A Local Operating License is essential for your company to manufacture, distribute, store, transport and sell your products in a regularized way, legalizing your enterprise with a Local Health Surveillance Agency (VISA).
It is a Local Health Surveillance Agency, which is generally situated in a city or municipality.
Stone Okamont provides all the advice you need to facilitate the process of acquiring a VISA Local Operating License. We aim to cooperate in any way necessary for the expedient establishment of your company in the market.
Obtaining a Local Operating License is the cornerstone of your company’s entire regulatory structure. If your company does not have this license, it will not be possible to obtain additional regulatory certificates such as an Operating Permit, Good Manufacturing Practices Certificate and Product Regularization. In other words, without a Local Operating License, it is not possible to proceed with any other regulatory processes, whether for the company or the product.
VISAs have a number of regulatory requirements to provide you with an Operating Permit (AFE), the stages of which are summarized below:
Drafting Articles of Incorporation for your company is only the first step.
In this first phase, it is important to verify whether your company’s identification in the National Classification for Economic Activities – Taxation (CNAE), and your corporate purpose, conform to all current corporate practices and are in agreement with existing sanitary legislation.
Stone Okamont’s objective in this stage is to assist your company with its application for a Local Operating License, in particular, to ensure that the CNAE identification and corporate purpose conform to VISA and ANVISA requirements. This saves time, and therefore reduces costs.
The Technical Assessment Report (LTA), or Sanitary Assessment Report (LAS), is an examination of both the physical and production infrastructure of the company, performed by an architect or engineer. This infrastructure is subject to sanitary engineering inspection by the city and/or municipality.
Stone Okamont offers advice throughout the technical process for the production and execution of an LTA, whether with a professional appointed by your company, or by handling the entire project. Our team includes highly capable professionals who respond to all of your institution’s needs.
To be fully functional in all of your company’s categories, it is essential that all parties speak the same language and are able to express exactly what was determined in terms of the manufacturing process and production flow of your company. With that in mind, Stone Okamont also develops all the indispensable quality system materials of your company in a customized fashion, including standards, records, forms, procedures, manuals, and whatever else may be required.
Even after the conclusion of all the steps above, the Local Health Surveillance Agency may require additional documentation, such as a municipal master plan, a local council business license, or a fire department permit, among others. Soon after these steps are completed, your inspection request is forwarded to the VISA. The Local Health Surveillance Inspectors analyze all supplementary documentation, and also judiciously analyze your entire quality system, intent on finding out if everything was properly executed. At the end of the inspection, the inspectors issue your Operating License and an inspection report, which must be annexed and sent to The Brazilian Health Regulatory Agency (Anvisa) for the Operating Permit (AFE) process.
It is paramount that the inspection report provided by the inspectors be free of any corrections. In other words, there should be no requirement that fixes be carried out to guarantee the approval and acquisition of an Operating Permit (AFE).
Sorting all of this out is easy. Stone Okamont provides a draft document that includes all the necessary steps for your company, preparing your team in a way that facilitates the inspection procedure. We provide training and accompany the process (including the sanitary inspection visit), identifying any non-conformities that are found and indicating the ideal actions for a successful result.
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