Revision of the European Variations System: EU Commission publishes the Outcome of the Public Consultation

The Variations Regulation (EG) No. 1234/2008 came into effect on 1 January 2010. Since that date, it has been binding for all Member States. Article 2 of this regulation provides that its scope should be extended in form of an implementing regulation to purely national authorisations. In preparing the regulation, the European Commission published a "Consultation Paper" entitled "Review of the Variations Regulation" at the end of September 2011. We reported about this paper in our News from 5 October 2011. The feedback authorities, industries and associations provided on the consultation paper has been processed and published by the Commission on its website.

In total, 43 comments were received. The Commission organised them into the following categories:

  • Extension of the scope of the Variations Regulation to purely national marketing authorisations
  • Adaptation of procedures for centrally authorised products
  • Mandatory date for implementation of changes in the product information
  • Extension of the time limits for assessment of complex grouped applications
  • Authorisation procedure for pandemic vaccines

Regarding the first point, all stakeholders support the extension of the scope of the Variations Regulation to purely national marketing authorisations. The purely national authorisation procedures should be similar to those already established in the regulation. Nevertheless, a majority of the comments indicated that - regarding the specific questions on worksharing - where dossiers are not harmonized, difficulties could arise to accept assessments carried out by other Member States. However, this should not prevent the application of worksharing procedures for variations to purely national marketing authorisations. The support of a pre-harmonisation of the application has also been rejected.

Read more about the summarised categories of feedback in the EU Commission document "Review of the Variations Regulations: Outcome of the Public Consultation".

Each comment to the concept paper can be read on the "Public Health" page of the EU Commission.

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

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