How to obtain operating authorization for carriers at ANVISA?

An Operating Authorization is a document issued by an authority or regulatory body that allows a company, establishment, or organization to legally and compliantly conduct its activities. This authorization is common in various fields of operation and serves as a way to ensure that the company meets certain standards, requirements, and regulations necessary to operate in a specific sector.

In the healthcare field, for example, the National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária - ANVISA) issues Operating Authorizations for pharmaceutical industries, medicine distributors, hospitals, laboratories, and other establishments related to the healthcare sector. This authorization confirms that these facilities are capable of carrying out their activities safely and in compliance with sanitary norms.

In the context of carriers, as mentioned earlier, ANVISA also issues Operating Authorizations for transportation companies dealing with products subject to health surveillance. This authorization is essential to ensure that the transportation of these products complies with established standards and does not jeopardize public health.

In other areas, such as food, chemicals, electricity, and others, specific Operating Authorizations may also exist, in accordance with the regulations of each sector.

This authorization typically needs to be periodically renewed and may be subject to audits and inspections to ensure that the company continues to meet established requirements. Obtaining an Operating Authorization is an important process for legalizing a company's activities and demonstrating its commitment to regulatory compliance.

The National Health Surveillance Agency (ANVISA) is responsible for regulating and authorizing the operation of carriers dealing with products subject to health surveillance in Brazil. To obtain the Operating Authorization for carriers from ANVISA, you should follow these steps:

Check Product Classification: First, it's necessary to determine if the products your carrier will handle are subject to health surveillance and if obtaining ANVISA's authorization is mandatory.

Company Regularization: Before applying for authorization, the transportation company must be properly established and in good standing with relevant authorities, such as the Federal Revenue and State Revenue Departments.

Prepare the Application: Compile the necessary documentation for the authorization request. The required documents may vary depending on the type of product being transported and the type of transportation (domestic or international).

Pay Fees: After submitting the application, a processing fee will be generated. It's important to pay the fee within the specified period to proceed with the review.

Monitor the Process: Track the progress of your application through the system and be prepared to respond to any requests for additional documentation or requirements from ANVISA.

Review and Issuance: ANVISA will review the application, and if everything is in order, it will issue the Operating Authorization for the carrier.

It's crucial to adhere to all ANVISA's requirements and regulations to ensure that the authorization is granted. It's worth noting that the process can be complex and may require some time for completion. If necessary, you can seek assistance from regulatory professionals to ensure that all steps are followed correctly.

Stone Okamont has over thirty years of experience in ANVISA's regulatory pathways. With highly trained consultants, we present the best solutions for obtaining your Operating Authorization for carriers.

Contact us, explore our efficient solutions, and obtain your registration with ANVISA!