CRED 8 Presentations

01/07/2024

 Paediatric Regulation

Reg. (EC) No 1901/2006

NB: revision of Paediatric regulation ongoing

The Organisation for Professionals in Regulatory Affairs 43

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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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The Organisation for Professionals in Regulatory Affairs

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