Module232025

07/05/2025

Article 32

Identification

The concept was to clearly identify medicines with paediatric indications

Forget all about it – it never happened

The Organisation for Professionals in Regulatory Affairs

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Article 33

Post-authorisation requirements

Adult MA

Paediatric indication based on PIP

Obligation to market for paediatric indication within 2 years

Appears logical at first… …but there is nothing compelling you to request the paediatric indication

The Organisation for Professionals in Regulatory Affairs

32