CRED ERP 25

01/07/2025

Example – Legal basis (1/2)

• Submission of a fixed combination medicinal product (FCMP): Article 10b • Dossier is only composed of references to published scientific literature; • Check Guideline on clinical development of fixed combination medicinal products - Revision 2 for requirements • 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;

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The Organisation for Professionals in Regulatory Affairs

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Example – Legal basis (2/2)

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• 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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