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The adverse effects of medicinal products will be better monitored in future, to prevent the recurrence of cases like the French diabetes medicine "Médiator" (benfluorex), which led to many deaths. Changes to existing EU legislation, backed by the Public Health Committee on Tuesday, would trigger an automatic EU safety evaluation in the event of a safety alert about a medicinal product in any EU Member State.
A breast implant register, more stringent checks and product traceability, and a pre-market authorisation system are among the measures proposed by the Environment and Public Health Committee on Wednesday to prevent a recurrence of the PIP defective breast implants case. The resolution was passed unanimously.
(a) air, soil and water pollution, waste management and recycling, dangerous substances and preparations, noise levels, climate change, protection of biodiversity,
(b) sustainable development,
(c) international and regional measures and agreements aimed at protecting the environment,
(d) restoration of environmental damage,
(e) civil protection,
(f) the European Environment Agency,
(g) the European Chemicals Agency;
(a) programmes and specific actions in the field of public health,
(b) pharmaceutical and cosmetic products,
(c) health aspects of bioterrorism,
(d) the European Medicines Agency and the European Centre for Disease Prevention and Control;
(a) the labelling and safety of foodstuffs,
(b) veterinary legislation concerning protection against risks to human health; public health checks on foodstuffs and food production systems,
(c) the European Food Safety Authority and the European Food and Veterinary Office.
