[ Diretor: Mário Frota [ Coordenador Editorial: José Carlos Fernandes Pereira [ Fundado em 30-11-1999 [ Edição III [ Ano XII

quarta-feira, 30 de novembro de 2011

Emplastros medicamentosos de capsaícina ou de sementes de mostarda - enquadramento regulamentar


Infarmed: Circular Informativa N.º 248/CD
Data: 29/11/2011


Foi detectada, na Lituânia, a comercialização de emplastros medicamentosos de capsaícina e de sementes de mostarda, de vários fabricantes sediados na Estónia e Letónia, qualificados como dispositivos médicos de classe I, ostentando indevidamente a marcação CE.

A capsaícina é o componente activo das pimentas chili, plantas que pertencem ao género Capsicum. As sementes de mostarda obtêm-se de várias plantas dos géneros Brassica e Sinapis. Os emplastros medicamentosos que contêm estas substâncias destinam-se essencialmente a promover uma analgesia local, sendo indicados para o alívio da dor e tensão muscular, dor reumática ou nevrálgica. O efeito principal é alcançado por meios farmacológicos, imunológicos ou metabólicos, pelo que estes produtos não se enquadram na definição de dispositivos médicos.

Adicionalmente, as orientações relativas à implementação das Directivas dos dispositivos médicos , determinam que os emplastros térmicos que contêm capsaícina sejam considerados medicamentos.

Face ao exposto, a autoridade competente da Lituânia para a área dos dispositivos médicos suspendeu a disponibilização no mercado dos referidos produtos.

Em Portugal, não existe registo da comercialização de emplastros medicamentosos de capsaícina ou de sementes de mostarda como dispositivos médicos. Contudo, atendendo a que existe livre circulação de produtos no espaço económico europeu, o Infarmed recomenda que caso estes produtos sejam detectados, em Portugal, ostentando marcação CE, este facto seja reportado à Direcção de Produtos de Saúde do Infarmed através dos contactos: tel.: +351 21 798 72 35; fax: +351 21 798 72 81; e-mail: daps@infarmed.pt.


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