Localization
Kinstellar / 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 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.
