Agência Nacional of Vigilância Sanitária published rules this Wednesday that change access to medical cannabis products on Brasil. The measure updates the prescription and opens up the possibility of exporting the plant grown in the country. The resolution came out in Diário Oficial from União.
The decision follows the release of cultivation for medicinal purposes announced in February. Agora, products with a THC content equal to or less than 0.2% have a simpler recipe. Antes, required more rigorous models.
Mudança in Prescription Type Reduces Barriers for Patients
Produtos of low-THC cannabis is now prescribed with Receita of Controle Especial. Esse model is white and is two-way. One copy is retained at the pharmacy. Médicos already use this recipe for antidepressants and some anxiolytics.
The change represents an important step towards expanding access. Pacientes no longer needs yellow or blue recipes, which take less time and have greater control. The black stripe should gradually come off the packaging. Enquanto this, the rule allows purchase with the new recipe even on old products.
The norm maintains vigilance. Apenas qualified doctors can prescribe. Clinical monitoring remains mandatory.
Cannabis Exportação gains unprecedented approval from the agency
Empresas can now grow cannabis sativa to sell outside of Brasil. The release applies to varieties with THC of up to 0.3%. Produtores need to prove international demand with contracts or formal documents.
The cultivation of plants with THC above 0.3% is restricted to research. Operações export products undergo strict inspection at ports and airports. Anvisa falls under special control rules for low-THC material.
Essa opening can position Brasil as a supplier in the global market. The country has already made progress with internal regulation since the beginning of the year.
- Produtos with THC up to 0.2% use special control white recipe
- Cultivo for export requires maximum THC of 0.3% and proof of demand
- Prescrição by veterinarians released for animals with regularized products
- Fiscalização maintains control over all stages of production and sales
- Tarja black gives way to lower restriction labeling over time
Veterinários gains authorization to prescribe derivatives
The same resolution extends its use to animals. Médicos veterinarians can recommend medications and cannabis derivatives. Products must have health authorization and registration with Ministério of Agricultura and Pecuária.
The recipe follows a model similar to that of humans. One copy is kept at the pharmacy or authorized establishment. The measure integrates the veterinary sector into the surveillance system already applied to human health.
Pacientes and animal owners must receive clear information about risks and benefits. Termo of Consentimento Livre and Esclarecido remains part of the process.
Regras seek to balance access and health control
Anvisa updates the regulatory framework that has existed since 2019. The new resolution replaces or complements previous standards. Objetivo is to provide predictability to the sector and expand therapeutic options where other treatments fail.
Especialistas monitors the impact on product offerings. Farmácias and distributors need to adapt to the new dispensing requirements. The agency reinforces that products without health registration remain prohibited.
The text of the resolution details deadlines and procedures. Empresas interested in exporting must meet technical and traceability criteria.
Impacto expected in the national and international market
Pacientes report difficulty accessing due to old recipes. Simplification can reduce costs and bureaucracy. In the field of exports, Brasil enters a segment that is growing in several countries.
The standard maintains alignment with international conventions on controlled substances. Fiscalização and monitoring remain priorities for Anvisa.
Profissionais health professionals receive guidance for responsible prescribing. The focus remains on the safety and quality of the products available.
