Brazil is the largest country in South America and the fifth largest country in the world. The total regulatory product market in Brazil is flourishing, due to a large and growing population (>200 million), a rising standard of living, and government commitment to increased investment in healthcare. Brazil is simply one of the largest markets of this type in the world.

The Agencia Nacional de Vigilancia Sanitaria (ANVISA) is the primary regulatory group responsible for GMP compliance. ANVISA is an autonomous agency under the Brazilian Ministry of Health. ANVISA was created for public health by ensuring the safety and quality of pharmaceuticals, medical devices, dietary supplements, and other health related products. Many expect the cosmetics market, popular in this appearance-conscious country, to be included at a later time.

Here is a breakdown by industry segment of this market:

Pharmaceuticals

• Drug Manufacturing is governed by RDC 17/2010, the guidelines for GMP pharmaceutical production. This resolution states the requirements for quality management, personnel, facilities, equipment, documentation, manufacturing, complaints, recalls, etc.

Other key resolutions:

• RDC 301/2019 that adopts international ICH Q7 GMP guidelines for API’s
• RDC 73/2016 for Good Distribution Practices throughout the supply chain

ANVISA also has a comprehensive, rigorous production facility inspection  program with a series of penalties for noncompliance.

Dietary Supplements

In Brazil, dietary supplements (also a growing market) is a subcategory of food, and thus should not make therapeutic or medicinal claims. Supplement producers must also go through a licensing process.

The resolutions applying to dietary supplements are as follows:

• RDC 275/2002 that provides the standards for Good Manufacturing Practices (GMP) in supplement production
• RDC 243/2018 covers quality, safety, and labeling guidance for dietary supplements

Cannabis

Medical Cannabis is legal in Brazil.  Medical cannabis products require a prescription and can only be sold through pharmacies. These products must include information about their CBD or THC content. Manufacturers are required to have a certificate of GMP production practices from ANVISA.

Although possession has been decriminalized, recreational cannabis is presently illegal in Brazil.

E-liquids

Brazil has taken a firm position on vaping with very strict laws and regulations for e-cigarettes and vaping products.

Due to its potential market, well defined regulatory framework, and actual size, Brazil is in a key position for regulatory product leadership, not only in South America, but also worldwide.

Look to Brazil for some important advances in the realm of human health.

InstantGMP has the software that covers the ANVISA and ICH requirements for pharmaceuticals, dietary supplements, and medical cannabis. Visit us out at www.instantgmp.com to learn more.

References

ANVISA

Global Regulatory Partners/Artixio

MyCannabis.com          Melanie Paige

Ecigator