Renewals

In compliance with Directive 2001/83/EC as amended, all granted Marketing Authorizations need to be renewed at least once, after five years after approval. As the renewal is supposed to be re-assessment by the Competent Authorities upon updated knowledge acquired during the period of marketing, expert statements or updated overviews need to be submitted on all (quality, non-clinical and clinical) aspects.

AccepTher assumes to provide the expertise required for the critical review of the benefit/risk ratio of the product, to review or prepare, as well as submit to Competent Authorities most of the documents needed for renewal.

The re-assessment usually results in either the prolongation of the validity of the Marketing Authorization for an unlimited time, or a renewal for another period of 5 years typically on Pharmacovigilance grounds.