Renewals: Regulatory and procedural guidance

This page lists the European Medicines Agency's regulatory and procedural guidance documents on renewals of marketing authorisation.

Guideline on the processing of renewals in the centralised procedure

Adopted Legal effective date: 01/11/2016 Reference Number: EMEA/CHMP/2990/00 Rev.5 Summary:

This guideline considers issues associated with the processing of renewals in the centralised procedure, with an aim of giving procedural guidance to marketing authorisation holders (MAHs). It has been developed by the CHMP following consultation of the interested parties and the European Commission Services.

English (EN) (311.38 KB - PDF)

First published: 04/08/2016 Last updated: 04/08/2016

Guideline on the processing of renewals in the centralised procedure: document with track changes

Consultation dates: 28/07/2015 to 14/09/2015 Draft: consultation closed Reference Number: EMEA/CHMP/2990/00 Rev.5 Summary:

In order for a marketing authorisation to remain valid, a renewal is required five years after the granting of the marketing authorisation (irrespective of whether the marketing authorisation is suspended). This guideline considers issues associated with the processing of renewals in the centralised procedure to provide procedural guidance to marketing-authorisation holders. It has been developed by the Committee for Medicinal Products for Human Use following consultation of interested parties and European Commission services.

English (EN) (334.54 KB - PDF)