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Regulation of Cannabis products in Brazil

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Angela Kung
Pinheiro Neto Advogados, São Paulo
akung@pn.com.br

Júlia Kesselring
Pinheiro Neto Advogados, São Paulo
jkesselring@pn.com.br

 

Since 2015, substances derived from Cannabis sativa L, tetrahydrocannabinol (THC) and cannabidiol (CBD) are allowed for medicinal use under certain restrictions imposed by the Brazilian Health Regulatory Agency (ANVISA). To qualify for ANVISA’s clearance, cannabis-based pharmaceuticals must comply with ANVISA’s Resolutions.[1] These require clinical data demonstrating the pharmaceuticals’ safety and efficacy for their intended indication and the Good Manufacturing Practice certification of the manufacturer, among others.

Cannabis sativa L remains, however, listed as a plant that cannot be cultivated, harvested, exploited, imported, exported, traded, extracted, handled or used in Brazil. There are currently bills of law under review in National Congress to remove Cannabis Sativa L as a prohibited plant, but there is no estimate of when and how those bills will be passed into law. In the current legal context, activities involving Cannabis sativa L are viewed as criminal conduct, with the exception of plant cultivation and harvest for scientific or medicinal purposes, authorised by the Ministry of Health for a determined period of time.

Nevertheless, with a view to expediting the access of patients to Cannabis products, ANVISA published Resolution RDC No. 327 on 9 December 2019 (‘RDC 327 of 2019’) to regulate the manufacture, import, commercialisation, prescription, dispensation, monitoring and inspection of a new category of products named ‘Cannabis Products’. ANVISA created a new, simplified pathway for the clearance of Cannabis Products, called Sanitary Authorisation. This is valid for five years only, during which time this authorisation can be converted into a marketing authorisation for pharmaceuticals.

The regulatory landmark for Cannabis Products in Brazil is still subject to review and RDC 327 of 2019 will be revisited by December 2022.

Cannabis Product

As defined in RDC 327 of 2019, ‘Cannabis Product’ refers to any product manufactured for medical use that contains, as active ingredients only, Cannabis sativa L plant derivatives or phytopharmaceuticals. 

Cosmetics, tobacco products, healthcare products or food items based on Cannabis spp (the name of the species of Cannabis Sativa L) and its derivatives do not qualify as Cannabis Products for medical purposes.

Under RDC 327 of 2019, the Cannabis Products:

• must primarily have CDB and THC;[2]

• must be oral or nasal administration only;

• must be of pharmaceutical quality for human use;

• must be duly registered with the competent authorities in their countries of origin if imported;

• cannot bear trade names, and must be identified by the name of the corresponding plant derivative or phytopharmaceutical and by the name of the company responsible for the product;

• cannot contain isolated substances of synthetic or semi-synthetic origin, except those serving as excipients;

• cannot contain substances that may be potentially toxic at the dosages being used;

• cannot be of modified release, nanotechnological and pegylated; 

• cannot be commercialised in the form of a plant drug made of Cannabis spp or its parts, even after stabilisation and drying processes, or in its shredded, ground or pulverised form, even if it is made available in any pharmaceutical form;

• cannot be advertised; and

• cannot be distributed as free samples. 

Sanitary Authorisation

The Sanitary Authorisation for manufacturing and/or importation of Cannabis Products is granted by ANVISA via a simplified procedure, initiated upon prior application made by the interested company. This is provided that the Cannabis Product satisfies the requirements set forth in RDC 327 of 2019 regarding quality control, labelling, packaging and traceability of the product, and also that the applicant itself meets the regulatory requirements.

Within this context, the applicant (either a manufacturer or an importer) must:

  • be a legal entity incorporated in Brazil;
  • bear an Operating License (AFE), Special Authorisation (AE) and Pharmaceuticals Good Manufacturing Practice Certificate (GMP) related to the Product manufacturer located in Brazil or abroad; and
  • in the case of an importer, bear a Pharmaceuticals Good Distribution Practices Certificate (CGDP). 

Until 9 December 2022, ANVISA will accept GMP certification or an equivalent document issued by the sanitary authorities of countries recognised by ANVISA. During such period, the company must apply for GMP certification by ANVISA.

The Sanitary Authorisation will be valid for a maximum of five years, during which time the company can pursue the product’s approval through the conventional pharmaceutical registration pathway. If the Cannabis Product is not approved as a pharmaceutical, then (upon expiration of the Sanitary Authorisation) the corresponding Cannabis Product can no longer be commercialised, imported or manufactured in Brazil.

Manufacture, import and commercialisation

As cultivation of Cannabis sativa L is still prohibited in Brazil, local manufacturers must import the active ingredient in the form of a plant derivative, phytopharmaceutical, bulk or industrialised product.

Hence, Brazilian legislation does not allow for any importation of:

  • Cannabis spp; 
  • Cannabis spp’s parts;
  • product in the form of the Cannabis spp plant or its derivatives; or
  • cosmetics, tobacco products, healthcare products and food items based on Cannabis spp and their derivatives.

Cannabis Products can only be commercialised by pharmacies (that do not compound pharmaceuticals) or drugstores.

Prescription/indication

Cannabis Products may only be prescribed by a physician duly licensed in Brazil and responsible for the patient. Patients, or their legal representative, must also sign an Informed Consent Form (TCLE) to use Cannabis Products. 

Prescription of Cannabis Products is permitted when other therapeutic alternatives available in the Brazilian market have been exhausted. Products with more than 0.2 per cent THC can be prescribed for palliative care solely to patients without other therapeutic alternatives and in irreversible or terminal clinical condition. Palliative care is defined as full, active care directed at patients with illnesses that no longer respond to curative treatment, notably aimed at ensuring the best quality of life for patients and their family members.

Post-commercialisation

The responsibility for reporting on any adverse events relating to the use of Cannabis Products lies with prescribing physicians, any healthcare professionals and the company holding the Sanitary Authorisation. The latter must also prepare an annual Periodical Risk-Benefit Analysis Report for the Cannabis Product and perform the post-marketing actions necessary for certain measures relating to their products.

In addition to the specific quality control, traceability, prescription and dispensation rules, pharmaceuticals rules on monitoring and inspection actions also apply to Cannabis Products.

 


[1] ANVISA’s Resolutions No. 24 of 14 June 2011 or Resolution No. 200 of 26 December 2017.

[2] CBD, plant cannabinoid of chemical name 2-[(1R,6R)-3-methyl-6-(1-methylethenyl)-2- cyclohexen-1-il]-5-penthyl-1,3-Benzenediol, CAS number 13956-29-1 and molecular formula C21H30O; and THC, plant cannabinoid of chemical name (6AR,10aR)-6,6,9-Trimethyl-3-pentyl-6a,7,8,10a-tetrahydro-6H-benzo[c]chromen-1-ol, CAS number 1972-08-3 and molecular formula C21H30O20.