QR Group analyzes the regulatory impacts and prospects for companies working with medical cannabis in Brazil

The advancement of the debate on the regulation of cannabis-based products for veterinary use in Brazil gained new developments with the recent meeting between representatives of ANVISA and the Ministry of Agriculture and Livestock (MAPA). The meeting, held in June 2024, aimed to align strategies between agencies to regulate the use of cannabis derivatives in animal care, especially in the treatment of chronic and neurological conditions.

QR Group, a national reference in health products regulation, analyzes the developments of the agenda and the possible paths for companies that wish to operate in this new market, still in formation.

A regulatory agenda under construction

Despite the growing demand from owners and animal health professionals, the use of cannabis in veterinary medicine still does not have specific regulations in Brazil. Currently, products intended for humans can be prescribed “off-label” by veterinarians, but there is no legal authorization for the manufacture, importation or marketing of products formulated specifically for animals.

The meeting between ANVISA and MAPA marks an important step towards the structuring of its own regulatory base, which allows the evaluation of the safety, efficacy and quality of the products before their release for veterinary use.

Opportunities and challenges for companies working with medical cannabis

For companies that already operate with medical cannabis or intend to enter this sector, regulation for veterinary use opens up a new horizon, but also imposes technical and regulatory challenges, such as:

• Need for specific efficacy and safety studies for animal species;

• Adequacy to the requirements of ANVISA and MAPA, which may share or share attributions;

• Definition of its own regulatory routes, different from those already existing for human use;

• Constant monitoring of regulatory advancement, still under construction.

Success in this segment will depend on the ability of companies to anticipate requirements, align their processes with the evolving regulatory framework, and act with technical and scientific responsibility.

How QR Group supports companies interested in this market

With recognized technical performance in Brazil and abroad, QR Group offers complete support for companies seeking to position themselves in the future market of cannabis-based veterinary products:

• Strategic regulatory feasibility analysis;

• Monitoring of ANVISA and MAPA’s agendas on the subject;

• Development of technical dossiers with a focus on safety and efficacy;

• Consulting to define the best route to enter the market, considering the evolving regulatory scenarios.

Our commitment is to ensure that our clients are prepared to act responsibly and quickly once the market is officially open.

Talk to QR Group

Does your company work with medical cannabis and want to explore the veterinary market?
Count on QR Group’s technical support to position yourself now and ensure regulatory compliance safely.

Source: QR Group