How to register your company at ANVISA?June 25, 2019
Do you know how to register your company with ANVISA? To be able to market products related to the care and beauty of people you must have your company regulated by ANVISA.
In this blog post, you will understand what business registration is and how it is done at ANVISA.
What is ANVISA Company Registration?
Company registration at ANVISA is the process of registration with the regulatory agency, in this case ANVISA. However, in order for your company to be able to operate according to the requirements and operating standards required by it.
Thus, we understand that without the company’s authorization to operate at ANVISA, the company cannot obtain the following approval regarding the Regulation of Products, whether national or imported.
How to register my company in ANVISA?
Primarily, the initial step in the company registration process is to apply for the Local Operating License (LOL). Therefore, the Local Health Surveillance (Visa) issues LOL, whether municipal or state according to the location of the company.
Thus, the issuance of the license at the municipal or state level will depend on the health surveillance actions of each municipality or state.
Therefore, for LOL to be acquired the company goes through some processes, including inspection of local health surveillance. Once purchased the LOL must have the Operating Authorization Company – AFE.
What is the Operating Authorization Company – AFE?
The Operating Authorization Company is a certificate of operating authorization. It refers to a document obtained by ANVISA, which proves that the company is authorized to perform the activities mentioned in the certificate.
Above all, AFE applies to drug companies and companies wishing to market health, cosmetic or sanitizing products.
Which companies do not need AFE?
According to ANVISA some companies do not need the Operating Authorization, ie are considered exempt from certification:
- Retail trade of lay health products.
- Subsidiaries that perform exclusively administrative activities, without storage, provided that the head office have AFE.
- Retail trade of cosmetics, toiletries, perfumes and sanitizers.
- Companies exclusively engaged in the manufacture, distribution, storage, packaging, export, fractionation, transportation or importation of raw materials, components and inputs not subject to special control, intended for the manufacture of health products, cosmetics, personal care products, perfumes and sanitizers.
- Companies that exclusively perform the installation, maintenance and technical assistance of health equipment are exempt from having AFE. In this case, they need the health license issued by the local health surveillance agency.
How to register my company the easy way?
You can register your company with ANVISA easily and securely. Licempre is a company specialized in regulatory affairs where, through a team of professionals prepared with the processes, takes care of all steps to register your company with ANVISA.
Finally, it is noteworthy that the entire process of gathering data and information requested by local Visa and ANVISA, as well as the requirements requested by the responsible body are analyzed and delivered so that the registration process of the company is performed quickly and effectively.
Our specialists can answer all your questions about company and product regulatory processes. Contact us and talk to a specialist.