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The current European variations Regulation came into force on 1 January 2010 and replaced Regulations 1084/2003/EC and 1085/2003/EC. Commission Regulation 1234/2008 (external link) originally only concerned variations handled in Mutual Recognition/Decentralised and Centralised Procedures. The UK also applied the same procedures to variations to purely national Marketing Authorisations from 1 January 2010. This was done through the UK fees legislation and accompanying guidance dated 30 November 2009 (UK national MA variations guidance (72Kb)).
However, Commission Regulation 1234/2008 (external link) has been recently updated by Commission Regulation 712/2012 (external link) and will introduce a number of changes. One of the main changes concerns the inclusion of a new chapter specifically to cover variations to purely national marketing authorisations. These changes become effective on 4 August 2013 and from this point onwards, the basis for processing variations to purely national Marketing Authorisations in the UK will be Commission Regulation 1234/2008 as amended. The separate UK guidance will therefore not apply to variations to the relevant Marketing Authorisations submitted on or after 4 August and the necessary changes have already been reflected in the updated UK fees legislation. The other key change is the extension of the worksharing procedure to also include purely national Marketing Authorisations (see additional detailed guidance).
The accompanying variation classification guideline on which the variations system operates has also been updated to reflect adaptation to technical progress, changes introduced in the basic legislation, and the experience acquired to date. This will replace existing guidance. The procedural and classification guidelines were originally separate documents, but they have now been combined and will apply to any variation submitted on or after 4 August to coincide with the updated Regulation.
It is therefore important that any individuals involved in the preparation of variation submissions familiarise themselves with the updated guidance and immediately take it into consideration for any new submissions made on or after 4 August 2013.
For further up to date guidance, please refer to the following external links:-
In particular the following documents:-
- Best Practice Guides
- Examples of acceptable and not acceptable groupings
- Explanatory notes on Variation Application Form
- Questions and answers on variations
- Published Article 5 recommendations
Notice to Applicants (Volume 2)
In particular the following documents:-
- Procedural and classification guidelines (also see below)
- Application form
- Categorisation of New Applications versus Variation Applications
In addition, where relevant, please also refer to additional guidance on this section of the MHRA website, in particular the FAQs, grouping and worksharing and experiences with variations sections.
The MHRA has revised its procedures for processing applications to vary marketing authorisations in line with the updated European legislation. However, in view of the fact that we have already been applying this on a voluntary basis since 1 January 2010, the impact of the changes for applicants will be minimal in terms of procedures.
The MHRA has operated an appeal procedure for refused national Type II variations that went to Committee since 2003. However, this procedure has not been used in practice and there has been no appeal procedure available for European variations since 2010. In view of the fact that national variations are now fully processed in line with European legislation, which does not include the possibility for appeal, we are currently reviewing this with a view of removing this option and will provide an update in due course.
Guidance on appeal procedures for refused national Type II variations can be found below:
In April 2012, following consultation with medicines trade associations and member companies we announced some procedural changes concerning the requirement to submit full-colour mock-ups of labels and patient leaflets. These can be found below:
The variations application form can be downloaded from the link below:
Variations application form (external link)
Guidance on the various categories of variations
The Guideline on Dossier Requirements for Type IA and IB notifications has been updated and can be found on the European Commission website on 16 May 2013 at European Commission public health – news and hot topics (external link)
Fees payable from 1 April 2013
The table on the page below provides the details of the fees payable for variation applications:
Contact for further information
For further information on variations, please contact our Variations Section, 5.Y, 151 Buckingham Palace Road, London SW1W 9SZ, telephone 020 3080 7400, email@example.com