Getting the Local Operating License with ANVISA can be a complicated process, so Stone Okamont explains the steps in a simple way with Zero Bureaucracy.
The first step for your company to be authorized to manufacture, distribute, store, transport and / or market products is to obtain the Local Operating License, the document that indicates that the company is regularized for such functions. Its issuance is made by VISA (acronym for Local Sanitary Vigilance, being of its city / municipality), which may or may not grant the license after analysis and rigorous structural and documentary evaluation.
To obtain the Local Operating License, VISA requires documents such as Social Contract and Social Purpose, evaluating if they correspond to the company's activities and verifying that the National Classification of Economic Activities - Fiscal (CNAE) is in conformity with the health activities of the company and in accordance with current health legislation, and whether they are in compliance with company practices and in accordance with current health legislation. The Technical Evaluation Report (LTA) or the Sanitary Assessment Report (LAS) is also requested.
In addition to those mentioned above, it is also required the implementation of the Quality System to prove organization and clarity in relation to the manufacturing and production flow processes, presentation of Operating Permits with the local city hall, Fire Department License, Building Project, accounting information, among other documentation. They are then audited by the Inspection of Local Sanitary Surveillance.
In the process, the two terms appear a lot and to avoid confusion, Stone Okamont explains each one and how they are intertwined.
ANVISA (Brazilian Health Regulatory Agency) is na agency linked to the Ministry of Health. Its objective is to control and regulate the sanitary area of services and products, whether domestic or imported.
The Local VISA is the Sanitary Surveillance of State and Municipality, and is linked to ANVISA.
This means that Local VISA acts as the "eyes and ears" of ANVISA, focused on that municipality, reporting if the company complies with legal norms and guidelines.
All necessary documents are audited by Local VISA and, if according to the norms, the company receives the Technical Report (or LTA).
This document is essential to continue the registration of your company, without it the Operation Permits, second stage of the process, can not be performed.
This report can be considered the response of Local VISA to ANVISA about the company being in compliance with the necessary norms and laws.
The process can be complicated for many, full of indispensable steps and a lot of paperwork. Therefore, Stone Okamont provides advice throughout the regulatory process, using the zero bureaucracy method and reducing the costs involved.
The Local Operating License is the basis to be able to regulate your enterprise and, without this initial stage, it is impossible to trace the rest of the journey to obtain the Operation Permits, Certification of Good Manufacturing Practices and Regularization of Products.
But there's no reason to worry. With a lot of experience, Stone Okamont performs, in a much more economical way, the entire process so that your company is regulated by ANVISA without letting you get lost in the midst of so much bureaucracy and detail.