WHAT IS ANVISA'S OPERATING LICENSE FOR?

ANVISA's Operating License is the authorization that allows a company to operate legally in activities subject to federal health surveillance. It is especially aimed at companies that manufacture, store, distribute, import or export products such as medicines, cosmetics, food, sanitizers, health products, among others. In addition to the Operating License, it is necessary to consider the role of the Company Operating Authorization (AFE), which is also issued by ANVISA and is often confused with the license. The AFE has a national scope, while the Operating License is generally granted by the local Health Surveillance Agency (state or municipal), and is one of the prerequisites for obtaining the AFE.

The Operating License is mandatory for all companies operating in sectors regulated by ANVISA. This includes:

• - Pharmaceutical industries and laboratories;
• - Distributors of medicines and health products;
• - Cosmetics and personal hygiene companies;
• - Manufacturers and importers of food and supplements;
• - Trade in controlled products (such as sanitizers and hospital disinfectants)

In other words, any company that deals with products that can have a direct impact on the population's health needs to go through the health licensing process. The absence of this license can result in serious sanctions, such as fines, interdiction of the establishment and even suspension of business activity. That's why having the support of regulatory experts, such as the Stone Okamont team, is essential to ensure compliance with all the requirements.

In addition to the legal obligation, being regularized with ANVISA brings a series of competitive and strategic advantages for companies:

• Access to national and international markets: many commercial partnerships and exports require the company to be up to date with health regulations.
• Brand recognition and credibility: licensed companies demonstrate their commitment to public health and compliance with quality standards.
• Legal certainty: avoids administrative penalties and guarantees the uninterrupted operation of the company.
• Easier future processes: companies that already have a license are able to speed up processes such as expanding activities, changing contracts, adding new products, etc.

For companies starting out or wishing to expand their activities, regularization with ANVISA is an essential step.

At Stone Okamont, we closely monitor all of our clients' regulatory processes, offering specialized advice on obtaining a license to operate. Our multidisciplinary team works strategically to ensure that your company is prepared to meet legal requirements and safely conquer its place in the market. If your company needs support to comply with ANVISA regulations, please contact us. We will be happy to be your partner on this journey towards regulatory excellence.