Minister Signs Veterinary Medicinal Products Regulations 2024
- Published on: 12 September 2024
- Last updated on: 12 April 2025
Minister for Agriculture, Food and the Marine, Charlie McConalogue, T.D., has signed the Veterinary Medicinal Products Regulations 2024 into law.
The aim of the Regulations is to address the significant One Health challenge of antimicrobial and antiparasitic resistance and to ensure the continuation of the current supply channels of veterinary medicines.
The regulations provide for tighter controls around the prudent use of antiparasitic medications. This includes the upregulation of all antiparasitics to prescription only medicine (POM) status. With antiparasitics now available only on foot of a veterinary prescription issued by a veterinary practitioner, the central role of professional veterinary advice in determining the necessity and suitability of anti-parasitic products will be reinforced.
Minister McConalogue said that his focus has been on ensuring appropriate and prudent use of antimicrobial and antiparasitic veterinary medicines but, without undermining existing supply channels for farmers through retailers, including licensed merchants and co-operatives. The introduction of a “Proper Assessment Protocol” for the prescribing of anti-parasitic veterinary medicinal products will facilitate this. He acknowledged that, despite the significant process of consultation in recent years, stakeholders had a range of concerns and perspectives on the changes being brought forward.
Commenting on the regulations, the Minister said:
“In finalising these regulations, I sought to strike a reasonable balance between the differing viewpoints of stakeholders, without compromising on the overall objective. There has been extensive engagement, which was important, but it is also important to bring clarity to matters that have been under consideration for some time. It is vital that appropriate veterinary expertise is brought to bear when it comes to prescribing medicines, but equally that farmers have access to these medicines from a variety of supply channels at reasonable cost. I am satisfied that these regulations achieve those objectives.”
Note for Editors:
The Veterinary Medicinal Products, Medicated Feeds and Fertiliser Regulation Act was introduced in July 2023. The Act provides the Minister with powers to make Regulations on areas of EU Regulations that may be determined by national law. The Veterinary Medicinal Products Regulations aim to address antimicrobial and antiparasitic resistance by ensuring prudent use of Veterinary medicinal products and will provide for:
• The regulation of retail and internet sales of veterinary medicinal products (VMPs)
• The possession, administration and storage of VMPs and medicated feed
• Licensing of importation of certain VMPs and mediated feed
• Rules pertaining to prescribing of Prescription Only Medicines (POM), including antiparasitics
• Introduction of a mandatory electronic national veterinary prescription system (NVPS) which will be required to be used by all dispensers of POMs including a responsible person at a licensed retailer such as a co-op.
Additional Notes
(Added 13 September 2024)
VMP Regulations 2024 – Q&A
What is the purpose of these Regulations?
These Regulations, which are introduced under the Veterinary Medicinal Products, Mediated Feed and Fertiliser Regulation Act, provide for a range of matters including the retail, handling and storage and supply of veterinary medicinal products, as well as the prescribing and dispensing of these products.
The Regulations aim to protect animal health and welfare, and public health by addressing antimicrobial and antiparasitic resistance and promoting prudent use of veterinary medicinal products.
How do the Regulations address antimicrobial resistance?
The Regulations aim to address antimicrobial resistance by promoting prudent use of antimicrobials.
These Regulations provide for the introduction of a mandatory electronic national veterinary prescription system (NVPS). The NVPS will provide greater oversight of veterinary medicinal products and in particular antimicrobials. This oversight will allow better assessment of current actions to curb the development and spread of antimicrobial resistance detailed in our second One Health national action to address antimicrobial resistance – iNAP 2.
When will use of the National Veterinary Prescription System (NVPS) be mandatory?
A commencement order for the NVPS will be drafted in due course. It is intended that use of the NVPS will be mandatory from mid-January 2025. From this date all veterinary medicinal products (with the exception of antiparasitics) will be required to be prescribed and dispensed using the NVPS.
When will the requirement for a veterinary prescription for antiparasitics be mandatory?
The requirement for a prescription for antiparasitics will be introduced in June 2025 and after that all must be prescribed using the NVPS.
How do the Regulations address antiparasitic resistance?
The Regulations aim to address antiparasitic resistance by ensuring prudent use of veterinary medicinal products. This includes:
• the up-regulation of all antiparasitics to prescription only medicine (POM) status, whereby they can only be purchased or supplied on foot of a veterinary prescription
• the reduction in the prescription validity period for antiparasitics to 6 months
Why do antiparasitics need a prescription when they were available over the counter until now?
Until now, Ireland availed of a derogation to allow the vast majority of antiparasitics to be supplied over the counter without a prescription. The up-regulation of antiparasitics to a prescription only medicine (POM) for food -producing animals is a result of a determination in 2019 by the Health Products Regulatory Authority (HPRA) that Ireland no longer met the criteria to avail of the derogation based on a growing problem with antiparasitic resistance and the risk of environmental contamination.
Antiparasitic resistance threatens the sustainability of the grass-based pasture production model in Ireland as parasitic disease is a major challenge to the health and welfare of animals and impacts farm productivity, farm profitability and food security.
This change brings Ireland into line with the rest of the European Union in relation to supply of antiparasitics for food producing animals.
Why are POM(e) vaccines not available in retailers including co-ops?
There has been no change to the route of supply for prescription only medicine (exempt) (POM(e)) vaccines. These vaccines can only be supplied by vets or pharmacists and were never permitted for supply by any retailers.
The Health Products Regulatory Authority has determined that these vaccines are used in relation to complex diseases, and therefore there is a need for professional point of sale advice regarding effective use, safety risk associated with use, and disposal of unused vaccine or vaccine containers.
How will the Regulations impact veterinary practitioners?
From mid-January 2025 all veterinary practitioners will be required to use the National Veterinary Prescription System (NVPS) when issuing a prescription.
From June 2025 all antiparasitics will require a veterinary prescription.
When prescribing antiparasitics a veterinary practitioner is required to complete a proper assessment protocol if he or she is not providing ongoing veterinary services to the farmer, including clinical contact with the animals.
In terms of record keeping vets are required to keep a statement justifying the prescribing of an antimicrobial, in particular for preventive use or group treatment.
How will the Regulations impact farmers?
From mid-January farmers will be receiving electronic prescriptions from their vet in place of paper prescriptions. Introduction of the National Veterinary Prescription System (NVPS) will offer greater choice to the farmer as to where they purchase their medicines as prescription is issued via email and text message to the farmer.
Farmers will be able to access veterinary medicines through the same supply channels as heretofore. When the requirement for a prescription for antiparasitics is introduced in June 2025, the Proper Assessment Protocol will facilitate access to antiparasitics through Licenced Retailers and Co-ops.
The requirement for a prescription for antiparasitics will ensure prudent prescribing and use thus improving animal health and efficiencies at farm level.
How will the Regulations impact retailers?
From mid January 2025 retailers will be required to use the NVPS when dispensing prescription only medicines.
From June 2025 retailers will require a veterinary prescription in order to supply antiparasitics.
How will the Regulations impact pharmacists?
From mid-January 2025 pharmacists will be required to use the National Veterinary Prescription System (NVPS) when dispensing prescription only veterinary medicines.
From June 2025 pharmacists will require a veterinary prescription in order to supply antiparasitics.