How to open a pharmacy in Bulgaria. Accounting and Licensing.

Opening a pharmacy in Bulgaria is a process that involves numerous steps and requirements that must be carefully fulfilled in order to ensure the successful functioning of the pharmacy. The accounting and consulting firm “Elan Consulting” is here to help you with all the necessary procedures related to accounting and obtaining permits for a pharmacy, whether it is a physical pharmacy or an online pharmacy.

Our customers often ask us: “How do you get a pharmacy license?” and “What are the requirements for the retail trade of medicinal products?”. At Elan Consulting we offer expert assistance in the preparation and submission of all necessary documents for licensing, ensuring that all legal requirements will be met. Important aspects such as “first loading a pharmacy” and “how much does it cost to open a pharmacy” are also within the scope of our services.

We are also often asked about the accounting of a pharmacy: “How is the accounting of a pharmacy?” and “What are the specific requirements for bringing a product to a pharmacy?”. We provide full accounting support, including the preparation of “pharmacy invoices”, “pharmacy financial statements”, as well as the submission of “NSOs annual report”. Our services also cover assistance in case of “NHS system crash” by offering pharmacy management software solutions.

In addition, Elan Consulting can advise you on issues such as “minimum square footage for a pharmacy” and “how much does a pharmacy earn”. We have information on “NCOS 2024 prices” and “NHIF ICD codes”, while providing references and notification letters to the NCOS.

Also, an important aspect is also “online pharmacy registration” and “round-the-clock pharmacy requirements”. We support you in the entire process of registration and compliance with the requirements for the premises, including the change of manager and the transfer of a pharmacy license.

Elan Consulting is your reliable partner in Sofia, Burgas, Pomorie, Karnobat, Sunny Beach, Aytos, Nessebar, Sozopol, Primorsko and throughout Bulgaria. Whether it is opening a pharmacy by an assistant pharmacist or closing a pharmacy, we are here to offer you professional and competent services that will help you successfully navigate the complex process of opening and managing a pharmacy in Bulgaria.

How is a license for retail sale of medicinal products issued in Bulgaria?

The issuance of a license for retail sale of medicinal products in Bulgaria is strictly regulated in the Law on Medicinal Products in Human Medicine. To obtain this authorization, it is necessary to fulfill certain requirements and provide the necessary documentation to the Executive Agency for Medicines (IAL).

The first step is to submit an application for an authorisation for the retail trade of medicinal products. The application must contain information about the merchant applying, including details of the manager and representative of the pharmacy, if the trader is not established in the territory of the Republic of Bulgaria (Art. 228, para. 1).

The following documents must be attached to the application:

1. A copy of the document on registration of the trader within the meaning of the Commercial Law (Art. 229, para. 1, item. 1).
2. Plan of the premises in which retail trade will be carried out, approved by the competent authority (Art. 229, para. 1, item. 2).
3. Documents certifying the right to use the premises (Art. 229, para. 1, item. 3).
4. Evidence of the professional qualifications and legal capacity of persons who will carry out retail trade in medicinal products (Art. 229, para. 1, item 4).

The premises in which retail trade in medicinal products will be carried out must comply with certain sanitary and hygienic requirements, for which a certificate is provided by the competent authority (art. 230). Also, the pharmacy must be equipped with the necessary technical means and facilities to ensure the safe storage and sale of medicinal products (Art. 230, para. 2).

After submitting the application and the necessary documentation, the Executive Agency for Medicines carries out an on-site inspection to ensure that all requirements are met. If the conditions are met, the IAL issues a permit for retail trade in medicinal products (Art. 232, para. 1).

The permit is issued for a certain period and is subject to renewal, provided that the trader continues to comply with the requirements of the law (art. 233). In case of a change in the circumstances related to the management or premises of the pharmacy, the trader is obliged to notify the IAL and submit the relevant documents for approval of the changes (Art. 234, para. 1).

Retail trade in medicinal products is an activity that is subject to strict control. Violations of the requirements of the law may lead to the imposition of sanctions and the withdrawal of the marketing authorization (art. 235).

For more information and assistance in preparing documents for obtaining a license for retail sale of medicinal products, you can contact Elan Consulting, which offers expert advice and assistance throughout the licensing process.

What are the requirements for opening a pharmacy in Bulgaria?

Opening a pharmacy in Bulgaria requires compliance with strict legal regulations, which are established in the Law on Medicinal Products in Human Medicine and other related normative acts. Here is a detailed description of the basic requirements and procedures:

To obtain permission to open a pharmacy, an application must first be submitted to the Executive Agency for Medicines (IAL). The application must contain the following information and documents:

Necessary documents for opening a pharmacy

1. Copy of the trader's registration documentwithin the meaning of the Commercial Law (art. 229, para. 1, item 1).
2. Plan of the premises, in which retail trade in medicinal products approved by the competent authority will be carried out (Art. 229, para. 1, item 2).
3. Documents certifying the right to use the premises(art. 229, para. 1, item. 3).
4. Evidence of the professional qualifications and legal capacity of persons, which will carry out retail trade in medicinal products (Art. 229, para. 1, item. 4).
5. Certificate from the competent authorityon the compliance of the premises with the requirements of Ordinance No. 28 on the conditions and procedure for keeping the register of pharmacies and the requirements therefor (Art. 230, para. 1).
6. Description of technical means and equipment, which will be used for the storage and sale of medicinal products (Art. 230, para. 2).

How many pharmacies can one person open

According to the Law on Medicinal Products in Human Medicine, a person can open no more than four pharmacies. This is regulated in Art. 232, para. 2, which states: “A person may open and operate no more than four pharmacies.” The purpose of this restriction is to prevent monopolization of the market and to ensure an even distribution of pharmacies in different settlements.

Is there a fixed minimum quadrature for a pharmacy under the law?

Yes, according to Ordinance No. 28 of December 9, 2008 on the device, order and organization of the work of pharmacies, there is a fixed minimum quadrature for a pharmacy. According to Art. 10, para. 1, the pharmacy must have a reception room with a minimum area of 10 square meters.

Sale of medicines in a locality without a pharmacy

In settlements where there is no pharmacy, the law provides for the possibility of opening branches of pharmacies. These branches can be located in medical centers, health offices or other suitable objects. Trade in medicines in these branches is carried out under the guidance of a master pharmacist, it is necessary to ensure compliance of the premises with the requirements for storage and sale of medicinal products. According to Art. 231, para. 1. “In settlements without a pharmacy, retail sale of medicinal products in branches of pharmacies may be carried out, provided that the presence of a master pharmacist at least twice a week is ensured.”

Difference between pharmacy and drugstore

Pharmacies and drugstores have different scope of activity and different requirements for detection and functioning. The main difference between them is in the permitted activities and the types of products they can sell.

Pharmacies:

• Can sell all kinds of medicinal products, including those dispensed with a doctor's prescription (art. 226, para. 1).
• Managed by Master Pharmacistswho have the necessary qualifications and legal capacity (art. 227, para. 1).
• Must meet strict sanitary and hygienic requirements, including separate storage areas for different types of medicinal products (art. 230).

Drugstores:

• Can only sell drugs that are dispensed without a prescription, as well as food additives, sanitary and hygienic products and other goods that do not require special storage conditions (art. 234).
• They are not required to have a Master Pharmacist on their staff, but must have persons with a certain qualification to lead the activity (art. 234, para. 2).
• Drugstore registration is simpler, with regional health inspectorates issuing certificates for registration of drugstores (art. 235).

Additional requirements

In order to ensure compliance with legal requirements and to ensure the safety and efficacy of marketed medicinal products, pharmacies and drugstores are subject to regular inspections by the competent authorities. Violations of the requirements may lead to the imposition of sanctions and the withdrawal of the marketing authorisation.

Opening a pharmacy in Bulgaria is a process that requires careful preparation and compliance with all legal requirements. Elan Consulting can provide you with expert assistance and advice to ensure the successful opening and functioning of your pharmacy, regardless of the location in Bulgaria.

What requirements does the Bulgarian legislation place on the staff of pharmacies and drugstores?

The requirements for the personnel of pharmacies and drugstores in Bulgaria are clearly defined in the Law on Medicinal Products in Human Medicine (ZLPHM) and Ordinance No. 28 of December 9, 2008 on the structure, order and organization of the work of pharmacies and the nomenclature of medicinal products.

Pharmacy staff are subject to strict requirements. According to Art. 219, para. 1 of the ZLPHM, a pharmacy can be opened and operated only by a master pharmacist who has the relevant professional qualifications and legal capacity. The master pharmacist must be registered in the register of the Bulgarian Pharmaceutical Union, which is a mandatory condition for practicing the profession.

According to Art. 6, para. 1 of Ordinance No. 28, there must be at least one master pharmacist in the pharmacy, who is responsible for the overall activity of the pharmacy. This master pharmacist is obliged to be present at the pharmacy during working hours. Pharmacists may also work in pharmacies, who carry out activities under the direct supervision and guidance of the Master Pharmacist (Art. 7, para. 1 of Ordinance No. 28).

The pharmacy must provide appropriate training and qualifications to its staff. According to Art. 20, para. 1, item 6 of the ZLPHM, the head of the pharmacy is responsible for increasing the professional qualifications of pharmacy workers, ensuring their participation in courses and other forms of training at least once a year.

The requirements for the staff of drugstores are less stringent compared to those for pharmacies. According to Art. 234 of the ZPCHM, drugstores can sell only medicines that are dispensed without a prescription, dietary supplements, sanitary and hygienic products and other goods that do not require special storage conditions. Drugstores cannot sell drugs that are dispensed with a doctor's prescription.

The manager of a drugstore can be a person who has a medical education or a relevant qualification for the sale of medicines without a prescription (Art. 234, para. 2 of the ZPCHM). Unlike pharmacies, drugstores do not require the presence of a master pharmacist.

Ordinance No. 28 also puts forward other requirements for the staff of pharmacies and drugstores. For example, according to Art. 31, para. 2, the opening hours of the pharmacy must be announced by means of an appropriate sign, which also includes information about the nearest round-the-clock pharmacy.

The work clothing of the staff is also regulated. According to Art. 30, para. 2, the pharmacy staff must work in work shoes and white aprons, on which an inscription is placed with the name, qualification and position of the person.

What are the requirements for opening an online pharmacy in Bulgaria?

The requirements for opening an online pharmacy in Bulgaria are strictly regulated by the Law on Medicinal Products in Human Medicine (ZLPHM) and related normative acts. To create and manage an online pharmacy, it is necessary to fulfill certain requirements that ensure the safety and quality of the services and products offered.

First, an online pharmacy can only be created by a person who already has a license to retail medicinal products or a drugstore registration certificate issued by the Executive Agency for Medicines (IAL). This is stated in Art. 232, para. 5 of the ZLPHM. In order for such a permit to be issued, the person must submit an application to the IAL, providing all the necessary documents, including evidence of legal capacity and qualifications of the manager and staff of the pharmacy.

According to Art. 40 of Ordinance No. 28 of December 9, 2008, in order to trade on the Internet, a person must have his own Internet site. The following information should be posted on this site: the name of the legal entity, registered office and address of management, address of the pharmacy or drugstore, number and date of issue of the permit or certificate, the three names of the head of the pharmacy or drugstore, as well as the nomenclature of the offered medicinal products, prices and conditions for delivery.

The Internet site must provide easy and safe access to user information. According to Art. 41, para. 2 of Ordinance No. 28, the information must be provided in a clear and understandable manner, emphasizing the commercial nature of the proposal and respecting the principles of good faith and good commercial practice. In addition, the person must provide conditions for the proper packaging, transportation and delivery of medicinal products so that their qualities and efficacy are preserved (art. 44, para. 1).

When starting an activity on the Internet, the person is obliged to provide written information in the IAL, which includes the data on the Internet site and a declaration that he has means of transport ensuring the proper storage of medicinal products during transportation (Art. 42 of Ordinance No. 28). After receiving the information, the IAL checks the website for the availability of the necessary data and enters the person in a list published on the website of the agency (Art. 43, para. 2).

The sale of medicinal products over the Internet can only be carried out with drugs that are dispensed without a doctor's prescription. Prescription drugs may not be sold online, according to Art. 43, para. 1 of the ICCPR. In addition, when selling via the Internet, the pharmacy must provide appropriate advice to consumers in Bulgarian language requested by them (Art. 47, para. 2).