Definition

In the EU, a moderate variation that requires approval but follows a simplified procedure. Implemented only after approval (or after 30 days if no objection in some cases).

Example

Change of manufacturing site for part of the process, or certain specification changes, may be Type IB.

Regulatory source

Commission Regulation (EC) 1234/2008

Common mistakes

Implementing before approval. Not grouping variations correctly (e.g. worksharing).

Inspector question

Show the variation register and how you ensure implementation only after approval.

Related terms