CRED 8 Presentations

01/07/2024

CMDh Q&A 4 on generics (3/3)

• In the context of this Q&A and in line with the information published at the NtA, the clinical studies that may be referred to should be those that resulted in new clinical data and with predefined clinical endpoints justifying differences of clinical particulars of a MA (e.g. new indication, strength, route of administration, pharmaceutical form). Applicants are advised to discuss the dossier requirements in such situations with the Reference Member State. The product used in the bioequivalence study should not be included in section 1.4.3 of the application form. The applicant should make reference in the cover letter to the studies in the Article 10(3) application.

The Organisation for Professionals in Regulatory Affairs

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 Importance of high quality and completeness of dossier (do not submit premature dossiers)  Choice of (correct) legal basis is basis for “success” of your application  Information in eAF is leading!  Always anticipate on possible comments  Always provide a justification in case of deviation from guidelines  Be aware that after re-start of a DCP no further clock stop is possible. It is also not possible in a DCP to resolve a MO/PSRPH via a commitment!  Contact with regulatory coordinator of procedure important Take-home messages

The Organisation for Professionals in Regulatory Affairs

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