Brazil’s National Health Surveillance Agency (Anvisa) has issued recommendations for companies importing active pharmaceutical ingredients (APIs) – GLP-1 agonists – used in the production of drugs known as weight loss pens.
Any importer of this product is required to accurately report the CAS number of the substance, which is an internationally recognized number used to identify chemical substances. Importers are solely responsible for providing accurate information. Details are provided below:
Commercial imports refer to goods imported by distributors for sale to pharmacies or pharmaceutical companies.
In these cases, in addition to providing the mandatory documents specified in RDC 81/2008, importers must also provide the TGR, a document that specifies the retention period and liability.
TGRs should submit applications in the Solicita system with the subject line: “70944 – GGIFS – GLP-1 API Agonist – Evaluation of documentation related to quality control performed in the country.”
Before authorizing import, Brazil’s National Health Surveillance Agency (Anvisa) requires products to undergo quality control in Brazil. The rules for conducting these tests are detailed in Technical Note No. 200/2025, issued by the agency.
Once the analysis is complete, the relevant technical specialist will provide their opinion, which must be taken into account in the import process before it can proceed.
The importer determines how many samples need to be taken specifically for laboratory analysis and quality control reporting. Information on the samples taken must be archived and included in the reports.
If the active pharmaceutical ingredient (API) is synthetic, importers can check the search engine of the Brazilian health regulatory agency, Anvisa, to see if drugs containing this ingredient are already registered. If so, import is permitted, subject to the provision of relevant supporting documentation.
If the active pharmaceutical ingredient (API) is of biotechnological origin, importers need to check whether they can import this ingredient from the same manufacturer as the registered medicinal product, as defined in Notification No. 97 dated 22 August 2025.
The source of active pharmaceutical ingredients (API) can be confirmed by the manufacturer’s certificate of analysis, and this verification is also the responsibility of the importer.
Anvisa will monitor the import of these goods. If any violations are detected, the case will be referred to other regulatory authorities, and the importer will be subject to sanctions in accordance with applicable law.
For further guidance on the procedures and agreements for Level 1 and Level 2 import applications, we recommend you refer to the Guide: Submitting LI/LPCO Applications and Making Integrated PCCE Payments.
Imports for industrial use: This category includes goods imported by pharmaceutical companies for their own use, either directly or through a third party (on behalf of a third party or on commission).
Imports for commercial use: This category includes goods imported by distributors for sale to pharmacies or pharmaceutical companies.
Post time: Oct-12-2026