Do you know how to Register nail polish at ANVISA? In today's blog we're going to talk about the fundamental steps for this process.
What will you see in this blog?
The AFE (Company Operating Authorization) is a document issued by ANVISA – National Health Surveillance Agency, so that the company can register Nail polish at ANVISA.
This authorization must be requested before starting any of the following activities: manufacture, distribute, store, transport, import or export.
If a company wants to accomplish more than one of the activities mentioned above, it must request the first one as a concession and the others as an extension.
In addition to the AFE (Company Operation Authorization), the company must also have a CNPJ registered at ANVISA, and in order for there to be more assertiveness in its regulatory process, a specialist is required, so that there are no unnecessary expenses, and our team is prepared to assist you.
The Certificate of Good Manufacturing Practices (CGMP) is the document issued by ANVISA to assess whether the company in accordance with Good Manufacturing Practices.The Good Manufacturing Practices must reflect the minimum requirements comply with industries in the manufacture, packaging and storage of said products, as well as in quality control. Certificate of Good Distribution and/or Storage Practices (CBPDA) - This is the document issued by ANVISA attesting that a certain establishment complies with the Good Distribution and Storage Practices or Good Storage Practices set out in the current legislation.
The establishment designated as “Satisfactory” meets the requirements of Good Manufacturing Practices during inspection. While the establishment designated as “Unsatisfactory” does not meet the critical standards of good practice in conducting an inspection.The establishment designated as “in demand” is the one where nonconformities considered to be of low critical index were found at the time of the inspection. After its inspection, the corresponding requirements must be met within a maximum period of 120 days from the date of its discovery.
Failure to comply with the requirements within the stipulated period will result in the rejection of the Certification requests by ANVISA.
The status of “awaiting inspection” that appears in the result of the Document Status Consultation means that the Good Practices Certificate application process is awaiting the result of a health inspection carried out by:
- Local visa, in the case of national inspection;
- ANVISA, in cases of specific products and in the case of international inspection; or
- If good practices are granted for biological products or for non-organic products upon request by ANVISA, the local visa and ANVISA are granted together.
Nail polishes are classified as grade 1, that is, they do not need registration, but this does not exempt you from notifying them with ANVISA.
The notification system eliminates the need for technical analysis before product regularization. However, when filing the petition, the processing of these requests will go through a strictly administrative initial process until the issuance of the notification number. Subsequently, the ANVISA will carry out audits with a periodicity determined by the database of notified products, as a way of verifying compliance.Technical information (dossier or technical report) must always be available to health authorities.
Although the notification is a simpler process, ANVISA has its evaluation criteria for granting nail polish notification. For example:
1º It is not allowed that the product contain restricted, prohibited or above authorized concentrations;
2º The function of each component of the formula must be declared;
3º Declare the purpose of the product;
4º Data on stability, among others mandatory documents.
Stone Okamont has specialized and qualified consultants in different subjects, and they are prepared to offer the answers you need in the nail polish notification process with ANVISA.We meet the expectations of each client with a personalized service, leaving your company closer to success.
Request a quote here.