Marketing authorisation
A marketing authorisation is the official permission a regulator gives a company to sell a medicine in a country or region. It is granted only after the company has shown the medicine is safe and works well enough for its intended use. In the US the same idea is called FDA approval.
For experts
In the European Union, EMA scientifically evaluates centralised marketing authorisation applications, and the authorisation, once granted by the European Commission, is valid in all EU Member States plus Iceland, Norway and Liechtenstein. Other regulators run their own processes. In the US, FDA approval requires the company to show that a drug is safe and effective for its intended uses.
Sources (2)
- 01Marketing authorisationEuropean Medicines Agency (EMA) · 2016-05-03 · accessed 2026-09-29
- 02Understanding Unapproved Use of Approved Drugs "Off Label"U.S. Food and Drug Administration · 2018-02-05 · accessed 2026-09-29