Module232025

07/05/2025

Article 24

Compliance with the PIP

A bit odd This can only happen if committee assessing the MAA disagrees with PDCO’s opinion on PIP compliance

The Organisation for Professionals in Regulatory Affairs

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Article 25

Procedure

• At the end of the procedure: • PDCO has 10 days to inform the applicant of its opinion

• Applicant can request re-examination within a further 30 days • PDCO appoints a new Rapporteur and issues a new opinion within 30 days • EMA converts the definitive PDCO opinion to a Decision within 10 days • The EMA Decisions are made public

The Organisation for Professionals in Regulatory Affairs

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