New veterinary drug rules – what to expect after January 28


In just over a week, new regulations on veterinary medicinal products and veterinary animal feed will be introduced across Europe under the EU Veterinary Medicines Regulation 2019/6.

The regulation, which comes into force on January 28establishes new rules for the sale, manufacture, import, export, supply, distribution, advertising, control and use of veterinary drugs and medicated feed.

However, in practical terms for all farmers, the new rules will end the prophylactic use of antibiotics to prevent disease and keep animals healthy; and will ensure that better husbandry, better hygiene and better management practices replace these antibiotics.

As we enter the final week before the changes kick in, Agriland provides an update on what exactly these changes entail.


According to the Department of Agriculture, Food and Marine (DAFM), there will be changes in prescriptions, and the validity period of prescriptions for antimicrobialsincluding antibiotics and medicated feed.

For the dairy sector in particular, one of the main changes from January 28 concerns the administration of antibiotic tubes to dry cows for the treatment and preventive prevention of udder infections and mastitis.

These will no longer be allowed to be given to all cows – blanket therapy – as a preventive measure; only cows that have an infection, and where that infection has been identified, will receive this treatment – ​​a selective therapy.

Under the new regulations, a prescription will be required which will be valid for five days from the date of issue and must be filled within that time.

But the animal, or animals, can be treated for as long as specified by the veterinarian on the prescription.

However, the requirement for a prescription for antiparasitics has been deferred to June 1, 2022 and this will be dealt with later.

DAFM advises that existing prescriptions you may have for specific antimicrobials such as intramammary tubes for cows will no longer be valid from February 2, 2022.

For all other non-antimicrobial veterinary drugs, a prescription is valid for a maximum of 12 months.

Image source: DAFM

HP-CIA and mastitis

As shown in the image above, starting January 28, some dry tubes will no longer be used routinely due to the presence of “Highest Priority Critically Important Antibiotics” (HP-CIA).

In 2005, the World Health Organization (WHO) classified all antibiotics into three categories based on their relevance to human health: Important; Very important ; and of crucial importance. HP-CIAs are a subset of those that are critically important.

According to Animal Health Ireland (AHI), although the overall use of HP-CIAs in the treatment of mastitis has been limited, “there was evidence of an increase from 2003 to 2015 in the number of intramammary probes used (both in lactation and at dry off), containing at least one HP-CIA”.

In 2018, 8% of the tubes of dry cow antibiotics used contained HP-CIA, AHI said.

Exceptional cases

There are always some exceptions to certain rules and according to the DAFM antimicrobials will be allowed for prophylaxis in ‘exceptional cases’ for administration to an individual animal or to a limited number of animals when the risk of infection is very high and the consequences are likely to be severe.

If an antibiotic is used in this scenario, it will be limited – in quantity and duration – and based solely on the needs of the animal or animals.

A prescription will be needed in this scenario.

A prescription will also be required where antimicrobials for metaphylactic treatment are needed – in exceptional cases, and only after diagnosis of infection.

This only applies when the risk of spreading the infection is high and no other alternative is available.

Medicines on the farm – what’s the problem?

According to the DAFM, there may be a small amount of medication on a farm that are essential to protect the health and welfare of animals.

However, prescription-only (POM) drugs can only be present if a veterinarian deems them necessary, the DAFM says, adding that it is up to your veterinarian to justify the veterinary drugs they have prescribed for your animals.

In the case of prescription-only antimicrobial drugs, a veterinarian may prescribe only a small amount of antimicrobials to be kept on farm when there may be an essential need for administration to an individual animal or a limited number animals when the risk of infection or an infectious disease is very high or its consequences are likely to be serious.

It is important to discuss such scenarios with your veterinarian to fully understand what is allowed.

Prescription – paper or digital?

DAFM will introduce a new National Veterinary Prescription System (NVPS) in 2022 to facilitate the recording of prescriptions in digital format.

This was due to be implemented on January 28, but has been postponed and will instead be done in stages, allowing paper scripts to continue for a limited time.

This period will, according to the DAFM, allow all stakeholders to prepare and familiarize themselves with the new digital system.

The NVPS is expected to be operational in June 2022.

Stay tuned Agriland over the coming week as we cover the impact of the new rules on veterinary medicines in more detail.


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