Bulgaria Pharmaceutical Licensing

This guide is limited to medicinal products for human use. The law regulates manufacturing, import, wholesale, retail, product marketing and controlled drugs separately; company registration does not confer the right to conduct pharmaceutical business.

The law frames the applicant as a commercial operator registered in an EU Member State. We have not identified a uniform rule on shareholding, capital or company form applicable to all non-EU/EEA investors; confirm this with BDA.

— Pharmacies may handle prescription and non-prescription medicines; drogerie may sell only listed non-prescription medicines and health-related products.

— An ordinary business authorisation does not automatically cover product marketing, third-country imports, parallel imports or narcotic substances.

Article 17 of the Medicinal Products in Human Medicine Act sets out BDA's licensing and inspection powers; BDA coordinates medicinal product control with RHI. Pharmacy, wholesale and manufacturing matters are handled by the BDA Executive Director, while narcotic substances are subject to a separate special-permit framework under the Ministry of Health.

— BDA: oversight of pharmacies, wholesale, manufacturing, imports, products and GDP/GMP.

— RHI/RZI: designated matters including health opinions and drugstore registration.

As a rule, retail sale of medicinal products may be conducted only by pharmacies and statutory drugstores. A pharmacy applies to BDA; core documents include entity registration, the responsible person's contract and qualifications, statutory declarations and proof of payment. BDA obtains a health opinion from RHI. The English text of the Act specifies a decision within 1 month after the file is complete; the period is suspended if documents are missing.

Online sales are permitted only for non-prescription medicines and only by pharmacies holding a retail pharmacy licence or registered drogerie. Online sales of prescription medicines are prohibited. Pharmacies handling narcotic substances must also obtain a separate special permit.

— Pharmacy: dispensing prescription and non-prescription medicines, providing advice and related activities.

— drogerie: a non-prescription medicine route; it does not replace a pharmacy licence.

Anyone establishing a medicinal product warehouse in Bulgaria must obtain a wholesale authorisation from the BDA and submit information on the operator, warehousing/equipment, the qualifications of the responsible person and the premises’ right of use, and undergo an on-site GDP inspection. The English text of the Act provides for a decision within 60 days. Holders of an existing wholesale authorisation from a Member State may obtain a BDA wholesale registration certificate on the basis of separate documentation; the text states 15 days.

A wholesale authorisation has no fixed term, but cessation of activities must be notified to the BDA in writing within seven days. Ongoing obligations include GDP, a quality system, an authorised supply chain, batch/transaction records, reporting of falsified medicines and recalls.

— The wholesale responsible person must hold a master’s degree in pharmacy and have at least two years of professional experience.

— Wholesale and retail pharmacy licences are mutually exclusive under the Act.

Manufacturing, manufacturing solely for export, packaging, repackaging and labelling, among other activities, require a BDA manufacturing authorisation. The application must describe the activities, dosage forms and premises and include personnel qualifications, registration, a capacity dossier, premises plans and, as applicable, environmental, nuclear regulatory or outsourcing documents. The BDA conducts an on-site GMP inspection.

The English text of the Act provides for a decision within 60 days and an authorisation with no fixed term; the BDA manufacturing services page still states 90 days. The two official sources are inconsistent, so the project cannot promise a fixed completion date for a manufacturing authorisation.

— Requirements: a qualified person, appropriate personnel, manufacturing/control/storage facilities, equipment and laboratories.

— Where manufacturing or control is outsourced, the site must be disclosed and GMP requirements and responsibilities clearly set out in a contract.

Pharmacy activities are carried out by a master of pharmacy; assistant pharmacists must work in the master’s presence and under their supervision and may not dispense prescription medicines or provide related control and counselling. A pharmacy manager must meet requirements concerning professional practice, absence of relevant convictions and at least one year of practical experience, among others.

The wholesale responsible person must hold a master’s degree in pharmacy and have at least two years of experience. The qualified person for manufacturing must hold a master’s degree in medicine, pharmacy, chemistry, biotechnology or biology and have at least two years of manufacturing/analytical experience, and is responsible for batch release.

— Recognition of foreign qualifications, registration with professional organisations and document format must be verified with the BDA for each candidate.

— This guide does not present consultants or business managers as locally mandated professionals.

Pharmacy Regulation No. 28 sets out requirements for pharmacy layout, a separate entrance, segregated storage of prescription medicines, temperature and batch records, and isolation of non-conforming products. Requirements should be determined in line with the actual activities and current annexes; this source does not establish a nationally uniform premises area.

Wholesale requires GDP-compliant premises, equipment and transport; manufacturing requires GMP-compliant manufacturing, control, storage and laboratory facilities. For imports from third countries, a local laboratory and storage site are conditions of the import authorisation.

— Premises documentation for pharmacies, wholesale, manufacturing and imports is not interchangeable.

— Before signing a long-term lease or carrying out fit-out work, obtain a local technical assessment against the target licence.

All applications start with the relevant BDA service: prepare documentation on the entity, premises, personnel, products/activities and fees; respond to requests for corrections and document verification/on-site inspection; obtain an authorisation or a reasoned refusal; and check the public register. Missing documents or non-compliance suspend the relevant time limit.

— Retail: responsible person, entity and RHI health opinion.

— Wholesale: GDP, warehousing, transport and responsible person.

— Manufacturing: GMP, capacity dossier, personnel and premises.

— Import: foreign GMP, local laboratory and storage.

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The BDA fee schedule was revised in 2026 and separately covers manufacturing, imports, wholesale, pharmacies and variations. Article 17 lists an initial pharmacy retail licence fee of 511.29 euros; manufacturing and wholesale fees are calculated by activity, premises or variation category and should be confirmed against the current schedule.

The English text of the Act specifies: one month for a pharmacy, 60 days for wholesale from a domestic warehouse, 15 days for wholesale registration by a Member State, 60 days for manufacturing, and 30 days for imports from third countries; requests for corrections and inspections may suspend the time limit. Wholesale, manufacturing and import authorisations have no fixed term. The term of a pharmacy licence was not verified in the sources reviewed using wording equally explicit.

— The decision period is not the total project duration.

— No commitment is made regarding total government fees, expedited processing, renewal periods or automatic licence renewal.

Pharmacies must maintain the scope of their licence, authenticity verification, reports on stocks of designated products, records and storage arrangements; wholesalers must maintain GDP, a quality system, traceability, reporting of falsified medicines and recalls; manufacturers must maintain GMP, batch release, audits, records and recalls.

No fixed term does not mean that maintenance is unnecessary. BDA may conduct inspections; failure to continue meeting the conditions, cessation of activities or a statutory circumstance may result in revocation or termination.

— Pharmacies: controls for temperature, prescriptions, stock and non-compliant products.

— Wholesale/manufacturing: quality system, batch records, quarantine and recalls.

Changes to a pharmacy operator's name/type, address, manager or activities must be applied for in accordance with the rules; a change to the name/type, pharmacy address or manager requires a new application and a new licence fee. Changes in wholesale activities require an application; changes to warehouse arrangements are subject to a 60-day review period and other changes to a 14-day period. Changes to key personnel, premises, activities, dosage forms or commercial registration for manufacturing must be applied for; equipment changes must be notified within 14 days.

No official basis was found to support automatic transfer of a licence following a share sale, change of control, asset transaction, merger or relocation. Before a transaction, compare the licence registration, manager, premises, activities and product scope individually, and obtain BDA's written opinion.

— Cessation: notification within 7 days for wholesale and within 14 days for pharmacies; cessation of manufacturing must also be notified.

— Do not assume that an equity transaction automatically renews or transfers a licence.

Product marketing authorisation is separate from authorisation of the business entity. The BDA catalogue separately lists national, DCP, MRP, traditional herbal, homeopathic, parallel import, renewal and product information variation procedures; a pharmacy, wholesale or manufacturing authorisation does not make an unauthorised product lawful to market.

Imports from third countries require a BDA import authorisation and submission of information on the foreign manufacturer and equivalent GMP, qualified personnel, a local Bulgarian quality-control laboratory and storage. Parallel imports and medicines containing narcotic substances follow separate routes.

— An import authorisation covers only the products, dosage forms, active substances and premises specified in the application.

— Ordinary wholesale, manufacturing or marketing documents must not be treated as a parallel import or controlled-drug permit.