The National Health Surveillance Agency (ANVISA) approved, on December 3, 2019, a new regulation for drugs made based on Cannabidiol.
According to the new rule, drugs can be sold in pharmacies only under medical prescription. That is, for the treatment of some diseases.
The type of prescription also depends on the level of concentration of tetrahydronacabidiol (THC) in the medication, which is the main active element of the Cannabis plant.
Concentrations of less than 0.2% need a type B prescription. Those with a concentration greater than 0.2% need a type A prescription, which is more restricted, usually indicated in cases of terminally ill patients or who have exhausted their options. treatment.
It is worth remembering that ANVISA also classified these drugs as “cannabis-based products”, being subject to health surveillance. Thus, their packaging cannot contain terms such as “medicines”, “supplements” or “herbal medicines”, for example.
In addition, only the manufacture or import of medicines is allowed, and cultivation or planting is not possible. It is also forbidden to sell or produce by handling pharmacies.
Who will benefit from the release?
According to the ANVISA report, the release of medicinal products based on cannabidiol assists those people who find, in these drugs, a therapeutic option for serious, debilitating or limiting diseases, which no longer respond to conventional treatments.
Cases of epilepsy , Parkinson’s disease, autism and cancer are conditions that can be assisted and benefited from regulation. This is because the drug tends to arrive faster and at less cost, since it will not have to go through the approval and import procedure.
Cannabidiol in Brazil
Today, in Brazil, there is only one medicine that has Cannabidiol in its formula. Known as Mevatyl , the medication to control moderate to severe spasms, resulting from multiple sclerosis (MS), has already needed an endorsement from ANVISA to be imported into the country at high costs.
Lawyer Fabiana Mascarenhas explains that before, a person could only plant, grow, harvest and exploit cannabis if they had the legal authorization to do this for medicinal purposes, according to Law 11.343, of 2006.
The planting and cultivation are still banned , but the import of raw materials for the production of medicines shall be authorized and supervised, says Fabiana.
For the lawyer specialized in regulatory affairs, in addition to doing good for the health of Brazilians who need cannabidiol-based oil to have a better quality of life, the release can also be beneficial for Brazil, since the country will gain prominence in the international pharmaceutical market, which is heated.
The release of health products based on cannabidiol will facilitate the treatment of those who need this substance, enabling better prospects for well-being and quality of life.
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