Veterinary Medicines and Medicated Feed

The Regulations set out new rules for the sale, manufacture, import, export, supply, distribution, advertising, control and use of veterinary medicinal products and medicated feed. These aim to increase the availability of veterinary medicinal products across the EU and address the One Health One Welfare challenges of Antimicrobial Resistance (AMR) and antiparasitic resistance by guaranteeing the highest level of public health, animal health and environmental protection.

The new EU-wide Veterinary Medicinal Products and Medicated Feed Regulations come into force on 28 January 2022.

The requirements on prescribing and time limit for valid prescriptions for antimicrobials, including antibiotics, and medicated feed, take effect on 28 January 2022. The implementation date of the prescription requirement for antiparasitics is now 1 December 2022.

The main changes that take effect on veterinary medicines from 28 January 2022 in Ireland include:

• rules on manufacturing of veterinary medicines
• labelling of veterinary medicines
• pharmacovigilance rules
• EU product database
• rules on the wholesale of veterinary medicines
• rules on prescribing
• validity of prescriptions for antimicrobials and medicated feed
• rules on use of veterinary medicines
• advertising of veterinary medicines

Read the full list on the Health Product Regulatory Authority (HPRA) website and on our website.

A prescription for antimicrobials is valid for five days from date of issue and must be filled within this timeframe. You can treat the animals for as long as is specified by the vet on the prescription.

Any existing prescriptions that you have for specific antimicrobials like intramammary tubes for cows will no longer be valid from 2 February 2022. You will need to contact your veterinary practitioner to get a new prescription.

A prescription for all other veterinary medicines that are not antimicrobials can be valid for a maximum of 12-months.

The new regulation requires that antimicrobials are not used routinely or to compensate for poor hygiene, inadequate animal husbandry or poor farm management.

After January 2022, antimicrobials are only allowed for prophylaxis in 'exceptional cases' for administration to an individual animal or restricted number of animals when the risk of infection is very high and consequences are likely to be severe. In the event of an antibiotic being used in 'exceptional' cases for prophylaxis, it will all be limited in quantity and duration to the treatment to cover the risk of an individual animal.

After January 2022, a prescription for antimicrobials for metaphylaxis may only to be issued after diagnosis of infection, when the risk of spread of an infection is high and when no other appropriate alternatives are available.

Antimicrobials will be prescribed by vets acting within a Client-Patient-Practice-Relationship (CPPR) in line with the Veterinary Council of Ireland’s Code of Professional Conduct for Veterinary Practitioners.

There can be a small quantity of medicines on a farm that are essential to protect animal health and welfare. Prescription Only Medicines (POM) can only be present if a vet deems them necessary. It is for your vet to justify the veterinary medicines they have prescribed for your animals. In the case of prescription only antimicrobial medicine, a vet can only prescribe a small quantity of antimicrobials to be kept on farm where there may be an essential need for the administration to an individual animal or restricted number of animals when the risk for infection, or an infectious disease is very high or its consequences are likely to be severe. Contact your vet for further details.

The requirement to only supply antiparasitic medicines on foot of a veterinary prescription is deferred until 1 December 2022. A prescription will not be required for such products until that date. This is to allow the necessary business and/or infrastructural adjustments that will ensure compliance and the Regulations will apply in full from 1 December 2022.

The new National Veterinary Prescription System (NVPS) is in place since January 2022. It is available for voluntary use by vets to ensure prescribers and dispensers are familiar with the system when it becomes compulsory on 1 December 2022. Veterinary practitioners can continue to issue paper-based prescriptions until then.

The implementation date of the prescription requirement for antiparasitics is now 1 December 2022.

From 2022, your vet will need to write you a prescription to get antiparasitics for food-producing animals. The time limit on a valid prescription for these products will be 12 months. Antiparasitic medicines can then be purchased by your preferred supplier in the timeframe of the valid prescription.

Further Guidance to Veterinary Medicinal Products Industry on elements of the Roadmap to Implementation of EU2019/6

The following guidance is bring provided to assist industry and provide further clarity on the practical implementation surrounding the decision announced to defer the requirement to only supply antiparasitic medicines for food-producing animals under prescription until December 1 2022.

Measures permitted until December 1 2022:-

1. Antiparasitics for food-producing animals can be supplied without prescription.

2. Antiparasitics for food-producing animals can continue to be sold online and at a distance.

3. Antiparasitics for food-producing animals can continue to be advertised.

4. Antiparasitics for food-producing animals can continue to be on display in retail premises.

These interim measures should provide adequate time to allow industry to move to full compliance by December 1 2022.

On that date there must be no supply of antiparasitics without a prescription, they must no longer be advertised, either in print or online, and they must not be on display in a retail premises.

Watch our recent recordings on the new rules below:

The Future of Prescribing – EU Regulations and What They Mean for You

Veterinary Medicines Landscape post 2022 EU Regulations and What They Mean for You

For more information visit our website or email vetmedregs@agriculture.gov.ie

Superintending Veterinary Inspector Dr Caroline Garvan speaks to RTE’s Countrywide here

Details of the full regulations are available at the links below:

• https://eur-lex.europa.eu/eli/reg/2019/6/oj
• https://eur-lex.europa.eu/eli/reg/2019/4/oj