Cannabinoid drugs, medicinal cannabis and opioid drugs in Russia – a legal guide. 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 USD 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?

Law project on changing of the Federal law of 08.01.1998 No. 3-FZ “On narcotic drugs and psychotropic substances” in part of plantation of narcotic croppers and processing of narcotic drugs stipulated in the “List I” for medical purposes. As of the date both processes are prohibited.

Based on the Cover letter on the Law project addresses Opioid Drugs and opioid croppers. At the same time, exact list of croppers for plantation shall be established by the Government.

11. When are they likely to come into force?

The Law project is under hearing and might be renewed. It is likely to come into force not earlier the year of 2020.

Medicinal Cannabis

12. Is Medicinal Cannabis authorized in the country?

Medicinal Cannabis is regarded as a narcotic drug of ‘List I’ which circulation within the Russian Federation is prohibited.

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 Medicinal Cannabis distribution, import and export;
• Russian Ministry of Health – the state authority responsible for establishing requirements as to Medicinal 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 Medicinal 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 Medicinal 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 Medicinal Cannabis is prohibited. Medicinal 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 Medicinal Cannabis is prohibited. Import of Medicinal 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 Medicinal Cannabis for medical use is prohibited.

18. How can patients obtain Medicinal Cannabis?

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

19. Who can prescribe Medicinal Cannabis?

Medicinal 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?

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

22. Where is Medicinal Cannabis available?

Medicinal 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?

Law project on changing of the Federal law of 08.01.1998 No. 3-FZ “On narcotic drugs and psychotropic substances” in part of plantation of narcotic croppers and processing of narcotic drugs stipulated in the “List I” for medical purposes. As of now, both processes are prohibited.

Based on the Cover letter on the Law project addresses Opioid Drugs and opioid crops. At the same time, the exact list of crops for plantation shall be established by the Government.

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 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,
• physician’s assistant, nurse-midwife – given the relevant individual physician’s functions are imposed on them by director of a healthcare organization, • sole entrepreneur performing medical activities.

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?

Please see Question 10 above.

35. When are they likely to come into force?

Please see Question 11 above.