We identify the procedure for the planned business and coordinate corporate records, premises information, professional credentials and regulatory submissions.
The team behind a pharmacy and medical business was unsure how to turn its licensing information into a coherent application. ARG coordinated the corporate documents, responsible people, policies and supporting evidence, so the team could see what remained outstanding and understand the role of each next step.
That same distinction matters for any Bulgarian health business. A pharmacy requires its own authorisation, while an out-of-hospital medical centre follows a separate registration route and must meet specific staffing conditions. If the pharmacy will handle medicines containing narcotic substances, an additional licence and continuing compliance duties apply.
ARG can help when you need to
A pharmacy needs IAL retail permission; an outpatient medical centre needs IAMN registration through the RHI process. Define the services and products before forming the filing plan.
A pharmacy normally needs a responsible master pharmacist. A medical centre needs the statutory team with different recognised specialties and an eligible professional manager.
Align the address, lawful use, layout, hygiene, equipment and staffing with the intended activity. The lease alone does not establish suitability for a pharmacy or treatment centre.
Controlled medicines, online sales, wholesale supply, radiation equipment and special clinical activities may add requirements. Base the launch on the actual assortment and care model.
The first step is to classify the project correctly, because in Bulgaria a retail pharmacy and an out-of-hospital medical centre do not rely on the same legal route. The pharmacy side is governed by the Bulgarian Medicines Act, "Закон за лекарствените продукти в хуманната медицина" [ЗЛПХМ], which sets the framework for retail sale of medicinal products in a pharmacy and for the specific authorisation that makes that activity lawful. The medical-centre side is governed by the Health Establishments Act, "Закон за лечебните заведения" [ЗЛЗ], which regulates out-of-hospital health establishments and their registration or authorisation route. The two regimes can meet in one commercial plan, but one approval does not automatically cover the other.
In practical terms, this means you first need to decide whether you are planning one of three models.
That distinction matters because the legal effect is different. A pharmacy is not treated as an ordinary retail business. The Ministry of Health states that the retail sale of medicines in a pharmacy rests on the relevant pharmacy authorisation, and the transfer of authority to issue, refuse, and terminate those authorisations is now with the Bulgarian Drug Agency. A medical centre, by contrast, is not opened through a pharmacy authorisation. Under article 40 of the ZLZ, registration is handled through the health-establishment system, and the certificate of registration has a different function from a pharmacy permit.
A medicinal product under Article 3 of the Medicinal Products in Human Medicine Act is defined by its presentation or function: this includes substances presented to treat or prevent disease and substances used to diagnose or modify physiological functions through the specified pharmacological, immunological or metabolic action. A supplement, cosmetic and medicine therefore cannot be classified merely by calling each a “health product”. Prepare a product list with intended claims and supply channels. Selling to the public, wholesaling and operating a treatment establishment are distinct activities with different authorisations.
If you mix the two concepts too early, you can prepare the wrong file. For example, a company may be fully prepared to apply for a pharmacy authorisation, yet still lack the structure needed for a medical centre. Or it may satisfy the medical-centre registration route, but that says nothing about whether it may retail medicines as a pharmacy. The legal question is therefore not only what you want to do commercially, but which regulated activity each part of the plan actually triggers.
The practical consequence is that ARG would start by mapping the business model to the correct Bulgarian regime, then separating the permit work from the registration work. That is usually the point at which the client learns whether the project needs one file or two, whether the premises and staffing plan fit the chosen model, and whether any part of the plan should be postponed until the right legal structure exists.
A pharmacy permit does not turn a health business into a medical centre, and a medical-centre registration does not replace a pharmacy authorisation.
For a cross-border client, this classification is also the point where the corporate and regulatory picture meet. The company form, the intended activity, the location and the responsible professionals all need to fit the route you choose before the authorities will accept the application in the right channel.
If your pharmacy will sell only ordinary medicines, you still need the relevant pharmacy authorisation because retail sale in a pharmacy is a regulated activity, not a general commercial one. If you also want to handle medicines containing narcotic substances, that adds a separate layer of control and a separate licence. The Ministry of Health procedure page makes this clear. Only a person who already has permission to open a pharmacy under the ZLPMH may apply for the narcotics retail licence, the authority must decide within 50 days from the application and documents under article 33 a(1) of the Narcotic Substances and Precursors Act, and the licence is indefinite.
The pharmacy retail permit is issued by the Bulgarian Drug Agency, known locally as IAL, under Articles 222–229. The file must identify the eligible operator, the specific pharmacy and its responsible pharmacist. Plan the manager’s employment or management contract, recognised professional status, premises and hygiene assessment together. The general rule requires a master pharmacist, with limited statutory exceptions; an investor need not personally dispense medicines, but cannot replace the legally responsible professional with an informal adviser. Check the permitted number of pharmacies and the ownership incompatibilities affecting medicine manufacture, import and wholesale before finalising the group structure.
That structure changes the compliance work in a very practical way. Ordinary pharmacy operation and narcotics handling are not one and the same file. The narcotics licence is an additional approval that depends on the pharmacy permission already being in place. In other words, you do not start from the narcotics licence and work backwards. You first need the legal basis for the pharmacy, and only then can you add the controlled-substances layer if your business model needs it.
ARG would first check whether your commercial model truly requires controlled-substances retail or whether the pharmacy will stock only ordinary medicinal products. That is important because the need for the extra licence changes the application set, the internal compliance controls and the timing of the launch.
For the additional controlled-medicines licence, prepare the following elements and keep its timetable separate from the underlying pharmacy permission:
That last point matters for foreign owners and cross-border groups. It shows that the authority is not only checking the pharmacy concept in the abstract. It is also checking who the applicant is, whether it is legally existing, and whether the person signing the file has a valid legal basis to do so. For an international client, that often determines whether the matter is ready for filing or still needs corporate documents, translations and alignment of the applicant entity.
If your business plan is a normal retail pharmacy, the key issue is the pharmacy authorisation. If your plan includes narcotic medicines as part of the product range, you must plan for the additional licence and the continuing duty to keep that permission properly maintained. A lost or destroyed licence is not just an inconvenience. It triggers a notification duty, so the post-approval side of the project matters as much as the initial submission.
In a real filing, this is where ARG would separate the basic pharmacy package from the controlled-substances package, confirm the applicant’s legal capacity and prepare the documentary sequence so that the two approvals are not confused or filed out of order.
Tell us where you live, how your business works and what you want to change. We will help you identify the questions to resolve and the next steps to consider.
Yes, but only if the proposed medical centre fits the statutory definition and not just the commercial idea. Under the Health Establishments Act [ЗЛЗ], a medical centre is an out-of-hospital establishment that carries out specialised outpatient care through at least three doctors or at least three dentists with different recognised specialties. That threshold is a legal condition, not a filing convenience, so if the staffing profile does not reach it, the project is not a medical centre in the Bulgarian sense and the registration route will not match the business plan. See Lex.bg, article 16.
The same law also matters for the legal form. Article 16(2) says these establishments are formed as sole trader companies or sole traders and then registered under article 40. Where they are founded by individual doctors, dentists, assistant doctors, nurses, midwives, or rehabilitators, they are registered only under article 40. In practice, that means the authority looks at both the organisational form and the personnel structure before it accepts the file. If the personnel base is too narrow, ARG would not try to force the project into the medical-centre route. It would first test whether the activity should be redesigned, delayed, or split from any pharmacy project.
A medical centre is not licensed like a hospital. It is registered as an out-of-hospital health establishment, and the registration route is handled within the health-establishment system rather than through a pharmacy permit. That difference matters because some clients assume that a single Bulgarian health business can be built around one general approval. It cannot. The staffing rule, the business form and the registration route all have to point in the same direction.
A useful way to check your position is this.
If any one of those points is missing, the issue is not a paper defect. It is a structural eligibility problem. That is exactly where ARG adds value, because it separates what can be cured by documents from what requires a different business model.
A medical centre under Article 16 requires at least three doctors and/or dental practitioners with different recognised specialties and the prescribed professionally qualified manager. One specialist’s practice is a different establishment type. List the services, specialties, staff schedules, rooms and equipment so the regulator can assess the actual care to be delivered. Additional activities such as ionising-radiation equipment or assisted reproduction require their own applicable permissions and standards. The clinical registration also does not automatically create an NHIF reimbursement contract.
The filing route depends on who the applicant is and whether the authority can see a valid legal person behind the request. For the medical-centre route, article 40(1) of the Health Establishments Act [ЗЛЗ] says registration is done by the Executive Director of the Executive Agency “Medical Supervision” on an application that states the company’s UIC or EIK and is accompanied by the listed documents. The Ministry of Health’s procedure page confirms that this agency sits inside the wider health-establishment control system, while the Minister of Health acts on its proposal for the broader authorisation framework. See Lex.bg, article 40 and Ministry of Health procedure page.
For a Bulgarian company, the EIK identifies the applicant in the Commercial Register. An eligible EU or EEA company must provide current home-state registration evidence. Match the legal person, representative, address and permitted corporate activity across the application, premises documents and professional contracts. For foreign healthcare professionals, a translated diploma is not itself recognition of the qualification or specialty. Establish the applicable recognition and professional-register requirements before committing to a staffing plan. The company’s right to invest and the individual’s right to practise are separate questions, and both must be resolved for the proposed establishment.
Under Article 40 of the Medical Establishments Act, outpatient registration is decided by the Executive Director of the Executive Agency Medical Supervision, or IAMN. The application is submitted through the regional health inspectorate (RHI), which performs its statutory checks and forwards the file; the RHI does not issue the final registration certificate. Article 40(13) gives IAMN one month from receiving the statutory package, with suspension for notified documentary deficiencies. The public register is maintained by IAMN under Article 41. Plan around both stages, professional-register confirmation and any premises corrections, rather than a supposed ten-day RHI registration.
A file can stall if the applicant name, the activity description and the speciality structure do not line up. It can also stall if the corporate evidence does not show a valid existing applicant or if the submitted materials do not match the route chosen for the establishment. In a cross-border case, the practical problem is often not the medical concept but the mismatch between the foreign corporate documents and the Bulgarian filing logic.
ARG’s role at this stage is to turn that into a filing sequence that the authority can read without guessing. That usually means confirming the applicant, organising the documents in the order the route expects and checking whether the business is being presented as a registration case, a pharmacy case or both.
After the initial approval, the real work becomes keeping the project within the same legal category that was approved. If the plan expands into a hospital-level establishment, the route changes. The Ministry of Health’s procedure page states that hospital establishments require a decision of the Council of Ministers under article 37 a of the Health Establishments Act [ЗЛЗ]. That is a materially different approval path from the out-of-hospital registration route, so a business that starts as a medical centre cannot quietly grow into a hospital service without a new legal review. See Ministry of Health procedure page.
For the pharmacy side, continuing compliance is also part of the project design. The Ministry’s procedure page for narcotics retail licensing says the licence is indefinite, but if it is lost or destroyed the holder must notify the Ministry of Health. That is a good example of how Bulgarian health regulation works in practice. The file is not finished when the permit is issued. The holder has to preserve the legal status of the approval and report changes or incidents that affect it. See Ministry of Health procedure page.
Online sales are a separate operational question. Article 234 prohibits online sale of prescription medicines and permits non-prescription online sales only through the qualifying authorised pharmacies or registered drugstores meeting the specific requirements, including the common EU logo and register linkage. A website is not a substitute for the regulated physical operation. A pharmacy’s permission also does not confer wholesale rights or the additional controlled-medicines licence. Review the assortment, ordering, storage, delivery and patient information before opening the online channel.
For a client, that means the post-approval checklist is just as important as the application package. ARG would normally separate the work into three layers.
If your project includes both a pharmacy and a medical centre, the next practical question is not whether one filing is enough, because it usually is not. The real question is whether the operating model, premises, staffing and ownership structure can support both regimes at once without creating a compliance gap. That is where ARG’s coordination work becomes most useful, because the business decision and the filing strategy have to move together rather than one after the other.
After opening a medical centre, Article 43 requires changes to the registration to be notified to IAMN through the Article 40 procedure within seven days, with the change documents and the prescribed declaration concerning unchanged facts. Pharmacy changes follow Article 231, including a new-application rule for the specified simultaneous changes. Before a relocation or acquisition, compare the operating entity, pharmacy address, manager and activities against the existing permission. Include medication storage, professional cover and continuity of patient records in the transition plan so the business remains operationally ready as well as correctly registered.
Compare the related procedures in this category, including their requirements and the stage at which you need them.
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