Licence for medicinal products wholesale
The procedure for the issue of the licence for wholesale medicinal products is initiated when the business entity with head office in the Republic of Slovenia submits an application.
The competent authority decides on the issue of the licence for wholesale medicinal products in 90 days after the receipt of the complete application based on the expert committee's opinion for establishing the fulfilment of conditions for wholesale medicinal products.
The competent authority can issue the licence for wholesale medicinal products:
- for the full scope of wholesale medicinal products, containing the wholesale of all medicinal products that are being sold based on valid regulations to all business entities, to whom the wholesaler can sell medicinal products in accordance with the valid legislation;
- for a contact limited scope of wholesale medicinal products that contains the wholesale of medicinal products that can only be sold based on valid regulations, i.e. only to other holders of the licence for wholesale medicinal products
- or for product-limited scope of wholesale medicinal products that entails the wholesale of such medicinal products to those business entities to whom wholesalers can sell medicinal products in accordance with the valid legislation;
- to the Directorate of the Republic of Slovenia for Commodity Reserves.
The licence under the previous paragraph can be issued for a definite time or conditionally.
The procedure for the issue of the licence for wholesale medicinal products (hereinafter referred to as the licence) is initiated when the applicant submits an application in printed or electronic form to the authority responsible for medicinal products.
An application must include the following data and documents:
- short description of the applicant and activities that are intended for implementation (e.g. import, export, entry, removal, purchase, sale, storage, distribution, quality control);
- indication of groups of medicinal products with regard to the special regime and conditions of storage;
- the indication of wholesale activities with regard to selling:
- risk medicinal products;
- other medicinal products; active substances;
- systemisation and occupation of jobs in accordance with these rules;
- the contract with the responsible person and other persons under Article 7 of these rules, in the scope that proves employment;
- evidence on disposing of business premises, the description and ground plan of premises in the scale that applies to the actual dimensional ratio of premises;
- evidence on disposing of equipment and technical data on equipment;
- list of written instructions describing standard operational procedures on good distribution practice, good storage practice, good transport practice and good control laboratory practice (if quality control is implemented in own laboratory) and on the procedure of withdrawing a medicinal product from the market and on the procedure of destroying medicinal products;
- written statement of the applicant that they will handle waste medicinal products in accordance with regulations on waste medicinal products;
- in the case of import of medicinal products, a contract with a legal or natural entity that has the permit of the authority responsible for medicinal products for analytically testing medicinal products, if the quality control is not performed in own laboratory;
- evidence on the payment of procedure fees;
- evidence on the payment of the administrative tax for the application and decision issue.
Conditions and evidence
- Organisation operates in accordance with the principles of good distribution practice Person responsible for the acceptance, storage and transport of medicinal products and review of documentation Additional data for acquisition of a marketing authorisation for radiopharmaceuticals Additional data in the application for the acquisition of a marketing authorisation for radiopharmaceutical precursors
- Judicial remedy: Appeal
- Competent authority: Ministry of Health