Spring Intro 2023

16/02/2023

QUIZ

If the MAH of a reference product registers a new dosage form during their first 8 years of data exclusivity, they are eligible for an extra 1 year of regulatory Market Exclusivity

TRUE OR FALSE?

FALSE: The only scope for obtaining an extra year of Market Exclusivity is through registering a new indication during the first 8 years which is deemed to be of significant clinical benefit over existing treatments.

The Organisation for Professionals in Regulatory Affairs

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The Presentation

We have covered: • Abridged applications vs stand alone files • Legal basis of abridged applications • Supporting data requirements for generic submissions • Data exclusivity, market exclusivity and patents • Hybrid and biosimilar applications and when they are used • Other types of application used by generic companies

Further questions?

The Organisation for Professionals in Regulatory Affairs

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