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The Operating Authorization (AFE) is the authorization granted by Anvisa to companies or establishments, institutions and bodies that wish to carry out activities with products subject to health surveillance, upon compliance with the technical and administrative requirements contained in RDC nº 16/2014.

What is AFE for other companies?

The Special Authorization (AE) is the authorization granted by Anvisa to establishments that wish to carry out activities involving pharmaceutical inputs, medicines and substances subject to special control, as well as the cultivation of plants that may give rise to substances subject to special control, upon proof of technical and administrative requirements contained in RDC nº 16/2014.

What is AE of other companies?

The retail trade of health products is the activity of selling health products for lay use, carried out directly to individuals for personal or domestic use, in quantities that do not exceed those normally intended for their own use.

What is the retail trade of health products for lay use?

The area of ​​Anvisa responsible for analyzing petitions for Operating Authorization (AFE) and Special Authorization (AE) of companies is the Company Operating Authorization Coordination (COAFE).

Which area of ​​Anvisa is responsible for analyzing AFE/AE petitions from other companies?

The standard that provides for the criteria for petitioning companies for AFE and AE is RDC nº 16/2014.

What is the Anvisa standard that deals with AFE/AE for other companies?

AFE is required from companies that carry out storage, distribution, packaging, shipping, export, extraction, manufacturing, fractionation, import, production, purification, repackaging, synthesis, transformation and transportation of medicines and pharmaceutical inputs intended for human use, products for health, cosmetics, personal hygiene products, perfumes, sanitizers and packaging or filling of medicinal gases.

Who needs AFE?

AFE is not required for the following establishments or companies: I - that carry out retail sales of health products for lay use; II - branches that exclusively carry out administrative activities, without storage, as long as the head office has an AFE; III - retailing cosmetics, personal hygiene products, perfumes and sanitizing products;

Who DOESN'T need AFE?

In order for the company to carry out its activities, it must follow the following steps (procedural steps): - Request the health inspection report from the health surveillance body in your location. - Register the company on the Anvisa portal. - Prove the size of the company. - Request the grant of AFE. - Request the grant of AE, if applicable.

What are the steps that the company must take to grant AFE/AE?

Law No. 13,043/2014 extinguished the mandatory annual renewal of Operating Authorization (AFE) and Special Authorization (AE) with Anvisa for all companies (manufacturers, distributors, importers, pharmacies, drugstores, etc., including those operating in ports, airports and borders).

Does the company need to request AFE/AE renewal?

Cancellation of AFE/AE must be requested if the company ceases to carry out activities that are authorized in AFE/AE. It is important to highlight that the cancellation of the AFE/AE does not eliminate the company or establishment's responsibility for products that are still on the market.

When is it necessary to request the cancellation of the AFE/AE of other companies?

Anvisa may, at any time, subject to due legal process, cancel the AFE and AE of companies or establishments if facts occur that justify such a measure.

Can Anvisa cancel the AFE/AE without the company requesting it?

Petitions relating to AFE/AE from companies and establishments that carry out activities covered by RDC nº 16/2014 must be made through the Solicita system (https://solicita.anvisa.gov.br/).

What is the Anvisa system used for petitions relating to AFE/AE from other companies?

Documentation for concession requests must be presented as per the following table: Company Documentation Manufacturers Inspection report issued by the competent local health authority, which attests to compliance with the technical requirements of RDC nº 16/2014 for the activities and classes requested. Other companies Inspection report or equivalent document issued

What is the document requested in the AFE/AE grant petition?

RDC nº 743/2022 establishes the deadlines for analyzing petitions submitted to Anvisa. In the case of AFE/AE of companies (except pharmacies and drugstores), the deadlines are described in the standard by type of petition (grant, amendment, rectification), product class (cosmetics, hygiene products, perfumes, sanitizers, medicines, inputs pharmaceuticals, health products) and type of company (industry,

What is the deadline for analyzing AFE/AE petitions?

Consultation on the company's AFE or AE status is available on the Anvisa website, at the following path: www.gov.br/anvisa > systems > consultation system > access the system > company operation, select “consult national company” .

How to consult a company’s AFE/AE?

The Operating Authorization Certificate (AFE/AE Certificate) is a document issued by Anvisa that proves that the company is authorized to carry out the activities described in the certificate. It contains the company's authorization number, the authorized activities, the company's corporate name and its address.

What is the AFE/AE certificate?

The request for an AFE or AE Certificate can be made by companies that have the respective active Authorization with Anvisa.

Who can request the AFE/AE Certificate?

The granting of AFE/AE is the permission granted by Anvisa for the company to carry out a certain activity. The AFE/AE certificate is a document issued by Anvisa, proving that the company has been granted Authorization. For each case, there is a specific subject code. It is important to consider that the Certificate is not a mandatory document, but the AFE and AE, when AE is applicable, are mandatory requirements for the operation of companies regulated by RDC nº 16/2014.

What is the difference between granting an AFE/AE and granting an AFE/AE Certificate?

The class refers to the type of product, such as: medicines, inputs, cosmetics, hygiene products, sanitizing products, health products. The activity is that carried out by the company, such as: manufacturing, importing, distributing, transporting, etc. Below is an example table of product classes and activities: Type of company Activities Product classes Health products company Manufacture, import, export, transport, distribute, pack, repack - Health products Cosmetics company Manufacture, import, export, transport, distribute, pack, repack and fractionate - Cosmetics - Perfumes - Hygiene products

What are activities and classes?

A distributor cannot register products. The only person who can register products is the manufacturer or importer. If the distributor wants to be the owner of the record, he can expand the activity to import or manufacture.

Can a distributor register products?

The regulated agent is allowed to carry out distribution and dispensing activities in the same company, as long as they are in different establishments. Different establishments are characterized by different CNPJ.

Is it permitted to carry out distribution and dispensing activities in the same company?

A distributor cannot split medicines. The fractionation of medicines can only be carried out by pharmacies and drugstores, as provided in art. 10 of RDC nº 80/2006.

Can a distributor split medicines?

The importer who wishes to sell the imported product will have to request not only the import activity, but also the distribution activity. To do this, it is necessary to request the expansion of activities at AFE.

Can the importer carry out distribution activities?

The importer will not be able to pack or repack or break apart without having such activities at AFE. The importer will only be able to place the words in Portuguese for sale on the national market (without changing the packaging model). If you are interested in packaging, repackaging or fractionation, the importer must request the expansion of activities at AFE.

Can the importer pack, repack or split imported products?

An importer that does not have its own warehouse can sign an outsourcing contract to store imported products, as long as the contracted company has an AFE/AE in force for the storage activity.

How can importers that do not have their own warehouse store imported products?

Manufacturers of medicines, pharmaceutical inputs, health products, cosmetics, personal hygiene products, perfumes and sanitizers must present general information and comply with the technical requirements listed below, which will be evaluated during inspection by the competent local health authority: - General information: a) articles of incorporation or minutes of incorporation registered with the commercial board and its amendments, if any; b) National Register of Legal Entities (CNPJ) covering the requested economic activity;

What are the technical requirements for companies that manufacture products subject to health surveillance?