Brazilian health authorities have approved regulations for the registration and sale of marijuana-based drugs in pharmacies. The decision by the Brazilian Health Regulatory Agency (Anvisa) on Tuesday will take effect in 90 days and will be subject to a review after three years. The objective of the measure is to find a way to guarantee access, by way of pharmaceutical assistance, and to ensure a minimum guarantee for users of the products, Anvisa said in a statement, Efe news reported.
The regulatory framework creates a new class of cannabis-based products, which will be subject to health surveillance, that must be sold only in pharmacies and have to be prescribed by a doctor.
These new rules also specify the procedures for obtaining different permits from Anvisa for the manufacture and importation of these types of drugs, as well as establishing the requirements for their commercialization, prescription and control.
Anvisa also said companies must continue research for the verification of efficacy and safety of their formulas.
The regulation approved on Tuesday requires companies interested in manufacturing marijuana-based medicines to obtain a certificate of good practices, issued by Anvisa.
Those who choose to import the cannabis substrate for the manufacture of the product must import the semi-finished raw material and cannot import the plant or part of it, according to Brazilian authorities.
To better monitor the batches of cannabis-derived drugs, Brazil limited the entry points of the products in its territory.
Anvisa was considering the possibility of authorizing the cultivation of cannabis to investigate and produce medicines made from the plant.
Brazilian legislation prohibits the growing, harvesting and use of cannabis, except in specific cases for medicinal and scientific purposes that also had to be endorsed by authorities.
Until now, patients who wanted these types of drugs were using oils and extracts based on cannabidiol, a substance found in cannabis, known for its therapeutic effects and which needed Anvisa's endorsement to import them.
The cannabis plant has a history of medicinal use dating back thousands of years in many cultures.
There is some evidence it can be used to treat certain types of epiletic seizures, chronic pain and improve sleep.