Brazil, as many other countries, is currently debating the use of cannabis-derived products. On the Regulatory side, the board of ANVISA (the Brazilian Food and Drug Administration) is analyzing proposals for regulation of medicinal cannabis in Brazil. More especially, two drafts of Resolutions (RDCs) are the focus of discussions: one addresses the technical and administrative requirements for growing Cannabis and the other deals with the procedure for the registration and monitoring of these products.
Since 2014, the government has begun to approve procedures for easing the importation of cannabis-based medicines into Brazil. In 2017, the first medicinal cannabis drug, Mevatyl®, had its Marketing Approval issued by ANVISA.
As you probably know, in Brazil, pharma patent applications are sent to ANVISA for prior approval. After many discussions, the rule now is that only if an application contains substances of Lists E (list of prohibited plants, which may originate narcotic and / or psychotropic substances) or F (banned use substances in Brazil), ANVISA can deny the prior approval and the PTO proceeds to shelving the case.
Although Cannabis, tetrahydrocannabinol (THC) and many synthetic cannabinoids are in these lists, there is an addendum allowing the importation of products containing the substances cannabidiol and / or tetrahydrocannabinol (THC) for own medical use, as well as the exclusion from this list of medicines registered by ANVISA that have in their formulation cannabis derivatives, with a concentration of up to 30 mg/mL of tetrahydrocannabinol (THC) and 30 mg/mL of cannabidiol.
It is interesting to note that Cannabidiol is in a different List – list C1- of other substances subject to special control (specific prescription needed).
Based on a quick search at the PTO’s website, we could find that last month, October 2019, the BRPTO sent most of the cannabis-related pending cases to ANVISA for prior approval.
From the cases already analyzed with a decision on prior approval by ANVISA, we found one with granted prior approval (the application is still pending at the PTO and refers only to CBD – which is not in lists E or F – see above).
All cases found in our search, which contained / claimed THC were rejected by ANVISA, including an application from a Brazilian university for a pharmaceutical composition comprising cannabinoids (including phytocannabinoids from cannabis, specifically THC).
Therefore, although we can see in Brazil an evolution concerning regulatory issues on cannabis-derived products for medical use, the fact that cannabis and THC are still on ANVISA´s lists E and F needs to be addressed urgently so that the regulatory and industrial property pathways are on the same page.
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