Variations

Variations to the Terms of a Marketing Authorisation

Information for applicants on the process and requirements for notification and approval of changes to the terms of a marketing authorisation.

After a medicine has been authorised, the terms of the marketing authorisation may subsequently be varied. The procedures around such variations are governed and harmonised throughout the EU by Commission Regulation (EC) No 1234/2008 of 24 of November 2008 (“the Variations Regulation”) which has subsequently been amended by Regulation (EU) 712/2012.

Regulation (EU) 712/2012, which came into force on 4th August 2013, extends the scope of the Variations Regulation to all marketing authorisations, human and veterinary, whether granted through national, mutual recognition, decentralised or centralised procedures. 

Detailed procedural guidance on the classification, submission and processing of variations has been published by the European Commission and is available on the link below.

Additional guidance in respect of variations for products authorised through the mutual recognition or decentralised procedures has been published by the Co-ordination group for Mutual Recognition and Decentralised Procedures – Human (CMDh) and is available on the link below. Applicants may wish to pay particular attention to the following CMDh documents:

- EC Guidelines
- Best Practice Guides for Submission and Processing of Variations
- Examples of acceptable and not acceptable groupings
- Questions & Answers on variations
- Recommendations for classification of unforeseen variations (“Article 5” referrals)
Application for Variation to a Marketing Authorisation PDF  (Version in word)

In relation to variations for products authorised on a purely national basis, HPRA applies the same principles as those set out by CMDh in their guidance documents.

Variation Worksharing Procedures

Regulation (EU) 712/2012 extends the possibility of worksharing procedures to all marketing authorisations, including those authorised on a purely national basis.

The HPRA would like to highlight its willingness to act as reference authority for variation worksharing procedures, especially those involving purely national products. Experienced assessment resources and capacity are available in both the quality and clinical assessment areas, to participate in these worksharing procedures. Interested parties are invited to approach HPRA with details of expected future worksharing applications including the scope and nature of the proposed changes, the number of products, and the Member States that would be involved. Information should also be provided on the anticipated timeline for the submission of the variations. 

Proposals or requests for further information can be addressed to worksharing@hpra.ie.