The National Health Surveillance Agency (ANVISA), an institution attached to the Brazilian Ministry of Health, approved on Tuesday a regulation for the registration and sale of cannabis-based medicines throughout the country.
The regulations that have as an objective, according to Anvisa, “find a way to guarantee pharmaceutical access and“ ensure a minimum guarantee for product users ”, will apply 90 days after being published in the Official Gazette.
This regulatory framework creates in Brazil the alternatives to register, manufacture and import pharmaceutical quality products. They added a new category called “cannabis-based products“.
If a patient would like to access a cannabis-based medication, they must first have a prescription and then go to a pharmacy to purchase the medicine.
For local production, Anvisa regulations require companies to have a certificate of “good manufacturing practices” (GMP), which consists of a certificate of production of medicines of all kinds, now also apply to cannabis.
For the production of products, companies must import raw material and produce products based on it.
The regulations still analyze the issue of national cultivation for pharmaceutical use. At the moment, planting and harvesting are prohibited. In medical and research cases the corresponding permits are needed.
Thus begins a new period in Brazil. Medical cannabis becomes a safe access medicine for patients.
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