What is a ‘Borderline Product’?
Determining which regulations should apply to veterinary healthcare products that fall outside of the scope of the EU veterinary medicines legislation (Directive 2001/82/EC as amended) can be a fraught exercise. Clear EU legislation and guidance exists for veterinary medicinal products, biocides for veterinary use, and for feed additives. However, many companies face bureaucratic obstacles when trying to decipher the standards applicable to products that do not fit in any of the foreseen categories of animal healthcare products: so-called borderline products. These may be animal ‘cosmetics’ (shampoos, cleansers, lotions, etc.), veterinary medical devices - or something else entirely. If you assume that absence of specific legislation for a category of product means it is unregulated, however, beware - your products could be in danger.
The European Legislative Background
Often, Cyton is approached by companies that already have a product which they sell in other territories, and it may come as a surprise that it is regulated completely differently in Europe as compared to their existing market. The situation is not helped by the fact that the EU National Competent Authorities (NCAs) often differ in their precise definitions of what is a veterinary medicine, and also vary greatly in the procedures used for registration of a ‘borderline product’. Working with Cyton to review the regulatory landscape that applies to your non-standard animal health products can avoid non-compliance issues, and can help to identify which European countries are the most desirable markets in each individual case.
Labelling and Advertising Claims, and Clarifying the ‘Grey Areas’
Cyton is in an unparalleled position in terms of our regulatory expertise for borderline products; as part of the knoell group, we can draw on extensive knowledge not only of Veterinary Medicinal Products and feed additives, but also of biocides and medical devices. We are familiar with many of the regulatory issues that companies encounter in the review of labelling text, and can provide valuable advice on the kinds of claims that are likely to be accepted and those that may be seen as problematic. Our long-standing experience of consulting with the EU NCAs regarding compliance queries for specific borderline products, and overseeing borderline review procedures, means that we can de-mystify the situation for our clients.