Type IB variation: minor change notified before implementation
A 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 IB is also the default category: under Commission Regulation (EC) No 1234/2008, a change not classified elsewhere is treated as Type IB unless a classification recommendation under Article 5 says otherwise. Many labelling changes fall here, such as aligning a generic's product information with its reference product.
Common problems: implementing before the 30 days have passed, filing without explaining why the change is not Type II, and supporting data so thin that the authority asks for the change to be resubmitted as a Type II variation.
Timing
After a valid Type IB notification the authority has 30 days to respond. If it raises no objection in that time, the change is deemed accepted and can be implemented. If it objects, the holder can amend the notification within 30 days; otherwise the variation is rejected.
Used in
Regulatory teams plan variations and renewals across the portfolio in the lifecycle planning workflow.
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 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.
- 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.
- 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.
Last updated