Authorization for Pharmaceutical Trade in Bulgaria — Pharmacy, Drugstore and Online Sales (2026)

Legal Framework — LMPHM, BDA and Ordinance No. 28

Trade in medicinal products for human use in Bulgaria is governed by a comprehensive regulatory system, the foundation of which is the Medicinal Products in Human Medicine Act (LMPHM). This law regulates the manufacture, import, wholesale and retail trade, clinical trials, advertising and control of medicinal products.

The key legislative instruments you should be aware of are:

• LMPHM (Medicinal Products in Human Medicine Act) — the primary legislation defining the types of trade, requirements for persons and premises, procedures for issuing and revoking authorizations, and penalty provisions. Articles 146 et seq. specifically govern retail trade.
• Ordinance No. 28 of the Ministry of Health — on the organization, activities and internal rules of pharmacies, and the nomenclature of medicinal products. The Ordinance specifies the requirements for premises, equipment, personnel, working hours, documentation and control in pharmacy outlets.
• Ordinance on the conditions and procedure for retail trade in medicinal products — supplements the procedural aspects, including specific rules for drugstores and online sales.

The competent authority for issuing retail pharmaceutical trade authorizations is the Bulgarian Drug Agency (BDA), which operates under the Ministry of Health. The BDA also carries out ongoing supervision of pharmacy and drugstore operations, including on-site inspections, product range monitoring and compliance checks.

At the regional level, the Regional Health Inspectorates (RHI) participate in the procedure by issuing hygiene assessments for the premises and registering drugstores.

Pharmacy and Drugstore — Key Differences

Bulgarian legislation distinguishes two types of retail outlets for medicinal products, each with a different scope of activity, staffing requirements and supervisory regime:

A pharmacy is a retail outlet authorized to sell the full range of medicinal products — both prescription (Rx) and over-the-counter (OTC) medicines, as well as medical devices, food supplements, cosmetic products and dietary foods for special medical purposes. Pharmacies may also compound medicines according to magistral and pharmacopoeia formulas.

A drugstore is an outlet with a more limited scope — it may sell only non-prescription (OTC) medicines, medical devices and food supplements. The staffing and technical requirements for drugstores are considerably lighter, and the regime is registration-based (before the RHI) rather than authorization-based.

Who Can Open a Pharmacy

Under Article 146 of the LMPHM, an authorization for retail trade in medicinal products through a pharmacy may be issued to:

• A natural person — master pharmacist, registered as a sole trader (ET) or practising a liberal profession.
• A single-member limited liability company (EOOD) or a limited liability company (OOD) whose manager or appointed pharmacy director holds a Master’s degree in Pharmacy.
• Other commercial entities (joint-stock companies, limited partnerships, etc.), provided they appoint a pharmacy director who is a master pharmacist.

The critical requirement is this: regardless of the legal form of the authorization holder, the pharmacy director must always hold a Master’s degree in Pharmacy. This individual bears professional responsibility for all pharmacy operations, including the proper storage, dispensing and control of medicinal products.

Membership in the Bulgarian Pharmaceutical Union (BPU)

The pharmacy director must be a member of the Bulgarian Pharmaceutical Union (BPU). The BPU is the professional organization of master pharmacists in Bulgaria, established under the Act on the Professional Organizations of Physicians and Dentists. Membership is a mandatory condition for practising pharmaceutical activity and for obtaining a pharmacy authorization.

Before submitting the application to the BDA, the pharmacist must obtain an opinion from the regional chapter of the BPU at the pharmacy’s location. The opinion is not binding on the BDA but is a mandatory component of the document set.

Who Can Open a Drugstore

The requirements for opening a drugstore are considerably lighter compared to a pharmacy. Drugstores are subject to a registration regime before the Regional Health Inspectorate (RHI) at the outlet’s location, rather than an authorization regime before the BDA.

To open a drugstore, you need:

• Manager — an assistant pharmacist (Bachelor’s or Professional Bachelor’s degree in Pharmacy) or a person with secondary pharmaceutical education. A Master’s degree in Pharmacy is not required.
• Holder — a natural or legal person registered under the Commerce Act. There is no restriction on the owner’s education — it is sufficient to appoint a qualified manager.
• Premises — must meet the hygiene and technical requirements, although these are less strict than for a pharmacy.

The registration procedure is shorter and less expensive. The application is submitted to the RHI, which inspects the premises and documentation and issues a registration certificate. The drugstore may begin operations after receiving the certificate.

It is important to emphasize that a drugstore has no right to sell prescription medicines. Violation of this prohibition is subject to severe sanctions, including revocation of the registration and substantial fines.

Procedure for Obtaining a Pharmacy Authorization

The procedure for opening a pharmacy goes through several sequential stages, each requiring careful preparation. Here is the detailed timeline:

1. Registration of a commercial company

   If you do not yet have a legal entity, the first step is to register a company (EOOD or OOD) with the Commercial Register at the Registry Agency. The stated business activity must include retail trade in medicinal products.

2. Securing suitable premises

   Find and lease (or purchase) premises that meet the technical requirements for a pharmacy. The premises must be designed and furnished in accordance with Ordinance No. 28 before submitting the application.

3. Obtaining a hygiene assessment from the RHI

   Submit an application to the Regional Health Inspectorate at the outlet’s location for a hygiene assessment. The RHI inspects the premises and issues a hygiene certificate confirming compliance with sanitary standards.

4. Obtaining an opinion from the BPU

   Approach the regional chapter of the Bulgarian Pharmaceutical Union for an opinion. The opinion typically takes into account the density of the pharmacy network in the area.

5. Submitting the application to the BDA

   Prepare the complete set of documents and submit it to the Bulgarian Drug Agency. The application is reviewed by a committee, which may also carry out an on-site inspection if necessary.

6. Review by the BDA — 1-month deadline

   The BDA reviews the application and documents within 1 month if the documentation is complete. If irregularities or omissions are identified, the applicant is notified and has 60 days to remedy them.

7. Issuance of the retail trade authorization

   Upon a positive decision, the BDA issues a retail trade authorization for medicinal products. The authorization is issued for an indefinite term but is subject to ongoing supervision and may be revoked in case of violations.

The entire procedure — from company registration to obtaining the authorization — typically takes between 2 and 4 months, depending on the readiness of the premises and the completeness of the documents.

Complete List of Documents for the BDA Authorization

The set of documents to be attached to the application for a retail pharmaceutical trade authorization includes:

1. Notarized copy of the Master’s degree diploma in Pharmacy — of the pharmacy director. If the diploma was issued in another country, it must be recognized under the Professional Qualifications Recognition Act.
2. Criminal record certificate — of the pharmacy director, certifying a clean criminal record. Issued by the Criminal Records Bureau at the district court.
3. Certificate of professional experience — documenting the director’s work experience in the field of pharmacy.
4. Medical fitness certificate — issued by the general practitioner or a medical committee, confirming the individual’s physical and mental fitness to practise pharmaceutical activities.
5. BPU membership certificate — a current certificate from the Bulgarian Pharmaceutical Union.
6. Opinion from the Bulgarian Pharmaceutical Union — from the regional chapter at the pharmacy’s location.
7. Certificate of current registration — from the Commercial Register, certifying the company’s registration and current status.
8. Authorization to use the premises — title deed, lease agreement or other legal document proving the right to use the premises.
9. Hygiene certificate from the RHI — confirming that the premises meet sanitary standards.
10. Investment project for the premises — architectural plan showing the designated zones (receiving, storage, dispensing, sanitary facilities), approved by the competent authority.
11. Proof of payment of the state fee — in the amount of BGN 1,000 (EUR 511.29).

If the documents are incomplete, the BDA notifies the applicant in writing and grants a 60-day period for supplementation. If the deficiencies are not remedied within this period, the proceedings are terminated and the fee is not refunded.

Technical Requirements for Pharmacy Premises

Ordinance No. 28 of the Ministry of Health sets specific requirements for the premises in which a pharmacy will operate. Non-compliance is grounds for refusal of the authorization:

• Minimum area — typically not less than 50 m², with specific requirements depending on the type of pharmacy (community, hospital) and whether compounding is performed.
• Designated zones — the pharmacy must have clearly separated functional areas:
  • Receiving zone — for accepting and performing incoming control of medicinal products;
  • Storage zone — shelves, racks and cabinets for properly organized storage;
  • Dispensing zone — for serving patients, with a counter or window;
  • Sanitary facilities — toilet and washbasin for staff.
• Controlled temperature and humidity — premises must maintain a temperature typically between 15°C and 25°C, with continuous monitoring and documentation. Humidity must also be controlled within specified limits.
• Refrigerator for thermolabile products — mandatory for storing medicines requiring 2–8°C (vaccines, insulins, biological products). The refrigerator must have a thermometer and monitoring system.
• Safe for narcotic substances — if the pharmacy handles narcotic and psychotropic substances, a metal safe (or armoured strongbox) is required, embedded in the wall or secured to the floor, with double-lock mechanism.
• Accessibility for persons with disabilities — the pharmacy must provide access for persons with reduced mobility — ramp, sufficiently wide entrance, low counter or the option for service at the entrance.
• Ventilation and lighting — natural or forced ventilation, adequate lighting in working areas.

Before submitting the application, it is advisable to engage an architect experienced in designing pharmacy premises to ensure the project will be approved on the first attempt.

State Fee for the Authorization

For reviewing the application and issuing a retail pharmaceutical trade authorization, a state fee of BGN 1,000 (EUR 511.29) is payable.

The fee is payable upon submission of the application and is non-refundable, including in cases of refusal or termination of proceedings due to unresolved deficiencies.

Additional costs you should budget for:

• RHI hygiene assessment fee — varies by region, typically between BGN 50 and BGN 150.
• Notarization fees — for certified copies of diplomas and other documents.
• Annual BPU membership dues — payable by the pharmacy director.
• Investment project — preparation by a licensed architect.
• Pharmacy equipment — shelving, refrigerator, software, cash register, etc.

The total investment for starting a pharmacy (excluding rent) typically starts from BGN 30,000–50,000, depending on the location and scale.

Online Sale of Medicines

With the development of e-commerce and following the COVID-19 pandemic, online medicine sales have gained increasing popularity. Bulgarian legislation permits distance selling under strict conditions:

What can be sold online

• Online sale is permitted only for non-prescription (OTC) medicines. Online sale of prescription medicines is strictly prohibited.
• Medical devices and food supplements may also be offered online.

Who can sell online

• Only licensed pharmacies (holding a valid BDA authorization) and registered drugstores (holding an RHI certificate) have the right to offer medicines online.
• Traders who do not operate a pharmacy or drugstore may not sell medicines online, even if they are OTC.

EU common logo

Every website offering medicines for sale must display the EU common logo for online sale of medicines. This is a standardized graphic symbol (white-green, featuring the flag of the respective Member State) that allows consumers to verify the pharmacy’s legitimacy through a link to the BDA database.

Notification to the BDA

Before launching online activities, the pharmacy or drugstore must notify the BDA of its intention to sell medicines via the internet. The BDA enters the website into a public list that is available for consumer verification.

Packaging and delivery requirements

• Medicines must be delivered in their original packaging with unbroken integrity.
• Appropriate transport conditions must be ensured during delivery — especially for temperature-sensitive products.
• A patient information leaflet in Bulgarian must be included.

Wholesale Trade — A Separate Regime

Wholesale trade in medicinal products is a separate regime that should not be confused with retail trade. If you plan to supply medicines to pharmacies, hospitals or other retailers, you will need a separate wholesale trade authorization issued by the BDA.

The main differences and additional requirements for wholesale trade include:

• GDP (Good Distribution Practice) — the wholesaler must comply with Good Distribution Practice as established by EU Delegated Regulation and transposed into Bulgarian legislation. GDP covers the entire distribution process — from receipt to delivery of medicines.
• Qualified Person — the wholesaler must have a Qualified Person responsible for GDP compliance. This is typically a master pharmacist with additional qualifications.
• Warehouse premises — requirements include spacious, climate-controlled warehouses with temperature monitoring, quarantine areas, zones for defective products, cold rooms and a batch traceability system.
• Documentation and traceability — full traceability of every batch of medicinal product from the manufacturer to the final recipient.

The wholesale authorization is independent and does not derive from the pharmacy authorization. A single company may hold both authorizations, but they are issued separately and for different premises.

Sanctions for Violations

The LMPHM provides for serious sanctions for violations of the rules governing trade in medicinal products. The penalty regime is differentiated according to the severity of the violation:

Trading without authorization

Conducting retail trade in medicinal products without a valid BDA authorization (for pharmacies) or without RHI registration (for drugstores) is punishable by a fine:

• For legal entities — from BGN 25,000 to BGN 50,000 (approximately EUR 12,782 to EUR 25,565).
• For repeat offences — the fine is doubled.
• Medicinal products that are the subject of the violation are subject to confiscation in favour of the state.

Violations of authorization conditions

Where violations of the conditions under which the authorization was issued are identified, the BDA applies a progressive system of measures:

1. Warning — for minor violations, with a deadline for remedy.
2. Temporary suspension — for repeated or more serious violations, for a specified period.
3. Revocation of the authorization — for systematic or gross violations, including:
   • Dispensing prescription medicines without a prescription;
   • Absence of a pharmacy director for an extended period;
   • Non-compliance with storage requirements endangering patient health;
   • Providing false information when obtaining the authorization.

Dispensing prescription medicines without a prescription

Dispensing medicines that require a medical prescription without a valid prescription is subject to separate sanctions, including fines and disciplinary measures by the BPU against the responsible pharmacist.

Frequently Asked Questions