The principle of Super-grouped and Workshare Variations is to make an “identical change(s)” to a number of difference licences via 1 Application form, 1 submission, & 1 Authority assessment.
The aim being that it makes it easier to harmonise National MA dossiers across different EU Member States. Also to avoid duplication of work by national authorities in assessing the variation(s). Advantages to both sides.
Sounds simple right? But there are many considerations that can end up making the preparation of these submissions quite complex to manage. Therefore, we have provided the below guide.
These types of grouped variation submissions can be used if the same change(s) is being made to more than one licence from the same MAH (or MAH group), i.e. same parent company.
Super-grouped variations
Super-grouped variations, appliable only to Type IA and Type IAIN variations, previously in Article 7a of Commission Regulation (EC) No 1234/2008, were only applicable to MR/DCP procedures, as guided by CMDh – Chapter 6 Best Practice Guide on Super-grouping. The amended Variations Regulation (EU) 2024/1701 implemented on 1 January 2025 means that National Marketing Authorisations can now also utilise this method of grouping.
Workshare variations
Workshare variations were previously optional, but as of 1 January 2025 in accordance with Article 20 of the amended Variations Regulation (EU) 2024/1701, Workshare variations have now become mandatory for Type IB and Type II variations.
The duplication of work across many authorities, is avoided by the Applicant choosing a “reference authority” Reference Member State (RMS) to lead the evaluation on behalf of the other impacted authorities. Although if the submission includes a Centrally Authorised Product (CAP), then this “reference authority” is always the EMA.
Challenges/Top tips:
- The latest Variation Form new tick box for the following declaration, appears for only Type IB and Type II Workshare variations “The applicant confirms that the same variation (or group of variations) does not apply to any other marketing authorisation held by the same holder (only applicable for Type IB and/or Type II variations)”. Companies may have a team dedicated to managing MR/DCP procedures. But with this new change to ensure mandatory Worksharing, these personnel now need to align with colleagues managing National licences, to check if the same change also applies to their National licences. If so then these National licences also must be included in the Workshare. This can be extra workload for those personnel.
- Including multiple MR/DCP procedures in a single Super-grouping or Workshare means that coordination of sequential procedure numbers is important. If there are other submissions going on with an MR/DCP, it may impact the procedure number that is included in the Variation Form and the eCTD tracking sheet. Make sure you discuss with other colleagues and agree order or submissions and the corresponding procedure numbers to avoid last minute changes.
If you would like to discuss how Fusion Pharma can support you with Variations, please email us at hello@fusion-pharma-limited.com or phone us on +44 (0) 203 1379 799.
While the information in this article is considered to be true and correct at the date of publication, changes in guidance and/or experience may impact on the accuracy of the information. Please refer to the relevant guidance for the latest information.
