THE licensing and manufacture of veterinary medicinal products (VMPs) are both regulated in Ireland by the Health Products Regulatory Authority (HPRA; full disclosure I am on their board of directors).

The wholesale and retail supply chain for VMPs, of more relevance to this readership, is under the control of the Department of Agriculture (DAFM; for whom I’ve never worked).

But what of supplements? Shampoos? Nutraceuticals? Medical devices?

The last of these is a bit, but only a bit, more straightforward! The HPRA has a role in overseeing the medical device market, but not their use in animals. We’re talking all kinds of kit and caboodle here – from intravenous catheters to surgical mesh used in hernia repair, to foal-side test kits.

There is oversight of the quality of these devices, by means of a kite mark, but there isn’t the same clarity regarding the regulation of devices as there is for drugs that we give our animals.

How are VMPs distinguished from shampoos, supplements and nutraceuticals? Under EU law (Regulation 6/2019), the criteria for a VMP include, and I paraphrase:

  • Its presentation as a substance to prevent or treat disease.
  • Its purpose is to affect normal biological functions by exerting a medicinal effect.
  • Its purpose is to make a medical diagnosis.
  • Its effect, when administered, is to cause euthanasia.

    • All the above in animals of course, not in humans! In many instances, the distinction seems pretty clear, but inevitably there are areas that need teasing out:

    What of a surface agent (shampoo) that promotes a healthy coat but also deters parasites?

  • A herbal supplement that pacifies the patient?
  • A disinfectant that kills infectious organisms on the skin surface?
  • Homeopathic products?
  • Vitamins/minerals that have to be given by injection?

    • Or one promoting good health but also preventing a nutritional deficiency?

    And so on; the HPRA has the answers.If the product is determined NOT to be a VMP, it must have a statement on the product literature to that effect. There must be no medicinal claims made in this literature.

    And it must not be marketed in such a way that the ordinary consumer might reasonably believe it to be a medicine. Beginning to sound like a lawyer here, which I am not!

    ‘Normal’ food and feeding stuffs are not generally held to be veterinary medicines. These often, rightly and of course, contain normal, health-conferring nutrients, such as vitamins/minerals, essential fatty acids or amino acids, or even antibodies (e.g. colostrum substitutes). They are usually eaten, drunk or applied topically. Consider is it:

  • Eaten, drunk or applied to the skin;
  • At a dose within the normal recommended daily intake; and/or
  • Marketed with strap-lines such as ‘supporting good health’?

    • Simply put, supplements and nutraceuticals are substances generally naturally occurring and not administered by injection, marketed for healthy animals and intended to support normal growth and function e.g. of bones and joints. They are not intended to prevent or treat disease (not so simple here!) by way of exerting a pharmacological, immunological or metabolic effect.

    If the substance and/or commercial product is determined not to be a VMP then it may be termed a ‘medicated feed or intermediate product’. DAFM, not the HPRA, becomes the single, sole regulatory authority.

    A word of caution: VMPs are subject to rigorous oversight to the principles of ‘Quality, Safety and Efficacy’.

    The same may not apply to all other products in all instances. For consumers, my advice would always be ‘caveat emptor’ – let the buyer beware!

    Think ‘why’ you are giving it – will it benefit my horses?

    Is there a significant risk e.g. of failing a dope test?

    Must I have them signed out of the human-food chain? And, fundamentally, does my horse need this?