The National Health Surveillance Agency (Anvisa) decides to simplify access to cannabidiol drugs

The National Health Surveillance Agency (Anvisa) decides to simplify access to cannabidiol drugs

Anvisa reduced the necessary documentation to request the import of the drug.
By: Agência Brasil January 26, 2020 | 09h58

Medicamentos com base em canabidiol são usados para tratamento de doenças raras, graves ou que podem levar à morte (Ilustração). Cannabidiol-based drugs are used to treat rare, serious or death-threatening diseases (Illustration)

Cannabidiol-based drugs are used to treat rare, serious or death-threatening illnesses (Illustration). Cannabidiol-based drugs are used to treat rare, serious or death-threatening illnesses (Illustration).
The National Health Surveillance Agency (Anvisa) has simplified the import of cannabidiol-based drugs. In a decision taken last Wednesday (22) by its board, the regulatory agency reduced the necessary documentation to request the import of the drug. Now, the presentation of the product’s medical prescription is enough.

This Wednesday’s meeting revised a 2015 standard, which defines the criteria and procedures for the exceptional import of cannabidiol-based products. The standard defines import criteria for this type of medicine for individuals only. Orders will continue to be placed through the federal government service portal.
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Another change is the validity of the prescription along with the registration, which will become two years. With that, Anvisa expects a reduction in the time to analyze and release orders. The review defined that the import can be done by the patient’s legal guardian or by his legally constituted attorney.

The time taken by Anvisa to analyze orders is 75 days. The agency, however, intends to reduce this period but does not specify how much that reduction would be. Anvisa recognizes that 75 days of waiting for analysis is harmful to the patient, hinders access to prescribed therapies and can cause irreparable damage to health.

Since the 2015 Resolution, Anvisa registered an increase of 700% in the number of orders to import these drugs. The monthly average jumped from 328 orders per month in 2018 to more than 900 in 2019. Cannabidiol-based drugs are used to treat rare, serious or life-threatening illnesses.

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