Navigating regulatory complexities in Brazil is a challenge for many companies, especially those operating in the healthcare field. In this context, understanding the differences between the Operating Authorization for Companies (AFE) and the Special Authorization (AE), as well as their applicability in registering products and services with the National Health Surveillance Agency (ANVISA), is crucial. This article seeks to clarify these differences and provide guidance on the applicability of each in the regulatory process.
What is AFE?
AFE is a mandatory license for companies involved in the production, distribution, storage, and transportation of products subject to health surveillance, including medications, food, cosmetics, sanitizers, among others. This authorization is issued by ANVISA and ensures that the company complies with the necessary technical standards and regulations for its operation. Obtaining the AFE is the first step for a company to start its activities in the healthcare sector.
What is AE?
Special Authorization (AE), on the other hand, is an additional requirement for companies intending to handle, store, distribute, or transport controlled products, including psychotropic substances, chemical precursors, among others. AE is, therefore, a complementary authorization to AFE, intended for a specific group of activities involving products with a higher level of control due to their potential risk to public health and safety.
Key Differences and Applicability:
The main difference between AFE and AE lies in the type of activity and products each company deals with. While AFE is broad and covers a variety of products subject to health surveillance, AE is specific to controlled products. This means that a company may only need AFE to operate, but if it decides to expand its activities to include controlled products, it will also need to obtain AE.
In the context of product registration with ANVISA, possession of AFE is a prerequisite for most processes. The company needs to prove its compliance with sanitary regulations before applying for product registration or notification. For controlled products, in addition to AFE, AE becomes an additional requirement, reinforcing the safety and control over these products.
Final Considerations:
Obtaining AFE and, when applicable, AE, is just the beginning of the regulatory compliance process for companies operating in the healthcare sector in Brazil. In addition to these authorizations, it is essential to stay updated with changes in legislation and technical standards, ensuring the continuity of operations and the safety of products offered to the market.
Understanding the difference between AFE and AE and their applicability is crucial for the success of companies in the healthcare sector and for the protection of public health. ANVISA plays a fundamental role in regulating and overseeing these activities, ensuring that only safe and effective products reach Brazilian consumers.
In the dynamic Brazilian healthcare sector, regulatory clarity and compliance are not just good practices – they are business imperatives. We hope this article has shed light on the path for your company to achieve not only compliance but also operational and market excellence.
Let’s navigate regulations together and pave the way for success in the healthcare sector!
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