Legal permit
Authorisation to Operate (AFE)
Authorisation to Operate (AFE) — legal permit, Brazil. It binds firms handling storage, distribution, manufacturing, import or export of medicines, pharmaceutical inputs, health products, cosmetics, personal-hygiene products, perfumes or sanitisers in Brazil.
- Jurisdiction
- Brazil
- Record class
- Legal permit
- Last verified
Where this applies
This record is scoped to Brazil. Scope is part of the claim: a rule that binds one part of a country does not bind the whole of it, and this library states the scope its sources state.
Instrument
ANVISA regulations (RDC 16/2014, RDC 743/2022, RDC 266/2019)
Who it binds
Firms handling storage, distribution, manufacturing, import or export of medicines, pharmaceutical inputs, health products, cosmetics, personal-hygiene products, perfumes or sanitisers in Brazil
What it requires
ANVISA (Agência Nacional de Vigilância Sanitária) issues the Autorização de Funcionamento de Empresa (AFE), a precondition for operating in the health-regulated categories listed above.
Route to the authority
Last verified:
This page is for information only; it is not legal advice, and it does not establish whether this record applies to your business. Verify current status through the official source above.