Brazil’s Health Regulatory Agency (Agência National de Vigilância Sanitária, “ANVISA”) has published two public consultations:
- for regulations regarding the procedures and monitoring of medicines containing Cannabis ssp. (Consulta Pública 654/2019); and
- for regulations regarding the cultivation of Cannabis ssp. for medicinal and scientific purposes (Consulta Pública 655/2019).
Under the consultations, interested parties may make submissions to the draft proposals published by ANVISA.
Draft Regulations for the Registration and Monitoring of Cannabis spp.-based medicinal drugs (Consulta Pública 654/2019)
The draft regulations for registration and monitoring sets out specific rules for the registration of medicinal drugs containing Cannabis spp., including its synthetic equivalents. The rules are succinct and do not vary substantially from procedures applicable to the registration of other drugs.
Among other things, there is a requirement that the request for registration contain “proof of the safe use by technical-scientific means”.
Moreover, where the medical drug depends “partly or exclusively on data from published literature for the purposes of supporting clinical safety and efficacy, the [applicant] will need to present evidence of experience in the market with the same active input, with the same conditions of use”. In these cases, the applicant will also need to “supply evidence showing the adequacy of the data for the therapeutic recommendation proposing the terms of posology, target population, interventions and outcomes”.
From a legal perspective, the use of the word “evidência” in the text of the draft regulations is likely to be a mistaken translation from the English word “evidence”. “Evidência” in Portuguese is more adequately translated as “indicia” (while “prova” is the correct translation of “evidence”).
All Cannabis spp.-based medical drugs will be included in the National System of Controlled Medical Drugs.
Initial registration will be for a period of three years.
Draft Regulation for the Cultivation of Cannabis ssp. for medicinal and scientific purposes (Consulta Pública 655/2019)
The draft regulations for the cultivation of Cannabis ssp. provide that a special authorisation will be required for carrying out activities that involve substances subject to special control. Also, a special authorisation for the cultivation for research purposes will be required for “sewing, growing, harvesting, transporting, transferring, importing, exporting, warehousing and processing plants subject to special control”.
These ANVISA regulations are to apply in addition to any requirements imposed by other government bodies. Moreover, the regulations give ANVISA concurrent jurisdiction over inspection and enforcement over the regulations, with States and Municipalities being free to set up their own rules over the same subject-matter.
When requesting the special ANVISA authorisations, details about the location, the size of the expected cultivation, estimated production and location where extraction will take place will be analysed. Detailed technical requirements must be fulfilled.
The draft regulations provide that all Cannabis spp. plants must be grown in greenhouses. The location where the plants will be grown and its adjacent areas must be in a protected area, “to stop access of unauthorised persons and ensure the necessary controls to mitigate the risks of dissemination and misappropriation”. The conditions for approval include having power generators to ensure that the security and video monitoring systems are available 24/7 and that strict access controls are in place.
ANVISA will impose quotas on the growth of Cannabis spp. Any additional quantities will require prior approval.
Additionally, there must be full traceability “from the acquisition of the seeds to its final processing and disposal”. There are detailed specifications relating to labelling requirements. Also, all vegetable materials must be disposed of in the same location where they are produced “so that they become non-recognisable”. After that, disposal must take place in accordance with the National Policy of Solid Residues. Transport companies must be specifically authorised to carry Cannabis spp. as well as its products and residues.
Various obligations will apply to the directors (responsáveis legais) of the company conducting the activities and the technical person (reponsável técnico) responsible for the activities. These individuals are personally liable for these obligations.
Dealine for Submissions
The consultations will open for submissions on 22 June 2019 and will remain open for 60 days.
Last modified: June 17, 2019