Variations

Following the granting of a marketing authorisation, the Marketing Authorisation Holder (MAH) is obliged to keep the regulatory authority up to date with changes to their product.

They do this by applying to vary their marketing authorisation.

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

Useful links

• 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

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.

Interested parties are invited to contact the HPRA by emailing worksharing@hpra.ie with the completed letter of intent form and details of planned 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.