Spring Intro 2023

16/02/2023

QUIZ

European Health Authorities cannot accept a Marketing Authorisation Application for a generic until the Supplementary Protection Certificate has expired.

TRUE OR FALSE?

FALSE: Health Authorities can accept a Marketing Authorisation Application from a generic company as soon as the Data Exclusivity period (and any additional Orphan Market Exclusivity) has expired.

The Organisation for Professionals in Regulatory Affairs

37

QUIZ

To accept a generic Marketing Authorisation in France, the reference product has to be approved in France

TRUE OR FALSE?

FALSE: The concept of a “European Reference Product” means that a generic could still be submitted into France even if the reference product has never been approved there, provided that it’s approved in another European member state.

The Organisation for Professionals in Regulatory Affairs

38