CRED ERP 25

01/07/2025

⚫ Paediatric Regulation

Reg. (EC) No 1901/2006

NB: amended in 2019 via REGULATION (EU) 2019/5 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 December 2018

The Organisation for Professionals in Regulatory Affairs 45

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EU Paediatric Regulation

⚫ EU Regulation 1901/2006 , as amended

⚫ Three groups of medicinal products:

⚫ - Products in development/ not yet authorised in the Community ( Art. 7 )

⚫ - Authorised products still covered by patents ( Art. 8 )

- Authorised products no longer covered by patents ( PUMA )

⚫ Articles 7 and 8 do not apply to applications based on

⚫ - Article 10 of Directive 2001/83 (generics, hybrids, WEU, biosimilars)

⚫ - Article 13 and 16 – homeopathic medicinal products

⚫ - Article 16a to 16i – traditional herbal medicinal products

NB: but Article 46 does apply!

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