Borderline Products
A veterinary medicine cannot be legally sold or supplied in Ireland without a marketing authorisation. In most cases the basis for classifying a particular product as a veterinary medicine is clear. However, in other cases, the position might be less clear, for example where a product includes ingredients that appear to be nutritional in nature but do in fact have pharmacological activity. In cases such as these, we have a procedure in place to review an application and to decide whether the product is a veterinary medicine, or is 'out-of-scope' of the legislation.
Under national legislation (S.I. No. 36 of 2022) the HPRA is the competent authority for deciding the categorisation of a product as a veterinary medicine or not.
For more information see the
Definition of a Veterinary Medicinal Product and the Classification Process. This guide also contains information on the steps involved in the classification procedure. The relevant application form is available from the Publications section of our website (Publications > Classification enquiries).