Definition

Phase of the product lifecycle after approval. Includes post-marketing surveillance, PSURs, RMP updates, variations, and compliance with conditions of the marketing authorisation.

Example

After approval, the MAH must fulfil post-marketing commitments, report adverse events, and submit variations for changes.

Regulatory source

GVP, 21 CFR 314.80, Directive 2001/83/EC

Common mistakes

Treating approval as the end of regulatory obligations. Missing commitments or variation deadlines.

Inspector question

What post-marketing commitments do you have and how do you track and complete them?

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