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Medicinal Product

All medicines legislation is controlled in the EU by 2001/83/EC Directive as amended. It defines a medicinal product as: 'Any substance or combination of substances presented for treating or preventing disease in human beings or animals'. Or 'Any substance or combination of substances which may be administered to human beings or animals with a view to making a diagnosis or to restoring, correcting or modifying physiological functions in human beings or animals is likewise considered a medicinal product'. 

Traditional herbal medicinal products and homeopathic medicinal products are the subject of additional specific EU legislation. 

All medicines must be registered with the appropriate government Health Authority and receive a Marketing Authorisation or Traditional Herbal Medicine Registration. The medicine can then be made available to the public, either with or without a prescription as appropriate. 

Borderline Product

Sometimes it is hard to determine if a preparation is a medicinal product or if it may be covered by other legislation such as that for a nutritional or cosmetic product or a medical device. These are known as borderline products. 

Borderline products require careful evaluation to decide into what legal category they will fall i.e. will the product be considered as a medicine or not.