Regulatory Affairs

In Brazil, regulations and certifications previously granted by the competent authorities are required to the manufacturers, distributors, transporters and importers of diverse areas, medicine, cosmetics, foods, perfumes and hygiene products, equipment, and medical products (medical device) and disinfectant sanitizing.

Without these authorizations, such products cannot be commercialized in the Brazilian territory.

The VILAGE multidiscipline team, composed of chemists, pharmacists, engineers, lawyers, administrators and qualified consultants, provide the best guidance, according to the Brazilian law, in order to identify, inform and perform all procedures in accordance the Brazilian Sanitary Legislation, in accordance with the referring legal ways the regularization, certification and obtaining competent licenses in the Federal, State or Municipal Agencies of Brazil:

Special Monitoring of Processes Between Foreign Manufacturer and Brazilian Importer

The relation between the foreign manufacturer and the Brazilian importer has a maximum importance, which have interests in common and appreciate the cooperation in the Brazilian market.

Through its office in London (UK), the VILAGE facilitates to the interaction between these two parts, guaranteeing security and agility in the information, managing and following the necessary regulatory procedures, as well as providing the competent authorizations, watching over for the integrity of the manufacturer, the importer and the product in itself.

Services

The register, regulations, licenses and certifications, beyond its posterior monitoring and maintenance, vary according with the nature of each product.

Thus, it is necessary to distinguish the requirements from the Brazilian Legislation for each category and, mainly, to fit them in accordance with the classification of its sub-section, what it is made by our team of highly qualified professionals, with technical ability and responsibility, especially in our portfolio:

I - Registration of Products (national and foreign origin)

  • Pharmaceutical Medications/Ingredients
  • Food (with analysis of the possibility of legal exemption in relation to registration in certain cases)
  • Equipment and Medical Products / Medical Device
  • Cosmetics
  • In vitro diagnostics
  • Disinfectant sanitizing

II - Certification of Good Manufacturing Practices (GMP)

Required the manufacturer (located in Brazil or abroad) and medical equipment (medical device). For foreign manufacturers, can be used reports and tests performed in laboratories accredited by INMETRO (National Institute of Metrology).

Check here laboratories accredited by IMMETRO abroad.

III - Special Licenses

  • Operating License- ANVISA/VISA
  • Licenses with the Federal Police, Civil Police and Ministry of Army

IV - Creation and Implementation of GS1 Brazil Bar Code in Products

The GS1 system is a proposal for standardization of processes for efficient management of supply chains in order to ensure the success of communication and international relations.