Spring Intro 2023

03/03/2023

National Marketing Authorisation Application

● Submissions for a medicinal product in a single MS ● In the past not following the stricter timelines of other EU procedures ● In principle a 210-day assessment period (excluding “clock stops”) ● An “abuse” of the clock stop by both Agencies and Applicants

– Numerous MAAs have been lodged with Agencies for several years

N.B. Not to be mixed up with “The National Phase” of MRP and DCP

The Organisation for Professionals in Regulatory Affairs

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National MAA

Over the last 20 years, with the advent of EU procedures, National MAAs have declined. However, still useful: ● Smaller companies only wishing to launch in one market ● “Test the market” before going MRP in order to produce a robust dossier ● Sometimes used to: – Trigger a site inspection (GMP) – Complete the assessment of an API (with a DMF) [e.g. to avoid a registration fee for a complex application]

The Organisation for Professionals in Regulatory Affairs

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