Module232025

07/05/2025

Article 29

Marketing authorisation procedures

• Article 29 • Existing MAs can be amended by variation for: • New indications (including paediatric indications)

• New pharmaceutical forms • New routes of administration

Use the variation framework to update SmPCs with emerging paediatric data

The Organisation for Professionals in Regulatory Affairs

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Articles 30 & 31

Paediatric Use Marketing Authorisation (PUMA)

• Article 30 sets out the legal framework for PUMAs • These are effectively “voluntary” PIPs • PIP process is the same as for mandatory PIPs • Tick a different box, but provide all the same information

• Aim is to encourage repurposing of off-patent drugs for paediatric use

• Industry response has been unenthusiastic (at best)

The Organisation for Professionals in Regulatory Affairs

30