Business entities that have acquired a permit for the wholesale of medicinal products in any other Member State of the European Union, and who will perform the wholesale marketing distribution of medicinal products in the Republic of Slovenia, must give notification of such activity to JAZMP before they start performing the activity in the Republic of Slovenia.
Responsibilities or tasks of JAZMP in the field of notification about wholesale distribution of medicinal products in the Republic of Slovenia are:
Certification regarding entry into/removal from the official record of entities who acquired the licence for performing activities in wholesale distribution in a European Union member state, and have notified JAZMP about performing wholesale distribution in the Republic of Slovenia.
The procedure for notification regarding wholesale distribution in the Republic of Slovenia is determined by Article 105 of the Medicinal Products Act (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 17/14 and 66/19), and Article 17 of the 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 and 17/14) determines the procedure and the content of the application for notification.
Agency for Medicinal Products and Medical Devices of the Republic of Slovenia
