributed in radio programs, the duration of such a warning should be not less than 3 seconds; in TV programs and film and video services – not less than 5 seconds and should be allocated not less than 7% of the area of the space, and in advertising distributed in other ways – not less than 5% of the advertising space. This obligation is not applied to the advertisements to be distributed in the venues of medical or pharmaceutical exhibitions, seminars, conferences, and other similar events, as well as in specialized printed publications intended for medical and pharmaceutical practitioners, and to other advertising, the consumers of which are exclusively medical and pharmaceutical practitioners.

 

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

Drugs can only be sold in pharmacy stores, healthcare organizations, or by sole entrepreneurs that have a license to carry out pharmaceutical activities, including the retail pharmaceutical trade. Prescription drugs can be sold only upon the doctor’s prescription.

Besides, starting from April 03, 2020, distance selling of drugs is allowed subject to the following requirements:

• The following types of drugs are excluded: prescription drugs, narcotic and psychotropic drugs, alcohol-containing drugs with a volume fraction of ethyl alcohol of more than 25%;
• Distance selling can only be performed by pharmacy organizations that have both (1) license to carry out pharmaceutical activities and (2) special distance selling permit issued by RZN;
• Distance selling of drugs is to be compliant with the applicable regulations (including the rules for distance selling of drugs approved by Resolution of the Government of the Russian Federation dd 16.05.2020 No. 697; rules for the sale of goods under a retail sale agreement approved by the Resolution of the Government of the Russian Federation dd 31.12.2020 No. 2463).

Delivery of drugs ordered via distance selling is carried out by an employee of the pharmacy organization or another (third-party) organization under the relevant agreement. When delivering orders containing thermolabile drugs, vehicles are used to ensure the maintenance of the required temperature regime, or other appropriate equipment (isothermal packaging, thermal container, etc.).

 

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

There are no special requirements and restrictions for individual channels, general and special rules for advertising of drugs and medical devices are to be applied (please, refer to Question 17). Different social media can establish their additional requirements for advertising posts and sanctions for the failure to comply with them (e.g. blocking a user’s account).

 

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

Drugs and medical devices may be advertised or sold directly to consumers, which is subject to certain restrictions provided by law (please, refer to Questions 17-19). Medical devices which use and operation require special skills (for instance, coronary stents) may be advertised on special events, organized among and for healthcare professionals.

Medicines and medical devices can be sold either with a doctor’s prescription or without it dependent on whether the drug is of prescriptive or OTC type. That is, for prescription drugs and medical products, there is an additional requirement to pre-receive a doctor’s prescription, but in this case, the sale itself is carried out directly.

 

21. How is compliance monitored?

Compliance in the sphere of healthcare is carried out by RZN and its territorial bodies (Chapter 13 of the Law on Circulation of Drugs).

Compliance in the sphere of advertising in the context of healthcare is carried out by the Federal Antimonopoly Service (FAS of Russia).

 

22. What are the potential penalties for noncompliance?

Depending on the type of committed noncompliance, either administrative or criminal liability is envisaged.

Also from this Legal Handbook

All about preclinical and clinical trial requirements in Russia. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, 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?

Under the EAEU regulations, clinical trials are to be conducted in the EAEU in compliance with the Good Clinical Practice of the EAEU (approved by the decision of the Council of the Eurasian Economic Commission dd 03.11.2016 No. 79).

 

2. How are clinical trials funded?

Subject to Art. 42 of the Law on Circulation of Drugs clinical trials may be funded with budgetary funds, funds of the developer of the drug, and other sources. The EAEU regulations do not include any specific provisions on this issue.

 

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

Preclinical data shall be collected to justify whether clinical trials can be conducted and are subject to the EAEU Good Laboratory Practice. The developer of the medical product shall maintain the study plan (protocol) of such preclinical trials. The study plan (protocol) for preclinical trials must include the main objectives, methodology, procedures, statistical aspects, organization, and resource planning of the preclinical trial (including its stages and parts), as well as measures to ensure the security of the systems involved. The study plan must be approved by the director of studies, test facility management, and sponsor of the trial, if this is required by the legislation of the member states of the EAEU or the legislation of the member state where the preclinical trial is conducted.

Clinical trial protocols must describe the objectives, design, methodology, statistical methods, and organization of the trial subject to the EAEU Good Clinical Practice. In addition, the clinical trial protocol usually contains previously obtained data and the rationale for the trial. The clinical trial protocol must be approved by the Institutional Review Board (Independent Ethics Committee).

Essentially, clinical trials are subject to ethical guidelines, rights, and welfare of human beings.

 

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

Participation of a patient in a clinical trial shall be voluntary and subject to his/her written informed consent that may be revoked.

 

5. May participants in clinical trials be compensated?

Under the EAEU Good Clinical Practice, participants may be compensated.

The Institutional Review Board (Independent Ethics Committee) reviews the amount and procedure of payments to the participants to ensure that there is no unreasonable interest or coercion of the participants. The number of payments to participants may be proportional to their participation in the trial but should not depend solely on whether the subject has fully completed the study or not.

Besides, the Institutional Review Board (Independent Ethics Committee) must ensure that the information about payments to participants, including the methods, amount, and procedure for payments, is reflected in the written informed consent and any other materials provided to the participants. The procedure for determining the amount of payments must be specified.

 

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

The risks of the participants shall be subject to compulsory insurance, as provided by Art. 44 of the Law on Circulation of Drugs. The minimum value of compensation in case of occurrence of each type is stated by the law.

Also from this Legal Handbook

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

 

 

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

The authorities responsible for applying and enforcing the regulatory framework shall be:

• concerning drugs and biologicals – the Ministry of Healthcare of the Russian Federation (the “Minzdrav”) and the Federal Service for Surveillance in Healthcare (the “RZN”);
• concerning medical devices – RZN.

 

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

The regulatory framework for pricing and reimbursement of drugs and biologicals includes Federal Law dd 21.11.2011 No. 323-FZ “On Fundamental Healthcare Principles in the Russian Federation” (the “Law on Fundamental Healthcare Principles”), Federal Law dd 12.04.2010 No. 61-FZ “On Circulation of Drugs” (the “Law on Circulation of Drugs”), which provisions are supplemented with the regulations, adopted by the Government of the Russian Federation and Minzdrav.

Russia, being the member state of the Eurasian Economic Union (the “EAEU”), complies with the EAEU provisions regarding the formation of the Common Market of medicines and medical devices under Art. 30 and Art. 31 of the Eurasian Economic Union Treaty dd 29.05.2014. Starting from 2021, authorization (i.e. registration) of new medical drugs in Russia is performed under the regulations of the EAEU that include the Rules of registration and examination of medical drugs approved by the decision of the Council of the Eurasian Economic Commission dd 03.11.2016 No. 78 (the “EAEU Rules”) and other applicable regulations of the EAEU.

The are no specific requirements for the pricing of drugs in the private sector, except common antitrust regulations that shall be considered. As well there is no reimbursement in the private sector. As for the public sector and the drugs included in the list of vital essential and necessary drugs, please, refer to Question 12.

The regulatory framework for authorization, pricing and reimbursement of medical devices includes the Law on Fundamental Healthcare Principles, the provisions of which are supplemented with the regulations, adopted by the Government of the Russian Federation and Minzdrav. Starting from 2022, registration of new medical devices is to be performed under the applicable EAEU regulations. Before that registration of new medical devices can be performed under national laws.

Cl. 2 Art. 38 of the Law on Fundamental Healthcare Principles provides for the segregation of medical devices for classes, depending on the degree of the potential risk of use of medical devices, and types, depending on the nomenclature classification of medical devices (i.e. the purpose of their use), that is set forth by Decree of Minzdrav dd 06.06.2012 No. 4н. The class of the medical device affects its registration, i.e. procedure for obtaining marketing authorization (please, refer to Question 4 ), and post-registration control.

The classes of the medical devices include the following:

• class 1 – medical devices with a low degree of risk (for instance, medical gauze);
• class 2b – medical devices with an increased degree of risk (for instance, solution for lens);
• class 2a – medical devices with an average degree of risk (for instance, X-ray apparatus);
• class 3 – medical devices with a high degree of risk (for instance, coronary stent).

The are no specific requirements for the pricing of medical devices in the private sector, except common antitrust regulations that shall be considered. As well there is no reimbursement in the private sector. As for the public sector, please, refer to Question 12.

 

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

The manufacturers or their authorized representatives in Russia shall obtain marketing authorization from Minzdrav for drugs and biologicals and from RZN – for medical devices. The registration procedures are outlined in Administrative regulations of Minzdrav on the provision of state services for the state registration of medical drugs intended for circulation in the EAEU common market of medical drugs under the EAEU Rules in respect of drugs, and by the Law on Fundamental Healthcare Principles and supplementary regulations of the Government of the Russian Federation and Minzdrav – in respect of medical devices.

3.A. DRUGS

The EAEU Rules provide for 2 different registration procedures:

1. Mutual recognition procedure
2. Decentralized procedure

A. Mutual recognition registration procedure

Within this procedure, the applicant chooses one of the EAEU member states as a reference state that will be responsible for a full-fledged cycle of procedures, including tests and inspections, resulting in an expert report. In other chosen member states (recognition states) only examination of the expert report from the reference state and particular modules of the registration dossier takes place. Registration in the reference state is first completed and then recognition in other EAEU member states (recognition states) follows. The applicant independently chooses the reference state and recognition state(s) between the EAEU member states.

The steps to obtain marketing authorization and approval timeframes through the mutual recognition procedure in the reference state shall be as follows:

• Step 1. Pre-registration stage

Preparation of documents to be filed with Minzdrav:

• • Application, confirmation of the fee payment, samples of drugs, and registration dossier that includes 5 modules:
    • Module 1: Administrative Information;
    • Module 2: Summaries of Common Technical Document;
    • Module 3: Quality;
    • Module 4: Non-clinical (preclinical) reports;
    • Module 5: Clinical reports.

• Step 2. Registration of a drug

• • Minzdrav verifies the completeness and accuracy of the documents submitted within the registration dossier within 14 working days from the date of filing an Application for registration;
  • Minzdrav appoints assessment of a medicinal product by an expert organization of a reference state, it is possible to appoint a pharmaceutical inspection (in parallel with the assessment, no more than 180 calendar days);
  • Minzdrav draws up the final expert report;
  • Within 10 working days after drawing up the final expert report:
    • Issuance of a registration certificate to the applicant;
    • Placement of information about a medicinal product in the Common Register.

 

The timeframes for Step 2 (the whole registration process in the reference state) shall be within 210 calendar days upon the receipt of the application and the relevant documents by Minzdrav.

The steps to obtain marketing authorization and approval timeframes through the mutual recognition procedure in the recognition state shall be as follows:

• Step 1. Pre-registration stage

Preparation of documents to be filed with the competent authorities (assessment organization) of such member states:

• • Application, Confirmation of the fee payment, and Module 1 of the registration dossier. Instructions for medical use and packaging layouts may also be required depending on the national legislation of the specific EAEU member state chosen as the recognition state.

• Step 2. Registration of a drug

• • The applicant submits a request to the authorized body of the reference state to open access to the Registration dossier and expert report;
  • The assessment of the drug includes:
    • Evaluation of the application and information provided in the registration dossier;
    • Evaluation of the expert report prepared in the reference state.
  • No later than 90 calendar days (in the absence of disagreements between the authorities of the relevant member state and the reference state) from the date of granting such access, the registration of the drug takes place;
  • Within 10 working days:
    • Issuance of a registration certificate to the applicant;
    • Placement of information about a medicinal product in the EAEU common register.

 

B. Decentralized registration procedure

Under decentralized procedure registration both in reference state and in recognition state(s) take place simultaneously.

• Step 1. Pre-registration stage.

• • Preparation of documents to be filed with Minzdrav (reference state): Application, Confirmation of the fee payment, samples of drugs, and registration dossier;
  • Preparation of documents to be filed with the competent authorities (assessment organization) of recognition state(s): Application, confirmation of the fee payment, and module 1 of the registration dossier. Additional documents may also be required depending on the national legislation of the specific EAEU member state chosen as the recognition state.

• Step 2. Registration of drug

• • The assessment of the drug by the competent authorities (assessment organization) of the reference state and the states of recognition:
  • Within 90 calendar days from the date of the beginning of the assessment, the competent authorities (assessment organization) of the reference state prepares a preliminary report and sends copies of this report with commentaries and a request to the applicant to the authorized bodies of the recognition state(s);
  • The authorized bodies of the recognition state, no later than 30 calendar days from the date of receipt of the preliminary report, shall send requests to the authorized body of the reference state;
  • The reference state, within 5 working days from the date of receipt of the request from the recognition state, prepares a single request and sends it to the applicant. The total term for the applicant to respond is within 180 calendar days;
  • Preparation of the final expert report and issuance of a registration certificate (205th calendar day from the date of applying for registration).

The timeframes for Step 2 should take not more than 210 calendar days. More time may be required for answering additional requests and in the case of other complications.

 

Generics

Applicants for marketing authorizations of generic drugs shall generally prove that their products are bioequivalent to the brand-name product under the EAEU regulations for conducting bioequivalence studies of drugs, and clinical trials are not conducted. Additionally, the EAEU Rules provide for specific requirements for the documents of the registration dossier of a generic drug accordingly.

 

Orphan drugs

According to the EAEU Rules, to orphan drugs, the main provisions of Part II (registration on conditions) may be applied. The applicant must justify in the preclinical and clinical summaries the reasons why it is not possible to provide complete information and provide a justification for the balance of benefits and risks for the orphan drugs in question.

Also, the submission of samples, specific reagents, and other materials is not required if it is impossible to conduct tests in an expert organization due to the inaccessibility of samples of medicinal products (if they are classified as an orphan), the impossibility of observing the conditions for transporting these samples to the territory of the member state and (or) their storage, lack of special equipment and consumables in an expert organization.

 

Biologicals

According to the EAEU Rules, there are special requirements for the documents of Module 3 of the registration dossier of biologicals.

 

3.B. MEDICAL DEVICES

The steps to obtain marketing authorization and approval timeframes for medical devices shall be as follows:

• Step 1. Pre-registration stage: Preparation of documents, which include:

• • Testing of medical devices:
    • Technical;
    • Toxicological;
    • Approval of measuring instruments (if applicable).
  • Preparation of documents for state registration of medical devices

• Step 2. Registration of medical devices (Stage I)

• • RZN reviews the documents submitted;
  • RZN appoints the examination with the state institution and such institution examines the quality, effectiveness, and safety of medical devices based on the documents submitted;
  • RZN permits to conduct clinical trials.

• Step 3. Clinical trials of medical devices, that are conducted by the applicant (state registration shall be suspended)

• Step 4. Registration of medical devices (Stage II):

• • RZN reviews the documents submitted;
  • RZN appoints the examination with the state institution and such institution examines the completeness and the results of trials;
  • RZN approves state registration and issues marketing authorization.

The timeframes for Stage I (Step 2) and Stage II (Step 4) shall be 88 business days (58 days for registration activity exercised by RZN and 30 business days for examination conducted by budgetary institution reported to RZN). The term for clinical trials is not included.

 

 

4. What are the approximate fees for each authorization?

According to Art. 333.32.1 – 333.32.2 of the Tax Code of the Russian Federation, government fees shall be as follows:

• for drugs and biologicals:
  • for issuing of marketing authorization – around USD 135 (RUB 10 000);
  • for examination of a drug at its registration – around USD 4 370 (RUB 325 000).

 

• for medical devices:
  • for issuing of marketing authorization – around USD 95 (RUB 7 000)
  • for quality, efficiency, and safety examination of a medical device at its state registration (dependent on the class of potential risk):
    • class 1 – around USD 605 (RUB 45 000);
    • class 2a – around USD 875 (RUB 65 000);
    • class 2b – around USD 1 145 (RUB 85 000);
    • class 3 – around USD 1 550 (RUB 115 000).

 

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

Under Cl. 18 of the EAEU Rules, marketing authorization validity for a drug to be registered for the first time is 5 years. Upon the expiration of this 5-year term the marketing authorization can be renewed for an indefinite term subject to confirmation of its registration (re-registration). In some cases (due to pharmacovigilance issues), a renewed marketing authorization can be issued for 5 years.

Marketing authorizations of those drugs that (A) were registered under national rules (under Russian laws) before 2021; and (B) have valid Russian marketing authorization, are valid until their expiration date, but no later than December 31, 2025. For these drugs, the procedures for making changes and confirming their registration in compliance with the EAEU regulations will be available until December 31, 2025.

According to Cl. 6 of Regulation of the Government of the Russian Federation dd 27.12.2012 No. 1416 marketing authorization for a medical device shall be issued for an indefinite term.

 

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 differences between the brand-name and generic product authorization process are covered in Question 3. In general, the differences are that for brand-name products it is necessary to demonstrate safety and efficiency, and for generic products it is required to demonstrate bioequivalence.

There are no differences for local manufacturers versus foreign-owned manufacturers in terms of marketing authorization.

 

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

Combination products shall be subject to marketing authorization. Combination products may be classified either as drugs or medical devices depending on the product’s basic purpose and effects on the human body. Separate elements of such products can be registered as a separate drug or medical device as the case may be.

 

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?

RZN has a permanent pharmacovigilance program, that is based on information on possible adverse effects of the drugs submitted, among others, by manufacturers, distributors, drug stores, healthcare institutions. Moreover, according to Cl. 22 of Art. 18 of the Law on Circulation of Drugs the holder of the marketing authorization shall submit a pharmacovigilance report to RZN on the registered drug regularly, as specified by the law.

Besides, the EAEU member states cooperate with respect to the registered drugs under the EAEU Good Pharmacovigilance Practice.

RZN as well monitors the registered medical devices based on notices submitted by the persons specified above and by individuals, as well.

Generally, RZN supervises pharmaceutical activities, supervision of production, manufacture, quality, efficiency, safety, turnover, and procedures for the use of medicinal products, which include the abovementioned pharmacovigilance activities. The regulatory regime in Russia is comparable to those conducted by U.S. Food and Drug Administration or the European Medicines Agency.

 

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

RZN is authorized to make on-site visits at any time to inspect premises and verify such compliance and may indicate ex officio legal proceedings to sanction non-compliance. Ultimately these legal proceedings may result in sanctions ranging from administrative fines up to revocation of the marketing authorizations and suspension of circulation of the medical product.

 

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

Following Art. 29 of the Law on Fundamental Healthcare Principles, the national healthcare system includes state (incl. federal and regional) and municipal healthcare systems, which respectively consist of relevant state and municipal authorities, operating administration, and healthcare institutions. The healthcare system is funded with respective national budgetary (federal and regional) and state non-budgetary funds.

Out-patient pharmaceutical care programs are financed via several different public sources: the federal budget, regional budgets, and compulsory health insurance.

Compulsory health insurance (via the Federal Fund for Mandatory Medical Insurance, FFOMS) funds the reimbursement of medicines provided for in-patient and emergency care. The government maintains the list of vital essential and necessary drugs (the “EDL”) outlining which drugs should be made available in the in-patient setting, and which is also used as the basis for several out-patient reimbursement schemes.

 

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

Public and private health sectors operate separately, and there is no interaction between one and another.

Private health insurance is voluntary, but quite common and is generally provided by the employer.

The public health sector normally faces financial issues and implements measures to limit costs, for instance, by pressing for price reductions in public bids and encouraging competition.

 

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

Prices for drugs are regulated in terms of public procurement: Cl. 2 Art. 80 of the Law on Fundamental Healthcare Principles, Art. 60 of the Law on Circulation of Drugs, Regulation of the Government of the Russian Federation dd 28.08.2014 No. 871, Regulation of the Government of the Russian Federation dd 29.10.2010 No. 865 provide for EDL, which prices are regulated by state authorities, and for the relevant procedures. Such maximum sale prices shall be submitted by the manufacturers or their authorized representatives and shall be subject to state registration with Minzdrav. Purchasing price in the public procurement sector shall not exceed the price calculated based on such registered price considering the relevant maximum wholesale mark-up.

Prices for medical devices are regulated in terms of public procurement as well: Cl. 2 Art. 80 of the Law on Fundamental Healthcare Principles and Regulation of the Government of the Russian Federation dd 22.09.2014 No. 968 provide for the list of medical devices, which prices are regulated by state authorities. Such maximum sale prices shall be submitted by the manufacturers or their authorized representatives and shall be subject to state registration with RZN. Purchasing price in the public procurement sector shall not exceed the price calculated based on such registered price considering the relevant maximum wholesale mark-up.

 

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

In the private sector, most payments are made on an out-of-pocket basis. Private insurers are improving the level of pharmaceutical coverage since the private market in medicines has grown considerably. Subject to Cl. 2 Art. 80 of the Law on Fundamental Healthcare Principles vital essential and necessary drugs are provided by the budgetary healthcare institutions within the framework of Medicare, that is subject to the following reimbursement with compulsory medical insurance funds (for more details, please, refer to Question 14).

 

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

Commonly, budgetary healthcare institutions dispense medical products prescribed by their healthcare professionals. Products are prescribed from EDL and the same list for medical devices, that is annually approved by the Government, and as stated by standards of care, that are approved by Minzdrav. Public healthcare institutions directly procure such medical products mostly by public tender process and provide Medicare, that is subject to the following reimbursement with the funds of public insurers.

At present, in-patients (including patients in day hospitals) and patients to whom emergency care is provided are fully reimbursed for the cost of medicines used as part of their treatment.

In the out-patient setting, however, only certain population groups are eligible to receive either free or partially subsidized prescription medicines. Eligibility for these benefits is determined by the federal government – although the regional authorities have the right to extend reimbursement to additional groups, provided that such coverage is funded by the regional (rather than federal) budget. The prescribed medical product shall be sold to welfare beneficiaries in a drug store, whether it is private or not, free of charge or with a 50% discount, as provided by Art. 6.1 of Federal Law dd 17.07.1999 No. 178-FZ “On state social assistance”. The cost of such medical products shall be reimbursed by public healthcare institutions, which prescribed the medical product.

 

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?

The Government provides for EDL and medical devices which may be procured by public healthcare institutions and therefore dispensed by their healthcare professionals.

RZN exercises complex control over the circulation of medical products, including the public sector, and monitors the indicia of preferential drug provision, and conducts inspections in medical institutions and drug stores, as well as in authorities of the subjects of the Russian Federation related to the healthcare sector.

Also from this Legal Handbook

The year 2019, which continued the trend of rapid and numerous changes in healthcare regulations in Russia, was rich with expectations, events and legislative proposals aiming to reform the Russian pharmaceutical industry: medical drugs labeling, reform of price determination, new procedure of entry into drugs civil circulation, amendments to regulatory framework of the Eurasian Economic Union, etc. This trend is likely to continue in 2020 as well.

 

Some of the major developments that are yet to be shaped into regulations are captured below.

 

Launch of the national project “Health Care”

The national project has significantly increased the volume of benefit drugs reimbursement for patients suffering from cancer and cardiovascular diseases. As a result, in 2019, revenues of almost all manufacturers and other participants of the pharmaceutical market have been highly increased in the public procurement segment. [1]

 

The 12 Nosologies programme has turned into 14 Nosologies programme

The following rare (orphan) diseases have been included in the programme:

– aplastic anemia unspecified (D61.9);

– inherited deficit of factors II (fibrinogen), VII (labile), X (Stuart-Prower) (D68.2).

Expenses on high-cost drugs for treatment of these diseases are reimbursed from the federal budget now.[2]

 

New procedure for the entry of drugs into civil circulation

This sphere has been excluded from technical regulation legislation. Under the new procedure [3] there is no need to obtain a certificate of conformity or to register a declaration of conformity for each series or batch of drugs.

Entry into circulation of drugs manufactured in Russia shall be made upon submission of a document by the manufacturer which confirms the quality of the drug and its compliance with the requirements established within its state registration.

In the case of drugs imported into the Russian Federation, the importer shall provide a manufacturer’s certificate which certifies compliance of the imported drugs with the requirements of the pharmacopoeia article or another regulatory act.[4]

The above-mentioned documents are provided via Roszdravnadzor’s automated information system.[5]

 

The deadline for introducing the mandatory labeling of drugs has been postponed till July 1, 2020

The labeling of drugs has not been introduced since January 1, 2020 as it was expected.[6]

According to the amendments, most of drugs, produced before July 1, 2020, can be stored, transported, released, sold, transferred, used without identification (labeling) until expiration of best before date.

In August, 2019 manufacturers managed to reduce the cryptographic code.

In October, 2019 the labeling for high-cost nosology has been introduced.

Before labeling came into force medical drugs were entered into civil circulation and tracked by batches.

 

Law on drug interchangeability has been adopted

A list of interchangeable drugs will appear, where drugs will be grouped together. It will be formed by an expert institution – the Federal State Budgetary Institution “Scientific Centre of Expertise of Medicinal Products” of the Russian Ministry of Healthcare (MOH).

Most of the amendments to the procedure for determining the interchangeability of drugs will enter into force from March 1, 2020.

Interchangeability will not be determined for herbal and homeopathic medicines.

For drugs that are recognized as interchangeable before March 1, 2020 in the process of their state registration, there will be no need to determine the interchangeability again.[7]

 

Rules for re-registration of price limits for vital and essential drugs (VED) have come into effect

From June 7, 2019 in certain cases, pharmaceutical manufacturers are obliged to reduce the price limits on VED. For example, it should be done when the prices for imported drugs are higher in Russia than in the country of their origin.

The Governmental Regulation came into force on December 17, 2019 and, inter alia, defined:

– rules for mandatory re-registration of manufacturers’ price limits for VED in 2020;

– the procedure of calculating of such price limits when they are re-registered in order to reduce them.

Starting from 2021, VED without mandatory re-registration of their price limits will be forbidden for selling.

Another important novelty: the MOH and Federal Antimonopoly Service FAS will be able to revise and reduce the registered price limits without pharmaceutical manufacturer application.[8]

 

The procedure of determining the maximum (starting) price of contract (MSPC) for the public procurement of drugs has been changed

Methods of determining the MSPC per drug unit have not been changed. However, there are new peculiarities. [9] E. g., when applying the method of comparable market prices, the customer will be obliged to send requests to suppliers along with the use of publicly available price information.

The rules of forming the weighted average price have been changed. When determining it, the customer will have the right not to take into account, in particular, the price of supplied drugs:

– with the remaining shelf life, which is 20% or more different from the remaining shelf life of the other purchased goods;

– for contracts under which the suppliers were subject to penalties;

– circulation of such drugs was suspended at the time of MSPC calculation.

Reference prices will be calculated in a different way: they will be automatically determined not four times, but twice a year.

 

Prolongation of the transition period for re-registration of medical devices with member-state registration according to Eurasian Economic Union (EEU) rules till 31 December, 2026

Till 2021 Manufacturer or authorized representative save the right to choose whether to register a medical device under EEU rules or rules of member-state. Starting from 2021 registration will be executed only under EEU rules.

From 2026 marketing authorizations issued under national registration procedure will be cancelled.[10]

 

References

[1] Passport of the national project “Health Care” (approved by the Presidium of the Presidential Council for Strategic Development and National Projects, Protocol dd 24.12.2018 No. 16), available at: http://static.government.ru/media/files/gWYJ4OsAhPOweWaJk1prKDEpregEcduI.pdf (Last Accessed January 27, 2020).

[2] Federal Law dd. 27.12.2019 No. 452-FZ “On Amendments to the Law “On fundamental healthcare principles in the Russian Federation”, available at: http://publication.pravo.gov.ru/Document/View/0001201912280022 (Last Accessed January 27, 2020).

[3] Federal Law dd. 28.11.2018 No. 449-FZ “On Amendments to the Law “On drugs circulation” available at: http://publication.pravo.gov.ru/Document/View/0001201811280057 (Last Accessed January 27, 2020).

[4] Ibid.

[5] Roszdravnadzor’s automated information system, available at: http://momi.roszdravnadzor.ru/?type=logon ( Last Accessed January 27, 2020)

[6] Federal Law dd. 27.12.2019 No. 462-FZ “On Amendments to the Law “On drugs circulation“ and to the Law “On Amendments to the Law “On drugs circulation“                                            available at: http://publication.pravo.gov.ru/Document/View/0001201912280029 (Last Accessed January 27, 2020)

[7] Federal Law dd. 27.12.2019 No. 475-FZ “On Amendments to the Law “On drugs circulation”, available at: http://publication.pravo.gov.ru/Document/View/0001201912280038 (Last Accessed January 27, 2020).

[8] Governmental Regulation dd. 16.12.2019 No. 1683, available at: http://static.government.ru/media/files/1riw7sArETmZp70rvcRLUywCOHOotEPk.pdf (Last Accessed January 27, 2020).

[9] Order of the MOH dd. 19.12.2019 No. 1064n, available at: https://cdnimg.rg.ru/pril/180/22/21/56926.pdf (Last Accessed January 27, 2020).

[10] Order of the Board of the Eurasian Economic Commission dd. 02.09.2019 No. 142 “On the draft Protocol amending the Agreement on common principles and rules for the circulation of medical devices (medical devices and medical equipment) within the Eurasian Economic Union dd. December 23, 2014”, available at: https://www.alta.ru/tamdoc/19r00142/ (Last Accessed January 27, 2020).

Also from this Legal Handbook

Nadezhda Fedotova and Andrey Zelenin of Lidings law firm gives an update on recent amendments to the labeling legislation for medicines in Russia, their potential impact on the Russian pharmaceutical industry, and the numerous uncertainties still remaining.

 

Despite the time moving up to January 1, 2020, it seems impossible to say whether the drugs labeling system will or will not be launched in time completely

Under the Decree of the Government of the Russian Federation No. 1556 dated December 14, 2018 (hereinafter – Decree No. 1556), the monitoring system of the medical drugs circulation should become effective from the January 2020 with the exception of medical drugs for healing high-cost ICD diseases, which have already been monitored from October 1, 2019.

 

Starting from the effective date of the Decree No. 1556 the whole pharmaceutical community of Russia, including pharmaceutical companies, distributing and pharmacies organizations, professional communities of the developers of equipment and program software, began to prepare themselves for the launch of the monitoring system. During the preparatory process, participants faced various problems, which were reported to the governmental bodies and authorized organizations immediately. Thus, the government was able to include necessary amendments to the strategy before the system launched.

 

The most discussed issue was the length and the entering of the cryptographic code (coding information) created by the Russian cryptographic technologies, what is thought to provide the legal circulation and help to secure the pharmaceutical products from criminals. During the first quarter 2019 the pharmaceutical companies were testing and analyzing the cryptographic code with different symbol-length – 32, 44, 88, 92 – as well as making records on defects in code within each of the code lengths. After many testing results and professional discussions, the approved cryptographic code length was cut back on from 92 to 44 symbols, whereas the whole size of the labeling module is set with 85 symbols. As a result, the manufacturers will be able to use the 32х32 module. Also, the numerous changing in cryptographic code length expanded the time of the pilot project as well as the costs on regular updating and amending the equipment and program software.

 

At the same time, the liability on failure with the requirement to join the labeling system was provided within the legal framework. Among the offences, the following should be pointed out: the manufacturing of the medical drugs without labeling or with wrong labeling process; sale of the medical drugs without labeling or with wrong labeling process; underfilling or undue completion of the information in the labeling data base. The liability for commitment of each of the offences is set between 5 000 – 10 000 rubles for the officials and between 50 000 – 300 000 rubles for the legal entities.

 

Nevertheless, the provision of the cryptographic code created by the Russian cryptographic technologies is not free. According to the Decree of the Government of the Russian Federation No. 577 dated May 8, 2019 the price for creating of the 1 labeling code is 50 kopecks excluding VAT. Also, the Ministry of Industry and Trade of the Russian Federation has proposed the bill that will allow the drugs manufacturers to get the labeling codes under the pilot project for free. However, on the December 15, 2019 this bill has not been approved yet. There is only the one requirement that drugs manufacturers are free from – they do not need to register in the system in 2020 again.

 

Despite the fact that the drugs labeling system was not still launched completely and the results of the experiments were not evaluated, the Ministry of Health of the Russian Federation has the intention to include the labeling to the licensing requirements for all who do wholesale and retail of medical drugs, including pharmacies, the individual entrepreneurs and medical organizations. On December 15, 2019 the relevant decree project has passed the public hearings and anticorruption expertise, but has not been sent to the consideration to the RF Government yet.

 

Up to the end of 2019 the Russian Government agreed with the professional community on the time extension for the labeling system process implementation and on December 5, 2019 officially published the project of the decree of the Government of the Russian Federation, which deferrals of the deadline for labeling of the non-VEN and non-ICD drugs to the July 1, 2020. This project provides some details regarding the stages before the labeling of the medical drugs package itself and the declines for their implementation. These stages include: 1) registration in the monitoring system starting from January 1, 2020 up to February 29, 2020; 2) preparing the program software and filing an application for testing the information exchange within 21 calendar day starting from the day of registration in the system; 3) testing the information exchange between the program software and the monitoring system regarding the drugs labeling, introduction into the drugs circulation, circulation itself and withdrawal from circulation within 2 calendar months, starting from the date of completion of the program software to the information exchange; and 4) entering the data regarding the whole operations with the drugs from July 1, 2020 into the monitoring system.

 

The public hearing of the bill and its anticorruption expertise will continue up to December 25, 2019. After that the results of the abovementioned analysis and expertise will be evaluated. Based on this evaluation the necessary amendments will be included to the text, which will be finally sent to the consideration and approval to the Russian Government.

 

Despite the time moving up to January 1, 2020, it seems impossible to say whether the drugs labeling system will or will not be launched in time completely or if the government will approve the stage-plan implementation; what the results of the pilot project, which officially ended on December 31, 2019, will be; or which way and within what limits the punishments for offences in labeling system will be.