The Minister for Agriculture has signed new rules around the sales of veterinary medicines into law. The Department of Agriculture has answered a number of questions on what the new rules will mean for farmers.
What is the purpose of these regulations?
These regulations 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 (AMR)?
The regulations provide for the introduction of a mandatory electronic prescription system (NVPS). The electronic system will provide greater oversight of veterinary medicinal products, and in particular antimicrobials. This oversight will allow for better assessment of current actions to curb the development and spread of antimicrobial resistance.
When will the requirement for a veterinary prescription for antiparasitics be mandatory?
A commencement order for the requirement for a prescription for antiparasitics will be drafted in due course.
The requirement for a prescription for antiparasitics will be introduced in June 2025 and after that, all must be prescribed using the electronic system.
When will use of the new prescribing system be mandatory?
A commencement order for the electronic system will be drafted in due course. It is intended that use of the electronic system 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 electronic system.
How do the new 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. This means they can only be purchased or supplied on foot of a veterinary prescriptionThe reduction in the prescription validity period for antiparasitics to six monthsWhy 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 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 exempt vaccines not available in retailers including co-ops?
There has been no change to the route of supply for POM exempt 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 vets will be required to use the electronic system when issuing a prescription.
From June 2025 all antiparasitics will require a veterinary prescription.
When prescribing antiparasitics, a vet is required to complete a proper assessment protocol if they are 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.
The introduction of the electronic system 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, the Department said.
Farmers will be able to access veterinary medicines through the same supply channels as before now.
When the requirement for a prescription for antiparasitics is introduced in June 2025, the proper assessment protocol will facilitate access to antiparasitics through licensed retailers and through 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 electronic system 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 electronic system when dispensing prescription only veterinary medicines.
From June 2025, pharmacists will require a veterinary prescription in order to supply antiparasitics.
The Minister for Agriculture has signed new rules around the sales of veterinary medicines into law. The Department of Agriculture has answered a number of questions on what the new rules will mean for farmers.
What is the purpose of these regulations?
These regulations 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 (AMR)?
The regulations provide for the introduction of a mandatory electronic prescription system (NVPS). The electronic system will provide greater oversight of veterinary medicinal products, and in particular antimicrobials. This oversight will allow for better assessment of current actions to curb the development and spread of antimicrobial resistance.
When will the requirement for a veterinary prescription for antiparasitics be mandatory?
A commencement order for the requirement for a prescription for antiparasitics will be drafted in due course.
The requirement for a prescription for antiparasitics will be introduced in June 2025 and after that, all must be prescribed using the electronic system.
When will use of the new prescribing system be mandatory?
A commencement order for the electronic system will be drafted in due course. It is intended that use of the electronic system 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 electronic system.
How do the new 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. This means they can only be purchased or supplied on foot of a veterinary prescriptionThe reduction in the prescription validity period for antiparasitics to six monthsWhy 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 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 exempt vaccines not available in retailers including co-ops?
There has been no change to the route of supply for POM exempt 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 vets will be required to use the electronic system when issuing a prescription.
From June 2025 all antiparasitics will require a veterinary prescription.
When prescribing antiparasitics, a vet is required to complete a proper assessment protocol if they are 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.
The introduction of the electronic system 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, the Department said.
Farmers will be able to access veterinary medicines through the same supply channels as before now.
When the requirement for a prescription for antiparasitics is introduced in June 2025, the proper assessment protocol will facilitate access to antiparasitics through licensed retailers and through 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 electronic system 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 electronic system when dispensing prescription only veterinary medicines.
From June 2025, pharmacists will require a veterinary prescription in order to supply antiparasitics.
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