Variations & Amendments

An evaluation of how a proposed change affects quality, validation, supply, labeling, and regulatory filings, informing change control decisions.

Submitting multiple variations together as one package when allowed, to support consistent assessment and implementation planning.

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).

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).