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Requirements that a drugstore has to comply with to get license

The pre-licensing inspection of a drug store institution is carried out by the territorial body of the State ServiceOf Ukraine On Medicines And Drugs Control in order to establish the conformity of the material and technical base and qualifications of personnel with the established requirements and the documents declared by the licensee.

In the process of inspecting a  business entity that has submitted documents to obtain a license for the production of medicines in a drug store, for wholesale or retail sale of medicines, two components of a drug store get checked: material and technical base and personnel.

Inspecting the material and technical base

At the time of the pre-licensing inspection of the premises, which will be used for a drug store, they must already be fully prepared, incl. and documentation for them. You need to have documents with you confirming the ownership of the premises or a lease agreement for the premises duly concluded, as well as a certificate of transfer and acceptance . Because only the signing by the parties of the  certificate of transfer and acceptance confirms the fact that the tenant has accepted the premises for use in a state that is fully satisfactory at the time of transfer.

An important document is also the sanitary passport of the premises. The premises that will be used as a drug store institution must meet the criteria established by the License conditions regarding the total area and area of ​​individual rooms, including the sales area and the room for storing medicines, and the location of the rooms. Availability of the necessary square area of the main drug store premises is a subject of strict inspection. For example, the area of ​​the trading floor should be at least 18 square meters for drug stores located in cities and urban-type settlements, and in rural areas - at least 10 square meters. Compliance of the areas of the premises can be checked not only by the passport, but also with the help of a tape measure.

Creating conditions for the disabled. The drug store should ensure easy access for people with disabilities via a ramp or a lift. If it is impossible to install these, there should be a button for calling a specialist.

At the time of the inspection, it is necessary that all equipment, furniture (cabinets - separate ones for medicines, clothes and equipment), safes, refrigerators (separate ones for medicines, separate one for food storage), shelves, be available. The drug store must have devices for monitoring temperature and relative humidity.

Water supply system and sewerage. For drug stores located in cities, the availability of a water supply system sewerage are a prerequisite, and for drug stores located in rural areas and settlements where there are no utility networks, it is allowed that the restroom be outside the drug store, while a separate place for hand sanitization must be put in place at a drugstore.

On the facade of the building where the drug store is located, there must be a sign indicating the type of institution. Before entering the drug store institution, information on the name of the drug store institution and its mode of operation should be placed in a prominent place. The working hours of the drug store institution must be agreed with local authorities.

Personnel qualification test

A drug store institution that submits documents for a license should already have duly executed labor relations with staff at the time of their submission, including - employment contracts and employment orders registered at the local employment center. The required minimum staff is the head of the drug store institution and an authorized person. Both positions may be held by the same person.

The drug store personnel directly related to the production and / or sale of medicines must have a higher pharmaceutical education degree  and a certificate of assignment (confirmation) of the title of pharmacist-specialist or must be certified in this specialty with the assignment (confirmation) of a qualification category.

For drug stores located in villages, towns and urban-type settlements, it is permitted that the positions of the drug store manager are held by persons with diplomas of educational institutions of I-II levels of accreditation, or persons who have received a bachelor's degree in educational institutions of III-IV levels of accreditation.

All originals of documents confirming the qualifications of the staff, as well as the originals of their employment books must be available at  the drugstore institution at the time of inspection. In addition, job descriptions and staffing schedule must be approved.

If you are interested in obtaining a license for a drug store or a drug store warehouse, you can learn more about our services or get in touch with our lawyers specializing in  medical and pharmaceutical law.

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