WHOLESALE DISTRIBUTION WITH MEDICINAL PRODUCTS

The field of wholesale distribution of medicinal products is defined by the Medicinal Products Act (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 17/14; hereinafter: ZZdr2) and with Rules on the detailed conditions of good distribution practice of medicinal products and on the notification procedure for the activities, and the procedure for obtaining the wholesale distribution authorisation  (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 46/09).

Wholesale distribution of medicinal products may be executed by  entities that obtain a licence from JAZMP. JAZMP issues licences for wholesale marketing of medicinal products in accordance with Article 107 of ZZdr2. More precise conditions will be determined in an executive act on the basis of ZZdr2.

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