In October 2021, some important rules were published for the process of importing Cannabis-based products by individuals, regulated in Brazil by RDC 335/2020.

These publications aimed to reduce the time for approval of the patient’s registration at ANVISA’s system and allow them to have faster access to the products, since the growing demand for imports of these products has resulted in a long time for the manifestation of the Agency.

In addition, in the last 6 years, the Agency saw an increase of more than 2,400% (average of 400% per year), from 896 applications in 2015 to 19,074 applications in 2020, and by mid-September 2021, there have already been 22,028 requests to import Cannabis-based products by patients for therapeutic purposes. Also, the pandemic related to Covid-19 worsened this scenario, causing an even greater increase in import orders for these products.

The publication of RDC 570/2021, which changes RDC 335/2020, brings the following changes:

Patient’s registration: After registering the patient at ANVISA’s system, if it is identified that the product of interest was mentioned in the Technical Note provided by the Agency, it will undergo a simplified evaluation and consequent approval. With this, it will be the applicant’s duty to correctly fill in the data requested in the form, as well as compliance with the requirements and legislation applicable to Cannabis-based product import.

Automation of ANVISA’s systems: For the products listed in the Technical Note, the approval of the registration may also occur automatically, from the updating of the systems that allow this automation. It is important to mention that this update has not yet been implemented, and as soon as this occurs, applicants will be informed.

Post-registration changes: If it is necessary to change the product and/or dosage, after evaluation and approval of the registration, the applicant must submit a new medical prescription and request the necessary change in the form previously submitted. This should be issued, preferably by electronic means, subscribed by a legally qualified professional and signed electronically through digital certification.

Import of the Product: Imports are subject to sanitary inspection, therefore, for each import procedure, the following documents must be presented before their customs clearance:

Application Form.

Bill of landing

Invoice.

Medical prescription.

Proof of patient’s address.

Imported units: The quantities actually imported must be compatible with the medical prescription and will be subject to monitoring by ANVISA.

The approval of the registration, in a simplified or automatic way, does not prevent the sanitary authority, at any time, motivated by technically justified criteria or indications of irregularity, to promote the suspension of import and use of imported products, in addition to adopting other measures that it deems appropriate according to current legislation.

Additionally, Technical Note No. 37/2021 presents the list of Cannabis-based products mentioned in RDC 570/2021, which may be approved in a simplified or automated way. These products were analyzed just for minimum criteria of the regularity of the manufacturer and distributor site for the competent authority in their country of origin.

The Technical Note clarifies that, from the publication of RDC 570/2021, the medical prescription will be valid for 6 (six) months, from the date of its issuance and the Import Authorization remains with the validity period of 2 years. However, during the public health emergency situation by Covid-19, the medical prescriptions will be valid for an indeterminate period.

On November 18, ANVISA published Technical Note No. 39/2021, which aims to update the list of Cannabis-based products that can be approved through a simplified analysis. (updated on November 29, 2021)

Access the complete Technical Note Nº 39/2021 by the link: https://bit.ly/32nWmd4.

Access the RDC 335/2020 (amendment by RDC 570/2021) by the link: https://bit.ly/30gNntj

NOTE: These guidelines have been published only in Portuguese.

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