Under national legislation, a veterinary medicine cannot be sold or supplied in Ireland without a marketing authorisation i.e. a veterinary product authorisation (VPA). In most cases the basis for classifying a product as a veterinary medicine is clear. However, in other cases, the classification may 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 been designated by the legislation as the competent authority for classifying the product either as a veterinary medicine or 'out-of-scope' of the legislation.
Where you are unsure as to the classification of your product, you may submit a request for classification of a borderline product for animal use, also termed a ‘classification enquiry’.
For more information see the Guide to the Definition of an Animal Remedy and the Classification Process
which contains additional information including an outline of the steps involved in the classification procedure.
The relevant application form (Publications > Classification enquiries) is available from the Publications section of the HPRA website.
Exemption from the requirement for a veterinary medicine
If you consider that your product might be borderline (medicinal or non-medicinal), you should seek the opinion of the HPRA by way of a classification enquiry. Note that national legislation is being elaborated that is expected to set out more detailed information. The HPRA understands that the national legislation will be available during summer 2022.