Opening a pharmacy in Bulgaria is not ordinary retail setup. The Bulgarian Drug Agency—known in Bulgarian as the Izpalnitelna agentsia po lekarstvata (IAL) and in English as the Bulgarian Drug Agency (BDA)—must authorise the named trader, premises, pharmacy manager, and permitted activities before medicinal products are sold.

The business model must be classified early. A pharmacy can dispense prescription and non-prescription medicines. A drugstore follows a lighter Regional Health Inspectorate registration but can sell only the permitted non-prescription range. Wholesale supply, online sales, reimbursed medicines, and medicines containing controlled substances add separate requirements.

Pharmaceutical, professional, pricing, reimbursement, and online-sales rules can change. This guide reflects official sources available on 1 August 2026, provides general information, and does not replace advice on a particular pharmacy or product range.

Pharmacy Retail Authorisation at a Glance

Pharmacy, Drugstore, and Wholesale Are Different Regimes

Article 218 of the current Medicinal Products in Human Medicine Act generally confines retail trade in medicines to authorised pharmacies and registered drugstores.

A pharmacy is a healthcare establishment. Its activities may include storage, preparation, packaging, control, professional consultation, and dispensing authorised medicinal products with or without prescription. The specific activities included in the BDA authorisation determine the premises and equipment required.

A drugstore is not a shortcut to a full pharmacy. It is registered by the competent Regional Health Inspectorate and cannot dispense prescription medicines or compound preparations. Entrepreneurs planning only a limited over-the-counter range should compare that regime before investing in pharmacy premises.

Wholesale distribution is also separate. Importantly, Article 222a prohibits the holder of a pharmacy retail authorisation from also holding a wholesale authorisation under the same Act. Separate companies do not automatically solve every conflict, ownership, sourcing, or competition issue, so a combined group structure needs specialist review.

Who Can Hold a Pharmacy Authorisation?

A natural or legal person registered as a trader under Bulgarian law—or under the law of an eligible EU/EEA state—may apply. The owner does not personally need a pharmacy degree, but must appoint a professionally eligible pharmacy manager under an employment or pharmacy-management contract. If the applicant is itself a master pharmacist and will manage the pharmacy, that separate contract is unnecessary.

The same holder may open no more than four pharmacies in Bulgaria. Each outlet needs its own premises-specific authorisation and professionally responsible manager.

Founders who have not yet established the applicant can review our company registration guide. Commercial Register entry alone does not permit medicine sales.

The Pharmacy Manager

The manager must normally:

• hold the recognised qualification of master pharmacist
• have at least one year of professional experience as a master pharmacist
• retain the right to practise the profession
• satisfy the statutory criminal-history requirements
• manage only one pharmacy and work in it
• be entered in the relevant professional register

BDA checks the pharmacist's diploma and requests professional-register and disciplinary information directly from the Bulgarian Pharmaceutical Union. A foreign qualification must be recognised before it can support the application.

Assistant pharmacists can carry out permitted tasks in the presence and under the control of a master pharmacist, but cannot dispense prescription medicines or perform the medicine-related control and consultation reserved by law.

A narrow exception exists in a settlement with no other pharmacy. There, an assistant pharmacist or a master pharmacist with less than one year's experience may manage under Article 225, but the permitted range is restricted to non-prescription medicines and specified other products. Do not rely on the exception without verifying the absence of another pharmacy and the exact activity scope.

Premises and Equipment Requirements

The current Ordinance No. 28 links the layout to what the pharmacy will actually do. A conventional public pharmacy that will not compound magistral or pharmacopoeial preparations needs, for one workstation:

• at least 30 m² total area
• a reception/dispensing room
• a storage room
• a sanitary unit with an isolated vestibule and sink
• another 5 m² for each additional workstation

If the pharmacy will compound medicines but not eye or parenteral preparations, the minimum rises to 40 m² and an assistant room with the prescribed sink and workstation is required. Compounding eye preparations raises the minimum to 50 m² and requires an aseptic box. Hospital and herbal pharmacies follow different specifications.

The ordinary public-pharmacy premises must have an independent entrance, be on the first above-ground floor, be accessible to visitors, and provide appropriate access for people with disabilities. The functional rooms are generally on one level, connected, and separated from space used for other activities.

Fit-out should account for cleanable surfaces, controlled shelving and cabinets, a suitable refrigerator, thermometers in every medicine-storage room, quarantine space for expired or damaged stock, pharmacy software, fire-safety equipment, and the specific compounding equipment where applicable. Prescription medicines must be stored separately and outside patients' visual access. The authorised scope should therefore be settled before the lease and construction budget are finalised.

Application Documents

The application is made to BDA using its approved form. Under Article 228, the core file includes:

1. The applicant's Bulgarian UIC/EIK or current EU/EEA commercial-registration evidence.
2. The employment or management contract with the pharmacy manager, unless the statutory owner-manager exception applies.
3. Evidence that the manager satisfies the qualification, experience, right-to-practise, and criminal-history requirements.
4. A criminal-record certificate for a non-Bulgarian manager; BDA verifies the corresponding Bulgarian circumstance ex officio.
5. A medical certificate for the manager.
6. Proof that the EUR 511.29 state fee has been paid.

BDA may require translations, recognition evidence, or further documents where the applicant or pharmacist is foreign. Names, outlet address, activities, contract, qualification records, and application scope should match exactly.

The hygiene conclusion is not ordinarily obtained by the applicant in advance. On receiving the application, BDA requests it directly from the Regional Health Inspectorate for the pharmacy location. BDA also requests confirmation from the relevant professional organisation rather than requiring the applicant to obtain a separate opinion about local pharmacy density.

Authorisation Procedure and Timing

1. Define the Retail Scope

Decide whether the outlet will dispense prescription medicines, compound preparations, sell controlled medicines, work with public reimbursement, or sell OTC products online. Each choice affects premises, staff, technology, and later approvals.

2. Establish the Trader and Secure the Manager

Register the applicant, check the four-pharmacy limit and wholesale incompatibility, and sign the correct contract with an eligible manager. Complete any foreign qualification recognition before filing.

3. Design and Equip the Premises

Have the site checked against Ordinance No. 28 before committing to a long lease. Build only to a verified activity specification and test access, ventilation, storage temperatures, refrigeration, sanitation, workflow, and staff supervision.

4. Submit the BDA File

Pay the current fee and file the application and evidence. BDA sends the hygiene request to the RHI on the day of receipt. The RHI has 14 days to issue and return its conclusion, and the main BDA decision clock is paused until BDA receives it. The professional organisation supplies its requested certificate and information within five working days.

5. Correct Any Deficiencies

BDA checks the submitted documents and notifies the applicant of identified omissions or discrepancies. The decision period stops while corrections are outstanding. If defects are not cured within 60 days after notification, the proceeding is terminated.

6. Receive the Decision and Enter the Register

The BDA executive director decides within one month, following the opinion of the expert council, subject to the statutory pauses. A refusal must be reasoned and may be appealed under the Administrative Procedure Code. Successful authorisations appear in BDA's public retail-authorisation register.

The authorisation has no routine renewal date, but it remains dependent on continued compliance. Do not stock or sell medicines before it is issued.

Fees and Later Changes

The current official medicinal-products fee tariff sets the initial documentation-assessment fee at EUR 511.29 from 1 January 2026. The narrow small-settlement route under Article 228(5) uses 50% of the standard fee.

The tariff currently sets EUR 127.82 for a change to the trader's name, form, registered office, or management address and for a pharmacy-manager change. Address and authorised-activity changes cost EUR 255.65. The correct change application and approval should be completed before operating on altered facts.

Selling Medicines Online

An authorised pharmacy may sell only non-prescription medicines online. A prescription medicine cannot be sold online merely because the prescription is electronic. The rules apply in addition to ordinary e-commerce, consumer, privacy, and advertising law.

Before launch, the operator must use its own website, publish the prescribed trader, pharmacy, authorisation, manager, product, price, delivery, payment, consumer, and regulator information, and notify BDA in writing. The notice includes website and maintainer details plus a declaration that transport will preserve required storage conditions.

BDA checks the website within seven days. Once compliant, the operator is entered on the official list. Every medicine-offer page must display the EU common logo, linked to the operator's entry in the national list, as explained on the BDA online-pharmacy page. Its design and verification link follow Commission Implementing Regulation (EU) No. 699/2014.

Online operations must also provide proper packaging and transport, delivery within 24 hours of the order, shipment traceability, requested consultation in Bulgarian, and five-year retention of orders and confirmations. Already purchased medicines cannot be returned, so the online terms must describe the applicable consumer position accurately rather than promise a generic return right.

Controlled Medicines Require Another Licence

The ordinary BDA authorisation is insufficient for medicines containing narcotic substances. The pharmacy holder must also obtain the relevant Ministry of Health licence, implement the special prescription and accountability rules, and provide secure storage, including the fixed alarm-connected metal safe specified for licensed pharmacies.

The Ministry's current controlled-medicines procedure is available only to holders of a pharmacy authorisation and provides a decision period of up to 50 days. Build this second procedure into the launch timetable rather than treating controlled medicines as an automatic extension of the pharmacy permit.

Ongoing Duties and Enforcement Risk

After opening, the holder and manager must ensure that the pharmacy:

• buys medicines only from authorised or registered wholesalers
• stores products under their authorised conditions and tracks stock by assortment and batch
• quarantines expired, damaged, recalled, or otherwise non-compliant stock
• verifies and decommissions applicable safety identifiers under Delegated Regulation (EU) 2016/161
• maintains the prescription journal, required pharmacy software, professional information, and staff training
• submits the required daily BDA data for products included in the Positive Drug List
• respects pharmacist independence, prescription, dispensing, advertising, and patient-information rules
• reports and obtains approval for changes to registered circumstances

Staffing is operationally critical. The pharmacy cannot simply remain open without its responsible manager; absence and statutory replacement rules are specific. Employers must also meet workplace obligations, including appropriate occupational-health coverage.

If food supplements or other foods are included, the product and food-law layer should be checked separately. Our food-facility registration guide explains the wider food-business framework, although pharmacy authorisation remains the controlling regime for medicines.

BDA, RHI, and other competent authorities may inspect. Violations can result in corrective orders, fines or property sanctions, suspension, confiscation where applicable, and cancellation or withdrawal of the authorisation. Unauthorised online trade, prescription sales online, unqualified dispensing, unlawful sourcing, and unsafe storage carry particularly high risk.

Common Mistakes and Launch Checklist

Frequent mistakes include fitting out the wrong pharmacy category, treating the RHI hygiene conclusion as a separate pre-application certificate, relying on an informal pharmacist arrangement, assuming a retail holder may also be the wholesaler, or launching an OTC website before BDA listing and common-logo verification.

Before filing, confirm that:

• the holder, number of outlets, and wider group structure are eligible
• the pharmacy manager meets every qualification and exclusivity condition
• the lease and design match the exact authorised activities
• the equipment, refrigeration, storage monitoring, software, and accessibility are ready
• the application, contract, qualification evidence, medical certificate, and payment record are consistent
• online, controlled-medicine, NHIF, food, data, employment, and consumer-law workstreams are separately planned
• no medicinal-product sale will begin before the required authorisation or listing

Lion Consult can coordinate the company, premises, professional-contract, application, and ancillary compliance workstreams for a Bulgarian pharmacy project. Contact our team for a scope-based review before signing the premises lease or filing with BDA.

This article is an informational overview, not legal, pharmaceutical, medical, tax, or investment advice. Confirm the current BDA forms, payment details, authorised product classification, and premises requirements for the specific project before acting.

Frequently Asked Questions

Who can own a pharmacy in Bulgaria?

An eligible Bulgarian or EU/EEA trader may hold the retail authorisation. The owner does not have to be a pharmacist but must appoint a qualifying pharmacy manager. One holder may operate no more than four pharmacies.

What qualifications must the pharmacy manager have?

The manager normally must be a master pharmacist with at least one year of professional experience, an active right to practise, and compliance with the statutory criminal-record conditions. The manager may manage only one pharmacy and must work in it.

What is the minimum pharmacy floor area?

A public pharmacy that does not compound medicines generally requires at least 30 square metres for one workstation. The minimum rises to 40 square metres for ordinary compounding and 50 square metres where eye preparations are compounded.

How much does the authorisation cost and how long does it take?

The 2026 state fee for an initial retail authorisation is EUR 511.29, with a 50% fee for the qualifying small-settlement exception. The BDA decision period is generally one month, but it pauses during the Regional Health Inspectorate review and while deficiencies are corrected.

Can a Bulgarian pharmacy sell medicines online?

Yes, but only non-prescription medicines may be sold online. The authorised pharmacy must notify the BDA, satisfy website and delivery requirements, appear in the public register, and display the EU common logo on every page offering medicines.

Can the pharmacy sell controlled medicines?

Controlled medicines require a separate Ministry of Health licence after the pharmacy authorisation is obtained. Additional storage, security, recordkeeping, and accountability rules apply, and the licensing procedure may take up to 50 days.

Can the same company hold pharmacy retail and medicines wholesale authorisations?

No. Article 222a of the Medicinal Products in Human Medicine Act prevents the pharmacy retail-authorisation holder from also holding a wholesale authorisation.