Grouping of variations: several changes in one submission
Grouping of variations is the filing of several changes to one or more marketing authorisations in one submission under Article 7 of Regulation 1234/2008.
Article 7 of Commission Regulation (EC) No 1234/2008 allows a holder to group changes instead of filing each one separately. Several Type IA changes to the same authorisation can always be notified together. Changes of different types can be grouped where they are listed in Annex III of the Regulation, for example a change with its consequential changes, or where the authority agrees to the group in advance. Since the January 2025 revision of the Regulation, a single notification can also cover the same Type IA changes across several authorisations of the same holder, often called super-grouping, and a Type IA annual update can collect a year's minor changes in one submission.
A grouped submission is handled as one procedure and assessed under the rules of the highest category it contains. A group that includes a Type II change therefore follows the Type II timetable, and a group of Type IB changes follows the Type IB one. The authority receives one cover letter, one application form listing every change, and supporting documentation that makes clear which documents belong to which change.
What goes wrong: grouping changes that are unrelated and not in Annex III without asking first, which leads to the group being refused at validation; mixing changes for which the conditions of a Type IA category are not met with ones that are, so the whole notification is questioned; and not anticipating that a single objection to one change in a group with Type IB or Type II changes can delay the implementation of all of them. Supporting documents filed as one undifferentiated block also slow validation.
Grouping pays off most for manufacturing changes that arrive together, for example a new site with its new batch size and test methods, and for aligning product information across strengths and forms of the same product. Worksharing is the related tool for the same change across different holders' procedures or different Member States, and the two can be combined.
Under the new pharma package (not yet in force), the conditions under which one application may cover several changes will be set in Commission delegated acts rather than in the current Regulation; see variations changes.
Timing
A group of Type IA changes is notified within 12 months of implementation, or immediately for Type IAIN changes, and reviewed within 30 days. A group containing Type IB changes follows the 30-day Type IB timetable, and a group containing Type II changes follows the 60-day Type II timetable, extendable to 90 days or shortened to 30 for urgent safety issues. Annual Type IA updates collect changes implemented over the preceding year in one notification.
Used in
Before preparing a submission, check whether a set of changes can be grouped and which category the group falls into in Workbench, which answers with cited sources.
Related terms
- Type IA variation: minor change notified after implementationA Type IA variation is a minor change with minimal or no impact on quality, safety or efficacy, which can be implemented before the authority is notified.
- Type IB variation: minor change notified before implementationA Type IB variation is a minor change that is neither Type IA nor Type II and must be notified to the authority before it is implemented.
- Type II variation: major change requiring prior approvalA Type II variation is a major change that may significantly affect a medicine's quality, safety or efficacy and needs approval before implementation.
- Worksharing: one assessment of a variation across several authorisationsWorksharing lets one authority assess the same Type IB or Type II variation for several marketing authorisations of the same holder in a single procedure.
- Classification guideline: Commission guideline on variation categoriesThe classification guideline is the Commission's list of variation changes, with the conditions and documents that make each one Type IA, IB or II.
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