Stone Okamont has prepared a content that will teach you how to regulate personal care products with ANVISA!
With a growing market, Brazil presents an excellent perspective for this sector. However, it should not be forgotten that the Brazilian Health Regulatory Agency supervises the quality of these products.
Before marketing or even producing, you need to regularize your company and product. Stone Okamont has more than 30 years of regulatory experience to help you regulate personal care products with ANVISA! Check out.
ANVISA defines personal care products as preparations consisting of natural or synthetic substances, for external use in various parts of the human body.
Their sole or primary purpose is to clean, perfume, alter appearance and / or correct bodily odors and / or protect or keep in good condition
Obtaining the Operating License is the first step to start regulating personal care products with ANVISA.
This document is acquired from a survey carried out by VISA, Local Sanitary Surveillance, in the establishment where the activity will be carried out.
If the site has technical and operational conditions to conduct the intended activity, it will be approved by VISA.
After obtaining the inspection report, you can continue the process to regulate personal care products with ANVISA.
The second step in order to regulate personal care products with ANVISA is to obtain the Operation Permits, the AFE.
After obtaining the VISA report, an AFE petition must be filed.
The Brazilian Health Regulatory Agency evaluates the application. If approved, the authorization will be published in the Official Gazette.
Without the AFE it is not possible to regulate personal care products with ANVISA.
To regulate personal care products with ANVISA, it is necessary to follow certain requirements of the regulatory agency.
The Brazilian Health Regulatory Agency establishes the following norms:
To regulate personal care products with ANVISA will require technical knowledge in the regulatory paths.
But do not worry! Stone Okamont has expert consultants ready to help you.
To regulate personal care products with ANVISA, it is not necessary to obtain the Certification of Good Practices.
This documentation is required only for products with III or IV risk classification.
Stone Okamont is a consultant with regulatory intelligence in the most diverse regulatory agencies in Brazil.
With more than 30 years of experience, we have the necessary knowledge to optimize your registry of personal care products at ANVISA.