ECJ boost for borderline Products
Borderline products and medicines
In today's markets it has become common for companies to try to differentiate their products by including substances that could, in certain circumstances, be held to have a metabolic, pharmacological or immunological effect. Such products are known as "borderline" products and can be difficult to distinguish from products that require marketing authorisations as medicines. Product classes where borderline products are typically found include food supplements and cosmetics.
Historically, European medicines licensing agencies have taken a strict line on such products, classifying them as medicines where it was likely any constituent could exert a metabolic, pharmacological or immunological effect.
Relaxation of policy?
The recent decision in Case C-140/07 from the European Court of Justice (ECJ) is likely to be welcomed by manufacturers of "enhanced" foods and cosmetics as it should require European medicines licensing authorities including the MHRA, to scientifically establish that a product can act as a medicine before they can require companies to comply with European medicines legislation. This relaxation of European policy to borderline products should save companies valuable market lead-time and costs. The decision should also minimise the fragmentation of product markets across Europe reducing the number of cases where products are classified as medicines in some Member States, but not in others.
The case will now go back to the German Appeal Court who will have to decide if the German Medicines Agency did in fact scientifically establish that the product in issue could act as a medicinal product.
To read Dr Gareth Morgan's fuller discussion of this decision click here.
Gareth Morgan
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