Glossary · Regulation
Marketing authorization (EMA, FDA, BfArM)
In short
A marketing authorization is the official permission to place a medicine on the market for a specific indication. It requires efficacy, safety and quality to be demonstrated.
In the EU, for centrally authorized medicines it is granted by the European Commission on the recommendation of the European Medicines Agency (EMA), for all member states at once. There are also national authorizations, in Germany mostly by the BfArM. In the US, the FDA is responsible. An authorization in one country does not automatically apply in another.
What is authorized is always a specific product for specific indications, patient groups and dosage forms. The same active substance can be authorized for one disease and unproven for another. If it is prescribed outside of this, that is called off-label use.
Food supplements do not need a marketing authorization; they are governed by food law, the novel food rules and the requirements for health claims.
What is authorized is a product for one use — not a substance for everything.
Where this comes up in the fact checks
- Tesamorelin – Authorized in the US for a narrowly defined group; the EU application was withdrawn.
- Methylene Blue – Authorized in the EU since 2011 and in the US since 2016 as an injection for methemoglobinemia.
- Omega-3 – In 2019 the EMA removed the indication for secondary prevention after heart attack; the authorization for lowering triglycerides remained.
Sources
Related terms: Trial phases (phase 1, 2, 3) · Off-label use · Gray market · § 3a HWG (German Medicinal Products Advertising Act)
Information only, not medical advice. The BK-Score is a subjective assessment according to disclosed rules – not a scientific evaluation. Scoring rules