Extension of the Variations Regulation to Purely National Authorisations coming: new Consultation Paper published by the EU Commission

The Variations Regulation (EC) No 1234/2008 contains rules on the handling of variations in authorisations of medicinal products for human and veterinary use. Purely national authorisations haven't been included within the scope of this Regulation until now. In order to extend the new regulation for variations in medicinal products to national authorisations, a so-called implementing regulation is necessary.  In the run-up to this Regulation, the European Commission has published a document entitled "Public Consultation Paper on the extension of Regulation (EC) 1234/2008 to the handling of variations to purely national marketing authorisations". In total 9 key questions are formulated in the consultation paper to adapt the implementing regulation to the needs of the industry. Companies, organisations or individuals who would like to submit their opinion should orientate themselves on these questions which deal with following topics:

  • Detailed description of procedures for variations to purely national authorisations
  • Adjustment of some of the procedures with a view to focus resources of the authorities on variations with the most impact on public health
  • Difficulties in reviewing and pocessing complex grouping applications
  • Particular procedures for the authorisation of human influenza vaccines in a pandemic setting

The deadline for public consultation is 22 October 2011.

For further details please also see the consultation paper of the European Commission


Note: During the ECA Education Course "Handling Changes and Variations

" in Vienna, Austria, on 15/16 March, you will receive first-hand information about the European Variations Regulation.

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

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