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ANVISA approves proposal to simplify the import of cannabidiol-based products

On January 22, 2020, the board of the National Health Surveillance Agency (ANVISA) approved a proposal to simplify the procedure for importing cannabidiol-based products for personal use. Despite the simplification, the requirement of evidencing the effective need for the drug persists.

The registration requires a prescription issued by a legally qualified professional, containing the name of the patient and the product, dosage, date, signature and number of the registry or prescribing professional. The importation of the product may be intermediated by a hospital or government unit linked to the health area.

Said decision is focused on patients who import drugs already available on the international market. Up to the third quarter of 2019, there were 6,267 import requests, against 3,613 in 2018, according to ANVISA.

The new resolution will be in force after publication in the Official Gazette (DOU). A draft of the new resolution was released during ANVISA’s Collegiate Board meeting, wherein the following changes were proposed:

  • Exclusion of requirement to inform the amount of drug to be imported. Monitoring starts to be done at customs.
  • Extension of the term of validity of the import authorization from one to two years.
  • Extinction of the list of products analyzed by ANVISA, in order to avoid “undue favoring of companies and products”.
  • Import can be carried out by the patient’s legal guardian or by a legally appointed attorney.
  • End of postal delivery of documentation; now the authorization request will be made exclusively through the Citizen’s Single Web.

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