Revised Guideline on Renewals in the Centralised Procedure Effective!

Generally, a marketing authorisation is valid for five years. If the marketing authorisation holder (MAH) doesn't submit the renewal application, the marketing authorisation will expire. How renewals in the centralised procedure should be processed is described in the "Guideline on the processing of renewals in the centralised procedure". The document describes a 120-day timetable presenting the respective actions at specific times which the applicant must observe. Moreover, the Guideline provides detailed information on the documents to be submitted.

Against the background of the requirements of the Variations Regulation valid since 2010 and the new provisions from the pharmacovigilance package, a revision of the original guideline dating back to 2005 had been long overdue. On 2 July 2012, the EMA (European Medicines Agency) published the 4th revision of this Guideline. The changes made are significant for marketing authorisation holders - information to be included in a renewal application is much more extensive. In the following, a few examples of documents which the applicant has to submit according to the new Guideline:   

  • Specimens of all products marketed for each strength, pharmaceutical form and container type (not just a "worst-case" specimen with multi-lingual texts). EMA will perform a complete examination of all marketed product presentations.
  • Extensive data on the benefit / risk balance and critical assessment. The applicant must consider the Good Vigilance Practice Module on PSURs.
  • Where available: a summary description of the pharmacovigilance system and the risk management plan. These are requirements of the new pharmacovigilance legislation which haven't been implemented in all companies yet because of the topicality.

Interestingly: since 2005, a so-called "QP Declaration" - according to which active substances which have been manufactured in accordance with the detailed guidelines on good manufacturing practice - must be provided by the Qualified Person of the drug manufacturer and be included in the application dossier. In the previous Guideline, blood and blood products were exempted from this requirement. In the current guideline this exemption doesn't exist any more, so a QP Declaration for APIs from blood products must be submitted too.

The new guideline also includes changes in the timetable: First of all, the application for a marketing authorisation renewal must be submitted at least nine months before its expiry - and not 6 months before like it was previously. It means that the applicant must provide answers to the list of outstanding issues by EMA's CHMP already on Day 91 (instead of Day 100).

For further information please see the new Guideline on the processing of renewals in the centralised procedure.

Note: At the conference "Marketing Authorisation Procedures in the EU and the US" taking place in Munich, Germany, from 16 - 19 November 2012 you will get first-hand information about the marketing authorisation and renewal procedures for medicinal products.

Dr Gerhard Becker
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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