CRED 8 Presentations

03/07/2024

Generic

Generic medicinal product shall mean a medicinal product which has…

• Same active substance • Same amount of active substance/strength • Same pharmaceutical form • Same qualitative and quantitative composition in active substances • Bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies

The Organisation for Professionals in Regulatory Affairs

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Generic

Art 10(1) – Generic (Essentially Similar) • ... the applicant shall not be required to provide the results of pre-clinical tests and of clinical trials , if he can demonstrate that the medicinal product is a generic of a reference medicinal product which is or has been authorised ... in a Member State or in the Community • Module 1 (justify legal basis in section 1.5.2 “ Information for generic, hybrid or bio similar applications ” ) • Modules 2 & 3 (complete quality data) • Module 4 omitted (literature papers cited from M 2, NCO) • Module 5 data showing bioavailability and bio-equivalence with the original medicinal product (section 5.3.1.2) • Biowaiver may be possible (no need for BE studies) in line with criteria defined in the Guideline on the investigation of bioequivalence • The SmPC should in all relevant aspects be consistent with that of the reference medicinal product

The Organisation for Professionals in Regulatory Affairs

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