The regularization of children's oral hygiene products is crucial to ensure the safety and effectiveness of products used by children. ANVISA (National Health Surveillance Agency) sets strict standards for these products to ensure they are safe for daily use and pose no risks to children's health. In this blog, we will explore the process of regularizing these products and how Stone Okamont can help your company ensure compliance with legal requirements.
What You Will See in This Blog:
Why is Regularization Essential?
Children’s oral hygiene products, such as toothpaste and mouthwash, are specifically designed to meet the needs of young ones and must be free from harmful ingredients. Regularization is vital to ensure these products are safe, effective, and meet the quality standards established by ANVISA. Unregulated products may contain harmful substances, cause adverse reactions, or fail to meet effectiveness claims.
Steps to Regularize Children's Oral Hygiene Products
1. Understanding ANVISA’s Regulations
Before starting the regularization process, it’s essential to understand ANVISA’s specific regulations for children's oral hygiene products.
2. Notification
Children's oral hygiene products must be notified to ANVISA. Notification is a simplified process, generally sufficient for products with basic formulas that do not pose high risks. The only products that require registration are sunscreens and repellents for children, as they need stricter control due to their direct interaction with the skin and the need to ensure efficacy and safety.
3. Submission of Notification in the Electronic Petitioning System
- Notification is submitted online through ANVISA's Solicita system. It is necessary to fill out the specific form, attach the required documents, and submit the notification.
4. Payment of the Inspection Fee (TFVS)
- After submitting the notification, the company must pay the sanitary inspection fee. The amount varies according to the size of the company.
5. Receipt of Notification Proof
- After submission and confirmation of payment, ANVISA will issue a notification proof, which is the authorization to market the product.
6. Label and Packaging Compliance
- Ensure the product's label and packaging comply with ANVISA’s regulations, including mandatory information such as ingredient nomenclature and warnings, if necessary.
7. Monitoring and Updates
- After notification, it is essential to monitor the product in the market and be aware of any updates in ANVISA’s regulations that may require changes to the notification or documents.
How Stone Okamont Can Help
Stone Okamont offers specialized support for companies looking to regularize children's oral hygiene products. Our services include:
- Consultancy and Document Analysis: We assist in preparing and reviewing all the necessary documentation for product registration or notification.
- Support in Registration and Notification: We manage the registration or notification process with ANVISA, ensuring all steps are correctly and efficiently completed.
- Regulatory Process Monitoring: We track the progress of your request and handle any additional demands or necessary adjustments.
- Compliance Consultancy: We provide ongoing support to ensure your products remain compliant with current regulations.
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