Important information for AMTRA RAMAs as the new Veterinary Medicines Regulations come into force
The Veterinary Medicines (Amendment etc.) Regulations 2024 came into force on 17 May 2024, with certain elements 6 months later (i.e. 17 November 2024).
The 2024 Regulations amend the 2013 Regulations, so formally it is the 2013 Regulations (as amended) that are in force: any references to the 2013 Regulations should be taken to be the amended version.
Note that the 2024 amendments to the 2013 Veterinary Medicines Regulations apply only in Great Britain (England, Scotland and Wales), so a different version of the 2013 Regulations applies in Northern Ireland. However, the SQP Code of Practice issued by DEFRA/VMD is a UK-wide document, and AMTRA expects all its RAMAs/SQPs to comply with the latest version, including those working in Northern Ireland.
There are a range of amendments to the VMRs, some of which are directly relevant to SQPs/RAMAs and may affect your day-to-day work.
AMTRA has developed a quick reference overview below to highlight some of the key updates relevant to SQPs/RAMAs to help support you in understanding the changes that have been made to the legislation.
Reason for prescribing and keeping records
Under the new Regulations any qualified person who verbally prescribes a prescription medicine (POM-V or POM-VPS) including pharmacists and SQPs, is required to document their rationale for doing so . This is in addition to the information you are already recording as per paragraphs 47 and 48 of the new Code of Practice. "Verbally" means where a veterinary medicinal product is supplied in accordance with a prescription which is not legally a "written prescription" (i.e. not one issued in accordance with paragraph 33 of the new Code of Practice), and so the vast majority of prescribing done by RAMAs/SQPs.
Paragraphs 47 and 48 of the new (May 2024) Code of Practice require the following:
47. An SQP supplying POM–VPS products must ensure the following information is recorded in relation to all
incoming and outgoing (which include medicines sold, returned to a supplier, destroyed or otherwise disposed of) POM-VPS transactions.
AMTRA has developed some guidance and commentary on the subject which should be read by those involved in POM-VPS (farm and equine medicines).
In practice, SQPs will rarely issue written prescriptions consistent with paragraph 33 of the Code and almost all prescriptions will formally be "verbal", but if they do issue such written prescriptions, AMTRA would strongly recommend that the "reason for prescribing that product" be recorded in all cases.
This is an update that AMTRA actively requested be included in the Regulations, as we believe it will support high quality prescribing. The reasons for prescribing a particular product will available for audit by VMD, and may be taken into account by AMTRA in any case that reaches our Professional Standards Committee.
The shift is aimed at encouraging and supporting evidence-based prescribing: for example, a faecal egg count (FEC) indicative of a parasite burden could be a good reason to prescribe, and evidence of a particular pattern of resistance on a farm would be a good reason to choose particular active ingredients.
For avoidance of doubt, the words "received or supplied" in this paragraph apply to all transactions, incoming and outgoing, including all the examples in the first sentence.
"Incoming" will normally be from a Wholesale Dealer (which might include the manufacturer with a Wholesale Dealer Authorisation), but any other sources should also be included such as any exceptional emergency supplies from another retailer.
Such record-keeping is not legally required for NFA-VPS or AVM-GSL medicines (nor those marketed through the Exemption Scheme for Small Pet Animals / SAES), but a number of businesses choose to do so, and this may be regarded as good practice, and could support an effective batch recall should that be required.
48. These records must be kept for five years at the authorised premises. The records may be kept electronically and must be made available for inspection by a duly authorised person on request. Further information on record keeping is available on GOV.UK under Veterinary Medicines Guidance.
Other changes relevant to RAMAs/SQPs:
- removing the requirement for an SQP to be in a position to intervene when a medicine is supplied (however they must still authorise each transaction individually and the person handing the medicine over must be competent to do so)
- adding a new offence for anyone who attempts to get a single use prescription filled more than once
Other changes affecting retailers potentially relevant to RAMAs/SQPs:
- There’s a new legal requirement in the revised Regulations to store products in accordance with the requirements of their SPC including during transport i.e. from warehouse to wholesale, wholesale to retail, and between retail outlets.
- A requirement for all online sellers of veterinary medicines classed as POM-V, POM-VPS and NFA-VPS to be registered with the VMD. Previously, the premises of online sellers had to be registered just as all other retailers, but now online retailers will have to be registered and inspected as such.
- There are four new categories of SQP retailer. SQP retailers may be authorised for one or more of the following new categories:
- Livestock medicines – category L
- Avian medicines – category A
- Companion animal medicines – category C
- Equine medicines – category E
- Changes to the requirements for written prescriptions and the requirements for prescribing antibiotics
- Clarification that the requirements for prescription medicines also cover medicines prescribed and supplied under the cascade in addition to medicines classified POM-V and POM-VPS
- There are a number of changes related to fees. Please refer to the VMD website for more information
See AMTRA's page on the Code and Guidance for more.