Regulatory Affairs

VILAGE provides consulting services to manufacturers, distributors (wholesale trade), storage companies, transporters, exporters and importers of: cosmetics, perfumes, hygiene products, foods, medicaments, cleaning products (household cleaning products), veterinary products, medical equipment and products, laboratory and hospital products (health products and related products), as well as related retail products and medicaments (pharmacies and chemists).

The principal services provided concerning regulatory matters are:

  • Registration of products (national and imported)
  • Foods
  • Health products and related products
  • Cosmetics
  • Household cleaning products
  • Medicaments / Pharmaceutical inputs
  • Operating Licenses – ANVISA
  • Licenses from the Federal Police, Civil Police and Ministry of the Army
  • Veterinary Products

We work directly with ANVISA – Brazilian Sanitary Vigilance Agency, Regional Class Councils (pharmaceutical, chemistry, etc.), state and municipal sanitary vigilance, Ministry of Agriculture, Fishing and Supplies – MAPA, Civil Police, Federal Police and Ministry of the Army.

The processes are filed and registered directly in Brasilia, through our office for general operations.

It is important to remember that companies can only extract, produce, manufacture, transform, synthesize, purify, fractionate, package, repackage, import, export, store or dispatch the products below:

  • medicaments
  • drugs
  • pharmaceutical inputs
  • related products
  • hygiene products
  • cosmetics
  • perfumes
  • domestic cleaning products
  • products for aesthetic interventions

After obtaining Operational Authorization – from the Ministry of Health ANVISA), which occurs following licensing from the health agencies (Sanitary Vigilance) of the respective states and municipalities.

Obtaining the registration of the COMPANY and PRODUCTS for all phases of commercialization (manufacture, distributions and sale) is extremely important to avoid the risk of operating without the correct registrations. Among the fines and punishments defined by the legislation (Law 6,437 Art. 2º) we highlight the following:

  • Seizure, destruction, interdiction of the product;
  • Suspension of sales and/or manufacture of the product;
  • Partial or total interdiction of the establishment;
  • Prohibition and suspension of advertising and publicity;
  • Imposition of a corrective message;
  • Fines that can vary from R$2,000.00 to R$1,500,000.00;

Before opening your business, it is important to be aware of all the stages necessary to obtain the registration of the COMPANY:

  1. Registration with the Regional Class Council: relationship of the responsible professional technician to the company for issuance of the certificate proving technical responsibility.
  2. Registration with Local Sanitary Vigilance: elaboration of the procedure and request for inspection of the company’s physical premises for issuance of the Sanitary License/Permit.
  3. Updating of Company Size in the company register with ANVISA: elaboration and physical filing in Brasilia for publication of the Operational Authorization – AFE.
  4. Registration of the Manual of Good Manufacturing Practices – BPF with ANVISA: obligatory stage only for manufacturers and importers of health and related products (medical, hospital and laboratory products and equipment) susceptible to registration.

Only after obtaining the AFE – Operational Authorization will the company be able to request the registration of PRODUCTS. Thus, organization, planning and cognizance of the necessary TERMS and STAGES are essential to minimizing costs and maximizing the opportunities for your business. VILAGE offers assistance in all these stages in order that your company can arrive in the market with peace of mind and security.

Can I regularize products with ANVISA without having concluded the regularization of the company?

No. In the process of regularizing products, it is necessary to present proof of conclusion of the regularization of the company.

What is the purpose of the Updating of Size?

It is through this updating that the current size/classification of the company is proved. By obtaining the classification, it is possible to enjoy discounts on ANVISA’s rates.

What kinds of companies can register products?

Only MANUFACTURERS (businesses) and IMPORTERS duly regularized before ANVISA. The distributor, for example, does not regularize products, since it buys them from the manufacturer and/or importer with the due regularization.

How can I know whether a product is exempt, notified or registered?

It depends on the characteristics and nature of the product. For this reason, it is necessary to undertake a technical analysis. VILAGE indicates the regularization appropriate to the type of product through a pre-analysis of the technical documents.

Can I regularize a product without having concluded the regularization of the company?

No. Because in the process of regularizing products, it is necessary to present proof of conclusion of the regularization of the company.

What is the difference between the retail and wholesale trade?

Retail: selling products directly to individuals, with the issuance of a tax invoice from an individual to an individual.
Wholesale: selling products directly to a legal entity, with the issuance of tax invoice from a legal entity to a legal entity. The company’s registration with ANVISA is different for retailers and wholesalers.

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ANVISA: Produtos Suspensos

A ANVISA – Agência Nacional de Vigilância Sanitária publicou no DOU (Diário Oficial da União) informações sobre produtos suspensos: *11/07/2017 – Alimentos – Clique aqui e confira a publicação na