Information regarding parallel import and parallel distribution of medicinal products

Parallel import of a medicinal product is entry of a medicinal product with marketing authorisation in the exporting country and which has adequate resemblance or similarity to the medicinal product which obtained marketing authorisation in the Republic of Slovenia in accordance with the national procedure, mutual recognition procedure or in the decentralised procedure, and is entered to the Republic of Slovenia with marketing authorisation with a parallel imported medicinal product issued by JAZMP, where parallel import of the medicinal product is performed by a wholesaler with no business relation regarding marketing of the medicinal product with the marketing authorisation holder.

In accordance with Article 117 of the Medicinal Products Act (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 17/2014), the application for obtaining, amending or extending marketing authorisation of parallel imported medicinal products includes information concerning the applicant, the medicinal product for which parallel import is proposed, and for the medicinal product with marketing authorisation in the Republic of Slovenia with which the medicinal product in the submission is compared.

Please follow the rules regarding the fees in the procedure.