Module232025

07/05/2025

Case study – When is a compliance check needed?

PIP approved in 2024 You plan a variation application for a new combination therapy (a labelling update with adult trial data) Indication not mentioned in PIP decision, but covered by overall condition Variation submission (VAA) planned for June 2026 EMA Procedure Manager recommends postponing VAA until August 10 (next submission date), for alignment with VAA of another, closely related product A trial in the PIP has the completion date: By July 2026 (LPLV 31 July 2026)

The Organisation for Professionals in Regulatory Affairs

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Case study

Do you need a compliance check now?

If yes, why?

If no, why?

What would you do?

The Organisation for Professionals in Regulatory Affairs

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