Traditional Medicines and OTC Products
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.
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