Global Cannabis: Brazil

Brazil

Despite making strides, Brazil’s medical cannabis market might never rival a tourism industry that features Rio de Janeiro. Photo by Marchello

Milestones in the Medical Cannabis Program

The National Sanitary Surveillance Agency regulated “compassionate use” imports in 2015.

 

Key Laws and Regulations

  • RDC No. 17/2015
  • Portaria 344/1998

 

Market Data

  • Since 2014, almost 10,000 authorizations were granted to individual patients, allowing them to import medical cannabis on a case-by-case basis, each for a period of up to one year. Renewals are possible.
  • During the first quarter of 2019, Brazil’s National Sanitary Surveillance Agency (ANVISA) granted 884 new authorizations and 170 renewals—more than one-third of all the authorizations that were handed out in 2018.

 

Products Available in the Market

  • Sativex, sold in Brazil under the name Mevatyl, is the only registered product available in the market.
  • Patients also can apply for authorizations on a case-by-case basis to import individual products from other countries. Bulk imports for distribution are prohibited.

 

North American Companies in the Market

  • Several U.S. companies—including Isodiol, Charlotte’s Web and Elixinol—export CBD oils to patients on a case-by-case basis. Exports from Canada are rare, but a couple of Canadian companies are active in one way or another, such as performing cannabis research.

 

Big Picture

  • Imports of medical cannabis started in 2014, when a handful of families obtained special authorizations from ANVISA to import CBD oils to treat children suffering from refractory epilepsy.
  • Cannabis products are imported as nonregistered medicines, and patients must obtain authorization from ANVISA to import them.
  • To get authorization to use medical cannabis, patients must get a prescription from their physician and a written report justifying the need.
  • Authorization is good for one year but can be renewed.
  • Importing in bulk for commercial purposes is prohibited. There are no commercial domestic grows.
  • A significant change could take place in the following months. ANVISA proposed two resolutions that, once adopted, would:
  • Regulate—for the first time—the domestic cultivation of cannabis exclusively for medical and scientific purposes, in compliance with the 1961 Single Convention on Narcotic Drugs.
  • Review the registration procedures for medicines manufactured with marijuana, its derivatives or synthetic analogues, possibly allowing the commercialization of products that have completed only the second phase of clinical trials.
2 comments on “Global Cannabis: Brazil
  1. Brenda Mitchell on

    This ia great. There are so many people syfferi g from a wide range of diseases that marijuana can control ir matbe even cure. Even these children that have epilepsy or autism.

    Reply

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