Pharmaceutical
For manufacturers, importers and distributors of medicines and pharmaceutical ingredients: licensing of the operation, the regulatory routine and import support.
- Regulators
- ANVISA, Local health authority, Federal Police, Army
Pharmaceutical fronts.
The segment combines ANVISA authorizations, special control of substances and a deadline routine with no room for delay.
Company authorization
Operating Authorization and, for substances under special control, Special Authorization; health, environmental and municipal licences.
- AFE and AE
- Health surveillance and LTA
- Professional council
Good Practices
Good Practices certification with ANVISA, from adaptation to inspection.
- Operation adaptation
- Inspection readiness
Controlled products
The routine of companies handling substances under special control and controlled chemicals.
- Control reports
- Import quota
- Federal Police and Army
Imports
Regulatory support for the import process, from tariff classification to release.
- NCM code suggestion
- Import approval
Regulatory management
Deadlines, renewals, ancillary obligations and third-party contracts followed continuously.
- Deadline control
- Licence renewals
- Filing of third-party contracts
Corporate moves
Regulatory planning for start-ups, mergers, acquisitions and other corporate transactions.
- Timeline and investment simulation
- Feasibility analysis
Foreign company?Explore the Market Entry path
Common questions before you start.
Which authorizations does a pharmaceutical company need to operate in Brazil?
The ANVISA operating authorization (AFE) for the activity performed, the special authorization (AE) if substances under special control are involved, the local health licence and, depending on the operation, environmental and municipal licences. Importers need an AFE to import the product class.
Who needs a special authorization (AE)?
Companies that perform activities with substances and medicines under special control. The AE is in addition to the AFE and brings its own obligations for controlling and recording the substances.
What changes for companies that import medicines?
Besides the AFE for importing, the company must be registered with ANVISA for import licensing, and each shipment goes through health consent. Tariff classification and proof of the product’s regulatory status in the country of origin become part of the routine.
Last updated: October 2026.
A pharmaceutical operation to license or maintain?
We start with the map of the activity’s authorizations and licences, and with what is about to expire.