Purchase of veterinary medicines online and accessing or importing them
Every veterinary medicine supplied in Ireland must be authorised for use in this country. Stringent legislation exists governing:
- The purchase of veterinary medicines on-line,
- The importation and use of veterinary medicines from abroad,
- The use of human medicines for the treatment of animals.
Indeed, under national legislation (Veterinary Medicinal Products, Medicated Feed and Fertilisers Regulation Act), it is illegal for a person to have in his possession or to supply a veterinary medicine that is not authorised here.
The Department of Agriculture, Food and the Marine (DAFM) is responsible for regulating the purchase, supply, use and importation of veterinary medicines in Ireland. The HPRA does not have a direct role; we are occasionally consulted by DAFM regarding specific applications for special import.
DAFM has provided useful information on the purchase of veterinary medicines over the internet, which is available on the DAFM website.
Veterinary medicines that are authorised in the UK or in an EU Member State might not have a marketing authorisation in Ireland. DAFM considers them as not being compliant. The products may be withheld by Customs officials on importation into the country.
Experience has shown that veterinary medicines ordered on-line and supplied from abroad using unlicensed websites might:
- be counterfeit, and not contain the active substance or contain it at a much lower concentration,
- be out-of-date, or be short-dated,
- be supplied in foreign labelling, not compliant with national legislation, or
- have been compromised during storage (for example. not stored or transported under the specified storage conditions).
Such products may not be effective at best and could cause injury to you or the animal concerned.
Veterinary practitioners should note that particular national rules apply to the importation of needed veterinary medicines from abroad. In these cases, vets should apply to DAFM for a special licence to import a veterinary medicine under the ‘cascade’ provisions of the legislation (a system for exceptional use where no authorised veterinary medicine is available in Ireland).
The HPRA continues to work to improve the range of authorised veterinary medicine in Ireland through a range of national and international initiatives.
Supply and use of human medicines in veterinary practice
Regulation 2019/6 allows veterinary practitioners to use certain human medicines when a suitable veterinary medicinal product is not available in Ireland. Veterinary practitioners can obtain these medicines from a retail pharmacy in Ireland, or from an Irish wholesaler authorised to supply human medicines.
Wholesalers of human medicines in Ireland are permitted to supply human medicines to veterinary practitioners in accordance with the national legislation. The term ‘supply by wholesale’ is defined in regulation 4(1) of the Medicinal Products (Prescription and Control of Supply) Regulations 2003 covers the supply of medicinal products for various purposes, including:
- supply in the course of a pharmaceutical business,
- administration in the course of a professional practice associated with a certificate of suitability, or
- for or in connection with a service provided by a hospital.
The HPRA interprets ‘professional practice’ to include practice by a registered veterinary practitioner. Veterinary practitioners have an ethical and professional responsibility to treat animals to relieve or prevent animal suffering.
In accordance Regulation 2019/6, human medicines that are centrally authorised (following the European Medicines Agency’s recommendation) or authorised in Ireland or in another EU Member State as a human medicinal product, can exceptionally be supplied to veterinary practitioners when no authorised veterinary alternative is available.
It is important to note that the ‘cascade’ provisions in Regulation 2019/6 do not entitle veterinary practitioners to access or use human medicines which have been supplied into Ireland without a marketing authorisation. This restriction applies to human medicines imported into Ireland which are intended for administration to a specific human patient under the care of a medical practitioner (and includes human medicines which are supplied as exempt medicinal products under Article 5.1 of Directive 2001/83/EC, as well as human medicines supplied via compassionate use programmes in accordance with Article 83 of EU Regulation 726 of 2004). It is also not permitted to import for veterinary use into Ireland human medicines which have been authorised for supply only within the UK in accordance with the Windsor Framework; such products are labelled as ‘UK only’ and are precluded from onward movement into the EU.
When veterinary practitioners order human medicines from a human medicines’ wholesaler in Ireland, they should refrain from writing a prescription (which should only be filled by a retail pharmacy or licensed veterinary retailer). Instead, they should maintain records in the veterinary practitioner’s order book, specifying that the medicines sought were for use in animals under their care and in accordance with their professional practice. In all such cases, veterinarians should keep detailed records to evidence that there is not a suitably authorised veterinary medicine available to justify using the chosen human medicine.