Revision of the Guidelines on Category Variations to the terms of Marketing Authorisations- EU Commission releases Public Consultation Paper

The Regulation of the European Commission (EC) No 1234/2008 is in force since the beginning of 2010. It determines the categorisation and the variations to the terms of marketing authorisations and for medical products for human use and veterinary medicinal products. More information about the categories of variations can be found in the "Guidelines on the details of the various categories of variations for medical products for human use and veterinary medicinal products" (2010/C 17/01). Article 4 (2) of the Regulation lays down that these detailed guidelines should take into account scientific and technical progress and be regularly updated.

Against the background of this provision and the fact that the new Pharmacovigilance legislation - which will enter into force in July 2012 - also requires the update of the guidelines, the Health and Consumers Directorate-General of the EU Commission published on 14 June 2012 a revised version of the "detailed guidelines" for comment.

The revised document contains numerous changes and is far more differentiated than the former version regarding the variations scenarios and presents additional categories: see the following example taken from the section B on "Quality Changes" in the manufacture of an API. In the event of "Change in the manufacture of a starting material/reagent/intermediate used in the manufacturing process of the active substance or change in the manufacturer (including where relevant quality control testing sites) of the active substance, where no Ph. Eur. Certificate of Suitability is part of the approved dossier", 5 new variation categories have been added: 

  • Introduction of a new manufacturer of the active substance that is not supported by an ASMF and requires significant update to the relevant active substance section of the dossier - variation type: II
  • Addition of an alternative sterilisation site for the active substance using a Ph.Eur. method - variation type: IB
  • Introduction of a new site of micronisation - variation type: IA
  • Changes to quality control testing arrangements for a biological active substance-replacement or addition of a site where batch control/testing including a biological / immunological / immunochemical methods takes place - variation type: II
  • New storage site of Master Cell Bank and/or Working Cell Banks - variation type: IB

Furthermore, section C "Safety, Efficacy, Pharmacovigilance Changes" has been significantly extended according to the provisions of the pharmacovigilance activities.

The 4-week deadline for public consultation ends on 15 July 2012.

You will find further information in the draft of the "Public Consultation Paper Review of the Variations Guidelines".

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

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