Spring Intro 2023

16/02/2023

Other Legal Bases Used By Generic Companies

The Organisation for Professionals in Regulatory Affairs

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Other Legal Basis Used By Generic Companies

Legal Basis

Type of MAA

Context

Article 10b

Fixed dose combination

Registering new FDCs containing existing drug substances - clinical supporting data requirements can be light. “Generics” of very old products for which there is no reference product available to demonstrate bioequivalence to. Preclinical and clinical requirements addressed using publically available literature. Buying a stand alone dossier from an innovator Company. Submission of M1 only with a letter confirming that other sections of the file are in your possession.

Article 10a

Well established use

Article 10c

Informed consent

The Organisation for Professionals in Regulatory Affairs

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