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

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

Draft: consultation closed Consultation dates: 28/07/2015 to 14/09/2015 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.

Overview of comments received on ‘Guideline on the processing of renewals in the centralised procedure

Reference Number: EMA/723788/2015

Guideline on the processing of renewals in the centralised procedure

Adopted Reference Number: EMEA/CHMP/2990/00 rev. 4 Legal effective date: 02/07/2012

Overview of comments received on 'guideline for the processing of renewals in the centralised procedure'

Reference Number: EMA/257975/2012

Overview of external comments received, and European Medicines Agency / Committee for Medicinal Products for Human Use feedback / action on each comment on guideline on the processing of renewals in the centralised proced...

Reference Number: EMEA/CHMP/2990/00 rev. 3 Legal effective date: 20/11/2005

Reflection paper criteria for requiring one additional five-year renewal for centrally authorised medicinal products

Adopted Reference Number: EMEA/131973/2006 Legal effective date: 01/12/2007

Overview of comments received on draft guideline on criteria for requiring one additional five-year renewal for centrally authorised medicinal products (EMEA/131973/2006)

Reference Number: EMEA/29922/2008

• Questions and answers: Renewals
• Application form and guidance