MRP/DCP procedure

In accordance with the Medicinal Products Act (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 17/14), the mutual recognition procedure is a procedure in which the selected EU member states acknowledge marketing authorisation issued by one of the EU member states. The applicant files the basic application for obtaining marketing authorisation in one of the EU member states - Reference Member State (RMS) which issues the marketing authorisation. Selected EU member states - Concerned Member States (CMS) then authorise or reject marketing authorisation issued by RMS within 90 days. Coordination group for Mutual recognition and Decentralised procedures (CMDv) which consists of representatives of all EU member states, including Norway, Lichtenstein, and Iceland, provides the process of mutual recognition of marketing authorisation for medicinal products in veterinary use. Selection of RMS and CMS depends on the applicant of the procedure. The procedure lasts 90 days.

Decentralised procedure is used when the medicinal product has not yet obtained marketing authorisation in the EU. The applicant of the procedure selects RMS and CMS. RMS conducts the procedure and in the first phase prepares a draft of an expert report, summaries of product characteristics (SPC), labelling and package leaflet, which are confirmed or rejected by CMS in the later phase. Coordination group for Mutual recognition and Decentralised procedures (CMDv) which consists of representatives of all EU member states, including Norway, Lichtenstein, and Iceland, provides the process of mutual recognition of marketing authorisation for medicinal products in veterinary use. Selection of RMS and CMS depends on the applicant of the procedure. The procedure lasts 210 days.

Detailed information on the procedures for marketing authorisation can be found in Notice to Applicants, Chapter 1 of Volume 6A.