Please note: In October and November 2010, the MHRA moved from its Market Towers address to a new location on Buckingham Palace Road. Please go to the contact us section of the website for updated contact details.
We 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 written comments received in response to this consultation are below.
Download documents:
-
Summary of written comments in response to the MHRA’s consultation on the European Commission’s proposal to amend Directive 2001/83/EC (69Kb)
-
04 - Revised variations regulation - 10 June 2008 (75Kb)
-
02 - Impact Assessment of the European Commission’s proposal to harmonise the handling of variations to national licences (1197Kb)
-
01 - Public consultation (MLX352): The European Commission’s proposal to harmonise the handling of variations to national licences (124Kb)
-
03 - Commission Regulations: The European Commission’s proposal to harmonise the handling of variations to national licences (171Kb)
