CRED 8 Presentations

01/07/2024

• Submission of a fixed dose combination (FDC): Article 10b • Dossier is only composed of references to published scientific literature; • Legal basis article 10b is not appropriate ( see section 5.5 of chapter 1 NtA volume 2A ); • Legal basis article 10a might be possible if all requirements for 10a application are fulfilled; …… Example – Legal basis (1/2)

The Organisation for Professionals in Regulatory Affairs

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Example – Legal basis (2/2)

……. • However: not possible to change the legal basis after the start of the procedure!

 Always carefully check if dossier fits with legal basis chosen

The Organisation for Professionals in Regulatory Affairs

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