Spring Intro 2023

16/02/2023

Regulatory Basis For A Generic Application Article 10(1), Directive 2001/83/EC: By way of derogation from Article 8(3)(i) …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 under Article 6…

• Only “exemption” for generics relates to the obligation to provide preclinical and clinical data. Other dossier requirements are the “same.”

• Obligation to demonstrate that the product is a generic: • Same active substance (easy!) • Same quantity of active substance (easy!)

• Same pharmaceutical form (easy!) • Bioequivalent ( not always easy! )

The Organisation for Professionals in Regulatory Affairs

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Visualising A Generic Application

Key difference between the dossier of a generic product and a reference product is Modules 4 and 5. Typically…

Module 1

Full M1 (state legal basis and identify proposed reference product)

Module 2

QOS, NCO and CO only. No requirement for non-clinical and clinical summaries

Module 3

Full M3. Key focus of 3.2.P.2 is demonstrating similarity to the reference product

Module 4

Literature

Don’t include a full preclinical and clinical study package as cross-reference is made to existing reference product study data.

Module 5

BE study, literature

The Organisation for Professionals in Regulatory Affairs

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