Brazilian Health Watchdog ANVISA Suggests Cannabis Regulation For Medicinal Use

The proposals made public 11 June may cause friction with central government ?Media outlet Estadao (André Borges, O Estado de S.Paulo June 11, 2019 ) report…

Anvisa will take to the public consultation the proposal for liberation of the cultivation and production of marijuana in the Country for medical and scientific purposes;currently the body authorizes the import of plants in cases of research or for the pharmaceutical industry

How does it work today in Brazil?
The production or commercialization of the marijuana plant (cannabis spp.) In Brazil is prohibited. Anvisa only authorizes the importation of plants in cases of research or for the pharmaceutical industry.
Is there a production of cannabis-based medicine and its derivatives in Brazil?
There is only one marijuana-based drug that is authorized in the country. Called Mevatyl – and approved in 28 other countries under the name Sativex – it is indicated for people who suffer from spasticity because of multiple sclerosis. The package costs, on average, R $ 2,500.
Is there a home production of cannabis remedies in Brazil?
Today, the legislation prohibits this practice, but patients, associations and some companies in the sector have obtained authorization to plant and produce marijuana and its derivatives in court.
What does Anvisa propose?
The holding of two public consultations to discuss safety and control requirements to allow the cultivation of marijuana for medical and scientific purposes and to evaluate the current requirements for regularization of cannabis spp products. in Brazil.
Is there a legal provision?
The possibility of authorizing cultivation for drug purposes is provided for in the Drugs Law 11,343 of 2006 and in Decree 5,912 / 2006. Brazil is also a signatory to an agreement at the UN in 1961 that already provided for the possibility of planting the plant for medicinal purposes.
Can anyone plant marijuana?
No. The cultivation can only be done by companies or legal entities authorized by Anvisa.
Can cannabis extract patients and associations involved produce?
No. No natural person can produce marijuana even if for medical or research purposes. The associations that want to produce will have to become legal entities and go through the accreditation process at Anvisa.
Does Anvisa’s authorization allow licensed companies to produce marijuana for recreational use?
No. Anvisa’s proposal is to release production only for medical or scientific purposes.
Besides Anvisa, will the Federal Police be required to release marijuana production?
The company will not have to go to the Federal Police or any security agency to request a special authorization for the production of the cannabis spp. However, Anvisa has informed that it will forward to PF, during the licensing process, an opinion request regarding the security plan of the installation, such as its location. The owners and technical directors of the company will have to file a statement of good criminal record.
Where can marijuana be planted?
Anvisa proposes that production be restricted to closed and controlled environments. It can not be produced in open environments such as farms and greenhouses. The place can not be identified by the placement of signs and signs.The building will have to have double door system, with automatic closing by interlocking. Walls, vents, doors, ducts and onlays built with durable material. The windows should be sealed with double glazing. It is necessary to maintain the security system 24 hours a day / 7 days a week throughout the production, including all entry points of the perimeter and windows, ducts and openings. The whole environment can only be accessed by biometrics.
In case of violation of the building where the planting will take place, what will the company have to do?
The companies have up to five consecutive days to inform Anvisa of the incident and to report immediately to the police authorities.
Can the plant be sold in natura?
Yes. The plant can be commercialized in natura since it is for research institutions, manufacturers of pharmaceutical inputs and manufacturers of medicines.
Can an ordinary person buy the plant?
No. Individuals and associations that today produce derivatives by judicial authorization will not be able to purchase the plant. In addition, there can be no distributors of marijuana for the pharmaceutical industry. The sale will have to be direct between producer and the authorized sector. Handling pharmacies are also prohibited from receiving the plant and its derivatives.
Who can produce drugs?
Only companies registered with Anvisa for these purposes or that obtain special authorization. Today, ten national and international companies of the sector have already shown interest.
Will you be able to make any kind of medicine?
No. Medicinal products based on cannabis spp., Their derivatives and synthetic analogues whose therapeutic indication is restricted to patients with severe debilitating diseases and / or life threatening and without existing therapeutic alternative in medicine, will be authorized.
Will marijuana cigarettes be available for medical purposes?
No. Only medicinal products in the form of capsules, tablets, powders, liquids, solutions or suspensions and whose route of administration are orally will be authorized.
Will there be control over the sale of cannabis-based drugs?
Yes. The remedies will have controls like the present ones, which may be just the presentation of revenue to purchase, to the more restrictive sales that need registration and retention of revenue.
The decision of Tuesday, 11, allows the production of marijuana in the country automatically?
No. After the public consultation, Anvisa technicians will evaluate the suggestions and decide whether or not to accept the contributions on the text and bring the debate back to the meeting of directors, to then vote the new rules on the sector.

https://saude.estadao.com.br/noticias/geral,veja-a-proposta-da-anvisa-para-regulamentacao-da-cannabis-para-uso-medicinal,70002865957

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