The renewal of a national marketing authorisation is carried out in accordance with the provisions of the Medicines for Human Use (Quality, Supply and Prices) Law of 2001 - 2020.
The marketing authorisation holder must submit to the Medicines Council an application for the renewal of the marketing authorisation at least 9 months before its expiry. The application for renewal must be accompanied by all the necessary documentation concerning the quality, safety and efficacy of the medicinal product, the company's PSMF, the RMP of the medicinal product as well as the summaries of Module 2 of the dossier.
The application is assessed and if the submitted data are considered satisfactory, the national marketing authorisation is renewed by the Medicines Council. Once renewed, the marketing authorisation shall be valid indefinitely, except in cases where the Medicines Council decides on a five-year renewal, if this is duly justified for reasons of Pharmacovigilance.
It is noted that if a medicinal product is not marketed within three years of the issuance of its marketing authorisation, the marketing authorisation shall cease to be valid.