How to regulate antiseptic personal hygiene products?

Antiseptic Hand Gel: A product based on alcohol that is rubbed on the hands to disinfect them, often used when handwashing with soap and water is not possible.

Antiseptic Soaps: Soaps formulated with antiseptic ingredients such as chlorhexidine or triclosan, which help eliminate bacteria and other microorganisms during hand or body washing.

Antiseptic Mouthwashes: Liquid solutions used for gargling, helping to reduce the presence of bacteria in the mouth and throat.

Antiseptic Wet Wipes: Disposable wipes impregnated with antiseptic substances for cleaning hands, face, or other areas of the body.

Antiseptic Hand Gels: Products similar to alcohol-based gels but with different active ingredients, such as benzalkonium chloride, for disinfecting hands.

These products are used in various situations, such as in daily personal hygiene routines, healthcare settings, during travels, and whenever hand and body cleaning and disinfection are necessary to prevent the spread of diseases and infections. It is important to use antiseptic personal hygiene products according to specific instructions and regulations to ensure their effectiveness and safety.

Antiseptic personal hygiene products may be subject to registration or notification at the Brazilian Health Regulatory Agency (ANVISA), depending on their classification and formulation. ANVISA regulates these products based on their potential risk to human health.

Here are the main categories regarding registration or notification:

Products Subject to Registration:

Some antiseptic personal hygiene products, especially those containing critically assessed active ingredients or with therapeutic claims, may require registration with ANVISA. This involves the submission of detailed technical documentation and clinical trials, where applicable.

Products Subject to Notification:

Products considered to pose lower risks and containing more common antiseptic ingredients may be subject to simplified notification to ANVISA. This requires less technical documentation compared to registration.

It is important to note that ANVISA's regulations may be updated, and the classification of specific products may vary based on changes in standards and regulations.

To regularize antiseptic personal hygiene products at ANVISA in Brazil, here are some of the steps you should follow:

• Classify the product according to ANVISA's standards, determining whether it is a cosmetic or medication based on its composition.
• Appoint a technical responsible person.
• Prepare the technical documentation.
• Determine whether the product requires registration or notification based on the classification.

ANVISA will review the documentation, conducting risk assessments, which may include the review of technical data and laboratory tests.

After a successful review, ANVISA will issue the product's registration or notification.

Remember that the process can be complex and time-consuming, varying with the product's classification. Consulting regulatory professionals or consultants is advisable to ensure compliance with ANVISA's standards.

Trust the expertise of Stone Okamont. We have a specialized team in regulatory affairs that masters the legislations, providing time and resource savings for the regularization of your antiseptic personal hygiene products. Contact us and leave the bureaucracy in the hands of specialists!