When opening a pharmacy, whether physical or online, you must meet a number of requirements. They are described in detail in the Law on Medicinal Products in Human Medicine and ORDINANCE No. 28 of 09.12.2008 on the structure, procedure and organization of pharmacy work, as well as the nomenclature of medicinal products.
You must register a company before opening a pharmacy. In addition, you will need to hire a chief pharmacist if you do not already have one. He needs to be employed on a contract basis at your pharmacy. This way he will be able to manage and administer it within the meaning of the law.
The head of the pharmacy must be a chief pharmacist or assistant pharmacist. He must not have been convicted of crimes related to the practice of his profession, crimes against property and conduct, or intentional crimes against the person. He must have at least one year of experience as a master pharmacist.
After covering the above, you should proceed to the essence of opening a pharmacy. Start by obtaining a marketing authorization for medicinal products. For this purpose, you need to submit an application form to the Executive Agency for Medicines. The same must meet the detailed requirements of the LLPHM, as well as Ordinance № 28. After its entry, BDA (Bulgarian Drug Agency) officially require a hygienic certificate. The certificate is issued by RHI after an on-site inspection at the site to be registered as pharmacy. With a positive opinion from the RHI, respectively from the BDA, the pharmacy will be entered in the register and you can operate through it. The term for issuing the hygienic conclusion by the RHI is 14 days, and the registration with the Executive Agency for Medicines takes 1 month.
Here are the requirements for the room:
- It is obligatory to have an external inscription “Pharmacy”;
- They must have a separate entrance and be located on the first floor.
- Observance of the minimum number of premises and the minimum area;
- Providing the necessary equipment for storage and preparation of medicinal products in the pharmacy;
Other requirements for opening a pharmacy:
- The staff in the pharmacy must work with work shoes and white aprons, which are inscribed with the name, qualification and position of the person
- Prescription medicinal products are stored separately in a way that prevents visual access of the patient / user;
- Information about the issued permit is placed in a visible place in the reception room of the pharmacy;
- When opening a pharmacy, it is necessary to have information in a visible place (address and working hours) about the nearest pharmacy, where medicinal products are prepared according to the main and pharmacopoeial recipe;
- Each pharmacy must have information displayed in a prominent place (address, telephone and working hours) for the control authorities on whose territory the pharmacy is located;
- The pharmacy has a stamp bearing the number and date of the issued authorization for retail trade in medicinal products. It is placed on all documents related to the marketing of medicinal products;
- Medical devices are stored and sold separately from other products in the pharmacy;
- When opening a pharmacy, keep in mind that the temperature in the rooms and refrigerators is recorded daily and recorded in a diary;
- A diary of completed prescriptions is kept and stored in the pharmacy;
When opening a pharmacy, the following documents must be kept in the room, which are provided upon request by the control authorities:
- permit for retail trade in medicinal products;
- license for retail trade and storage of medicinal products containing narcotic substances, when the pharmacy has received a permit for this activity;
- copies of the documents for legal capacity and of the labor contracts with the persons working in the pharmacy, as well as the respective notifications under art. 62, para. 3 of the Labor Code;
- the invoices or a copy of them with which the medicinal products have been purchased;
- copies of reports for performed inspections by the control bodies
We at T&G Consulting are here to assist you in starting your business.