Dermocosmetics are pharmacological products that act on beauty and also on skin health. To register dermocosmetics it is important to know their classification. ANVISA classifies them as grade II, and although they are considered "cosmetics", dermocosmetics need to go through these and clinical studies to prove safety and efficacy.
Theyare products intended for skin care, with cosmetic and dermatological action, i.e. contains substances that can be used in different treatments. While conventional ones act only on the surface layer, promoting immediate effects, dermocosmetics act on the deepest layers.
To register dermocosmetics will be necessary initially to obtain the regularization of the company, this consists of the Operating License and Operating Authorization. After these steps are complete, you can begin the product registration process.
This content will be divided into 3 parts: Operating License, Operating Authorization and Product Registration. In this way the reading can be directed to the current need of the reader.
See what steps are required to register dermocosmetics.
Step 1: Operating License
Before registering dermocosmetics, the first step is to obtain the Operating License for your establishment.
The Operating License the first document issued by the Health Surveillance (VISA), legalizing the operation of the activities of your company and respecting all the standards established by the DRC corresponding to the activity performed. It is the most judicious phase of the whole process to register dermocosmetics.
In this process it is up to the institution to adapt its physical structure to receive the inspection of a visa supervisory agent to evaluate the technical and operational conditions of the site, so that its establishment can function and take you to the next step that is the Authorization of Company Operation.
The Operating License is necessary and indispensable for the next step that is the petitionof the Company Operating Authorization.
Step 2: Company Operating Authorization
The Company Operating Authorization (AFE) is one of the most important regulatory steps for the success of your business, and for this reason, it is necessary to count on specialized technical support.
The Company Operating Authorization,better known as "AFE", is a permission of ANVISA for the company to carry out its activities. The document, which will be published in the Official Gazette (DOU), must be requested to start activities such as: manufacture, distribute, store, transport, import or export.
In this phase there are petitions, verification of documents, collection of fees among others. Each type of category requires specific documentation, it is very important to look at the basic documents, because the lack of these can result in instant rejection.
Obtaining The AFE, means that the company operates in accordance with Brazilian legislation and is able to act throughout the national territory and consequently move on to the next phase that is to register dermocosmetics.
Step 3: Register dermocosmetics
The Product Registration the document issued by ANVISA legalizing the commercialization of the same. From that moment on, the Agency will review the petition in the most appropriate way, verifying the documentation presented to certify that the company is in accordance with current legislation and able to develop its activities.
In this final step, product information such as: composition material, instructions for use, disposal instructions, and more are presented. In this way, the petitioning process must be respected, and mandatory documentation must be attached and the petition must be filed with ANVISA.
All companies offering products that may be harmful to health, such as medicines, pesticides, cosmetics, etc.; need to be up to date with all regularizations with ANVISA.
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