Anvisa authorizes prescription of cannabidiol and THC medicines in the country

RIO – The National Agency of Sanitary Surveillance (Anvisa) has authorized the prescription and importation of cannabidiol and / or tetrahydrocannabidiol (THC) drugs and products, substances found in marijuana and widely used in medicines that inhibit seizures. The authorization was disclosed through Resolution 66 of Anvisa, published on Monday in the Federal Official Gazette.

In practice, THC is now also regulated, but the component was only allowed in a secondary way, that is, when it was present in some medicine with a permitted composition.

– Now if I need a drug on which the base is THC I can import it, it will follow the same procedure as the CBD. Before, the THC ended up going to trailer, for example, if I had a medicine with 50% CBD and 50% THC it ended up being allowed. With resolution, if I have a THC-only drug I can care- explains Noberto Fischer activist and father of Anny, who has a severe type of epilepsy. “That’s another step in the search for regulation. The fact that regulation is moving forward means that society is changing thinking and reducing prejudice about the medical use of marijuana.

According to the DOU, drugs containing the substances must be imported on an exceptional basis by individuals, for their own use, for medical treatment, by medical prescription. The measure continues a whole process of flexibility with respect to cannabis-derived medicinal products. In January 2015, Anvisa withdrew Canabidiol (CBD oil) from the list of banned substances in Brazil. With this, the CBD became controlled and included in list C1 of Portaria 344/98, which regulates defines the controls and prohibitions of substances in the country.

In fact, the resolution takes away the CBD and THC from the list of substances that can not be prescribed or manipulated in the country, mentioned in Portaria 344 of the Ministry of Health.

– There is a very large stigma surrounding the regulation of THC, because it is the psychoactive substance of cannabis. There is the idea that the medicinal can not pass through the narcotic, but there is much research that proves that it has medicinal functions. This regulation is another step towards ensuring access to medicines. We hope that Anvisa will continue a series of other decisions that will guarantee access to these remedies, such as national production and regulation of self-cultivation.

“Article 1 Article 61 of Ordinance SVS / MS No. 344, of May 12, 1998, shall be in force with the following wording:

‘Art. 61 (…)

Paragraph 1 Except for the provisions of the caput:

I – the prescription of medicinal products registered in Anvisa containing the plant Cannabis sp., Its parts or substances obtained therefrom, including tetrahydrocannabinol (THC).

II – the prescription of products containing the substances cannabidiol and / or tetrahydrocannabinol (THC), to be imported on an exceptional basis by an individual, for own use, for medical treatment, by medical prescription.

Paragraph 2 – The same requirements established by the Resolution of the Collegiate Board of Directors – RDC No. 17, of May 6, 2015, shall apply to the importation contemplated in item IIdo above. “(NR)

According to Anvisa, the discussion about the reclassification of Canabidiol began in 2014 from the identification of patients with syndromes that lead to spasms and epilepsy and who find in CBD the best therapeutic response for their treatments. Canabidiol is a substance extracted from the Cannabis plant, whose use in Brazil is prohibited. “

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