Veterinary Medicines Regulations 2013: A Compliance Guide for UK Practices

The legislative framework in one paragraph

The Veterinary Medicines Regulations 2013 (SI 2013/2033) set out the legal controls on the manufacture, authorisation, possession, distribution, use and post-authorisation surveillance of veterinary medicines in Great Britain. For the average vet practice, what this means in practice is a set of obligations attached to each medicine category — covering who can prescribe, who can supply, what the prescription must contain, and how records must be maintained. A VMD inspection will check all of these. So will an RCVS inspector checking against Core Standards.

This guide covers the compliance structure your practice needs to have in place.

The four medicine categories

Every authorised veterinary medicine in Great Britain sits in one of four categories. The category determines who can prescribe it, who can supply it, and what records are required.

POM-V (Prescription Only Medicine — Veterinarian)

Only a veterinary surgeon who has the animal under their clinical care can prescribe a POM-V product. The prescription must be written before the product is supplied. Supply is restricted to veterinary surgeons and pharmacists acting on a valid prescription.

This is the most regulated category. Most antimicrobials, controlled substances, and anaesthetic agents fall here. The full prescription requirements are set out in Schedule 3 of the VMR 2013 and include: the prescriber's name, address, telephone number and qualifications; the animal owner's details and animal identification; the date and signature; the product name, amount and dosage; and withdrawal periods where applicable.

POM-VPS (Prescription Only Medicine — Veterinarian, Pharmacist or Suitably Qualified Person)

Can be prescribed and supplied by a veterinary surgeon, pharmacist, or a Suitably Qualified Person (SQP) registered with AMTRA. A prescription is required before supply. This category covers many livestock medicines and some antiparasitic products.

NFA-VPS (Non-Food Animal — Veterinarian, Pharmacist or Suitably Qualified Person)

No written prescription is required, but supply is still restricted to veterinary surgeons, pharmacists and SQPs. The supplier must carry out a satisfactory assessment before each supply. Companion-animal antiparasitic products commonly appear in this category.

AVM-GSL (Authorised Veterinary Medicine — General Sales List)

No prescription needed. Can be sold by any retailer. Basic products such as certain wormers and some topical preparations fall here.

Record-keeping: the obligations most practices underestimate

The record-keeping obligations under the VMR 2013 apply to both dispensing and receipt of medicines. For practices, the key requirements are:

• Incoming medicines: records must show the date received, product name, batch number, quantity, and the name and address of the supplier
• Outgoing medicines (dispensed): records must show the date of supply, product name, batch number, quantity, the name and address of the recipient, and — for POM-V — the name of the prescribing veterinary surgeon
• Retention period: all medicine records must be kept for at least five years
• Annual reconciliation: incoming and outgoing medicines must be reconciled against current stock annually; any significant discrepancies must be investigated and documented

This is a verbatim requirement from Schedule 3: "incoming and outgoing veterinary medicinal products must be reconciled with products currently held in stock." Practices that rely on the PMS to record dispensing but have no formal annual reconciliation process are non-compliant.

Prescriptions: what must be included

A written POM-V prescription is not optional. It must precede supply. Under Schedule 3, a valid prescription must include:

• Name, address, telephone number and qualifications of the prescriber
• Owner/keeper's name and address, and sufficient identification of the animal (species, breed, age, sex, colour, name or ID number as appropriate)
• Date of the prescription and the prescriber's signature
• Name and amount of the product and the dose instructions
• Any warnings (including withdrawal period if applicable)
• The prescriber's statement that the animal is under their care

A prescription for most products (not controlled drugs) remains valid for six months or such shorter period as the prescriber specifies. Controlled drug prescriptions are valid for 28 days.

The "under their care" requirement is material: a veterinary surgeon cannot write a prescription for an animal they have not examined within a period consistent with maintaining clinical responsibility. RCVS guidance on the prescribing of medicines reinforces this. The VMR 2013 does not allow a vet to prescribe across clinical responsibility boundaries.

The cascade

Where no authorised product exists for a condition in a given species, a veterinary surgeon may prescribe under the "cascade" — prescribing a product outside its marketing authorisation in a defined order: first, a product authorised in another species or for another condition in the same species; second, a product authorised in another country; third, a product prepared specifically for the case by a pharmacist. Each step requires documented clinical justification.

Cascade use must be recorded and the records are subject to the same five-year retention requirement as standard dispensing records.

Where compliance gaps appear in practice

Based on the inspection-readiness issues the non-clinical compliance framework covers, the most common VMR compliance failures in vet practices are:

Incomplete dispensing records — PMS records who received what, but batch numbers are missing or the annual reconciliation has never happened. Both are required.

Prescriptions written without a recent examination — particularly for long-term repeat prescriptions. The clinical assessment requirement applies each time a prescription is issued.

Cascade records not maintained — cascade use is accepted and legitimate; undocumented cascade use is not.

SOP gaps — practices often have no written procedure covering the dispensing record-keeping process. This becomes visible in a VMD inspection when a member of staff cannot demonstrate how records are created and maintained.

A SOP for medicines dispensing and record-keeping is not required by the VMR 2013 in so many words, but it is the mechanism through which the requirements become consistently met — and it is exactly what an inspector asks to see.

What a VMD inspection covers

The Veterinary Medicines Directorate inspects veterinary practices to verify compliance with the VMR 2013. An inspector will typically review:

• The medicines store (security, temperature controls, separation of internal/external medicines)
• Dispensing records for a sample of medicines (batch numbers, prescriptions, dates)
• Controlled drug register and reconciliation records
• A sample of prescriptions against the Schedule 3 requirements
• Cascade records if any cascade use is occurring
• How the practice manages expired stock

A practice with well-maintained electronic dispensing records, a completed annual reconciliation, and an SOP covering the process is well-placed. The inspection is not intended to catch small errors — it is checking whether the system is functioning.

Staying current

The VMR 2013 has been amended several times since it came into force. The VMD's veterinary medicines legislation guidance page is the appropriate place to check for current requirements. The VMD also publishes updated guidance on specific topics — the prescribing cascade, controlled drugs, and SQP registration — separately from the legislation itself.

Review your medicines record-keeping procedures against the current version of Schedule 3 at least annually. If your practice has changed PMS or moved dispensing records to a new system, verify that all five-year historical records are accessible and that the new system captures the required fields.

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Sources:

• Veterinary Medicines Regulations 2013 (SI 2013/2033) — legislation.gov.uk
• Schedule 3, Veterinary Medicines Regulations 2013 — prescription and record-keeping requirements
• Veterinary medicines legislation — VMD, gov.uk