Anvisa (National Agency for Sanitary Surveillance) approved the entry into the country of medicines with up to 30 mg / ml of CBD (cannabidiol) and THC (tetrahydrocannabinol), two important derivatives of marijuana. Decision was made by the agency’s board of directors meeting on Tuesday (22) and should be published in the Official Gazette in the coming days.
This resolution differs from import mechanisms in force since 2014 for cannabidiol use in an exceptional way. In this importation, patients with serious diseases for which there is no therapeutic equivalent, can import the substance and use it on account, signing a term of responsibility. Cannabidiol is not a medicine: patients use the compound in an attempt to achieve positive effects.
Now, what Anvisa’s ordinance does is to allow drugs with marijuana substances to be approved, provided that the concentration limits (30 mg / ml) are respected. The measure opens up space in the market for new products, but that does not mean that they are already available in the gondolas of the pharmacies or that can be used immediately.
Companies will still need to conduct all clinical trials and submit them to agency approval. The difference is that now they can do this with marijuana derivatives, which were previously not allowed in any concentration.
The release was motivated by the registration process of Mevatyl, which is in the final phase. The product is used for multiple sclerosis (MS) symptoms and is best known under the name Sativex. MS is an uncured disease in which the immune system corrodes membranes that attacks the nerves. Causes a series of symptoms: fatigue, speech and movement difficulties, bladder and bowel dysfunctions. The Brazilian Multiple Sclerosis Association (ABEM) estimates that 35,000 Brazilians live with the disease. The sativex acts on a specific symptom: the spasticity, muscular rigidity that is associated with movement dysfunctions.
The opening of the agency for marijuana derivatives began in 2014, when patients started to apply for the right to import cannabidiol, a substance that has satisfactory results mainly for the treatment of severe epilepsy. Motivated by this struggle, the agency removed the substance from the list of banned substances and patients could, under a special regime, import the CBD.
You can even import CBD oil, or wholesale CBD isolate, crystals too.
The importation, however, is permeated with bureaucracies and delays: patients must present prescription and medical report, term of responsibility and fill out a special form. The diseases must also be serious and have no therapeutic equivalent in the country.
Use of other derivatives and expedited import
Another novelty regarding the import of CBD is that the agency has added new companies to the import list. This process was adopted after the withdrawal of the CBD from the list of prohibited substances and allows the agency to have a control of the products that enter the country and its reliability. Here is the list of permitted companies:
|Product’s name||Company Name|
|Cibdex Hemp CBD Complex||Hemp Meds Px|
|Hemp Blend||Bluebird Botanicals|
|Real Scientific Hemp Oil (RSHO) CBD||Hemp Meds Px|
|Revivid LLC Hemp Tincture||Revive|
|CBDRX CBD Oil||CBDRX|
|Charlotte Web Hemp Extract||CW Botanicals|
|Endoca Hemp Oil||Endoca|
|Elixinol Hemp Oil CBD||Elixinol|
|EVR Hemp Oil CBD||EVR|
|Mary’s Elite CBD Remedy Oil||Mary’s Nutritionals|
|Purodiol CBD||Purodiol Limited UK|