The Pharma Legal Handbook: Bulgaria

All legal aspects surrounding localization 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.

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

In order to be considered generic biosimilar medicines shall fulfill the requirements for categorizing a product as generic, namely: Generic medicinal product shall be a medicinal product of the same qualitative and quantitative composition in terms of its active substances and of the same pharmaceutical form as its reference medicinal product (e.g. the biological product), and its bioequivalence with the reference medicinal product has been substantiated through suitable bioavailability tests.

If the biosimilar medicine could not be considered generic, the latter would be categorised as new active substance.

 

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

In order to be patentable in Bulgaria, a biological medicine shall be new, have an inventive step and be industrially applicable. A biosimilar medicine may also be patentable, to the extent it meets the above general requirements.

 

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 rules and procedures of the MPHMA and Ordinance No. 27 of 15.06.2007 on the requirements to the data and documentation for authorisation for use and registration of medicinal products (“Ordinance No. 27”) for marketing authorisation of medicinal products apply also to biosimilar medicines. In case the biosimilar medicine meets the criteria for a generic drug (please see p.1 above), the process may be shorter, as the presentation of pre-clinical and clinical study results is not required, if the so-called “data exclusivity” period has expired. However, where a biosimilar medicinal product does not meet the requirements for qualification as a generic medicinal product, due to a difference in the manufacturing process or to different starting materials compared to the reference product, or due to any other reasons, the applicant has to submit to the Bulgarian Drugs Agency the results from the required pre-clinical and/or clinical trials associated with those requirements.

 

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?

Please see p. 3 above.

 

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

By choosing the reference comparator products the existence of bioequivalence and bioavailability should be assessed.

According to the MPHMA bioequivalence shall be deemed present where medicinal products are pharmaceutically equivalent or pharmaceutical alternatives, and where their bioavailability after administration in the same molar dose is similar to the extent that their effect in terms of efficacy and safety is substantively similar.

Bioavailability is the speed and level at which the active substance or its therapeutically active part are absorbed from the pharmaceutical form and become available at the location of activity. When the medicinal substance is intended to have a systemic therapeutic effect, bioavailability shall mean the speed and level at which the medicinal substance or its therapeutically active part are released from the pharmaceutical form and pass into the general circulation.

The existence of bioequivalence and bioavailability is assessed through clinical trials.

 

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

The comparator product may be sourced from another Member State. In such case the Bulgarian Drug Agency requests from the regulatory body of the Member State, where the reference product is authorised, information about the product’s market authorisation, the quantitative and qualitative composition of the reference product and, if necessary, additional documentation.

 

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

There are no special rules for regulation of the prices of biological or biosimilar products. In general, after its market authorisation the National Council on Prices and Reimbursement of Medicinal Products (“NCPRMP”) regulates the price of a medicinal product depending on its designation:

• To be used only upon medical prescription;
• To be used without medical prescription as OTC product;
• To be covered by state funds through its inclusion in the Positive Drug List (“PDL”).

In Bulgaria at current date biosimilar and biological products have received market authorisation and price regulation as products to be used upon medical prescription and products covered by state funds through their inclusion in the PDL.

 

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

In order to be included in the PDL and reimbursed, a biosimilar medicine should have a manufacturer price that does not exceed 70% of the price of the originator reference product (if the biosimilar product meets the criteria for a generic product) or 80% of the price of the originator reference product (if the biosimilar product does not meet the criteria for a generic product).

 

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

So far, biosimilar competition did not have any material impact on the reimbursement policy of the originator reference products.

 

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 is no special legal framework regulating biosimilar and biological medicines prescription and dispensing. The general legal framework applicable to prescription and dispensing of medicinal products applies also to biosimilar and biological medicines.

 

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

Prescription of biological and biosimilar products may be done by trade name rather than by international non-proprietary name. Changes to the treatment may be done only by the clinical decision maker. Where the prescription contains the specific trade name of the product (which may be the case of biological and biosimilar products), pharmacies are obliged to dispense the specific product and may not provide substitutes.

 

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?

There are no special post – authorisation requirements for biosimilar and biological products.

As a general rule, after the authorisation the BDA may request the holder of the authorisation to conduct post-marketing study for the product’s safety or efficiency, if there are concerns or lack information with regard thereto.

Any changes with regard to the product occurring post-authorisation should be approved by the BDA.

 

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

No special policies and requirements with regard to biosimilar and biological products labelling have been introduced under Bulgarian law.

 

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 significant legal/judicial developments in relation to biosimilars  have been introduced in Bulgaria.

 

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?

No proposals for reform or significant change to the regulation of biosimilars in Bulgaria have been introduced.

Also from this Legal Handbook

All legal aspects surrounding localization 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.

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?

Under the general regulation for encouraging investment initiatives in Bulgaria and provision of support thereof contained in the Investment Promotion Act (“the IPA”), subject to certain conditions, persons investing in Bulgaria could benefit from certain incentives such as administrative burden relief, simplified procedures for acquiring assets, tax relief, state aid, institutional support, etc. However, these are not specifically focused on the pharmaceutical and medical sector.

As a member of the European Union, Bulgaria has to ensure free movement of goods, capital and people and equal treatment of economic operators within the Union. To this end, as a general rule under the Medicinal Products in Human Medicine Act (“the MPHMA”) production, import and sale and holding of marketing authorization of medicinal products could be performed by natural or legal persons domiciled in Bulgaria or another Member State. These activities are restricted for natural or legal persons domiciled outside of the European Economic Area.

Localization rules for marketing of products in Bulgaria require certain information or documents to be provided in the Bulgarian language. In particular, the information on the packaging and the leaflet of a medicinal product has to be provided in Bulgarian, although additional languages can also be used.

 

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

No recent significant changes have been adopted.

 

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)?

As mentioned above under p. 1, in order to be approved for trading of medicinal products on the territory of Bulgaria, a natural or legal person shall be registered in Bulgaria or a Member State. Only medicinal products whose holder of the authorization for use/certificate of registration is established on the territory of Bulgaria or a Member State may be released on the Bulgarian market. Other than that, there are no specific requirements or incentives for localization vis-à-vis the marketing authorization process.

 

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)?

As only medicinal products whose holder of the marketing authorization/certificate of registration is established on the territory of Bulgaria or a Member State may be released on the Bulgarian market, the National Council on Prices and Reimbursement of Medicinal Products is authorised to approve the price of medicinal products produced in Bulgaria or a Member State. Prices of medicinal products produced in third countries could be approved, only if traded by natural or legal persons registered in a Member State.

No incentives are envisaged with regard to the pricing of medicinal products produced in Bulgaria.

 

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)?

Only medicinal products with marketing authorization may be reimbursed. Thus, only medicinal products whose marketing authorisation holder is a natural or legal person domiciled in Bulgaria or another Member State are covered by the reimbursement legal framework.

No incentives are envisaged with regard to the reimbursement of medicinal products produced in Bulgaria.

 

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)?

As a general rule under the Public Procurement Act, which is applicable to public tenders of pharmaceutical products, any Bulgarian or foreign natural or legal person or their associations, as well as any other entity authorized to perform supplies or services in accordance with the law of the country of registration, may participate as a candidate or a participant in a public procurement procedure in Bulgaria.

However, according to the MPHMA, as mentioned above under p. 1, in practice candidates or participants in public tenders of pharmaceutical products may be producers, wholesalers or importers registered in Bulgaria or a Member State authorized to carry out the said activities on the territory of Bulgaria.

 

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?

Please see above p. 1.

 

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

No other incentives provided.

 

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?

No discussions are being held.

Also from this Legal Handbook

Keen to learn more about orphan drugs & rare diseases in Bulgaria? Read on! Prepared in association with Kinstellar and PharmDedict, this is an extract from The Pharma Legal Handbook: Bulgaria, available to purchase here for GBP 75.

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

Under the Medicinal Products in Human Medicine Act (“MPHMA”), a “rare diseases” is defined as a disease characterized by an incidence not higher than 5 per 10,000 individuals.

 

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

The term “Orphan Drug” is reflected under Bulgarian law as “A medicinal product intended for treatment, prevention and diagnosis of rare diseases”. According to the MPHMA, these are products which:

1. are intended for the diagnosis, prevention or treatment of life-threatening diseases or chronic diseases with a progressive course affecting no more than 5 out of 10,000 people on the territory of the country, or
2. are intended for the diagnosis, prevention or treatment of life-threatening diseases and of chronic conditions that seriously damage health (diseases with a high share of disease-related inability to work and disability), evidence being attached that the sale of the product does not provide a satisfactory level of return that would justify the required investment in scientific research and development operations without further incentives for the author of the product, and
3. when there is no satisfactory method for diagnosis, prevention or treatment of the respective condition or, if one exists, the proposed medicinal product has significantly more advantages the existing method and it is of significantly bigger benefit for the those affected by the said condition.

 

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?)

There is no specific procedure for authorisation of Orphan Drugs in Bulgaria and for authorisation of such products the MPHMA refers to (i) Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (the “Orphan Drugs Regulation”) for the designation of a product as an Orphan Drug; and (ii) Regulation (EC) No 726/2004 of the European Parliament and of the Council¹ (“Regulation (EC) 726/2004”) regarding the marketing authorisation of Orphan Drugs.

More specifically, in order to be marketed in Bulgaria, an Orphan Drug shall have received a market authorisation by the European Medicines Agency (“EMA”) through a centralised procedure under Regulation (EC) 726/2004.

 

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

There are no provisions for relaxed clinical trial/scientific evidence requirements in respect of Orphan Drugs effective in Bulgaria.

 

5. Is there an expedited pathway for Orphan Drugs?

EMA has implemented an adaptive pathways approach for authorisation of Orphan Drugs. The adaptive pathways approach is a scientific concept for medicine development and data generation which allows for early and progressive patient access to a medicine.

The adaptive pathways approach is based on three principles:

• iterative development, which either means:

1. approval in stages, beginning with a restricted patient population then expanding to wider patient populations;
2. confirming the benefit-risk balance of a product, following a conditional approval based on early data (using surrogate endpoints) considered predictive of important clinical outcomes;

• gathering evidence through real-life use to supplement clinical trial data;
• early involvement of patients and health-technology-assessment bodies in discussions on a medicine’s development.

 

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

In general, any Orphan Drug that has received market authorization by the EMA would also be recognized in Bulgaria. This, means that Orphan Drugs from each Member State may receive market authorization in Bulgaria. There is no separate register for the Orphan Drugs authorised in Bulgaria.

 

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

There is no specific procedure for reimbursement of Orphan Drugs in Bulgaria.

As a general rule, the reimbursement status of a medicinal product is determined by the National Council on Prices and Reimbursement of Medicinal Products (“NCPRMP”).

In order to be reimbursed a medicinal product (including an Orphan Drug) has to be included in the Positive Drug List (“PDL”) by the NCPRMP.

Only medicinal products which have received market authorisation may be included in the PDL. The medicinal products included in the PDL receive a ceiling price defined by the NCPRMP. Another requirement is the product to be reimbursed by a public health insurance fund in at least five of the following countries: Belgium, Greece, Estonia, Latvia, Lithuania, Poland, Portugal, Romania, Slovakia, Denmark, Italy, Slovenia, Hungary, France, Finland, Czech Republic, Spain. The above requirement applies also for Orphan Drugs with the specific that it may not only be reimbursed by a public health insurance fund but also paid by with other public funds.

The medicinal product should also be suitable for the respective disease (rare disease). Assessment on certain aspects of the medicinal products is also conducted such as effectiveness, efficiency, safety, pharmaco-economic parameters, effect on budget.

The medicinal products included in the PDL are paid with public funds.

 

8. How are the prices of Orphan Drugs regulated?

The prices of medicinal products included in the PDL, including Orphan Drugs, are regulated by the NCPRMP.

The price of the medicinal products included in the PDL is defined on the basis of the following elements:

• Manufacturer price;
• Wholesale price;
• Retail price;
• Value added tax;
• Reference prices and margins.

 

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

Please see above p. 7 above.

 

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

No significant legal/judicial developments in relation to Orphan Drugs  have been introduced in Bulgaria.

 

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?

No proposals for reform or significant change to the regulation of Orphan Drugs in Bulgaria have been introduced.

 

—————————————————–

1. Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency

 

Also from this Legal Handbook

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

Also from this Legal Handbook

The low-down on the situation regarding regulatory reforms 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.

 

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

The topic of changing the existing healthcare system has been thoroughly debated in Bulgaria. In the final quarter of 2018, the Bulgarian minister of healthcare proposed two alternative models (“Model A” and “Model B”) to fight the inefficiencies of the current system. Both models entail the apportion of a more significant role to private health insurers.

Model A essentially envisages the de-monopolization of the National Health Insurance Fund (the “NHIF”) and immediate competition between private health insurers. It is meant to enable insured individuals to choose between insurers for the purposes of the mandatory health security. The NHIF would, however, continue its operation in competition with the private actors. Model A further entails that insured persons could transfer the payment of their premiums directly to the new health insurance provider of their choice. In case of insolvency, the NHIF or another fund would step in to cover the servicing of the insured persons.

Model B envisages that the solidarity model currently in place in Bulgaria would be transformed into a more personalized health security model. The NHIF would be gradually demonopolized. Model B would essentially be comprised of three pillars: (i) mandatory health security (8%); (ii) mandatory additional health security with a fixed premium amounting to a small sum; and (iii) voluntary health security. In this case, the NHIF would cover the treatment fees to a certain threshold, and the rest would be covered by the patient.

 

2. When are they likely to come into force?

There is certain scepticism in Bulgaria about the prospects of the healthcare system changing in the near future. However, the goal is for the new system to be introduced by the end of 2019 or in 2020.

 

 

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Click the following links to read more legal articles from Bulgaria:

1. Regulatory Pricing and Reimbursement Overview
2. Preclinical and Clinical Trial Requirements
3. Marketing, Manufacturing, Packaging & Labeling, Advertising
4. Traditional Medicines and OTC Products
5. Product Liability
6. Patents & Trademarks
7. Regulatory Reforms

Also from this Legal Handbook

A brief overview of the situation regarding patents and trademarks 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.

 

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

A) Patents

In Bulgaria, the legislative framework regulating legal relations arising in connection with the creation, protection and use of patentable inventions comprises of the Patents and Utility Models Registration Act and secondary legislation for its implementation.

An invention may be patent protected provided that (i) it is new; (ii) it involves an inventive step; and (iii) it is industrially applicable (see further the answer to question 3).

A patent is granted with a decision of the Bulgarian Patent Office upon submission of an application and provided that the patent applied for meets the statutory requirements under Bulgarian law.

Supplementary protection for medicinal products is granted in accordance with Council Regulation (EEC) No. 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal product.

 

B) Trademarks

Regulation of trademarks under Bulgarian law is provided in the Marks and Geographical Indications Act and secondary legislation for its implementation.

A trademark may be protected if it is a sign that is capable of distinguishing the goods or services of one person from those of other persons and can be represented graphically. Such signs may be words, including the names of persons, or letters, numerals, drawings, figures, the shape of the article or the packaging thereof, a combination of colours, sound signals, or any combination of such elements.

A right over a trademark is granted upon registration of the trademark with a registry kept at the Patent Office.

 

2. What agencies or bodies regulate patents and trademarks?

In Bulgaria, patents and trademarks are registered with and regulated by the Bulgarian Patent Office.

 

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

(A) Patents

Any invention can be patent protected provided that (i) it is new; (ii) it involves an inventive step; and (iii) it is industrially applicable.

An invention is considered new if it does not form part of the state of the art.

An invention is considered involving an inventive step if, having regard to the state of the art referred above, such invention is not obvious to a person skilled in the respective area as at the date of filing of an application for obtaining a patent or, respectively, the priority date.

An invention is considered industrially applicable, if it could be manufactured or repeatedly used in industry and in agriculture.

The following cannot be patent protected:

1. discoveries, scientific theories and mathematical methods;
2. works of creative art;
3. schemes, rules and methods for performing mental acts, playing games or doing business;
4. computer software;
5. the presentation of information;
6. the human body at the different stages of its formation and development, as well as the discovery of one of the elements of the human body, including the sequence or the partial sequence of a gene;
7. inventions the commercial use of which would be contrary to public order or morality, including such pertaining to:
   – human cloning methods;
   – methods of changing human embryo genetic identity;
   – use of human embryos for industrial or commercial purposes;
   – methods of modifying the genetic identity of animals where there is a danger of such modifying to cause the animals suffering, without any essential benefit to human or animals from a medical perspective, as well as of animals created by such methods.
8. methods for treatment of people or animals by way of therapy or surgery, as well as diagnostic methods that are applied to people or animals, where as this provision does not apply to products, particularly substances or compounds that are used in such methods;
9. plant varieties and animal breeds;
10. essentially biological methods for the production of plants and animals, as well as plants and animals, produced through such methods.

 

(B) Trademarks

A trademark may be protected if it is a sign that is capable of distinguishing the goods or services of one person from those of other persons and can be represented graphically.

The following signs/trademarks are not eligible for registration:

1. any sign that is not a trademark within the meaning specified above;
2. any trademark which is devoid of any distinctive character;
3. any trademark consisting exclusively of signs or indications that have become customary in the current language or the established trade practices in the Republic of Bulgaria with respect to the goods or services applied for;
4. any trademark which consists exclusively of signs or indications which designate the type, quality, quantity, purpose, value, place of origin, time or manner of production of the goods, manner of provision of the services, or other characteristics of the goods or services;
5. any sign that consists exclusively of:
   – the shape which results from the nature of the goods themselves;
   – the shape of goods which is necessary to obtain a technical result;
   – the shape which gives substantial value to the goods
6. any trademark which is contrary to public order or morality;
7. any trademark which may deceive the consumers, as to the nature, quality or geographical origin of the goods or services;
8. any trademark which consists of or includes escutcheons, flags or other symbols, as well as their imitations, of any states which are parties to the Paris Convention, as well as any escutcheons, flags or other symbols, abbreviations or names of international intergovernmental organisations, covered by Article 6ter of the Paris Convention;
9. any trademark which consists signs, emblems or escutcheons other than those covered by Article 6ter of the Paris Convention and which are of particular public interest;
10. any trademark which consists of or includes official signs and hallmarks indicating control and warranty, where such signs and hallmarks are used for identical or similar goods;
11. any trademark which consists of or includes a name or a representation of a cultural value or parts of cultural values designated in accordance with the procedure provided for in the Cultural Heritage Act;
12. any trademark which consists exclusively of a geographical indication applied for or already registered, which geographical indication is effective within the territory of the Republic of Bulgaria, or of any derivatives of such geographical indication;
13. any trademark which consists a name or an image of cultural value or parts of cultural values, designated under the Bulgarian Cultural Heritage Act;
14. any trademark which consists exclusively a registered geographical indication or of geographical indication already applied for, whereas such geographical indication is effective within the territory of the Republic of Bulgaria,
15. any trademark which consists a geographical indication applied for or already registered, effective within the territory of the Republic of Bulgaria, or any derivatives of such geographical indication, where the applicant is not a user of the geographical indication.

The restrictions regarding items 2, 3 and 4 above do not apply where the trademark, through use, has become distinctive in relation to the goods or services in respect of which the said trademark is applied for.

The restrictions regarding items 8, 9, 10 and 11 above do not apply where the consent of the relevant competent authority has been obtained.

 

4. How can patents and trademarks be revoked?

(A) Patents

Termination of the patent

A patent is being terminated in any of the following cases:

• expiration of the term for which the patent was granted;
• surrender of the patent by the patent holder – by way of written application submitted to the Bulgarian Patent Office;
• failure by the patent holder to pay the fees for maintaining the patent in force.

Invalidity of the patent

At the request of any third interested party, a patent may be declared invalid in any of the following cases:

• the invention does not meet the legal requirements for being patented;
• the essence of the invention has not been expounded in sufficient clarity and exhaustiveness;
• the patent holder does not have a right of patent which circumstance was established with a final court decision;
• the object of the patent goes beyond the content of the application as it was submitted, or if the patent was granted on the grounds of a divided application, when the said object is beyond the content of the earlier application as it was submitted.

 

(B) Trademarks

A trademark’s registration will be terminated in any of the following cases:

• the period of the registration has expired;
• surrender of the trademark owner of the right over the trademark;
• upon termination of the legal entity which is a trademark owner;
• cancellation of the registration of the trademark owner in his/her/its capacity of a user of a geographical indication with respect to trademarks, which include that geographical indication;
• upon request by any person, if within a period of five years after the date of registration of the trademark, the trademark owner has not started actual use of the trademark within the territory of the Republic of Bulgaria. Actual use means any of the following:

• • affixing the sign to goods or to the packaging of such goods;
  • offering the goods which bear the sign for sale, placing such goods on the market or storing such goods for those purposes, as well as offering or providing services under that sign;
  • importing or exporting goods which bear such a sign;
  • using such a sign in business papers or in advertising;
  • using of the trademark by the trademark owner in a form which does not substantially differentiate from the form in which the trademark was registered;
  • affixing of the mark to goods or to the packaging of such goods in the Republic of Bulgaria, irrespective if said goods are intended for export only.

• if the trademark was registered in breach of the requirements for registration of a trademark under Bulgarian law;
• upon request by any person, if as a result of an act or omission of the trademark owner, the trademark has become a common designation for the product or service for which the trademark is registered;
• upon request by any person, if the trademark is used by the trademark owner or by another person with the trademark owner’s consent as regards the goods or services for which the trademark is registered in a manner misleading consumers as to the nature, quality or place of origin of said goods or services;
• surrender of the trademark owner of the right over the trademark with respect of all or some of the goods or services for which the trademark is registered.

 

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

(A) Patents

Bulgaria has been bound by the Patent Cooperation Treaty since 21 May 1984. The Bulgarian Patent Office is the designated, elected and receiving office within the meaning of Article 2 (xiii), (xiv) and (xv) of the Patent Cooperation Treaty.

Bulgaria has also been a member of the European Patent Organisation since 1 July 2002 and is bound by the European Patent Convention. Respectively, a European patent which refers to the Republic of Bulgaria gives to the patent holder the same privileges as those under the Bulgarian Patents and Utility Models Registration Act, subject to submission with the Bulgarian Patent Office of a translation into Bulgarian of the description and the claims and payment of the publication fees. Where a national patent has been issued for an invention for which a European patent has been issued with reference to the Republic of Bulgaria and where both patents have the same date of application, or priority dates, and belong to one and the same person or successor of such a person, the national patent is terminated.

 

(B) Trademarks

With respect to trademarks, the Madrid Agreement Concerning the International Registration of Marks and the Madrid Protocol have been in force in Bulgaria since 1 August 1985 and 2 October 2001 respectively. In addition, marks registered with the European Union Intellectual Property Office are recognised in Bulgaria.

 

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

Bulgarian law provides exclusivity periods for medical products.

A person applying for a marketing authorisation of a generic medicinal product is not obliged to perform a full clinical trial if it proves that the medicinal products specified in the application is generic (similar) to another medicinal product for which a marketing authorisation has already been granted to another person (originator) in another EU Member State not less than 8 (eight) years ago. After expiration of said 8 (eight) years the applicant can make use of the clinical trials data of the originator but cannot place the medicinal product on the market.

The applicant may place the medicinal product on the market after the expiration of additional 2 (two) years, i.e. after the expiration of 10 (ten) years from the date of receiving the marketing authorisation by the originator.

The 10-year period may be prolonged with no more than 1 (one) additional year if the originator receives a permit for significant new indication as regards the relevant medicinal product under the marketing authorisation. In such a case, the applicant may place the medicinal product on the market after the expiration of 11 (eleven)

 

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

Other than the general restrictions described in the answer to question 3, and the restrictions applicable to generic medicinal products described in the answer to question 6, there are no restrictions on the type of medicines or devices that can be granted patent and trademark protection.

 

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

A licence agreement is not subject to approval/acceptance by any government body or regulatory authority. However, in order to become opposable to third parties, a licence agreement has to be registered with the Patent Office, irrespective if it is concluded with a foreign or a local licensor.

 

 

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Click the following links to read more legal articles from Bulgaria:

1. Regulatory Pricing and Reimbursement Overview
2. Preclinical and Clinical Trial Requirements
3. Marketing, Manufacturing, Packaging & Labeling, Advertising
4. Traditional Medicines and OTC Products
5. Product Liability
6. Patents & Trademarks
7. Regulatory Reform

Also from this Legal Handbook

All legal aspects surrounding product liability 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.

 

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

There are three types of liability recognised in Bulgaria, as follows:

• civil liability;
• administrative liability; and
• criminal liability.

(A) Civil Liability

There are two types of civil liability under Bulgarian law:

• contractual liability, which results from non-performance by the obligor of contractual obligations towards the creditor;
• non-contractual liability (tort), which results from a failure of a person (damaging person) to comply with the general obligation not to cause damage to third parties (damaged person). This liability is not preceded by a contractual relation between the damaging person and the damaged person.

 

(B) Administrative Liability

Administrative liability results from committing an administrative violation. An administrative violation is such an act (action or omission) that (i) breaches the established order of state government, (ii) has been committed guiltily and (iii) has been declared punishable by an administrative sanction to be imposed following an administrative procedure.

The general rules on administrative violations are set out in the Bulgarian Administrative Violations and Penalties Act. Specific administrative violations and administrative sanctions thereof are regulated in other legislative acts covering different spheres of state government (e.g. tax, customs, etc.).

 

(C) Criminal Liability

Criminal liability results from committing a crime. All crimes are explicitly regulated in the Bulgarian Criminal Code. Only natural persons can bear criminal liability.

 

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

(A) Civil Liability

Under the Bulgarian Consumers Protection Act, manufacturers are liable towards consumers for damages caused by defective goods on the basis of tort. In deviation from the general rules of the non-contractual liability, the Bulgarian Consumers Protection Act provides for the following specific rules for this non-contractual liability (product liability):

• only damages resulting from by the following could be compensated:

• • death or injury of a natural person;
  • damage to, or destruction of, any item other than the defective product itself, which item amounts to not less than BGN 1,000 (approximately EUR 510), provided that said item is principally intended for private use and was used by the injured person as intended.
• the manufacturer shall be liable for the damages caused by defective goods, irrespective if the manufacturer is guilty for the respective defect;
• a product is deemed defective when it does not meet the common expectations of customary use, taking all circumstances into account, related to: (i) quality, quantity, name, type, composition, origin, durability, distinctive features, customary and possible use of the product, advertisement of the product and the information provided about it; (ii) the time when the product was put into circulation.

A consumer may claim a compensation of damages caused by defective goods on the grounds of the specific regulation in the Bulgarian Consumers Protection Act or the general rules of non-contractual liability provided in the Bulgarian Obligations and Contracts Act.

In addition, under the general provisions of Bulgarian contract law, in case of a non-performance of its contractual obligations a manufacturer may be liable towards any third party with which the manufacturer has entered into an agreement.

 

(B) Administrative Liability

An administrative liability of a manufacturer of medicines is provided in the Law on Medicinal Products in Human Medicine (e.g. for manufacturing of medicines without a licence or in non-compliance with the requirements of Bulgarian law).

 

(C) Criminal Liability

The Bulgarian Criminal Code does not explicitly provide for a specific crime related to the manufacturing of medicines, except in case of manufacturing of veterinary medical products without the required licence. Specific crimes related to manufacturing or trade with narcotic products or substances or manufacturing that is dangerous for the health or the environment may be relevant for manufacturers of medicines and medical devices.

 

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

In general, product liability under the Bulgarian Consumer Protection Act does not extend to corporate executives, employees and representatives of the manufacturer.

Liability for tort under the general civil liability rules in most cases requires some sort of guilt that is attributable to a natural person. Therefore, in general, only natural persons can be liable for tort. However, certain exceptions exist and legal entities may also be held liable for tort in specific cases.

Contractual liability lies with the manufacturer that is a party to a contract. Administrative liability may extend to corporate executives, employees, and representatives, if they are found responsible for breaching the respective administrative obligations or requirements.

After the manufacturer compensates the third party, it is entitled to seek recovery from its employees who are responsible for the damages.

Since only natural persons can be criminally liable, in case of a crime the liability is usually borne by an employee or another person acting on behalf of the manufacturer.

 

4. How can a liability claim be brought?

(A) Civil Liability

A civil liability claim can be brought before court or an arbitration institution (if given the specific contractual relation, an arbitration clause is permitted under Bulgarian law and is included in the respective agreement). The claimant must substantiate the claim and prove the elements that trigger the liability.

 

(B) Administrative Liability

Administrative liability is imposed by the respective administrative authority responsible for the specific sector of state government following an administrative procedure described in detail in the Bulgarian Administrative Violations and Penalties Act.

 

(C) Criminal Liability

Criminal liability is imposed by the court following a criminal prosecution procedure initiated by the investigative and prosecution authorities and described in detail in the Bulgarian Criminal Procedure Code.

 

5. What defenses are available?

(A) Civil Liability

Contractual Liability

The plaintiff should prove before the court that the defendant has failed to perform one or more of its contractual obligations and that has caused damages to the claimant. The defendant is not obliged to prove that it has duly performed its obligations but could simply deny the claimant’s assertions.

In addition, the defendant could claim that the limitation period of the claimant’s claim has expired. The limitation period of a contractual claim for compensation of damages is 3 (three) years.

 

Non-Contractual Liability

In case of a general tort, the guilt of the damaging person is presumed by law. This means that the claimant is not required to prove that the defendant has guiltily caused the damages. Therefore, the defendant could not as in the case of a contractual liability simply deny the claimant’s assertions but should actively prove that it is not guilty for the damages caused to the claimant. Still, the claimant must prove the damages and that they were caused by an act (action or omission) of the defendant.

In addition, the defendant could claim that the limitation period of the plaintiff’s claim has expired. The limitation period for civil claims based on tort is 5 (five) years.

If the claim is brought on the grounds of the Bulgarian Consumers Protection Act for damages caused by defective goods, the manufacturer shall not be responsible for the damages caused to the consumer if the manufacturer proves one or more of the following circumstances:

• the manufacturer has not put the goods into circulation;
• considering all circumstances, it is probable that the defect which caused the damage has not existed at the time when the product was put into circulation by the manufacturer or that this defect became apparent afterwards;
• the manufacturer neither manufactured the product for sale or any form of distribution for economic purposes nor manufactured or distributed said product in the course of the its business activity;
• the defect is due to compliance of the product with mandatory requirements established by the public authorities;
• due to the level of scientific and technical knowledge at the time of placing the product on the market, the deficiency could not have been detected;
• the damage is caused both by the defective product and by the damaged person or by a person for whom the damaged person is responsible.

In addition, the manufacturer could claim that the limitation period of the damaged person’s claim has expired. The limitation period for such claims is 3 (three) years as of the date on which the damaged person has become aware or should have become aware of the damages, the defect and the manufacturer’s identity.

 

 

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Click the following links to read more legal articles from Bulgaria:

1. Regulatory Pricing and Reimbursement Overview
2. Preclinical and Clinical Trial Requirements
3. Marketing, Manufacturing, Packaging & Labeling, Advertising
4. Traditional Medicines and OTC Products
5. Product Liability
6. Patents & Trademarks
7. Regulatory Reform

Also from this Legal Handbook

The key facts about traditional medicines and OTC products in Bulgarian Pharma. Prepared in association with Kinstellar and PharmDedict, this is an extract from The Pharma Legal Handbook: Bulgaria, available to purchase here for GBP 75.

 

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

Bulgarian law regulates medicinal products and medical devices differently.

Medicinal products are grouped in three categories: (i) conventional medicinal products; (ii) traditional herbal medicinal products; and (iii) homeopathic medicinal products.

Medicinal products in general can be marketed in Bulgaria only if the marketing authorisation holder/the holder of registration certificate is established in an EU Member State.

The marketing authorisation (for conventional medicinal products) or registration certificate (for traditional herbal and homeopathic medicinal products) is issued by the Executive Director of the Bulgarian Drug Agency.

The Bulgarian Law on Medicinal Products in Humane Medicine (LMPHM) allows for a simplified registration procedure for herbal and alternative medicines provided that certain criteria is met.

Herbal medicines are subject to a simplified registration procedure if they satisfy the following requirements:

• They have therapeutic indications inherent to traditional herbal medicines;
• They are administered only in specified amounts (doses);
• They are administered orally, through inhalation or are intended for external use;
• They have been used for at least 30 years worldwide and at least 15 years in an EU Member State;
• The data regarding the traditional use of the medicine proves that it is not harmful if used in compliance with its specific conditions for use.

Homeopathic medicines are subject to a simplified registration procedure if they meet the following criteria:

• They are administered orally or externally;
• No specific therapeutic indications have been listed on the external package of the product or in any other information related thereto;
• There is sufficient dilution to guarantee the safety of the product.¹

Medical devices can be marketed in Bulgaria only if they have passed the conformity assessment and meet the requirements for safety and intended use. The manufacturer is the person responsible for the activities related to marketing of medical devices. If the manufacturer is not established in the EU/EEA, it must authorize a representative.

 

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

As far as traditional herbal and homeopathic products are non-prescription products, they can be advertised to the general public.

 

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

Medicinal products can be advertised only if they have received marketing authorisation.

As far as traditional, herbal, complementary and alternative products are non-prescription products, they can be advertised to the general public. The advertising of non-prescription medicines (including traditional herbal and homeopathic products) shall not contain any misleading information and any promise for pecuniary or non-pecuniary benefit. In particular, the content of an advertisement of medicinal products comply with the data of the current summary of product characteristics and only the approved therapeutic indications may be claimed.

 

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

OTC (over-the-counter) products can be marketed in Bulgaria only if they have received marketing authorisation or registration certificate and the marketing authorisation/registration certificate holder has to be registered in EEA.

OTC products generally follow the same regulatory requirements as to marketing authorisation/registration, manufacturing, placing on the market, wholesale and retail trade, clinical trials, pharmacovigilance, etc.

The main differences from prescription medicines apply to dispensing, advertising and pricing and reimbursement. Unlike prescription medicines, OTC products can be advertised to the general public and can be sold through the internet by websites maintained by pharmacies or drugstores.

On the other hand, OTC products are not reimbursed or paid by public funds of the National Health Insurance Fund or the state or municipalities.

 

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

OTC products may be sold only by pharmacies and drugstores. Unlike prescription medicines, OTC products can also be sold through the internet by websites maintained by pharmacies or drugstores. In exceptional cases, when there is no pharmacy in the town, doctors may sell OTC products only if they have obtained the respective permit for that.

 

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

Medicinal products can be advertised only if they have received marketing authorisation. As far as OTC products are non-prescription products, they can be advertised to the general public. The advertising of non-prescription medicines shall not contain any misleading information and any promise for pecuniary or non-pecuniary benefit. In particular, the content of an advertisement of medicinal products comply with the data of the current summary of product characteristics and only the approved therapeutic indications may be claimed.

 

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

OTC products, like non-prescription products, can be advertised directly to the public (please see the answers to questions 17, 19 and 20 of Marketing, Manufacturing, Packaging and Labeling Advertising, and to question 6 above).

 

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

A prescription-only product can be converted to an OTC product and vice versa if new data has been obtained for the respective product, which requires a change of the classification of the product.

Medical products are classified as prescription-only when they meet one or more of the following conditions:

• are likely to present a danger either directly or indirectly, even when used correctly, if administered without medical supervision; and/or
• are often administered incorrectly and as a result of which are likely to present a danger to a person’s health; and/or
• contain substances and preparations the side effects of which require additional research; and/or
• are usually prescribed by doctors for parenteral usage; and/or
• contain narcotics; and/or
• may lead to addiction if administered incorrectly; and/or
• contain new substances the characteristics of which have not been sufficiently researched; and/or
• are distributed only in hospitals; and/or
• are prescribed only for conditions which can be diagnosed only in hospitals; and/or
• the administration of which can lead to significant undesired side effects.

If a medical product ceases to meet any of the criteria under which it has been classified as prescription-only product, the product may be re-classified. The conversion process is initiated with an application of the market authorisation holder submitted with the Bulgarian Drug Agency.

 

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

Medicines in general can be imported in Bulgaria only by natural persons or legal entities that are registered as traders in the EEA and have obtained import authorisation by the Bulgarian Drug Agency. Such persons or entities should also have at least one person that holds a master’s degree in medicine, pharmacy, biotechnology or chemistry and a quality control laboratory.

 

 

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1. In particular, the medicinal product may not contain either more than one part of the mother tincture per 10,000 or more than 1/100th of the smallest dose used in allopathy, as regards active substances whose presence in an allopathic medicinal product results in mandatory medical prescription

Also from this Legal Handbook

Marketing, manufacturing, packaging & labeling, advertising in Bulgaria – a comprehensive legal overview. Prepared in association with Kinstellar and PharmDedict, this is an extract from The Pharma Legal Handbook: Bulgaria, available to purchase here for GBP 75.

 

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

Homeopathic and traditional herbal medicinal products may be placed on the market in Bulgaria based on а registration certificate. All other medicinal products may be placed on the market subject to the issuance of a marketing authorisation. Only marketing authorisation holders whose place of residence or seat is located in a Member State of the European Economic Area (EEA) can apply for the marketing authorisation. A medicinal product may be marketed in Bulgaria based on a marketing authorisation, issued under one of the following procedures: (i) National Procedure; (ii) Decentralized Procedure; (iii) Mutual Recognition Procedure or (iv) Centralized Procedure at the European Medicines Agency (EMA).

Under the National Procedure, the marketing authorisation is issued by the Executive Director of the BDA based on submission of application and proper documentation, in Bulgarian and/or English language – the dossier is filed in e-CTD format. The application is a standard-form template and may be submitted by an individual or a legal entity established in EEA, whereas, in case this is not Bulgaria, an authorized representative for representation before the Bulgarian regulatory authorities must be appointed. The marketing authorisation is granted subject to fulfilment of all applicable legal requirements aiming at providing scientific evidence for the quality, safety and therapeutic efficacy of the medicinal product.

Under the Decentralized Procedure (DCP), the application for the issuance of a marketing authorisation is filed simultaneously with the BDA and with the regulatory authorities of other member states, in which the product is intended to be marketed. The applicant must indicate the state, which shall be the reference member state (RMS) leading the assessment process. The applicant must also indicate, which are the other concerned member states (CMS). The BDA have limited capacity to act as RMS and Bulgaria is usually appointed as CMS. The product dossier is submitted in e-CTD format. The outcome of the procedure is that the BDA (along with RMS and the rest of the CMS) issues a marketing authorisation for Bulgaria, together with the approved summary of product characteristics (SPC), patient’s leaflet and packaging mock-up (all together referred to as the product information or PI).

The Mutual Recognition Procedure (MRP) is similar to DCP, however in this case the product has already been authorized in an EEA state, and the MAH further applies to authorize this same product for marketing in other countries – CMS. Again, usually BDA acts on the CMS side. The applicant must submit the identical product dossier, as such is provided to the reference state and the concerned member states. Again, the outcome of the procedure is that the BDA (along with the rest of the CMS) issues a marketing authorisation for Bulgaria, together with the approved PI.

The DCP and MRP result in multiple national marketing authorisations and this is the main difference from the centralized procedure where there is one marketing authorisation for all member states.

Under the centralised authorisation procedure, pharmaceutical companies submit a single marketing-authorisation application to EMA. This allows the marketing authorisation holder to market the medicinal products throughout the EEA on the basis of a single marketing authorisation granted by the European Commission. The centralised procedure is compulsory for certain type of medicinal products and optional for others; some medicinal products are not eligible to this procedure.

Regarding medical devices the general rule is that the manufacturer shall be liable for applying the CE Marking, which is a process that indicates that the medical device complies with European Union legislation on medical devices Bulgarian Law on Medical Devices (LMD) follows the EU classification rules pertaining to medical devices. Apart from CE marking, a registration or notification procedures at the BDA could be applicable (see question 3 in the Regulatory, Pricing, and Reimbursement Overview).

 

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

For the generic versions of these products, the same authorisation procedure to obtain the marketing authorisation is followed, except that the applicant must evidence bioequivalence with the reference medicinal product and does not need to submit the results and documentation of the clinical and preclinical data. The generic application would result in marketing authorisation only after the data exclusivity period has expired (usually 10 years from the date of the first authorisation).

 

3. What are the typical fees for marketing approval?

The typical fees for marketing approval are described in the answer to question 4 in the Regulatory, Pricing, and Reimbursement Overview.

 

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

Marketing authorisations are valid for 5 (five) years. Renewals must be applied for not later than 9 (nine) months prior to the expiration date, after an assessment of the benefit-risk ratio is made. After the first renewal, marketing authorisations are valid for an indefinite term. In the event of duly justified reasons related to pharmacovigilance, the BDA may require an additional 5 (five) year renewal.

 

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

The reporting modalities and rules governing the post-approval pharmacovigilance are harmonised for the EU. The pharmacovigilance system at union level is managed by European Medicines Agency (EMA) and they maintain the online reporting system EudraVigilance. EudraVigilance is a single repository for reports of suspected adverse reactions seen in healthcare practice. It is used by EMA, BDA and industry. At national level the BDA also maintain pharmacovigilance system in full compliance with the requirements of the EU regulations and EMA guidelines. In addition, in order to abide by Bulgarian and EU pharmacovigilance requirements, marketing authorisation holders are under the obligation to maintain their own internal pharmacovigilance systems, which systems must regularly be audited internally and is subject to inspections by the competent authorities.

The Bulgarian LMPHM is harmonized with EU pharmacovigilance requirements: suspected serious adverse reactions occurring within and outside the EEA are subject to reporting by marketing authorisation holders to the EudraVigilance within 15 days. Suspected non-serious adverse reactions occurring within the EEA must be reported within 90 days.

 

6. Are foreign marketing authorisations recognized?

Marketing authorisations issued by the competent authorities within the EEA are recognised via MRP or DCP: both procedures resulting in a national marketing authorisation. Medicinal products authorised via the centralised procedure managed by EMA are recognised and valid without the need of further national marketing authorisation. Marketing authorisations issued outside the EEA are not recognised.

 

7. Are parallel imports of medicines or devices allowed?

Bulgarian law expressly regulates parallel import from EEA pertaining to medicinal products. Parallel importers of medicinal products may be individuals or legal entities having commercial registration in Bulgaria or other EU-member state, which have received a parallel import permit from the BDA. The BDA maintains a public register with all registered parallel importers. Parallel import is allowed in Bulgaria, provided that the medicinal product is authorized for marketing in an EU-member state and is identical or similar (same active substance, pharmaceutical form and primary packaging, and similar outer packaging design) to a product already authorised for use in Bulgaria.

There are no special rules for the parallel import of medical devices. The general principle of free movement of goods within the EEA applies, as well as the principle of exhaustion of the rights conferred by a trademark. If the medical device is placed on the EEA market bearing CE marking, it could be subject to parallel import, provided that it meets the requirements for labelling and instructions for use in the local language. Considering that Bulgaria is the only EU member state using the Cyrillic alphabet, this may bring the need for repackaging or applying a local label which, depending on the case, may have implications – see the case-law of the European Court of Justice in that respect (e.g. Junek Europ-Vertrieb, C-642/16; Servoprax C-277/15).

 

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?

In terms of interactions with HCPs – Bulgarian law prohibits provision of gifts and other pecuniary benefits (cash, as well as in-kind) to HCPs. In addition to the legal restrictions, there are also the ethical rules adopted by the local pharma trade associations of originators and of generic companies, which in general follow the corresponding rules adopted by the relevant trade associations at EU level (e.g. EFPIA). These rules are coded and are binding on member companies.

HCPs may not be compensated solely for their attendance of an event or a training. Consultancy agreements must be in writing and against payment of remuneration. Written consultancy agreements are not required for incidental marketing survey services (telephone interviews, questionnaires by post/internet/email), provided that the agreed remuneration does not exceed 60 Bulgarian Leva, VAT inclusive.

Under the law, hospitality to HCPs is restricted to travel expenses, accommodation and registration fees, whereas under the ethical rules, meals are covered as well, but only up to a threshold of 100 Bulgarian Leva, VAT inclusive per meal. There are certain restrictions as to the acceptable accommodation and flight arrangements.

 

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

Manufacturing of medicinal products is subject to authorisation by the BDA. The rules and requirements are provided in the LMPHM and the Good Manufacturing Practices (GMP) rules. The supervision over the premises, equipment and manufacturing conditions pertaining to medicines, is vested with the BDA.

Although regarding medical devices there is no manufacturing authorisation similar to the one for drugs, the BDA is responsible for the registration of manufacturers of medical devices established in Bulgaria.

 

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)?

The BDA has announced that after auditing, the US FDA confirmed the BDA capacity and ability to perform GMP inspections equivalent to the US standards. Based on the sector agreement between the European Commission and the USA, there will be mutual recognition of GMP inspections of drug manufacturing sites. Currently the sector agreement covers the medicinal products for human use except vaccines, plasma-derived medicinal products and medicinal products intended for clinical trials.

Bulgarian GMPs is compliant with EU-GMP defined by the European Medicines Agency. EU directives, regulations and guidelines, pertaining to medicinal products and to medical devices are implemented in Bulgarian law, and it is in line with the European Medicines Agency expectations and requirements.

 

11. What is the inspection regime for manufacturing facilities?

The BDA is responsible for inspection of manufacturing sites in Bulgaria. Inspections may be requested by the industry in relation to a marketing or manufacturing authorisation procedure. Inspections could also be triggered at the initiative of the BDA as part of the on-going control activities.

The BDA may participate in inspections of manufacturing sites located in other EU-member states or third states at the request of the European Commission, the European Medicines Agency or a member state. The BDA cooperates with the European Medicines Agency in coordinating inspections in third states.

Compliance with GMPs is verified by means of a certificate, issued within 90 days as of the inspection.

 

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

No. Only officials from the BDA may conduct inspections.

 

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

Storage and handling of medicinal products in Bulgaria is done in accordance with the Good Distribution Practices (GDPs), outlined in the secondary legislation on implementation of the LMPHM, and namely Ordinance 39 dated 13 September 2007 on the Good Distribution Practices. Bulgarian GDPs are harmonized with EU GDPs. Storage premises and transportation means are subject to inspection by the BDA within the procedure for issuance of a wholesale distribution authorisation, and thereafter – for compliance with GDP.

Packaging/repackaging of medicinal products is considered to be a manufacturing activity and is subject to a manufacturing authorisation.

Storage and handling of medical devices is regulated under the LMD. Such activities must be performed in appropriate premises or transportation means and further to the requirements, set forth in the device documentation issued by the manufacturer of the specific device. Responsibility for compliance with such requirements is vested with the wholesale distributors with medical devices. If the manufacturer does not provide specific conditions for the handling and storage of medical devices, they must be handled in such a way, so as their safety is not compromised.

 

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

With respect to medicinal products, labelling and packaging requirements are set forth in the Bulgarian secondary legislation, and namely Ordinance 38 dated 13 September 2007 on the requirements for the information on packaging and leaflets of medicinal products. Such information (except, when a product for use in a clinical trial is concerned) must follow strictly the product SPC, as approved by the BDA, and the product marketing authorisation. The Ordinance sets forth an express list, detailing the information to be included on the product package, including product and active substance name (including in the Braille alphabet), pharmaceutical form, administration route, expiry date, registration and batch number, specific storage conditions, children warnings, indication whether the product is prescription product or OTC, etc. In the cases of small primary packages of medicinal products, manufacturers are allowed to refrain from putting on the package some of the required elements, provided that the available packaging space is insufficient.

With respect to medical devices, labelling is done by the manufacturer. It must be in abidance with medical device classification rules. The requirements are provided in the LMD and the regulations on the essential requirements for the concerned type of medical device. As a rule, the labelling and the instructions for use (where such instructions are applicable) have to be in the Bulgarian language. Certain exceptions are allowed for the labelling in case the medical device is intended for professional use only.

The labelling of drugs and medical devices is also affected by the requirements of other legislation, e.g. the waste management legislation in respect of the recycling symbols found on consumer packages.

 

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

Product packages may contain an indication as to whether the product is reimbursed with public funds, as well as a barcode for verification of product identity and authenticity. Multi-lingual packs are allowed (where the information on the packaging and leaflet is presented in more than one language), provided that one of the languages is Bulgarian. There are exceptions when the information could be provided in foreign language upon ad hoc request to the BDA. On case by case basis, if needed, the BDA may request additional information to be included in the leaflet or labelling.

The labelling and packaging of medical devices additionally may contain symbols explaining the provided mandatory information.

 

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

Labelling and packaging of medicinal products may not contain items of promotional nature, as well as misleading information and indications.

 

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

Only authorized medicinal products may be advertised and promoted in Bulgaria. Any advertising or promotion of a medicinal product must correctly indicate the products’ therapeutic effect, and must not over-exaggerate therapy, prophylaxis or diagnostics’ options. Advertising and promotional materials pertaining to medicinal products may not be misleading and may not imply gifts and/or other pecuniary and non-pecuniary benefits. Such materials must strictly follow the latest approved SPC. Off-label advertising and promotion is prohibited. In addition, prescription products may not be advertised directly to patients, but only to healthcare professionals (HCPs). Prescription products cannot be advertised over Internet.

There are no specific rules with respect to advertising and promotion of medical devices. However, the general rules of the safeguarding consumers and fair competition would apply.

 

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

With respect to patients (retail sales), medicines may be sold (dispensed) only in pharmacies (including also hospital pharmacies) and drugstores. In some cases, dentists and medical doctors are also able to dispense medicinal products to patients. For medical devices the scope of dispensing places/entities is wider.

Prescription medicinal products may not be traded over the internet, only OTCs. Internet trade of OTCs may be performed only by pharmacies and drug stores which have obtained a specific authorisation for retail trade over the internet, issued by the BDA.

No special provisions exist in Bulgaria concerning sales of medicinal products by post. However, both wholesalers and retailers trading over the Internet are responsible for ensuring appropriate means of transportation, especially if special conditions are necessary (e.g. temperature, humidity, etc.). Between wholesalers, medicines and devices may be sold and delivered to duly authorized warehouses and in accordance with the respective contractual arrangements.

Natural persons may import/export only medicinal products intended for their treatment and certain limitations apply.

Regarding medical devices the law requires from wholesalers to engage appropriate means of transportation. However, there are no specific rules for retail sales via post service.

 

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

Prescription medicinal products may not be advertised and promoted over the internet. In addition, certain requirements prohibit the sending of commercial notices via e-mail without customer consent.

 

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

Only OTCs may be advertised to the population directly. An exception is the advertising of vaccine campaigns, which are allowed to be conducted directly to the consumers. Prescription drugs may be promoted and advertised only to healthcare professionals, and following strict rules in the LPMHM, the secondary regulation and the applicable industry ethical codes.

Prescription medicinal products may be sold to consumers directly only in pharmacies. Bulgarian law allows trade over the internet, but only of OTCs. Wholesale traders may sell to other wholesale traders, pharmacies and drugstores, the Ministry of Healthcare, the Ministry of Interior and the Ministry of Defence, and hospitals.

 

21. How is compliance monitored?

Compliance is monitored by means of periodic and planned, as well as ad-hoc, on-site inspections of the competent regulatory authority the BDA.

 

22. What are the potential penalties for noncompliance?

Penalties for noncompliance vary depending on the infringement, and whether it is a one-time violation, or a repetitive one (in which case, the double amount of the penalty is usually levied). Penalties represent monetary sanctions, levied at the discretion of the penalizing bodies, within a certain range, whereas minimum and maximum amounts are set forth in the LMPHM. For different infringements, penalties may range between BGN 750 (appr. EUR 385) and BGN 150,000 (appr. EUR 76,923). In case the infringer is a legal entity, sanctions are the triple amount envisaged for the respective infringement. Additional ancillary sanctions in the form of pecuniary measures are also levied in cases of serious violations, whereas these include (possible) suspension of an authorisation, a license or a permit, deprivation in favour of the State of products and equipment used by the infringer, or such subject of the infringement, prohibition to exercise professional activities for up to 2 years, etc. For the purposes of the administrative penal procedures, the regulatory authorities partner with the customs, the revenue and internal affairs authorities.

 

 

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Click the following links to read more legal articles from Bulgaria:

1. Regulatory Pricing and Reimbursement Overview
2. Preclinical and Clinical Trial Requirements
3. Marketing, Manufacturing, Packaging & Labeling, Advertising
4. Traditional Medicines and OTC Products
5. Product Liability
6. Patents & Trademarks
7. Regulatory Reform

Also from this Legal Handbook

The ins and outs of preclinical & clinical trial requirements: 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.

 

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

There is no requirement for clinical trials to be conducted locally as a condition for obtaining market authorisation. However, if the clinical trials have been conducted outside of the European Union, the applicant for market authorisation shall submit a declaration that the trials meet the ethical requirements of the Good Clinical Practice set forth in the applicable Bulgarian legislation.

 

2. How are clinical trials funded?

Clinical trials are usually funded by a sponsor. The sponsor is an individual, a company, a healthcare institution or an organization which initiates, organizes and/or funds the clinical trial. Non-profit organizations sponsoring a clinical trial have to provide evidence for the sources of funding for the clinical trial. The sponsor is liable for the compliance of all aspects of the clinical trial and the conduct thereof.

 

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

The protocol shall describe the objective, design, methodology, statistical considerations, purpose and organization of the clinical trial. The protocol is identified by: (a) the title of the clinical trial; (b) the EU trial number; (c) the sponsor’s protocol code number specific for all versions of it (if relevant); (d) the date and number of the version, to be updated when it is amended; (e) a short title or name assigned to the protocol; and (f) the name and address of the sponsor, as well as the name and function of the representative or representatives of the sponsor authorised to sign the protocol or any substantial modification to the protocol.

The protocol has to include at least: (a) assessment of the expected benefits and risks; (b) a description of the subject inclusion and exclusion criteria; (c) a justification for including subjects, especially in cases where subjects who are incapable of giving informed consent or other special populations, will be included; (d) a detailed description of the recruitment and informed consent procedure, especially when subjects are incapable of giving informed consent and when it is envisaged the consent to be given by an independent witness; (e) a description of the arrangements for taking care of the subjects after their participation in the clinical trial has ended; (f) a description of arrangements for monitoring the conduct of the clinical trial; and (g) a description of the publication plan. Upon Regulation (EU) No 536/2014 ¹ (the “Clinical Trials Regulation”) becoming applicable ², the protocol and its content has to be made in compliance with the requirements of Part D (Protocol) of Annex I of that Regulation.

The protocol needs to receive a positive opinion by the respective Ethics Committee for Clinical Trials ³ (either local Ethics Committee ⁴ at the site where the trial will be conducted or the Ethics Committee at the Ministry of Health, in case of multicenter clinical trials). The protocol has to be approved also by the Executive Director of the Bulgarian Drug Agency.

 

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

There are no restrictions with respect to who can participate in clinical trials, as long as the participants have given their consent for participating. Participant of full age can give their consent freely, while the consent of under-aged participants and incapacitated participants of full age is given by their parents or custodians.

There are several requirements, which the consent should meet:

1. the participants should receive clear, comprehensive and concise information which enables them to understand the nature, objectives, implications, risks and inconveniences of the clinical trial;
2. the participants should receive information on their rights and guarantees regarding their protection, in particular the right to refuse to participate and the right to withdraw from the clinical trial at any time without any resulting detriment and without having to provide any justification;
3. the consent should be obtained in writing. ⁵

 

5. May participants in clinical trials be compensated?

Participants in clinical trials may receive compensation for their participation in a clinical trial. This can be contractually arranged. Information regarding such compensation has to be included in the documentation for the trial and reviewed and approved by the respective Ethics Committee. The Ethics Committee should review both the amount and method of payment to subjects to assure that neither presents problems of coercion or undue influence on the trial subjects. Payments to a subject should be prorated and not wholly contingent on completion of the trial by the subject.

No incentives or financial inducements are given except compensation in case of clinical trial on minors or clinical trials on incapacitated adults not able to give informed legal consent (vulnerable subjects).

 

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

Under Bulgarian law, the sponsor of the clinical trial and the investigator are required to conclude a civil liability insurance, which covers the pecuniary and non-pecuniary damage that might be caused during the trial.

Apart from this, participants in clinical trials (or their families, in cases of death) are entitled to receive compensations in cases of death or health detriment due to the clinical trial.

 

 

 

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1. Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC.;

2. Regulation (EU) No 536/2014, including the requirements regarding the protocol, will become applicable six months after the European Commission publishes a notice under Article 82(3) of the Regulation.

3. The Ethical Commission for Clinical Trials is a commission established at the Bulgarian Ministry of Health.

4. The amendments of LMPHM from October 2018 replaced the existing local Ethics Committees at the healthcare establishments (LEC) by a “contact person” appointed at each site. The contact person will have monitoring functions and will partially take over the functions of the former LECs. The change is supposed to enter into force simultaneously with the Clinical Trials Regulation (expected to become applicable in 2021). For centres with operative LECs – they will operate according to the old rules until replaced with a contact person. It is not possible to establish new LECs any more, as the legal basis for this is no longer available.

5. Certain deviations from this rule are envisaged in cases when the participant cannot write, e.g. the consent can recorded in another suitable way.

Also from this Legal Handbook

Key legal info on regulatory, pricing and reimbursement 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.

 

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

The following authorities are responsible for applying and enforcing the regulatory framework pertaining to drugs (including biologicals) and medical devices in Bulgaria:

• The Bulgarian Drug Agency (BDA) is a specialized State regulatory authority established to the Minister of Health, which exercises supervision over the quality, safety and efficacy of drugs (including biologicals), and of medical devices. The BDA is responsible for authorizing and registering drugs and medical devices to be placed on the market, as well as for issuing of permits, authorisations and certificates for various activities, including without limitation import/export, wholesale distribution and retail trading, manufacturing and brokering activities. It assesses and confirms the conformity with the law of manufacturers, marketing authorisation holders, wholesalers, retailers, of both drugs and medical devices. It has a role in initiation and carrying out of clinical trials and supervises the trial procedures. The BDA has also control functions related to pharmacovigilance. In addition, the BDA performs supervision over promotional activities pertaining to drugs. In its activities, the BDA correlates with the State customs authorities, revenue authorities, the National Health Insurance Fund (NHIF), the National Council for Prices and Reimbursement of Medicinal Products (NCPRMP), as well as with the Ministry of Health (MoH).
• The NCPRMP is a specialized administrative body established to the Minister of Health and responsible for inclusion and exclusion of drugs from the Bulgarian Positive Drug List (PDL), as well as for determining, registering and controlling the prices of drugs, including reimbursed products, and of maintaining their reimbursement status. The NCPRMP performs health technology assessment of drugs and issues pharmaco-therapeutic guidelines.
• The NHIF is a State authority responsible for the reimbursement of drugs and medical devices and is one of payers with public funds.

 

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

The main local statutory act pertaining to the authorisation, pricing, and reimbursement of drugs (including biologicals) is the Law on Medicinal Products in Human Medicine (LMPHM), and the secondary legislation on its implementation. The main local statutory act pertaining to the registration, pricing, and reimbursement of medical devices is the Law on Medical Devices (LMD), and the secondary legislation on its implementation. Depending on the type of the statutory act, secondary legislation is issued by the Council of Ministers or by the Minister of Health. Relevant guidelines and authority practice are also deemed of relevance. In addition, Bulgarian pharmaceutical legislation is, for the most part, harmonized with the EU Directives and Regulations (the latter, being directly applicable in Bulgaria), e.g. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amended and Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, as amended.

 

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

A) Medicinal Products

In order to develop and test medicinal products (drugs) in Bulgaria, it is necessary to obtain an authorisation for manufacturing of medicinal products. This is so, insofar as both the development and the testing activities would qualify as “manufacturing of medicinal products”, as such term is defined in the LMPHM. The manufacturing authorisation is issued by the Director of the BDA. Applicants must comply with certain requirements set forth in the law. Manufacturing sites are subject to inspections by the competent authorities for compliance with the applicable Good Manufacturing Practices. The manufacturing authorisation is issued only for the manufacturing activities, the pharmaceutical forms and the premises, which have been applied for by the applicant. Changes to the circumstances subject to authorisation (including – with respect to manufacturing activities, manufacturing sites/premises, pharmaceutical forms, the qualified person, and other significant personnel, etc.) are subject to additional manufacturing authorisation for the change.

A medicinal product may be placed on the market in Bulgaria based on a marketing authorisation, issued under one of the following procedures: (i) National Procedure; (ii) Mutual Recognition Procedure; (iii) Decentralised procedure or (iv) Centralized Procedure at the European Medicines Agency.

Homeopathic and traditional herbal medicinal products may be placed on the market in Bulgaria based on registration certificate.

 

B) Medical Devices

There is no specific authorisation for manufacture of medical devices required; however, manufacture of medical devices may, depending on the circumstances, include activities for which authorisation is required (e.g. handling of chemicals, usage of radiation, etc.).

There is no marketing authorisation for medical devices. However, depending on the medical devices class, certain requirements have to be met. Medical devices shall bear CE marking indicating that they have been the subject of an assessment of their conformity (there are certain exceptions, e.g. for custom-made devices not bearing CE marking).

In case the manufacturer or its EU-based authorised representative are established in Bulgaria, there is a special registration procedure at the BDA depending on the medical device type and class.

For certain types of medical devices there is a notification procedure at the BDA.

 

4. What are the approximate fees for each authorization?

A) Medicinal Products – Marketing Authorisation

National Procedure	Amounts in BGN
Referent medicinal product	15,000
Medicinal product with well-established use	15,000
Medicinal product with active substances with well-established use, but not known in that combination	15,000
Generic medicinal product	7,500
Medicinal product according to Art. 32 of the LMPHM with informed consent, regarding the preclinical and clinical parts	7,500
Medicinal product according to Art. 29 (1) of the LMPHM	15,000
Medicinal product according to Art. 29 (2) of the LMPHM	15,000

 

Decentralized Procedure	Fees in BGN (RMS)*	Fees in BGN (CMS)**
Referent medicinal product	20,000	10,000
Medicinal product with well-established use	20,000	10,000
Medicinal product with active substances with well-established use, but not known in that combination	20,000	10,000
Generic medicinal product	14,000	7,000
Medicinal product with informed consent regarding the preclinical and clinical parts	14,000	7,000
Medicinal product according to Art. 29 (1) of the LMPHM	20,000	10,000
Medicinal product according to Art. 29 (2) of the LMPHM	20,000	10,000

 

Mutual Recognition Procedure	Fees in BGN (RMS)	Fees in BGN (CMS)
Referent medicinal product	16,000	8,000
Medicinal product with well-established use	16,000	8,000
Medicinal product with active substances with well-established use, but not known in that combination	16,000	8,000
Generic medicinal product according to Art. 28 of the Drug Law	12,000	6,000
Medicinal Product with informed consent regarding the preclinical and clinical parts	12,000	6,000
Medicinal product according to Art. 29 (1) of the LMPHM	16,000	8,000
Medicinal product according to Art. 29 (2) of the LMPHM	16,000	8,000

 

* Reference member
** Concerned member state

 

B) Medicinal Products

Between 5,000 and 20,000 BGN depending on the types of products. Good Manufacturing Practice on-site inspections are subject to separate fees.

Note: 1 EUR = app. 1.95 BGN

 

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

Marketing authorisations are valid for 5 (five) years. Renewals must be applied for not later than 9 (nine) months prior to the expiration date, after an assessment of the benefit-risk ratio is made. For the renewal of the marketing authorisation, a marketing authorisation holder must submit an application together with supplementary documentation to the BDA. After the first renewal, marketing authorisations are valid for an indefinite term. In the event of duly justified reasons related to pharmacovigilance, the BDA may require an additional 5 (five) year renewal.

 

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

Further to the LMPHM, marketing authorisation for generic products is subject to the same procedures, as those applicable to brand-name products. However, for generic products, the process may be shorter, as the presentation of pre-clinical and clinical study results is not required, if the so-called “data exclusivity” period has expired. This rule applies equally for both local and foreign-owned manufacturers. However, only marketing authorisations holders whose place of residence or seat is located in a Member State of the European Economic Area can apply for the marketing authorisation.

 

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

There are no specific rules regulating combination products (except for some rules in the reimbursement process). As far as biologics are classified as medicinal products, combinations of medicinal products and biologics are subject to the regulations under the LMPHM.

When combination products of medical devices and medicinal products is concerned, these would require considering the regulatory framework for both types of products individually – for the medicinal products and for the devices:

• where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in LMPHM and which is liable to act upon the body with action ancillary to that of the device – the LMD shall apply, however the quality, safety and efficacy of the substance must meet the LMPHM requirements;
• if the devices are intended to administer medicinal products they are governed by the LMD but must be designed and manufactured in such a way as to be compatible with the medicinal products concerned according to the provisions and restrictions governing medicinal products (LMPHM); if, however, such a device is placed on the market in such a way that the device and the medicinal product form a single integral product which is intended exclusively for use in the given combination and which is not reusable, that single product shall be governed by LMPHM – the relevant essential requirements of the LMD shall apply as far as safety and performance-related device features are concerned.

 

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?

Compliance with regulations pertaining to medicinal products is monitored by the MoH via the NCPRMP, the BDA and the Regional Health Inspections, i.e. the supervisory authorities with respect to the healthcare policy in Bulgaria. Compliance with medical devices regulations is monitored by the BDA. The BDA ensures supervision and enforcement of the law through (i) periodical inspections (both sudden ad-hoc on-site inspections, as well as planned inspections) and (ii) audit and reporting requirements, including for pharmacovigilance compliance. Within its competencies, the BDA follows European Commission guidelines. The regulatory regime set forth in Bulgarian law, as well as the relevant authority practice of the competent authorities, is compliant with EU directives, regulations and guidelines, pertaining to medicinal products and to medical devices. It is in line with the European Medicines Agency expectations and requirements.

The EU and the U.S. regulatory authorities are parties to a sectoral mutual recognition agreement on GMP inspections. In performance thereof, as a result of an audit conducted by the FDA on the BDA, on 29 April 2019 Bulgaria was confirmed by the FDA as a capable State, having an equivalent to the U.S. GMP-requirements, including conflict of interest avoidance rules.

 

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

Penalties for noncompliance vary depending on the infringement, and whether it is a one-time violation, or a repetitive one (in which case, the double amount of the penalty is usually levied). Penalties represent monetary sanctions, levied at the discretion of the penalizing bodies, within a certain range, whereas minimum and maximum amounts are set forth in the LMPHM. For different infringements, penalties may range between BGN 750 (appr. EUR 380) and BGN 150,000 (appr. EUR 76,000). In case the infringer is a legal entity, sanctions are triple the amount envisaged for the respective infringement. Additional ancillary sanctions in the form of pecuniary measures are also levied in cases of serious violations, whereas these include (possible) suspension of an authorisation, a license or a permit, deprivation in favour of the State of products and equipment used by the infringer, or such subject of the infringement, prohibition to exercise professional activities for up to 2 years, etc. For the purposes of the administrative penal procedures, the regulatory authorities partner with the customs, the revenue and internal affairs authorities.

 

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

Yes, there is a national healthcare system in Bulgaria. It is (in the most part) funded by the NHIF budget, which is formed from compulsory health security contributions made by the population, collected by the National Revenue Agency and administered by the NHIF. Certain products and services are subject to financing from the State budget. Healthcare services may also be funded by private health insurers, based on voluntary insurance contributions. As a matter of practice, due to the underfinancing of the public healthcare system, healthcare services are often co-financed by the patients themselves, or co-reimbursed by pharmaceutical companies by means of participation of pharmaceutical companies in co-reimbursement schemes under agreements with the NHIF.

 

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

The healthcare system financed with public funds covers a specific, exhaustive set of products and services, which is subject to update on an annual basis, and is conditional on the meeting of numerous criteria and requirements of all stakeholders – marketing authorisation holders, medical services providers, healthcare establishments, pharmacies. It is dramatically underfinanced, resulting in the necessity for active co-funding by companies and by patients. Bulgaria recognizes both public and private healthcare organizations (both for inpatient and for outpatient medical care), all of which are entitled by law to participate in the reimbursement model subject to meeting certain criteria set down by the NHIF towards its contractual partners. With respect to the provision of healthcare services funded with public funds, the NHIF contracts with both public (i.e. State or municipal) and private healthcare establishments.

 

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

Price regulation is applicable to all drugs, regardless of whether they are prescription (Rx drugs) or over-the-counter (OTC) products, subject to reimbursement or not. The reimbursed Rx drugs are listed in the PDL that contains a list of the maximum prices subject to regulation by the NCPRMP. For reimbursed products included in the PDL there is an internal price reference system (reference is made to the lowest price within the concerned group). For all Rx drugs (reimbursed or not), there is an external reference pricing system in place. The following ten EU member states are considered reference states: Belgium, Greece, Spain, Italy, Latvia, Lithuania, Romania, Slovakia, Slovenia and France. Depending on the price level of the specific medicine, the markup for a wholesaler could be up to 7%, 6%, or 4% above the manufacturer price and the markup for a retailer could be up to 20%, 18%, or 16% above the manufacturer price. For OTC drugs the maximum retail prices are subject only to registration by the NCPRMP and there is no external price reference system.

For medical devices there is a separate registration procedure for products subject to payment with public funds. There is an e-register managed by the BDA for that purpose. The prices of the medical devices reimbursed by the NHIF are subject to an annual negotiation procedure. The maximal value reimbursed by the NHIF is subject to an internal reference system applied to the concerned groups of medical devices. Apart from that, the prices of medical devices not paid by public funds are not regulated.

 

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

There is a relevantly complex reimbursement system depending on the type of product and the public payer. The main payers are the MoH and NHIF. Some medical devices are paid by the budget of the Ministry of Labour and Social Policy. Reimbursement could be channelled in different ways. For example, payments by the NHIF to contracted hospitals (both public and private) on the basis of clinical pathways and then public tender procedures initiated by the concerned hospitals; or direct reimbursement of outpatient drugs by the NHIF to the dispensing pharmacies – based on contractual arrangements negotiated and concluded year-by-year. In some cases, there are centralised tender procedures by the MoH.

Payments may also be covered by private health insurers or paid by the patients themselves. A possibility exists in Bulgarian drug legislation for patients’ co-payment to be covered by pharmaceutical companies based on an individual agreement concluded by the MAH with the NHIF for specific discounts distributed in favour of the patients.

 

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

Medicinal products prescribed by healthcare professionals are dispensed in pharmacies. In addition to pharmacies, OTC products, as well as medical devices, may also be sold by drugstores or on the Internet.

Retailers are entitled to their commercial discounts and margins which, in the case of medicinal products, may be administratively regulated. For medicinal products intended for outpatient treatment and 100% reimbursed by the NHIF, the pharmacies are entitled to a fixed fee per prescription.

 

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?

Prescription medicinal products are prescribed by healthcare professionals and are dispensed by pharmacies – either hospital pharmacies or retail pharmacies. OTC drugs are dispensed in pharmacies and drugstores. In some cases, dentists and medical doctors are also able to dispense medicinal products to patients. For medical devices the scope of dispensing places/entities is wider.

Pharmacists are responsible to provide all necessary information to the patients concerning the use and safety of the products and they may also consult the patients in relation to medicinal products. The organisation and operation of the pharmacies is regulated by the legislation. Pharmacists who are entitled to exercise their profession on the territory of Bulgaria are members of the Bulgarian Pharmaceutical Union (BPhU) established according to the national Law on the Professional Organization of Master Pharmacists. BPhU adopted a Code of Ethics and rules of Good Pharmacy Practice which further regulates the pharmaceutical care provided to patients/consumers.

 

 

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Click the following links to read more legal articles from Bulgaria:

1. Regulatory Pricing and Reimbursement Overview
2. Preclinical and Clinical Trial Requirements
3. Marketing, Manufacturing, Packaging & Labeling, Advertising
4. Traditional Medicines and OTC Products
5. Product Liability
6. Patents & Trademarks
7. Regulatory Reform