Module 18 2021

07/02/2021

Articles 10(3) and 10(4)

 Where: ● the strict definition of a generic cannot be met

● bioavailability studies cannot be used to demonstrate bioequivalence ● There are changes to the drug substance, indications, strength, pharmaceutical form or route of administration compared to the reference product

 Nonclinical / Clinical data may be needed.

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Article 10a

 WELL ESTABLISHED USE (WEU) ● Entirely bibliographic support for Nonclinical / Clinical

● Well-established? – Drug substance has been on the market for at least 10 years AND has recognised safety and efficacy.

● WEU – relies on the same therapeutic use!

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