Variations to licences

What's new

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 guidancePDF file (opens in new window) (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.

Specific guidance

For further up to date guidance, please refer to the following external links:-

Heads of Medicines Agency (CMDh)

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

European Commission (Eudralex)

Notice to Applicants (Volume 2)

In particular the following documents:-

  • Procedural and classification guidelines (also see below)
  • Application form

Extension applications

  • 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.


MHRA procedures

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.

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:

Procedural changes concerning the requirement to submit full-colour mock-ups of labels and patient leafletsPDF file (opens in new window) (1020Kb)


Application form

The variations application form can be downloaded from the link below:

Variations application form (external link)


Guidance on the various categories of variations

Current guidance can be found in the guidelines on the details of the various categories of variations, on the operation of the procedures laid down in Chapters II, IIa, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products and on the documentation to be submitted pursuant to those procedures can be found in Chapter 5 of Eudralex (Volume 2A) (external link)


Fees payable from 1 April 2013

The table on the page below provides the details of the fees payable for variation applications:

Fees for licence variations 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, variationqueries@mhra.gsi.gov.uk


Page last modified: 08 April 2014