RECALL DE MEDICAMENTOS

• Autor(a) principal: Alves, Adirley Machado
• Data de Publicação: 2017
• Outros Autores: Kallas Filho, Elias
• Tipo de documento: Artigo
• Idioma: por
• Título da fonte: Revista de Direito Sanitário (Online)
• Texto Completo: https://www.revistas.usp.br/rdisan/article/view/142020
• topic: Acesso à Informação; Consumidor; Direito à Saúde; Recall de Medicamentos.; Access to Information; Consumer; Drugs Recall; Right to Health.

Recall is an instrument which enables the supplier to comply with surveillance and reporting duties, serving as a mandatory means of communication of the dangerousness presented by the product and a warning for this product withdrawal. It is an instrument that assures the protection of the consumer’s right to health and safety, consistent with principles of prevention/precaution, applying also to consumer relations involving drugs under a specific legislation. Bibliographic research together with a comparative analysis with the Portuguese legislation, showed that the Brazilian Law establishes very similar guidelines to those of Portugal. However, while in Portugal, the supplier has the obligation of tracing the product for recall, in Brazil, it is the customer’ responsibility to exchange the defective drug, once they become aware of the problem. Therefore, it is important to create an official and efficient channel of information with customers, where clear, complete and accurate information about all drug recalls can be made available, to allow the instrument to accomplish its main objectives effectively.