Overview:

Before starting the registration process, it is essential that the company complies with all regulatory requirements. This involves obtaining the Operating License/Authorization from the local health surveillance agency and the AFE/AE from Anvisa.

Introduction:

Registering cosmetics with Anvisa is crucial to ensure that products comply with legislation and guarantee consumer safety. Proper preparation can significantly simplify this process. We will cover the main aspects of cosmetics registration in a clear and practical way.

Initial Preparation Stage:

Appointment of your Brazilian Registration Holder : Foreign Companies without the appropriate licenses cannot register health products directly with Anvisa. 

Sending documents: Submit all the documents required by Anvisa through the system. These documents are essential to prove the safety, efficacy and quality of the product.

Paying the Anvisa fee: Pay the Union Collection Form (GRU) generated after the application. The amount of the fee depends on the size of the Brazilian Registration holder. 

Monitoring the process: Regularly monitor the progress of the process. Anvisa may request clarifications or additional documentation during this period.

After approval

The registration will be published in the Federal Official Gazette (DOU). Once published, the product can be marketed throughout the country, following the authorized specifications. It is important to remember that any change to the product’s formula requires a new analysis process by Anvisa.

Validity of registration:

Registration of cosmetics is valid for 10 years from the date of publication in the DOU. To keep the registration active after this period, the company must apply for renewal.

Conclusion

The process of registering cosmetics with Anvisa, although detailed, can be conducted efficiently with proper preparation. The GRP Brazil team is available to help your company ensure that all the requirements are met, and that the registration process is a success.

If you are interested in registering your products in Brazil, GRP is ready to help. Our team of experts can simplify the process of registering products in Brazil and make it easier to schedule meetings with Anvisa more efficiently.

Brochure : GRP Brazil Services

GRP Brazil Office provides Regulatory Affairs, Quality, Clinical and Safety services to pharmaceutical, medical device, and life-consumers companies worldwide to register them product with ANVISA the local Health Authority (HA).

About Global Regulatory Partners

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.

GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations. 

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