Key Takeaways
- Learn about the licensing scheme under the Pharmaceutical Act, regulated by the Bulgarian Drug Agency and regional health inspectorates. Identify community, hospital, and online pharmacies and tailor operations with their compliance rules.
- Setup main licensing prerequisites such as registration in the Bulgarian Commercial Register, a clean criminal record, and no conflict of interest with wholesalers or producers. Name a master pharmacist who is a member of the Bulgarian Pharmaceutical Union and ensure premises are hygienic, secure, and have temperature control, for example, between 2 and 8 degrees Celsius for cold chain medicines.
- Prepare a full application file with ownership or lease documents, employees’ diplomas, layout plan, technical equipment list, and evidence of fee payment. Coordinate early with the regional health inspectorate for premises approval and file an accurate application to the BDA to avoid delays.
- For foreign pharmacists, ensure Professional Qualifications Recognition Act recognition and Bulgarian language certification. Non-EU applicants should bring diploma supplements, apostilles, and verified translations if you want to avoid rejection.
- Remain compliant with timely accounting books and quarterly and annual reporting to the Bulgarian Drug Agency and National Revenue Agency and documented stocktakes. Maintain pharmacy software, provide ongoing staff training and be ready for scheduled and surprise inspections with all documentation easily available.
- Organise renewals by monitoring deadlines, fees, and updated documentation like staff lists, premises certificates, and finance statements. Fortify operations with dependable accounting and regulatory-compliant pharmacy management software and explore avenues such as online pharmacy licence Bulgaria for lasting expansion.
A pharmacy license in Bulgaria is a formal permit issued by the Bulgarian Drug Agency and the Regional Health Inspectorate to open and run a community pharmacy. The license is connected to a particular location, design, storage standards, and cold-chain at 2 to 8 degrees Celsius. Owners have to comply with fit-and-proper rules, and at least one registered master pharmacist has to act as manager. Usual procedures involve site approval, GMP or GDP-aligned processes, equipment validation, and inspection prior to issuance. Typical timelines are between 2 and 4 months, based on paperwork and build-out. Charges differ by area and range, with distinct fees for inspections and the license. To assist in planning each stage, the core text details documents, floor plan specifications, staffing, timelines, and typical stumbling blocks for applicants.
Understanding Bulgarian Pharmacy Regulations
Bulgarian pharmacy regulations, consistent with EU directives, outline the necessary documents for opening a pharmacy, what can be sold, and how pharmaceutical care is delivered daily within the health care system.
Legal Framework
The main regulations derive from the Medicinal Products in Human Medicine Act, commonly referred to as the Pharmaceutical Act, supplemented by the Health Act, the Medical Devices law, and ordinances of the Ministry of Health. The initial contemporary legislation on drugs and pharmacies came into effect in 1995, and the framework has since been amended to align with EU standards. Under Bulgarian legislation, medicinal products and medical devices authorized in the Republic, both with and without prescription, as well as food additives, cosmetic, and sanitary-hygienic articles are sold only in pharmacies by law. In little towns without a pharmacy, a branch pharmacy is permitted to sell medications if a master pharmacist can be present twice a week. Proof of pharmacist qualifications must demonstrate a minimum of five years of training. Both community pharmacies and industrial pharmacy programs are integrated into some university curricula, and post-graduation pharmacists can compound, dispense, counsel, and devise care plans. The remit is the same as community pharmacists in other EU members.
Regulatory Authorities
BDA’s scope covers the medicinal products’ life cycle, including marketing authorization and safety (pharmacovigilance), as well as the inspection of manufacturing and distribution. Regional Health Inspectorates (RHI) under the Ministry of Health are typically the competent authority for pharmacy premises permits and continuing supervision at a regional level. This policy, established by the Ministry of Health, includes key ordinances issued to ensure compliance with regulatory requirements. The Bulgarian Pharmaceutical Union oversees professional standards and continuing education.
Pharmacy Types
Community pharmacies play a vital role in the retail sale of Rx and OTC medicines, providing essential patient counselling and compounding when necessary. In contrast, hospital pharmacies cater to inpatients and clinical wards, managing formulary and sterile preparations under stringent oversight. In Bulgaria, the legal framework prohibits mail order pharmacies and distance sale models, ensuring that patients receive their medications through authorized brick and mortar locations.
Key Compliance Obligations
Area | Minimum expectations |
|---|---|
Licensing | Valid RHI permit; notification to BDA where required |
Responsible person | Master pharmacist designated; on-site availability per law |
Staffing | Qualified pharmacists/assistants; documented training and CPD |
Premises | Secure, clean, accessible; separate storage; compounding area if used |
Storage | Temperature logs (e.g., 2–8°C cold chain), humidity, security for controlled drugs |
Sourcing | Purchase from licensed wholesalers; keep supplier licenses on file |
Dispensing | Verify prescriptions; counsel; document substitutions and refusals |
Records | Keep purchase, sales, batch, and controlled-substance logs as required |
Safety | Report adverse events to BDA; device vigilance; recalls handling |
Data | Protect patient data under GDPR and national rules |
Labeling | Bulgarian language; clear dosing and warnings |
Pricing | Follow national price/reimbursement rules; NHIF contract if applicable |
Your Pharmacy License Requirements
In Bulgaria, the pharmacy license requirements necessitate that applicants demonstrate legal standing and professional supervision, along with suitable facilities and continued accounting obligations to comply with Bulgarian legislation.
- Business registration in the Bulgarian Commercial Register
- Retail permit for medicinal products from the health authority
- Appointment of a master pharmacist as manager
- Premises that meet health, safety, and equipment standards
- Complete documentation set and fee payment
- Accounting books and annual reports to the NRA.
- Insurance coverage and internal quality procedures
- Adherence to laws that drugs are dispensed exclusively in pharmacies.
1. Owner Eligibility
Only companies or individuals with full legal capacity may apply. Entry in the Bulgarian Commercial Register is a fundamental requirement.
A clean criminal record, plus no prior pharmaceutical law violations. They verify for conflicts of interest with wholesalers or manufacturers.
Make statements that it has no control links with distributors. If ownership is indirect, provide a basic chain of ownership diagram.
2. Manager Qualifications
Designate an experienced master pharmacist as chief pharmacist or manager. To meet the specific requirements for pharmacy practice, your pharmacy degree must be recognized in Bulgaria, typically involving a five-year pharmacy course and a six-month practical traineeship in a pharmacy or hospital department under EU legislation. Managers are required to be members of the Bulgarian Pharmaceutical Union, demonstrating competence and, where applicable, EU recognition of foreign diplomas. Common duties include medication preparation, dispensing, and patient counseling, which are vital to the nation’s health care system.
3. Premises Standards
Provide minimum usable area, hygienic surfaces, and appropriate work areas for the receipt, storage, and dispensing.
Comply with the Health Act with respect to physical premises and ingress. Ensure accessible entry when necessary.
Secure storage for controlled drugs, calibrated refrigerators with a temperature range of 2 to 8 degrees Celsius, temperature logs, and back-up power for the cold chain. Install fire protection, CCTV if necessary, and access control to narcotics.
4. Essential Documents
To comply with Bulgarian legislation, submit the application form along with necessary documents such as the business registration certificate, retail permit request, and a floor plan that includes the storage and narcotics room. Additionally, ensure you provide accounting obligations like tax registration and financial statements.
Include staff diplomas and licenses, proof of fee payment, insurance documents, and declarations of compliance with health and pharmaceutical rules to meet the regulatory requirements for pharmacy practice.
5. Staffing Mandates
Hire a master pharmacist and supplement with assistant pharmacists for every shift. In less populated centers without a pharmacy, a master pharmacist should be present twice a week.
Make sure all staff are registered with the Bulgarian Pharmaceutical Union or an equivalent.
Conduct in-service trainings and CEU hours. Maintain signed logs.
Align your staff with the National Pharmacy Map and local health advice.
The Licensing Application Process
In Bulgaria, pharmacies must obtain a license to distribute medicinal products, and sales are permitted only in licensed drugstores. The Bulgarian Drug Agency (BDA) is responsible for issuing licenses, while regional health inspectorates (RHI) monitor compliance with regulations. At the forefront of each pharmacy is a master pharmacist, who must hold a five-year degree, complete a six-month traineeship, and submit a master thesis. The BDA and RHI require proof of these qualifications through official records to ensure adherence to the pharmacy practice standards.
To begin the licensing process, secure a site that meets the necessary documents for hygiene, access, storage, and security regulations. This includes obtaining floor plans that detail storage zones, cold chain equipment, and designated waste areas. It’s advisable to consult RHI tools and seek early feedback before signing a lease or commencing construction. This proactive approach can help avoid costly redesigns. Concurrently, appoint a master pharmacist and compile their credentials, such as diploma, proof of traineeship, professional registration, and a clean criminal record if required.
Next, gather the application materials for the BDA. This involves including necessary documentation such as company registration, proof of legal use of the premises, detailed floor plans, and a comprehensive equipment list, which should feature calibrated refrigerators, data loggers, and controlled-temperature cabinets. Additionally, outline your standard operating procedures, quality system, and pharmacovigilance contact. Ensure to include contracts for waste disposal and pest control, a recall principle, and temperature records. Requirements can vary significantly by area and activity, so it’s crucial to consult the most recent BDA and RHI checklists to avoid delays due to incomplete files.
Submit the dossier to the BDA along with the government fee. The BDA conducts a completeness check and arranges a site visit with the RHI. Think paper screening initially, then an inspection that examines storage conditions between 2 and 8 degrees Celsius and areas at room temperature up to 25 degrees Celsius, security, prescription handling, and SOPs in action. Timelines vary by volume, but most applicants get an inspection within weeks of file acceptance and a decision a few weeks after the clean inspection. If the BDA finds gaps, it will request corrections, and the clock stops until you reply.
See separate rules on compulsory licenses for inventions concerning medicines. The authority will decide within nine months from receiving all evidence in the dispute. Such a license can be terminated if use has not commenced within two years of grant or if no preparation to use has commenced within one year.
Navigating Foreign Pharmacist Hurdles
Foreign-trained pharmacists face additional hurdles in Bulgaria due to strict requirements surrounding evidence of equivalent training, safe practice, and proficiency in the Bulgarian language program.
Recognition of degrees and qualifications under the Act
Recognition is covered by Bulgaria’s Professional Qualifications Recognition Act, which ensures that your degree meets the legal requirements equivalent to their five-year Master’s in Pharmacy. This ‘tunnel degree’ has no entrance or exit halfway through, as demanded by Bulgarian legislation. If your program is shorter or lacks certain core subjects, you might need to fulfill additional practice hours or pass exams to meet the specific requirements. A common scenario involves a four-year degree plus internship from abroad that does not fully comply with Bulgaria’s extended scope, potentially leading to compensatory measures. Final registration is required to practice, assuming approval by the Ministry of Education and Science and the Bulgarian Pharmaceutical Union (BPhU).
Language proficiency requirements
Bulgarian language skills, typically at a B2 level or above, are required by law for the safe practice of patient care and medical documentation, which includes understanding pharmacy practice regulations. This could be through an approved language center or a recognized exam. Strong language skills greatly assist with counseling on prescription drugs, narcotics, and OTC product restrictions. Most pharmacists complete a 6 to 12 month language course prior to application, then continue to enhance their skills during their traineeship.
Documentation for non-EU applicants
Non-EU applicants typically require a diploma supplement that includes subjects, hours, and grades, sealed transcripts, and an apostille for degrees and main documents. A certified Bulgarian translation is standard. Additionally, demonstrating good standing with your home regulator and a clean criminal record, along with meeting specific requirements for practical training hours, can be requested. Keep course syllabi; they help demonstrate equivalence when curricula vary.
Common pitfalls and how to avoid them
Common causes of delays in obtaining marketing authorization include incomplete files, expired apostilles, and missing translations, particularly regarding Bulgarian legislation on dispensing antibiotics or product types sold in community pharmacies. Applicants should plan for living costs during bridging, which include rent BGN 500–1,000 and utilities BGN 150–250. Language barriers can hinder progress, so it’s wise to schedule exam dates well in advance. Even graduates from foreign institutions may face scrutiny, necessitating the collection of evidence of supervised practice to meet specific requirements, along with confirmed paperwork and early outreach to the BPhU.
Maintaining Operational Compliance
Compliance in pharmacy practice runs on three tracks: regulatory updates, transparent records, and daily operational controls. It is crucial to keep an eye on new Bulgarian legislation regarding pharma regulations and spacing rules over 100 meters in small towns since 2015, as well as ownership caps. A master pharmacist can own one retail license and work there, while a single owner can manage four community pharmacies. Contracts should be kept up-to-date in cases where proprietors are merchants who hire a master pharmacist with more than one year of experience and no criminal record. Additionally, ensure that necessary documents like accounting ledgers, quarterly reports, and annual financials are prepared for submission. Keeping patched pharmacy software and validated inventory systems aligned with Good Pharmacy Practice is essential for effective pharmacy work.
Renewals
Renewal filing depends on current staff lists, premises certificates, accounts, software maintenance confirmation, and master pharmacist presence. Ensure the retail license holder has no companies manufacturing or dealing in medicinal products other than permitted. Plan fees in EUR for clarity and pay by bank transfer with a reference number that corresponds to the license ID or your payment will be rejected.
Requirement | What to submit | Notes |
|---|---|---|
Application form | Signed renewal form | Use latest template |
Staff list | Roles, licenses, contracts | Include manager’s 1+ year experience |
Premises documents | Hygiene and storage certificates | Temperature mapping if cold chain |
Financials | Annual statements, tax clearance | Match accounting ledgers |
Software proof | Valid support/validation letter | Include version and patch date |
Inventory controls | Stock reconciliation report | Variance log for narcotics |
Fee payment | Bank slip (EUR) | Correct payer and IBAN |
Declarations | Conflict-of-interest statements | Manager works at the site |
Late or incomplete files can spark fines, suspension, or a license lapse that requires closure until corrected.
Reporting
Regulators anticipate timely sales and dispensing data, controlled-substance logs, ADR reports, and batch recalls, ensuring compliance with Bulgarian legislation. It is essential to file timely quarterly and annual reports to the Bulgarian Drug Agency (BDA) and the National Revenue Agency. Additionally, have necessary documents such as purchase invoices, wholesaler pedigrees, and inventory change logs available for inspection. For operational compliance, export structured files from validated pharmacy software, reconcile cashless and cash sales, and flag outliers. The pharmacovigilance file must be updated within 24 hours of awareness, as precision keeps you in compliance and expedites audits.
Inspections
Anticipate both planned and surprise inspections by the BDA and regional health inspectorates.
Inspectors verify cleanliness, cold and room temperature (2 to 8 degrees Celsius and 15 to 25 degrees Celsius zones) storage, expiry segregation, staff qualifications, and paperwork like licenses, premises certificates, and accounting.
Non-compliance could result in corrective orders, fines, suspension, or revocation. Keep a grab file at the counter with licenses, the last two quarterly reports, calibration logs, and emergency SOPs.
Beyond the Counter: A Strategic View
Pharmacy licensing in Bulgaria is not just about approval and shelves. It connects to market laws, location, community health demands, and your management of the store on a daily basis.
Employ error- and waste-minimizing tools. Combine full-service accounting with pharmacy software that integrates inventory, e-prescriptions, and transactions. Modules for batch tracking, expiry alerts, and narcotic logs. Connect the POS with inventory to flag slow movers and auto-reorder essentials. For example, set alerts when insulin pens drop below a 7-day buffer and match this with monthly cost reports to keep gross margin steady. An ad hoc quarterly audit by an outside accountant is important for tax, pricing, and reimbursement claims.
Scan for new lines of growth that conform with the local regulations. Pharmacies have a legal monopoly on medicinal products, medical devices, food additives, cosmetics, and sanitary or hygienic items. That coverage includes online pharmacy registration for select classes and click-and-collect services. Build a simple digital funnel: symptom education page, product page with clear dose info, and pharmacist chat hours. Marketing includes search ads around generic names, seasonal care for flu, and chronic needs like blood pressure cuffs. Make prices and supply transparent. In urban areas, 61.3% live within 800 meters of a pharmacy, 90% within 2 kilometers, and 99.2% within 5 kilometers, so online convenience has to be more appealing than short walks.
Design sites employing the distance rule. Since 2015, towns with up to 4,500 people are required to have more than 100 meters between pharmacies. Map existing licenses and foot traffic around clinics and labs. Bulgaria’s life expectancy is 71.2 years for men and 78 years for women, with healthy life expectancy nine years less than the European average. That indicates a consistent need for chronic care goods and compliance solutions. Health spending is $1,399 ppp, 8.4% of GDP, so they are cost sensitive and offer low-cost generics and loyalty plans.
Put the money in staff. Pharmacists do a five-year degree with a six-month traineeship and a master’s thesis. The Faculty of Pharmacy at the Medical University in Sofia spans six departments: Pharmaceutical Technology and Bio-Pharmacy, Pharmacognosy and Pharmaceutical Botany, Pharmaceutical Chemistry, Chemistry, Pharmacology and Toxicology, and Social Pharmacy. Fund short courses in pharmacovigilance, sterile compounding, and patient counseling. Drive language training for cross-border exchange programs. Tie bonuses to training milestones and error-free audits.
For setup, licensing, and compliance, bulgarian.llc, part of the bugarska NET network, provides end-to-end support. They steer site selection based on the 100 meter rule, prepare online registration files and sync SOPs to Bulgarian standards. They assist in selecting software, designing inventory policies and determining equitable marketing that is appropriate for the monopoly range and advertising restrictions.
Obtain Your Pharmacy Licence in Bulgaria with the Support of Bulgarian.LLC
Launching a pharmacy or pharmaceutical business in Bulgaria requires legal precision, reliable local guidance, and compliance with national healthcare regulations. Bulgarian.LLC provides complete assistance for both EU and non-EU investors who wish to obtain a pharmacy licence and operate legally within Bulgaria and the European Union.
Our dedicated team of lawyers, consultants, and regulatory experts manages every aspect of the process — from company registration and document preparation to coordination with the Ministry of Health and the Bulgarian Drug Agency. We ensure that your business fully meets the standards for licensing, qualified staff, premises, and pharmaceutical compliance.
We offer:
- Full legal and administrative representation before Bulgarian authorities
- Preparation and certified translation of all required documents
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- Assistance with registration at the Bulgarian Drug Agency (BDA)
- Accounting and tax setup for pharmacy operations
- Support with residence or work permits for non-EU company owners
Our mission is to make the licensing process transparent, secure, and efficient, giving you confidence and peace of mind while entering the healthcare sector in Bulgaria. Whether you are establishing a local pharmacy, expanding an international brand, or setting up a wholesale distribution company, Bulgarian.LLC provides a reliable foundation for your success.
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Conclusion
You have a direct route to a legit stable pharmacy in Bulgaria. The regulations are strict, but they are explicit. Comply with RHI and BDA guidelines. Maintain a licensed lead pharmacist on-site. Maintain clean logs for fridge inventory at 2 to 8 degrees Celsius. Maintain close records for controlled drugs. Conduct short-staff drills monthly. Schedule an audit every quarter. Establish reasonable SOPs for intake, storage, and recall. For cross-border professionals, arrange degree evidence, EU recognition, and Bulgarian language evidence. Plan cash, rent, and fit-out. A lean timeline goes something like three to six months for real projects.
Want a brief, a doc pack, or a quick once-over before you submit? Drop a line and make a fresh launch without fumbling.
Frequently Asked Questions
Who issues pharmacy licenses in Bulgaria?
Pharmacy licenses are granted by the Bulgarian Drug Agency (BDA) under the Ministry of Health, and the registration with the Bulgarian Pharmaceutical Union is a necessary requirement for pharmacists. Local health authorities can inspect drugstores prior to approval.
What are the basic requirements to open a pharmacy?
To operate a drugstore, you must have a licensed pharmacist in charge, compliant premises, approved equipment, and documented quality systems. Additionally, adherence to legal requirements, ownership and managerial requirements, and anticipation of inspections are crucial.
How long does the licensing process take?
Timelines differ by the necessary documents and inspections. Plan on weeks to months. Pre-application consultations and a detailed dossier minimize delays in the application process.
Can foreign pharmacists practice in Bulgaria?
Yes. EU/EEA qualifications are usually recognized under Directive 2005/36/EC. Non-EU pharmacists must navigate the application process for diploma recognition, language skills, and professional registration, along with necessary documentation like a certificate of good standing.
What documents are commonly required?
Anticipate necessary documents such as the diploma and license, certificate of good standing, language certificate, and blueprint of premises. Additionally, include employment contracts and lease or title, as these are essential for compliance with Bulgarian legislation.
Are there language requirements?
Yes, knowledge of the Bulgarian language is essential for patient safety and inspections, as it ensures compliance with regulatory requirements. Evidence can be demanded at registration and pharmacy practice, while patient advising and records must be maintained in Bulgarian.
How do I stay compliant after licensing?
To ensure safe pharmacy practices, maintain staff certifications and calibrate equipment while adhering to the strict requirements of narcotics controls and pharmacovigilance, and notify the BDA of any changes in ownership or responsible pharmacist promptly.
Daniel Malbašić is a business expert with extensive experience in the field of business consulting, organization and business optimization. His expertise includes market analysis, strategic planning, and implementation of effective business solutions. Daniel is dedicated to helping companies grow and improve their operations, providing them with comprehensive support in making key business decisions.
