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 your product is intended solely for an aquarium fish, a caged bird, a homing pigeon, a terrarium animal, a small rodent, a ferret or a rabbit (kept exclusively as a pet) it may be eligible for exemption from the requirement for an animal remedies authorisation. This exemption is detailed under Regulation 3(3) of the European Communities (Animal Remedies) (No. 2) Regulations 2007 (S.I. 786 of 2007), as amended. In such a case a classification enquiry should be submitted.