Module232025

07/05/2025

Other implications of Global Marketing Authorisation for the PIP

Remember to submit annual deferral reports for agreed article 8 PIPs A reward for a PIP can only be given once for any medicinal product. Article 45 and 46 of the Paediatric Regulation: Marketing-authorisation holders must submit results of studieson authorisedmedicines conducted in children to EMA or to EU national competent authorities.

The Organisation for Professionals in Regulatory Affairs

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Agenda

 GMA and implications for PIP Procedures  Scope of PIP  PIP approval  PIP opinion  PIP modification, Stepwise PIP  Compliance check  Paediatric scientific advice  PDCO PIP assessment, recurring issues

The Organisation for Professionals in Regulatory Affairs

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