Constantly presenting new possibilities for the prevention and treatment of disease. Directive 2001/82/ EC, which both sets out standards for veterinary medicinal products and outlines the authorisation procedures, focuses on the established pharmaceutical and immunological product types, and has no scope to provide a framework for innovative products that fall outside these categories. Anja Holm, independent consultant at Central VetPharma Consultancy, and Pascale Canning at Cyton Biosciences discuss how this can often frustrate and confuse companies wishing to market a product, and may be a block to useful products becoming available to veterinarians, farmers, and pet owners.