CRIMINAL AND REGULATORY ASPECTS OF THE SALE OF PHARMACEUTICALS WITHOUT REGISTRATION

Abstract

The purpose of this essay is to deal with the criminal and regulatory aspects of the pharmaceuticals sale without previous registration in Brazil, as a consequence of the rule established in article 273, paragraph 1-B, of the Penal Code, by the so-called "Remedies Law", through an analytical investigation, based on a legal-theoretical research using the inductive method, of the legislation and jurisprudence of the Superior Courts. Faced with the controversy that has been going on for approximately 20 years regarding the reasonableness of the criminal type, and given the recognition of the constitutionality of this criminal law by the Superior Court of Justice and the Federal Supreme Court, this work aims to offer a counterpoint to the restriction imposed by Brazilian legislation on the production and commercialization of medicines without previous registration with the understanding adopted by the Judiciary Court regarding the possibility to the State to grant funds and supply medicines not yet registered with Anvisa. In the end, we intend to question the overlapping of criminal law to the regulation of the National Sanitary Surveillance Agency

Keywords

• reflexos penais da regulação. comercialização de medicamentos. registro de medicamentos. crimes de perigo e dano. interpretação conforme a constituição.