In its submission to the consultation on the Regulation Impact Statement for country of origin labelling, ASMI says it advocated for voluntary country of origin labelling for therapeutic goods.
“ASMI supports sponsors who wish to include a country of origin statement on therapeutic goods labels,” says Steve Scarff, ASMI Regulatory and Scientific Affairs Director.
“However, inclusion of the statement, graphics or visual representations should not be mandated because all therapeutic goods are already highly regulated for safety and quality and all are manufactured in sites that have been approved by the Therapeutic Goods Administration – including overseas sites.
“Further, ASMI supports the removal of the “50% or more of total costs” element from the safe harbour defence since it will make the process simpler and will align with international practice.
“ASMI supports education, awareness-raising activities and guidance materials for industry and for consumers.
“Given the lack of therapeutic goods examples in current and proposed guidance materials, ASMI proposes the Australian Competition and Consumer Commission and industry develop them.
“ASMI would welcome the opportunity to collaborate with the ACCC to develop guidance materials,” he says.