Also known as Sanitary Law, the Regulatory Law in Health Area comprises a set of laws, decrees, ordinances, resolutions, etc., from municipal, state, and federal powers, which aim to protect the population’s health.
In this sense, the National Surveillance Sanitary Agency – ANVISA, which is linked to the Ministry of Health, plays an important role as a regulatory and surveillance state agent of the subject matter. Among other obligations, the ANVISA is responsible for authorizing the operation of producers, distributors, and importers of medicines; for granting registration for these products; for inspecting manufacturing, control, import, storage, distribution, and sale facilities, as well as places where services related to health are rendered.
Aware of the increasing importance of this law field, our firm has assembled a specialized team of attorneys and technical professionals with substantial multi-disciplinary experience in transactional, regulatory, and intellectual property practice areas to handle both complex legal and regulatory challenges, including drug marketing approval, advertising and labeling, unfair competition and data protection. Our experience extends beyond administrative practice before ANVISA to also include litigation at all levels and venues in the Country.
Our highly qualified professionals are able to provide wide-angled legal perspectives and to develop creative approaches to help clients achieve their commercial goals for this market sector.