Standards & Advice update: Advice published on amended Veterinary Medicines Regulations

As the profession will be aware, the Veterinary Medicines Regulations 2013 was amended by the Veterinary Medicines (Amendment etc.) Regulations 2024 (VMRs 2013 (as amended)) which together set out the controls on the marketing, manufacture, distribution, possession, and administration of veterinary medicines and medicated feed.

These amendments apply in England, Wales, and Scotland only. This means that in Northern Ireland, the previous VMRs will continue to apply. Notwithstanding this, the RCVS Standards Committee has decided that many of the amendments will be reflected in PSS Core Standards, making them applicable to all practices in the UK, including those in Northern Ireland.

The amendments are designed to ensure continued availability of safe and effective veterinary medicines and include measures to help reduce the risk of development and spread of antimicrobial resistance.

The VMD has published updated guidance that reflects the amendments, which can be found under Veterinary Medicines Guidance on GOV.UK, and further information can be found on the VMD Information Hub. The RCVS’ guidance and PSS Core Standards have also been updated to reflect the changes.

For some amendments, the VMD provided a transitional period to enable the profession to adjust its guidance, policies, and practices to work towards compliance over several months. For further information in relation to specific transitional periods that still apply, please see PART 10, Transitional provisions of the VMRs 2024.

Veterinary surgeons and veterinary nurses are encouraged to review VMD Guidance in full and contact the VMD with any questions on [email protected]

In the meantime, the main amendments relevant to veterinary surgeons and veterinary nurses, are summarised as follows:

New offence relating to misuse of the cascade

Veterinary surgeons and veterinary nurses (and any person) must not promote or facilitate any purported use of the cascade which is not in accordance with the VMRs, and to do so is now an offence in England, Wales, and Scotland.

This does not change VMD guidance (see final paragraph) relating to medicines commonly found around the home where the advice is that in exceptional emergency circumstances, veterinary surgeons may recommend that an animal owner use a human medicine they already have in their possession, such as antihistamine tablets.

If a human medicine is not already in their possession, it will need to be prescribed under the cascade and usual prescribing and supply rules apply. 

New offence relating to submitting a written prescription to a retailer more than once if the prescription is not repeatable [or is not an instalment prescription]

To tackle prescription fraud/misuse, the VMD has introduced a new offence in England, Wales, and Scotland which practices may wish to reference when providing information to clients about written prescriptions/obtaining veterinary medicines from retailers of their choice.

Wholesale supply of veterinary medicinal products must now be to a registered veterinary practice premises (RVPP)

Previously, wholesalers were permitted to deliver veterinary medicinal products to any person authorised to prescribe and/or supply those products, which might have included a veterinary surgeon’s home address. It is now the case that in England, Wales, and Scotland, delivery can only be to a RVPP.

Requirement to conduct a clinical assessment of animals under care before prescribing now extends to veterinary medicinal products prescribed under the cascade

The profession has been advised by the RCVS, with confirmation from the VMD, for some time to treat medicines prescribed under the cascade the same as POM-Vs for the purposes of the expectations set out in Chapter 4 of the supporting guidance, however, this is now an explicit requirement under the VMRs.

New rules relating to the prescribing of antibiotics

1. The prescribing of antibiotics to be used routinely, to compensate for poor hygiene, inadequate animal husbandry, or poor farm management practices, or to promote growth or increase yield, is now prohibited. This is subject to a veterinary surgeon’s professional conduct obligation to make animal health and welfare their first consideration when attending to animals.

2. Prophylactic use of antibiotics save for in exceptional circumstances is also prohibited. Veterinary surgeons must not prescribe an antibiotic for prophylactic purposes, unless it is an exceptional circumstance (i.e., where the risk of an infection or of an infectious disease is very high and where the consequences of not prescribing the antibiotic are likely to be severe). 

3. Veterinary surgeons must now ensure that veterinary medicinal products that are antimicrobials are prescribed for the most limited period that is consistent with the risk to be addressed. This will be a matter for the clinical and professional judgement of the prescribing veterinary surgeon in each case considering relevant guidance set out from paragraph 4.30 of Chapter 4 of the supporting guidance relating to antimicrobial and anthelmintic resistance.

New written prescription requirements

More details must now be included on written prescriptions. In summary, they are as follows:

1. More details of the prescriber are required, including the prescriber’s full name and MRCVS number;

2. Contact details of the owner or keeper, as well as their name and address, are now required;

3. An issue date rather than a prescription date is now required; 

4. An electronic signature is now permitted as well as a hand-written signature;

5. The pharmaceutical form and strength and dosage regimen is now required;

6. The words “it is an offence under the Veterinary Medicines Regulations 2013 for a person to alter a written prescription unless authorised to do so by the person who signed it” must now be included on each written prescription;

7. A statement confirming if antibiotics have been prescribed for prophylactic purposes or metaphylactic purposes must be included where applicable.

Please see the relevant section of the VMRs 2024 for full requirements and to ensure that prescription templates are updated accordingly.

New record keeping requirements

1. Where a veterinary medicinal product is supplied against a prescription that is not a written prescription, i.e., a verbal prescription or a record of a verbal prescription in the clinical notes, the person prescribing it must record the reason for prescribing it and keep a record of that for 5 years. Due to the existing RCVS Code obligation to keep clear, detailed, and accurate clinical and client records, this change does not significantly impact veterinary surgeons and veterinary nurses.

2. Veterinary surgeons who prescribe antibiotics must make a record of the satisfaction of the relevant conditions (see above and the VMRs) for the purposes of its use under the VMRs 2024 and keep that record for at least five years.

Internet retailers selling or supplying veterinary medicinal products online in England, Wales, and Scotland must now be registered with the VMD

They must also include on their websites:

1. the statement “registered internet retailer of veterinary medicines” on each part of the website where products are offered; 

2. the contact details of the Secretary of State; and

3. a link to the published register.

Change to rules relating to the advertising of veterinary medicinal products

Advertising of veterinary medicinal products must now:

1. be set out in a way that makes it clear that it's an advertisement;

2. be objective;

3. promote responsible use;

4. not be misleading;

5. not be incompatible with the summary of product characteristics;

6. not encourage improper use;

7. include the statement, "prescription decisions are for the person issuing the prescription alone"; and

8. ensure that all factual statements regarding the characteristics of the veterinary medicinal product are consistent with the summary of product characteristics.

New rules relating to inducements and hospitality

Veterinary surgeons and veterinary nurses who are also SQPs must not solicit or accept any gift, monetary advantage, benefit in kind, hospitality or sponsorship prohibited under the VMRs 2024.

Those who promote veterinary medicinal products to veterinary surgeons and veterinary nurses who are also SQPS cannot offer or promise a gift, monetary advantage, benefit in kind unless it is inexpensive and relevant (has a clear business use, i.e. pens/notebooks) to practicing veterinary medicine (including loyalty schemes).

Hospitality must be subordinate to the main objective of the event and be offered only to animal health professionals.