Legal & Regulatory > Bulgaria > Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs

The key facts about the cannabinoids drugs in Bulgaria. Prepared in association with Kinstellar and PharmDedict, this is an extract from The Pharma Legal Handbook: Bulgaria, available to purchase here for GBP 75.

Cannabinoid Drugs

1. Are Cannabinoid Drugs authorized in your country?

Pursuant to the Narcotic Substances and Their Precursors Act and secondary legislation for its implementation, Cannabis, as well as Cannabinoid Drugs, are classified in Bulgaria as plants constituting high risk to public health due to the harmful effect of their abuse. As a general principle the growing, import and trade of Cannabis and Cannabinoid Drugs are prohibited under Bulgarian law.

However, there are several explicit exclusions of the above prohibition, where:

1. Cannabis, containing less than 0,2% by weight of tetrahydrocannabinol (THC) could be grown, imported and traded for exhaustively listed purposes under the provisions of Ordinance No. 1 of 12.03.2018 ¹ of the Minister of agriculture, foods and forestry (“Ordinance No. 1”);
2. limited quantities of Cannabis are used for medical, scientific or laboratory research, for educational purposes, as well as for maintaining the ability of dogs uncovering narcotic substances with maximum quantity allowed of 30 grams of THC or 30,000 grams of hemp.

Currently in Bulgaria the production of Cannabinoid Drugs and Products, containing Cannabidiol (CBD) is not permitted. However, as there is no explicit prohibition for the import of products, containing CBD, such as cosmetics, essential oils, food supplements, etc., CBD containing products could be found on the Bulgarian market.

1.Grow and sale of Cannabinoid Drugs, containing less than 0,2% by weight of THC

Under fulfilment of strict requirements (e.g. lack of criminal history in connection with drugs and/or their analogues for natural persons, registration for seed production for the purpose of animal feed) and after receiving permit by the Ministry of Agriculture, Food and Forestry (“the MAFF”) individuals and legal entities who are registered farmers are permitted to grow and sale Cannabis containing less than 0,2% by weight of THC, intended for:

1. (i) fiber;
2. (ii) animal feed and food seeds;
3. (iii) seeds for sowing.

2. Purchase of Cannabis, containing less than 0,2% by weight of THC

The following categories natural and legal persons are permitted to purchase the said Cannabis or the production obtained from the cultivation thereof:

1. Cannabis Stem processors and / or fiber producers, where the obtained production is purchased for the purpose of fiber production;
2. natural and legal persons registered under the terms of the Animal Feed Act, where the seeds are purchased with intention for animal feed usage;
3. natural and legal persons registered according to the procedure of the Food Act, where the seeds purchased with intention for food usage;
4. natural and legal persons who have obtained permission for growing Cannabis containing less than 0,2% by weight of THC and have been registered under the Sowing and Planting Material Act, where the seeds are purchased with intention for usage as sowing material.

3. Cannabis limited usage

Usage of limited quantities of Cannabis for medical, scientific or laboratory research, for educational purposes, as well as for maintaining the ability of dogs uncovering narcotic substances is subject to licencing procedure.

Permit for these activities may be issued to:

1. persons who are entitled to carry out expert, research and educational activity, medical or scientific research, whereby the premises in which the said quantities of Cannabis are used for medical, scientific or laboratory research, for educational purposes shall fulfil certain requirements;
2. employees of the specialized services, research and scientific institutes of the Ministry of Internal Affairs (“the MIA”);
3. employees of the Customs Agency;
4. employees in the Directorate-General for Execution of Punishments and its territorial offices for the purpose of maintaining the ability of dogs uncovering narcotic substances.

4. Cannabis seeds import not intended for sowing may be performed only by legal entities and sole traders, cooperatives and registered producers or civil societies for animal feed trading with the respective licence. The licence is issued by the MAFF.

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

The following authorities have jurisdiction over Cannabinoid Drugs:

1. the MAFF is competent for issuance of permit for growing, importing and trading Cannabis, containing less than 0,2% by weight of THC, and exercising control over the production of and trading with the plants;
2. the MIA, the Minister of Health (“the MH”), the Minister of Justice (“the MJ”) and the Director of Customs Agency are competent for issuance of permits for usage of limited quantities of Cannabis for medical, scientific or laboratory research, for educational purposes, as well as for maintaining the ability of dogs uncovering narcotic substances;
3. the Agricultural Regional Directorates, the Executive Agency of Variety Testing Field Inspection and Seed Control and the Bulgarian Food Safety Agency are competent for exercising control over the cultivation and trading of the Cannabis;
4. the MIA through its specialized departments and the State Agency for National Security is competent for prevention, detection and countering crimes related to the illegal traffic of narcotic drugs and precursors, including Cannabinoid Drugs;
5. the MH is competent for exercising control over the production, processing, import, export, transit, trade, storage, reporting, transfer, transportation, use and advertising of the plants and narcotic substances and drugs, including Cannabinoid Drugs, as well as on the treatment of drug addicts;
6. the Ministry of Finance (“the MF”), through the customs administration, is competent for exercising control over the import, export and transit from and to third countries of narcotic drugs and precursors and performs activities to prevent and detect their illegal traffic;
7. the National Council on Narcotic Substances (“the NCNS”) for conducting and implementing the national policy on drug abuse, as well as the fight against drug trafficking.

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

The legal framework for authorization of Cannabinoid Drugs includes the following legal acts:

1. Narcotic Substances and Their Precursors Act (“NSTPA”);
2. Medicinal Products in Human Medicine Act (“MPHMA”);
3. Ordinance on the Rules for Classification of Plants and Substances as Narcotic;
4. Ordinance on the Rules and Procedure for Permitting the Activities under Art. 73(1) of the NSPA;
5. Ordinance No. 1;
6. Criminal Code.

The general legal framework regulating authorization, pricing and reimbursement of medicinal products in general is the MPHMA. However, as Cannabinoid Drugs are still not permitted for usage in human medicine in Bulgaria, there is no specific regulation on authorization, pricing and reimbursement of Cannabinoid Drugs.

4. Which are the Cannabinoid Drugs that have received market approval to date?

In Bulgaria no Cannabinoid Drugs have received market approval to this date.

5. Who can prescribe Cannabinoid Drugs?

As mentioned above, since the usage of Cannabinoid Drugs for medicinal purposes is not permitted in Bulgaria, medicinal products containing such ingredients could not be prescribed.

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

N/A, please see above p. 5.

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

N/A, please see above p. 5.

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

1. As mentioned above THC containing products could be traded by the persons under p. 1.1. above.
2. At current date, there are no authorization requirements for sale/distribution of CBD containing products.

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

The MAFF maintains a registry of the persons authorized to grow and sell THC containing products. There is no such list for persons who import and sell CBD containing products.

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

Since 2018, when the growing, import and production of THC containing products was first regulated in more detail, no further amendments and supplementations have been adopted.

However, due to a recent decision of the European Court of Justice stating that CBD derived from the entire hemp plant is not a narcotic and is therefore subject to EU law on the free movement of goods among member states, and the subsequent decision of the EU Commission for recategorizing CBD containing foods, gives us a reason to believe that a future development in the EU and national legal framework may be expected.

11. When are they likely to come into force?

N/A, please see above p. 10.

Medicinal Cannabis

12. Is Medicinal Cannabis authorized in the country?

In Bulgaria the usage of Medicinal Cannabis is prohibited.

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

The following authorities have jurisdiction over medicinal Cannabis:

1. MIA through its specialized departments and the State Agency for National Security competent for prevention, detection and countering crimes related to the illegal traffic of narcotic drugs and precursors;
2. MH competent for exercising control over the production, processing, import, export, transit, trade, storage, reporting, transfer, transportation, use and advertising of the plants and narcotic substances and drugs, as well as on the treatment of drug addicts;
3. MF, through the customs administration, for exercising control over the import, export and transit from and to third countries of narcotic drugs and precursors and performs activities to prevent and detect their illegal traffic;
4. NCNS for conducting and implementing the national policy on drug abuse, as well as the fight against drug trafficking.

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

As the Medicinal Cannabis is not permitted for usage in Bulgaria, there is no regulatory framework on the authorization, pricing, and reimbursement thereof.

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

N/A, please see above p. 12 and p. 14.

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

N/A, please see above p. 12 and p. 14.

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

N/A, please see above p. 79.

18. How can patients obtain Medicinal Cannabis?

N/A, please see above p. 12.

19. Who can prescribe Medicinal Cannabis?

N/A, please see above p. 12.

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

N/A, please see above p. 12.

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

N/A, please see above p. 12.

22. Where is Medicinal Cannabis available?

N/A, please see above p. 12.

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

N/A, please see above p. 12.

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

Since 2018, when the growing, import and production of THC containing products was regulated, no new further amendments and supplementations have been adopted. There have been some public discussions on the legalization of Medicine Cannabis, but no specific steps have been taken on behalf of the government towards adoption of new legal acts in that sphere.

Opioid Drugs

25. Are Opioid Drugs authorized in your country?

As a general rule under Bulgarian legal framework Opium production in Bulgaria is prohibited.

1. However, certain types of Opioid Drugs could be used for treatment of Opioid addiction, namely: (i) Morphine Sulphate; (ii) Methadone Hydrochloride; (iii) Buprenorphine Hydrochloride.
   These medicinal products are permitted to be used for treatment only in certain substances, namely: (i) caps. prolong. 120 mg, 200 mg of Morphine Sulphate; (ii) solution 10 mg/ml of Methadone Hydrochloride; (iii) sublingual tablets – 2 mg, 4 mg, 8 mg of Buprenorphine Hydrochloride.
2. Other Opioid Drugs such as Morphine, Oxycodone, Remifentanil, Tilidine, Tramadol, Tramadol, Xanax, Diazepam, etc. (hereinafter referred to as Other Opioid Drugrs) are used for overcoming severe pain of different origins and treatment of anxiety, mixed anxiety-depressive states or depression associated with other diseases, and treatment of panic disorders. These medicinal products are available with a doctor’s prescription.

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

The following authorities have jurisdiction over Opioid Drugs and Other Opioid Drugs:

1. MH is competent for monitoring compliance with the storage, release, recordkeeping and reporting requirements for medicinal products used in the programs for and issuance of permits for conducting treatment of Opioid addiction;
2. the National Focus Centre in the Field of Drugs and Drug Addictions competent for exercising control over the performance of the programs and maintaining a registry of the individuals enrolled in the programs for Opioid Drugs addiction treatment;
3. NCPRMP with the competences as listed above under p.3.
4. MIA through its specialized departments and the State Agency for National Security for prevention, detection and countering crimes related to the illegal traffic of narcotic drugs and precursors;
5. NCNS for conducting and implementing the national policy on drug abuse, as well as the fight against drug trafficking.

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

The legal framework for authorization of Opioid Drugs and Other Opioid Drugs includes the following legal acts:

1. NSTPA;
2. MPHMA;
3. Ordinance on the Rules for Classification of Plants and Substances as Narcotic;
4. Ordinance No. 2 of 20 June 2012 on the terms and conditions of implementing programmes for treatment with agonists and agonist-antagonists of Opioid-addicted persons which regulates the treatment of this population of patients (“Ordinance No. 2”);
5. Ordinance No. 34 of 25 November 2005 on the procedure for payment by the state budget of the treatment of Bulgarian citizens for diseases outside the scope of compulsory health insurance (“Ordinance No. 34”);
6. Ordinance on the Terms, Rules and Procedure for Regulation and Registration of Prices for Medicinal Products;
7. Criminal Code.

Please note that there are no separate acts regulating the pricing and reimbursement of Opioid Drugs and Other Opioid Drugs, whereby the Ordinance on the Terms, Rules and Procedure for Regulation and Registration of Prices for Medicinal Products shall apply.

Ordinance No. 2 and Ordinance No. 34 regulate the sale and purchase of Morphine Sulphate, Methadone Hydrochloride and Buprenorphine Hydrochloride used for Opioid addiction treatment. Methadone Hydrochloride is purchased by the State and shall be provided upon request of the facilities under p. 29.1. below by the MH. These facilities could apply for state aid for the purchase of Morphine Sulphate and Buprenorphine Hydrochloride.

The NCPRMP has approved the whole sale and retail price of Other Opioid Drugs. These products could also be approved for reimbursement.

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

Morphine Sulphate, Methadone Hydrochloride and Buprenorphine Hydro-chloride are approved for marketing. Morphine Sulphate and Buprenorphine Hydrochloride could be sold/distributed only by the traders under p. 32.1. below and used by the facilities under p. 29.1. below. Methadone Hydro-chloride is provided by the MH.

Other Opioid Drugs are medicinal products, which have received market approval and are available with a doctor’s prescription.

There are specific rules on the labelling and advertising of these products. Direct and indirect advertising of Opioid Drugs and Other Opioid Drugs, as well as medicinal products, containing those, is strictly forbidden.

29. Who can prescribe Opioid Drugs?

1. Opioid Drugs under p. 25.1. above could be used in treatment of Opioid addiction performed by individual psychiatric care practices, group psychiatric care practices, medical centres and diagnostic consultative centres, where a doctor with a recognized specialty in psychiatry practices, mental health centre and hospital care facility, providing psychiatric help.
2. Other Opioid Drugs could be prescribed by any medical doctor authorized to provide healthcare services.

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

1. There is a registry of the facilities approved for conducting treatment programs of Opioid addiction individuals maintained by the MH.
2. Other Opioid Drugs could be prescribed by any medical doctor authorized to provide healthcare services, whereby there is no specific list of the doctors authorized to prescribe it.

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

1. Facilities as listed above under p. 29.1. applying for permission for conducting programs for treatment of Opioid addiction before the MH shall fulfil several requirements, including to have (i) treatment program; (ii) plan, indicators and procedures for evaluating the effectiveness of the program; (iii) Instructions for performing activities with Medicinal Opioid Drugs; (iv) qualification of the experts responsible for managing the program; (v) security system, etc. The Opioid Drugs under p. 29.1. are prescribed by doctors practicing in these facilities.
2. Other Opioid Drugs could be prescribed by any medical doctor authorized to provide healthcare services.

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

1. Morphine Sulphate and Buprenorphine Hydrochloride could be purchased only from wholesale traders licensed for wholesale of medicinal products containing narcotic substances by the MH under fulfilment of the requirements of MPHMA. Methadone Hydrochloride is purchased by the State and shall be provided upon request of the facilities under p. 29.1. above by the MH.
2. Other Opioid Drugs could be sold/distributed by (i) wholesale traders licensed for wholesale of medicinal products containing narcotic substances by the MH under fulfilment of the requirements of MPHMA; (ii) pharmacies licensed for retail of products containing narcotic substances by the Ministry of Health under fulfilment of the requirements of MPHMA.

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

There is a public register of the wholesalers and retailers licensed to sell/distribute medicinal products containing narcotic substances, which is maintained by the MH. There is no separate register of those licensed for Opioid Drugs and Other Opioid Drugs sell/distribution.

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

To date there are no proposals for reform or significant change to the regulation of Opioid Drugs and/or Other Opioid Drugs.

35. When are they likely to come into force?

N/A, please see above p. 34.

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1. Ordinance No. 1 of 12.03.2018 on the terms and conditions for the issuing of a permit for the cultivation of plants such as Cannabis for fibre, seeds for animal feed and food and seed for sowing, containing less than 0,2% by weight of THC, as defined in the leaf, petal and fruit tips, for trade and control