Module232025

07/05/2025

Article 26

Miscellaneous provisions

Scientific advice on paediatric development is free

The Organisation for Professionals in Regulatory Affairs

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Articles 27 & 28

Marketing authorisation procedures

• Article 27 • MAA procedures per Reg (EC) 726/2004 & Directive 2001/83/EC apply • Article 28 • MAAs including paediatric indication(s) according to a PIP can access the centralised procedure • Results of paediatric studies are to be included in SmPCs / PILs even if not all paediatric indications were approved • Waivers and deferrals are to be recorded in SmPCs / PILs • SmPCs are to include a statement that SmPCs resulted from data generated in compliance with an agreed PIP

The Organisation for Professionals in Regulatory Affairs

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