Spring Intro 2023

Jenny Lamport

Types of applications

‘Abridged’ applications ● Known active substance ● ‘Second’ or subsequent applications ● Reduced data requirements – Cross reference to fulfil requirements

The Organisation for Professionals in Regulatory Affairs

43

‘Abridged’ applications

Generic products ● Article 10(1) ● Article 10(3)

– Hybrid (product not essentially similar to originator) – Differences supported by data ● Article 10(4) – Similar biological product [Informed consent ● Article 10c]

The Organisation for Professionals in Regulatory Affairs

44

22