NATIONAL PROCEDURE

In accordance with the Medicinal Products Act (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 17/14), the national procedure starts at JAZMP with the application of the applicant - future marketing authorisation holder - for a medicinal product that will be marketed only in the Republic of Slovenia or as the basis for future mutual recognition procedure. Marketing authorisation is valid for the period of five years. After the first extension, the medicinal product has an unlimited duration of marketing authorisation.

Detailed information on procedures for obtaining marketing authorisation are in Notice to Applicants, Chapter 1 of Volume 6A.