Anvisa advises on the correct way to petition.
The procedures for obtaining consent for the import of products that are subject to health regulations, intended for clinical research or technological research conducted under the supervision of Anvisa, have been recently reviewed and adjusted. To ensure that there is no confusion or uncertainty when submitting your petitions, below we detail the specific codes for each type of petition, the necessary procedural instructions, and the different categories of products involved.
When medicine is the target of clinical research at Anvisa
- Importation of medicines, the target of clinical research defined by Resolution of the Collegiate Board (RDC) 9/2015:
- 90350 – Anvisa Consent for the Import of medicines under or for monitoring of Clinical Research, except procedures 1, 1A, and 3, in LI/LPCO; or
- 90409 – Anvisa Consent for the Import of medicine samples under or for monitoring Clinical Research containing substance from procedure 1 or 1A, in LI/LPCO; or
- 90424 – Anvisa Consent for the Import of medicine samples under or for monitoring Clinical Research or expanded access programs, compassionate use, and post-study supply containing substance from procedure 3, in LI/LPCO.
- Import of medical devices for monitoring clinical research on medicines established by RDC 9/2015:
- 90504 – Anvisa Consent for the Import of medical devices or IVD intended for monitoring and evaluation of Clinical Research on medicines, in LI/LPCO.
- Import of a biological material collection kit, intended for monitoring and evaluating clinical research on medicines defined by RDC 9/2015:
- It must be carried out using the following subject code: 90504 – Anvisa Consent for the Import of medical devices or IVD intended for monitoring and evaluation of Clinical Research on medicines, in LI/LPCO.
- In this sense, to simplify procedures, the subject code 90352 – Anvisa Consent for the Import of biological material collection kit intended for monitoring and evaluation of Clinical Research of medication, medical device, or IVD, in LI/LPCO, will be discontinued.
- Import of food, to monitor clinical research on medicines, as provided in RDC 9/2015:
- 90496 – Anvisa Consent for the Import of food intended for the monitoring and evaluation of Clinical Research of medicine, medical device, or IVD, in LI/LPCO.
- Import of cosmetics and hygiene products, to monitor clinical research on medicines defined by RDC 9/2015:
- 90503 – Anvisa Consent for the Import of cosmetics, hygiene products, and perfume, intended for monitoring and evaluation of Clinical Research on medicines, medical devices, or IVDs, in LI/LPCO.
- Import of sanitizing agents, to monitor clinical research into medicines or medical devices, established by RDC 9/2015:
- 90506 – Anvisa Consent for the Import of sanitizing agents intended for monitoring and evaluation of Clinical Research on medicines, medical devices, or IVDs, in LI/LPCO.
When the medical device is the subject of clinical research at Anvisa
- Import of medical devices for clinical research defined within the scope of RDC 837/2023:
- 90351 – Anvisa Consent for the Import of medical devices or IVD, under Clinical Research, in LI/LPCO.
- Import of medical devices, to monitor clinical research on medical devices, within the scope of RDC 837/2023:
- 90351 – Anvisa Consent for the Import of medical devices or IVD, under Clinical Research, in LI/LPCO.
- Import of biological material collection kit linked to monitoring or evaluation of clinical research on medical devices, within the scope of RDC 837/2023:
- 90351 – Anvisa Consent for the Import of medical devices or IVD, under Clinical Research, in LI/LPCO.
- Importation of food for monitoring clinical research on medical devices, within the scope of RDC 837/2023:
- 90496 – Anvisa Consent for the Import of food intended for the monitoring and evaluation of Clinical Research of medicine, medical device, or IVD, in LI/LPCO.
- Import of cosmetics and hygiene products to accompany clinical research on medical devices, within the scope of RDC 837/2023:
- 90503 – Anvisa Consent for the Import of cosmetics, hygiene products, and perfume, intended for monitoring and evaluation of Clinical Research on medicines, medical devices, or IVDs, in LI/LPCO.
- Import of sanitizing agents to monitor clinical research on medical devices, within the scope of RDC 837/2023:
- 90506 – Anvisa Consent for the Import of sanitizing agents intended for monitoring and evaluation of Clinical Research on medicines, medical devices, or IVDs, in LI/LPCO.
When the advanced therapy product is the target of clinical research, at Anvisa, under the scope of RDC 506/2021:
- 90292 – Anvisa Consent for the import of advanced therapy products under clinical research, in LI/LPCO.
When cosmetics, sanitizers, or foods are imported for monitoring or as the subject of clinical trials, outside the scope of RDCs 9/2015 and 837/2023:
- 90459 – Anvisa Consent for the import of food intended for scientific or technological research, in LI/LPCO; or
- 90460 – Anvisa Consent for the import of cosmetics, perfumes, personal hygiene products, sanitizers, and other products intended for scientific or technological research, in LI/LPCO; or
- 90498 – Anvisa Consent for the import of sanitizing agents intended for scientific or technological research, in LI/LPCO.
The instruction documents for each subject code can be consulted in the Manual Manual “Peticionamento de Licença de Importação por meio de LPCO”, available in the current version at https://www.gov.br/anvisa/pt-br/centraisdeconteudo/publicacoes/portos-aeroportos-e-fronteiras/guias-e-manuais