Regularizing dietary supplements with ANVISA is a crucial process to ensure that these products are safe and effective for consumption. The National Health Surveillance Agency (ANVISA) is responsible for regulating and overseeing the commercialization of dietary supplements in Brazil. In this article, we will detail the steps for regularization and show how Stone Okamont can assist your company in this complex process.
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Understand What Dietary Supplements Are
Dietary supplements are products intended to complement the diet, providing nutrients such as vitamins, minerals, amino acids, proteins, among others. They are especially important for people who have specific nutritional needs or who cannot obtain all the necessary nutrients solely through their diet.
Necessary Documentation
The regularization of dietary supplements requires a series of documents, including:
- Product Dossier: Must contain detailed information about the composition, formulation, purpose, usage instructions, and target audience of the supplement.
- Test Reports: Laboratory tests that prove the safety and efficacy of the product.
- Technical Reports: Evidence that the ingredients used are safe and comply with legislation.
- Labels and Packaging: Must follow ANVISA standards, including mandatory information such as ingredients, nutritional table, expiration date, and warnings.
Submit the Electronic Petition
The submission of the dossier and documentation to ANVISA is done through an electronic petition on the ANVISA Petitioning System. It is necessary to follow the system's guidelines and ensure that all documents are complete and correct.
Monitor the Evaluation Process
After submission, ANVISA will analyze the documentation. This process may take some time, and it is important to regularly monitor the petition's status. The agency may request additional information or corrections, and it is crucial to respond promptly to avoid delays.
Receive the Authorization for Commercialization
If the documentation is complete and correct, and the product meets all the requirements, ANVISA will issue the commercialization authorization. With this authorization, the supplement can be legally manufactured, imported, and sold in Brazil.
How Can Stone Okamont Help?
Regularizing dietary supplements with ANVISA is a complex process that requires technical knowledge and attention to detail. Stone Okamont is a company specialized in assisting other companies in the regularization of products with ANVISA. With a team of experienced specialists, Stone Okamont offers support at all stages of the process, from composition analysis to the submission of the electronic petition.
Benefits of Counting on Stone Okamont:
- Technical Expertise: Highly skilled professionals updated with ANVISA regulations.
- Process Agility: Reduction of time and costs with the correct preparation and submission of documentation.
- Comprehensive Support: Complete support from the initial analysis to obtaining the commercialization authorization.
- Safety and Compliance: Ensuring that the product complies with current regulations, avoiding future problems.
The regularization of dietary supplements is crucial to ensuring the safety and quality of products available on the market. Counting on Stone Okamont in this process is a differentiator that can bring peace of mind and success to your company. Be sure to seek the support of those who understand the subject and maximize your chances of success with ANVISA.
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