Type IA variation: minor change notified after implementation
A 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 IA changes are defined in Commission Regulation (EC) No 1234/2008 and listed in the Commission's classification guidelines, and every condition and documentation requirement of the relevant category must be met. Some are Type IAIN, which must be notified immediately after implementation; others can be collected into an annual update.
What goes wrong: claiming Type IA when one condition is not met, which makes the notification unacceptable and can mean the change was implemented without a valid basis; missing supporting documents; and holding back IAIN changes for the annual update.
Timing
Type IA changes are notified within 12 months of implementation and Type IAIN changes immediately after. The authority reviews the notification within 30 days. If it is not accepted, the marketing authorisation holder must stop applying the change straight away.
Used in
Before filing, check a change against the classification guidelines in Workbench, which answers with cited sources.
Related terms
- 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.
- Type IAIN variation: minor change notified immediately after implementationA Type IAIN variation is a minor change the holder may implement first but must notify to the authority immediately afterwards, not in an annual update.
- 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.
Last updated