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Navigating the World of ANVISA with Passarini Group

You might think dealing with ANVISA is a Herculean task, an insurmountable mountain of bureaucracy that drains your company’s time and resources. But the truth is that ANVISA, as a health protection agency, ensures the safety of products reaching Brazilian consumers, and Passarini Group is here to demystify this process and make it easier for you!

ANVISA, the National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária), acts as a guardian of public health in Brazil, ensuring the safety and quality of a wide range of products, from medicines to cosmetics. For companies wishing to market their products in the country, understanding ANVISA’s rules and regulations is crucial. This is where Passarini Group’s expertise makes a difference.

Created in 1999, the National Health Surveillance Agency is an autonomous agency under a special regime, linked to the Ministry of Health, with the mission of promoting the protection of the population’s health. Its activities include sanitary control of ports, airports, and borders, as well as a variety of products and services, including:

  • Agrotoxins (Pesticides): ANVISA classifies agrotoxins into four hazard levels, using colors to indicate toxicity – red for extremely toxic, yellow for highly toxic, blue for moderately toxic, and green for slightly toxic. The agency also offers a poison information hotline for inquiries and reports.

  • Food: ANVISA regulates food labeling, ensuring that essential information, such as the list of ingredients, origin, expiration date, batch, and net content, is present on packaging. The list of ingredients must be presented in descending order of quantity.

  • Cosmetics: ANVISA requires registration for the marketing of cosmetics in Brazil. The labeling of children’s products is especially rigorous, prohibiting packaging with sharp edges, toxic substances, and aerosol format.

  • Public Health Laboratories: All public health laboratories in Brazil must be approved by ANVISA and are monitored by SISLAB (National System of Public Health Laboratories).

  • Medicines: ANVISA regulates drug leaflets and labels, ensuring they contain essential information such as batch, expiration date, manufacturer’s telephone number, and security seal. The agency is also responsible for the Brazilian Pharmacopoeia, which defines standards for medicines and pharmaceutical inputs.

  • Vaccines: ANVISA authorization is a crucial step for the commercialization of vaccines in the country. The agency analyzes safety, efficacy, and quality data before granting registration.

  • Sanitizing Products (Household Cleaning Products): ANVISA provides guidance to consumers on the correct use of sanitizing products, such as cleaning products and repellents, warning about the health risks associated with improper use and the purchase of clandestine products.

  • Blood, Tissues, Cells, and Organs: ANVISA sets standards for establishments that work with blood and blood products, carrying out inspection, audit, and monitoring activities.

  • Health Services: ANVISA receives reports about health services, including beauty salons, tattoo studios, gyms, and daycare centers, that pose risks to users’ health.

  • Tobacco: ANVISA regulates the advertising, sale, and consumption of smoking products, including electronic cigarettes, prohibiting sales in unauthorized locations and consumption in enclosed environments.

Navigate regulations with Passarini Group

Passarini Group: Your Partner for ANVISA Compliance

Passarini Group, a specialist in regulatory intelligence, acts as a bridge between companies and National Health Surveillance Agency, simplifying the process of obtaining licenses and registrations.

Passarini Group offers a wide range of services, including:

  • Good Manufacturing Practices (GMP) implementation

  • Company registration with ANVISA

  • Submissions of sanitizing materials

  • Process validation

  • Medical device registration

  • ANVISA import license

  • Assistance in preparing clinical evaluations

  • Cosmetic registration

With a team of experts in each area, Passarini Group offers customized solutions, guiding companies through every step of the process, from document preparation to obtaining the necessary certifications.

For companies seeking to enter the Brazilian market or ensure the compliance of their products with ANVISA regulations, Passarini Group presents itself as a strategic partner, offering expertise, agility, and results beyond expectations.

Contact Passarini Group to learn more about how we can assist your company. Send an email to contato@passarini.com.br

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