Regulation in Areas Other than, but Related to, Medicinal Products for Human Use

Abstract

The previous two chapters have addressed the controls that are developing throughout the EC on medicinal products, although they have not addressed in especial detail what is meant by the term ‘Medicinal Product’, and in particular where its boundaries lie. The term is defined in Directive 65/65/EEC as:

‘Any substance or combination of substances presented for treating or preventing disease in human beings or animals.

Any substance or combination of substances which may be administered to human beings or animais with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings or in animals is likewise considered a medicinal product.’