Wholesale of medicinal products
Wholesale of medicinal products means the activities of purchase, storage, sale, admission, removal, import or export of medicinal products, except for dispensing medicinal products to individuals or legal entities for their personal use or use in health care or veterinary medicine.
Wholesale of medicinal products can be performed by legal entities or individuals who fulfil the prescribed conditions and have a valid permit issued by the authority competent for medicinal products (hereinafter referred to as wholesalers).
Business entities who fulfil the following conditions can obtain a permit for wholesale of medicinal products:
- having under contract an appropriate number (relative to the scale of the activity) of experts with a master’s degree in pharmacy or with a level of education which corresponds to that level in accordance with the law, and if necessary also experts in other relevant professions;
- from among the experts referred to in the previous item they should appoint a person responsible for the reception, storage, dispensing and transport of medicinal products and reviewing of documentation that enables the traceability of medicinal products. The responsible person should have a master’s degree in pharmacy or a level of education which corresponds to that level in accordance with the law;
- and the wholesaler should have adequate premises and necessary equipment relative to the type of medicinal products which being sold,
- keep appropriate documentation in a way that allows for the immediate recall of a medicinal product from the market and settlement of complaints;
- organise work in accordance with the principle of good distribution practice and
- have a quality assurance system which determines responsibilities, procedures and measures of risk management in relation to their activities.
A wholesaler of medicinal products may purchase medicinal products only from business entities which have a permit to produce medicinal products or a permit for wholesale distribution of medicinal products.
Conditions and evidence
- Status and registration Licence for medicinal products wholesale Certificate of good distribution practice Wholesale distribution of medicinal products as per the Compilation of Community Procedures Obligation to perform services in the public interest Conditions for advertising medicinal products Professional co-worker for advertising of medicinal products A professional co-worker for advertising medicinal products which can be sold in specialised stores Mandatory use of applicable prices of medicinal products Reporting data on prices of medicinal products Other obligations of the wholesaler of medicinal products Compulsory management of information on merchandise Establishment of working hours Minimum technical conditions in specially arranged room in a wholesale outlet Regular certification of metering devices