The Company Operation Authorization (AFE) is the second regulatory step for the success of your business. It’s an act of competence issued by the Brazilian National Health Surveillance Agency (ANVISA), granted to the company through compliance with technical and administrative requirements to prove that it’s authorized and qualified to perform its functions.
AFE is required for each company performing the activities of storage, distribution, packaging, shipment, export, extraction, manufacture, fractionation, import, production, purification, repackaging, synthesis, processing and transport of medicines, pharmaceutical inputs intended for human use, cosmetics, personal care products, perfumes, sanitors and others.
Remembering that before obtaining the Product Registration, your company needs to be regularized at ANVISA. Otherwise the petition to register the product may be rejected.
If you need to get the Company Operation Authorization (AFE), come to Stone Okamont. We do give all the necessary support for the process at ANVISA, directing all steps in a simple way, reducing costs and eliminating bureaucracy. Click on the link and ask for your quote.
What is a Company Operation Authorization?
The Company Operation Authorization (AFE) is a document that contains the permission for companies to perform their activities under sanitary surveillance regime, upon proof of technical and administrative requirements.
It must be requested to start activities such as: manufacturing, distributing, storing, transporting, importing or exporting. In summary, it contains the authorization number and the address of the establishment.
Company Operation Authorization (AFE) Renewal
ANVISA published in the brazilian Official Gazette (DOU) in 2014, the law 13.043/14 that extinguishes the renewal of Company Operating Authorization (AFE) and Especial Authorization (AE). Therefore, from this date there is no obligation in annual renewals.
However, it remains mandatory the request and approval of the initial AFE and AE. So, the authorization publication in DOU is the only necessary requirement to authorise the operation of new companies, without renewals, including factories, distributors, importers, exporters, carriers, pharmacies and drugstores.
Company Operation Authorization (AFE) Change
The change request of the Company Operation Authorization (AFE) must be made through the ANVISA’s Petitioning System. The publication of the result is made in the brazilian Official Gazette (DOU) and is sufficient to prove the concession given by ANVISA.
The change of Company Operation Authorization (AFE) is mandatory in the case of pharmacies and drugstores that have undergoing changes in the items below:
- Legal representative;
- Technical manager;
- Company name (company tax name);
- Address (location of the establishment);
- Reduction or expansion of activities (e.g.: expansion of drugstore activities for compounding pharmacy).
When can I request a change of AFE?
The change of the Company Operation Authorization (AFE) are possible in the following cases:
- Expansion of activities;
- Reduction of activities;
- Expansion of product classes;
- Reduction of classes;
- Address alteration;
- Corporate name alteration;
- Alteration by modification in the CNPJ extension of the headquarter, exclusively due to a declaratory act of the brazilian Federal Revenue;
- The alteration of technical officer;
- The alteration of legal responsible.
The expansion and reduction of product classes is only allowed between cosmetics, toiletries, perfumes, medicines and pharmaceutical inputs.
Company Operation Authorization (AFE) Expansion or Reduction
The expansion or reduction of Company Operation Authorization (AFE) is done according to the demand and production of the product. It’s usually used by companies that already have the Company Operation Authorization (AFE) and want to change the information, requesting another new activity or reducing some existing activity.
For companies that intend to request a Company Operation Authorization (AFE) with two or more activities, the petition will be carried out separately and independently for each activit.
Distinct activities should be petitioned as an expansion of activity, taking into account the segment that each one is integrating. It is important to remember that for each new segment or new activity will be charged a brazilian Health Surveillance Inspection Tax (TFSV).
The value of the tax varies according to the product class (food, medicine, cosmetic and others), the company's size and its annual billing
How to issue the Company Operation Authorization at ANVISA?
Stone Okamont is an advisory with regulatory intelligence in the most diverse regulatory agencies of Brazil.
With many years of experience, we have the necessary knowledge to optimize and accelerate your Company Operation Authorization obtention at ANVISA. Contact us, and know our efficient solutions.
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