The regulatory law in the health area involves all the legislation that has ties with areas of medicine, biological products, active pharmaceutical ingredients, medical devices, cosmetics, food and agrochemicals, whose goal is to ensure the regulation, control and protection of the population health. For this reason, introducing new products into the market requires a deep knowledge of Brazilian legislation and regulations.

Our multidisciplinary team acts before regulatory and ruling bodies in order to enable the marketing of products and services, and the authorization of operations, including import licenses, project approvals and product registration.

In Brazil, the health control of food is a shared responsibility between various bodies and entities of the public administration, such as INMETRO, the National Agency of Health Surveillance – ANVISA and the Ministry of Agriculture, Livestock and Supply – MAPA.

Our work in this field includes:

  • Regulatory consultancy before the Ministry of Health, ANS (National Agency for Complementary Health), ANVISA (National Agency for Health Surveillance), MAPA (Ministry of Agriculture, Livestock and Supply).
  • Advice in compliance with regulatory standards from development to approval of new products, renewal and transfer of registers;
  • Assessment of cases involving permissions and restrictions on products advertising submitted to the Health Surveillance System;
  • Monitoring of the registration process of companies and products subject to health surveillance;
  • Regulatory advice for conformity of product labelling;
  • Elaboration of defenses and appeals related to sanitary infractions;
  • Advice on the importing of regulated products;
  • Consulting on product, label and packaging safety standards, including clients representation to regulatory agencies and public bodies;
  • Representation of corporations in litigation against public agencies or authorities;
  • Representation of clients in any administrative procedures under ANVISA, and Health Surveillance.
  • Review of advertising campaigns, package leaflet and product labels as approved by ANVISA.

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