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.
MLX 361 seeks your views on proposals to amend the current UK fees legislation (SI 2009/389) relating to variations to marketing authorisations (MAs) to include new fees for MA variations.
This is in order to comply with the new EC Regulation No. 1234/2008 ‘Concerning the Examination of Variations to the Terms of Marketing Authorisations for Medicinal Products for Human Use and Veterinary Medicinal Products’ (external link).
We would also like to draw your attention to Directive 2009/53/EC
Directive 2009/53/EC, amending Directive 2001/82/EC and Directive 2001/83/EC as regards variations to the terms of marketing authorisations for medicinal products was published in the Official Journal of the European Community on 30 June 2009.
It includes a provision that permits Member States if they so wish to exempt from application of EU variations provisions those national marketing authorisations granted before 1 January 1998, unless a marketing authorisation for that product is subsequently granted in another Member State, when EU rules shall apply from the date of the granting of the subsequent marketing authorisation.
The MHRA does not intend to avail itself of this derogation on behalf of the UK, which will mean that the EU variation procedures that will come into force on 1 January 2010 will apply to all medicines with a valid UK marketing authorisation.
Any comments on these proposals should be sent to the address below by 29 September 2009:
Tracy Murray
16th Floor
Market Towers
1 Nine Elms Lane
London
SW8 5NQ
Email: tracy.murray@mhra.gsi.gov.uk
Please use the subject reference ‘Directive 2009/53/EC’.
Alternatively, comments can be included as part of the response to our current consultation letter:
