Spring Intro 2023

16/02/2023

Legislation scope

• Exempt • Products for which the MAA legal basis will be: • Article 10 (abridged) • Article 10a (well-established use / bibliographic) • Articles 13-16 (herbals) • Articles 16a-16i (homeopathic)

X

• Products covered by a class waiver

The Organisation for Professionals in Regulatory Affairs

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What is a PIP?

A plan for an R&D programme investigating possible value to the paediatric population Specifies what will be studied, by what means and when Should be submitted before phase II clinical trials

Reviewed and approved by EMA’s Paediatric Committee (PDCO)

Waivers are available if paediatric studies are not appropriate Paediatric work may be deferred in some circumstances

The Organisation for Professionals in Regulatory Affairs

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