Definition

In the EU, a major variation that requires full assessment and approval before implementation. Includes significant CMC, indication, or safety-related changes.

Example

New strength, new therapeutic indication, or significant change in manufacturing process are typically Type II.

Regulatory source

Commission Regulation (EC) 1234/2008

Common mistakes

Implementing a Type II change before approval. Underestimating data requirements and review time.

Inspector question

Describe your change control process and how it links to variation classification and submission.

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