Definition

In the EU, a minor variation that does not require prior approval. Notified to the authority and deemed approved if no objection within a short period (e.g. 30 days).

Example

Typographical corrections, change of contact details, or certain stability protocol updates may be Type IA.

Regulatory source

Commission Regulation (EC) 1234/2008

Common mistakes

Incorrectly classifying a change as Type IA when it is Type IB or II, leading to non-compliant implementation.

Inspector question

How do you classify variations and ensure correct procedure and timing?

Related terms