01.08.2012

EMA updates Post-authorisation procedural advice and CHMP dossier requirements

The European Medicines Agency (EMA) has released another update of the "Post-Authorisation Procedural Advice" for users of the EU Centralized Procedure. The new revision 24, dated July 2012 contains one update regarding question 4.1 clarifying when a variation application will be considered as a Type II variation or an Extension application. The following examples have been included in the answer to question 4.1 in the new revision as examples for changes that should be submitted as variations:

Addition or replacement of a presentation for a solution for injection with a different immediate container (e.g. vial, syringe, pre-filled pen, cartridge, ampoule…)
Addition or replacement of a presentation for an eye drops solution with a different immediate container.

In addition, reference is made to the Guideline on the categorisation of New Applications (NA) versus Variations Applications (V), January 2002.

A further update concerns the Dossier requirements for Members of the Committee for medicinal products for human use (CHMP). The new version, dated 20 July 2012 includes some updates in the addresses of the current CHMP members for Cyprus, Czech Republic (alternate member only), Estonia, Iceland (representative member), Lithuania (representative member), and Slovenia. There are no changes regarding the dossier requirements themselves.

[Source: EMA]

Links:

www.emea.europa.eu

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