Definition

A change to a marketing authorisation after approval. In the EU, classified as Type IA, IB, or II with different procedures and timelines.

Example

Changing a manufacturer, updating the SmPC for a new safety finding, or adding a pack size all require a variation.

Regulatory source

Commission Regulation (EC) 1234/2008

Common mistakes

Implementing the change before variation approval when required. Wrong classification leading to compliance issues.

Inspector question

How do you maintain the variation register and ensure implementation dates align with approvals?

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