How to register infant formulas at ANVISA?

How to register infant formulas at ANVISA?

The registration of infant formulas at the National Health Surveillance Agency (ANVISA) is an important process to ensure the safety and effectiveness of these products. To start the registration process, you need to follow a few steps.

Before starting the registration process of infant formulas at ANVISA, it is important that the manufacturer of the product verify that the infant formula is in accordance with ANVISA’s rules and regulations. The formula must be safe for human consumption and free of toxic substances or contaminants.

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Company Operating Permit (AFE)

The first step to register the infant formula at ANVISA is to obtain the company’s operating permit (AFE). This authorization is obtained through a specific process with ANVISA. The company must submit a series of documents, such as company registration, product registration and proof that the company meets the requirements of good manufacturing practices.

Several safety and efficacy tests are conducted on infant formula. These tests must be conducted in laboratories accredited by ANVISA, an evaluation of the company's infrastructure and processes and that prove the quality and safety of the product.

Safety tests involve evaluating the product's acute and chronic toxicity, while efficacy tests assess whether the infant formula meets the nutritional needs of the target audience.

Registration of infant formula

After the initial documentation, it is possible to prepare the necessary documentation for registering the infant formula with ANVISA. The required documentation includes information about the formula, such as the list of ingredients, the physical, chemical and microbiological characteristics of the product, and information about production and quality control. The manufacturer must also provide information about packaging and labeling of the formula, including information on instructions for use and storage.

Infant formula compliance

The registration of infant formulas at ANVISA involves checking the conformity of the infant formulas with the regulations in force, obtaining the company's operating authorization, carrying out safety and efficacy tests, and submitting complete documentation for ANVISA’s evaluation. With this registration, it is possible to guarantee the quality and safety of the products offered to the infant market.

The National Health Surveillance Agency (ANVISA) is responsible for regulating and inspecting products that may affect the population’s health, including infant formulas. The registration of these products with ANVISA is essential to ensure the safety and efficacy of the infant formulas marketed.

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Our technical team is able to assist your company in the ideal regulatory path for your infant formula to be safely marketed. We rely on our Zero Bureaucracy method, created and used to translate the bureaucratic language to a language accessible to all, delivering faster, more accurate results, with reduced costs. We look forward to hearing from you.

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