EU Consultation on Variation Guideline 2012

The Variations Guideline which came into force in January 2010 is currently under review with respect to the variation categories and their content.  Contributions to this review are invited from all stakeholders dealing with medicines for human and/or veterinary use.

The review takes into account scientific and technical progress and the recommendations delivered in accordance with Article 5 of the Variations Regulation. In addition, particular attention is given to the updates required as a result of the implementation of the new Pharmacovigilance legislation, anticipated to be enforced by July 2012. Some of the key suggested changes include:

  • Amendments to the administrative section to facilitate ease in deletion of manufacturing sites of differing responsibility levels along the supply chain.
  • Amendments to the quality section, including addition of categories to facilitate ASMF updates, changes to the supply chain for the active ingredient, and where a Ph. Eur. CEP is not available, it is proposed that changes to sections such as the stability protocol can be done as Type IA variations.
  • For SmPC amendments, the variation category will be updated to include Articles 29, 30, 31, 34, 35, 107g, 107k or 107q of various EC directives.
  • Introduction of new categories, namely for post-approval change management and changes in PSUR submission frequency.
  • The variation categories have also been re-formatted to include more criteria per category, thus easing the selection of variation type.

Overall, the proposed changes should provide clearer guidance and make the selection of the appropriate variation category simpler.

The consultation period ends on the 15th July 2012, after which the revised guideline will be finalised and published.