Classification guideline: Commission guideline on variation categories
The classification guideline is the Commission's list of variation changes, with the conditions and documents that make each one Type IA, IB or II.
Article 4(1)(a) of Commission Regulation (EC) No 1234/2008 requires the Commission to publish guidelines on the details of the various categories of variations. The current text was first published as Commission Guideline 2013/C 223/01 and has been amended since, most recently in step with the revision of the Variations Regulation that applies from 1 January 2025. It is organised in four annexes: A for administrative changes such as the holder's name or a manufacturer's address, B for quality changes to the active substance and finished product, C for safety, efficacy and pharmacovigilance changes, and D for plasma master files and vaccine antigen master files.
Each line in the guideline names a change, sets the category and lists the conditions that must all be met and the documents that must all be supplied. Meeting every condition is what makes a change Type IA or Type IAIN; failing one usually moves it to Type IB, and the guideline often says when a change is Type II instead. A change that appears nowhere in the guideline defaults to Type IB under Article 5 of the Regulation, unless the holder asks for a classification recommendation before filing. Many entries also point to related changes that must be submitted together, which is where grouping comes in.
What goes wrong: teams read the change title and skip the conditions, then file a Type IA that is rejected because one condition is not met, with the change already implemented; they rely on an outdated copy of the guideline after an amendment; they confuse a change to the finished product manufacturing site with the same change for the active substance, which sits in a different part of Annex B; and they miss the documentation line that asks for an updated SmPC section or a declaration from the qualified person. A rejected notification means the change was never validly made, which matters for batches already released.
Under the new pharma package (not yet in force), the categories themselves move to Commission delegated acts, which will set risk-based categories and the rules for database updates; the Commission has published no draft yet, so today's guideline remains the reference until then; see variations changes.
Used in
Before filing, look up the conditions and documents for a change in the classification guideline in Workbench, which cites the line it relies on.
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.
- Article 5 recommendation: classification request under the Variations RegulationAn Article 5 recommendation is a formal classification ruling from the CMDh or EMA on a change that the variation classification guideline does not cover.
- Grouping of variations: several changes in one submissionGrouping of variations is the filing of several changes to one or more marketing authorisations in one submission under Article 7 of Regulation 1234/2008.
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