Pharmaceutical products wholesale trade
According to the current legislation, the wholesale trade in pharmaceutical products (hereinafter referred to as “goods”) comprises the activities on purchase, storage, transportation and sale of goods to wholesale and retail trade companies, as well as to health care facilities, subject to the relevant license being obtained.
What criteria shall a company meet to obtain a wholesale license?
To obtain the license, the company shall meet the following mandatory requirements:
- Availability of material and technical base, which is compliant with the rules governing sale and storage of goods;
- Availability of qualified personnel;
- Quality control of goods;
- Compliance with all standards and norms related to the sanitary conditions of premises.
What are the requirements for premises?
In order to carry out activities related to the wholesale trade of goods, it is necessary to have a warehouse complex (used by right of ownership or lease). The total area of the complex shall be no less than 250 square meters. The complex shall comprise premises for receiving, storing and selling goods. There must be a loading area in front of each entrance to the warehouse.
Warehouses must be located in a separate single-storey building. It is forbidden to locate warehouses on a second floor and above, in lower ground floors and semi-basement floors.
The minimum distance between the warehouse complex and other buildings shall be as follows:
- 60 meters to residential buildings;
- 80 meters to public buildings;
- 30 meters to facility buildings.
Psychotropic, poisonous and flammable substances shall be stored separately from other substances in a specially equipped zones for their storage.
What are the qualification requirements for employees?
An enterprise that carries out activities related to wholesale trade in goods is obliged to have a pharmacist, a senior pharmacist and a warehouse manager in its staff. These employees must have the appropriate diplomas confirming their education, because only senior pharmacists and pharmacists can sell the goods. There are no special educational requirements for other employees.
All employees are required to undergo a medical examination.
What is the procedure for obtaining the relevant license?
Licensing of activity related to the wholesale trade in the goods is performed by the State Service of Ukraine on Medicines and Drugs Control (hereinafter - the Service). To obtain the appropriate license, the applicant shall submit to the Service a package of documents, which consists of:
- The application;
- Statements on the material and technical basis and personnel qualifications;
- Copies of the deeds of title to the enterprise certified by the enterprise;
- Copies of employee employment record books and diplomas certified by the enterprise;
- Extended extract from Unified State Register of Enterprises and Organizations of Ukraine (EDRPOU);
- List of documents submitted (2 copies);
- A power of attorney (if the documents are submitted by any person other than the director of the company).
The Service reviews the documents within 10 business days upon submission of the documents. At the same time, the commission of the Service carries out an on-site inspection of the production facilities, after which they will make a decision to issue or refuse the license.
This overview indicates that in order to obtain the wholesale licence, the applicant shall ensure the compliance of its production facility (a drugstore) with all building and sanitary requirements, presence of the qualified personnel and properly executed documents to be submitted to the licensing authority.
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