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Public consultation (MLX352): The European Commission’s proposal to harmonise the handling of variations to national licences

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Document details:

Type: Publication
Series No: none
Audience: All
Published: 1 July 2008
Format: Electronic and paper
Size: A4
Pages: 9
Price: Free
ISBN/ISSN: n/a
Author: MHRA
Copyright: Crown
   

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MHRA pages:

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We have published a public consultation and Impact Assessment on the European Commission's proposed amendments to Directive 2001/83/EC.  This will pave the way for future proposals to extend the Variations Regulation to cover variations to purely national marketing authorisations.

The closing date for responses is 17 september 2008

› Online response form for MLX 352

Page last modified: 02 July 2008