Definition

Application to a regulatory authority (e.g. EMA or national CA) to obtain approval to market a medicinal product in that region. Centralised, decentralised, or national procedures apply.

Example

For EU centralised procedure, the sponsor submits one MAA to EMA; approval grants marketing authorisation in all EU member states.

Regulatory source

Regulation (EC) 726/2004, Directive 2001/83/EC

Common mistakes

Mixing up centralised vs decentralised procedure eligibility. Missing CHMP/PRAC clock stops and response timelines.

Inspector question

Which authorisation procedure did you use and why? How do you track and meet clock-stop response deadlines?

Related terms