Market surveillance and reports of violations

The medicinal products market is supervised by JAZMP inspectors who supervise the implementation of the provisions of the Medicinal Products Act (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 17/14), the Manufacture and Trafficking of Illicit Drugs Act (Official Gazette of the Republic of Slovenia [Uradni list RS], Nos. 108/99, 44/00, 2/04-ZZdrl-A and 47/04 - ZdZPZ), some provisions of the Pharmacy Services Act (Official Gazette of the Republic of Slovenia, No. 36/04), and some provisions of the Decree on the management of waste medicines (Official Gazette of the Republic of Slovenia [Uradni list RS], No.105/08), and of the implemented executive acts.

Market surveillance relating to the marketing of medicinal products is carried out as triggered inspection on the basis of received notifications, reports, recalls conducted by other authorities, media, inspection of websites, and internal investigations. Supervision is performed on both legal and natural persons who are operating in the area of the Republic of Slovenia and are within its jurisdiction, in order to ensure compliance with the provisions of the above stated legal regulations.

The JAZMP inspection service also cooperates with the customs authorities.

For all the above stated legal regulations the Inspection Division of JAZMP acts as minor offence authority.