national medicines authority
Formal Definition
National competent authorities are organisations that have the legally delegated or invested authority, or power to perform a designated function, normally monitoring compliance with the national statutes and regulations.
Formal Definition
medicines regulatory authority in a European Union member state that, according to the legal system of that member state, is responsible for the granting of marketing authorisations, clinical trial authorisations and manufacturing authorisations for medicinal products
- Abbreviation(s): NMA
- Synonym(s): national competent authority | NCA national drug authority