Authorized veterinary medicines fall within the first four categories established by the Veterinary Medicines Regulations (VMR) 2005. These categories have continued through subsequent revisions of the VMR and are as follows:

1. AVM-GSL Authorized veterinary medicine – general sales list.
2. NFA-VPS Non-food animal medicine – veterinarian, pharmacist, suitably qualified person (SQP).
3. POM-VPS Prescription-only medicine – veterinarian, pharmacist, SQP.
4. POM-V Prescription-only medicine – veterinarian.

In addition, medicines marketed under the Small Animal Exemption Scheme (SAES) do not have a legal distribution category but may be considered for sale and supply purposes to be equivalent to AVM-GSL.

AVM-GSL
Medicines in the AVM-GSL category may be legally supplied by any retailer, to anyone, without restriction. However, veterinary surgeons should take account of their professional duties in deciding when to supply all medicines, regardless of classification.

AVM-GSL medicines are authorized through the same process as medicines in ‘higher’ classifications and the manufacturer will have had to prove safety, quality and efficacy to the same standards; however, label claims may be different.

A medicine is classified as an AVM-GSL when:

• There is no statutory requirement for a prescription-only status
• Its use has a wide margin of safety
• It is used to alleviate or prevent the signs of disease or support the treatment of common ailments
• Special advice is not required to permit safe and effective use.

All medicines previously classified as GSL were automatically reclassified as AVM-GSL on 30 October 2005.

NFA-VPS
Medicines in the NFA-VPS category are for companion animals
(excluding horses). They must be supplied by a veterinary surgeon, pharmacist or SQP from registered premises.

A clinical assessment of the animal(s) is not required for supply of this category of veterinary medicine.

Each time a supplier supplies a NFA-VPS medicine they must:

• Before doing so, be satisfied that the person who will be administering the medicine is competent to do so safely, and intends to use it for a purpose for which it is authorized
• Advise on the safe administration of the medicine and on any warnings/contraindications stated on the label or package leaflet
• Not supply more than the minimum amount required for treatment.

In respect of the last point, it is a defence under the VMR to show that:

1. The medicine was in a container specified in the marketing authorization.
2. The manufacturer does not supply that medicine in a smaller container.
3. The person supplying the medicine is not authorized to break open the package before supply.

Since veterinary surgeons are permitted to break open packages before supply, that defence may be difficult to invoke, and so it is particularly important for veterinary surgeons in complying with the VMR to ensure that only the minimum amount of a medicine required for treatment is supplied.

A medicine is classified as NFA-VPS when:

• It is indicated for use only in non-food animals
• There is no statutory requirement for a prescription-only status
• It is used routinely to prevent or limit the effects of endemic disease in non-food animals
• Its use implies risks for the user, the animal, for consumer safety or for the environment but users can be made aware of suitable countermeasures through simple oral or written advice
• The animal owner/keeper can be given sufficient practical advice to permit effective and safe usage.

All medicines for companion animals (excluding horses) previously classified as PML and a small number of P medicines were automatically reclassified as NFA-VPS on 30 October 2005.

POM-VPS
Medicines in the POM-VPS category must be both prescribed and supplied by a veterinary surgeon, pharmacist or SQP. This can be more than one person: any authorized supplier may supply in accordance with a written prescription from any authorized prescriber. The medicine must be supplied from registered premises.

The client may request a written prescription if they do not want the prescriber to supply the medicine.

A clinical assessment of the animal(s) is not required when prescribing this category of veterinary medicine.

Each time a prescriber prescribes a POM-VPS medicine they must:

• Before doing so, be satisfied that the person who will be administering the medicine is competent to do so safely, and intends to use it for a purpose for which it is authorized
• Advise on the safe administration of the medicine and on any warnings/contraindications stated on the label or package leaflet.

A medicine is classified as a POM-VPS when:

• It is used to reduce or prevent the effects of endemic disease in herds, flocks or in individual animals
• Its use implies risks for the user, the animal, for consumer safety or for the environment but users can be made aware of suitable countermeasures through simple oral or written advice
• A professional user can be given adequate training in its regular use.

POM-V
Medicines in the POM-V category must only be prescribed by a veterinary surgeon following a clinical assessment of the animal or group of animals, which must be under their care. The medicine may then be supplied by that veterinary surgeon or in accordance with a written prescription by another veterinary surgeon or a pharmacist. The medicine must be supplied from registered premises.

There is no definition of ‘clinical assessment’ in the VMR and veterinary surgeons are expected to use their professional judgement in deciding how this should be interpreted in their particular circumstances. The RCVS interprets ‘clinical assessment’ as meaning an assessment of relevant clinical information, which may include an examination of the animal under the veterinary surgeon’s care.

The client may request a written prescription if they do not want the prescribing veterinary surgeon to supply the medicine.

A medicine is classified as a POM-V when:

• It requires a strict limitation on its use for specific safety reasons
• It requires the specialized knowledge of a veterinary surgeon for its
• use/application
• It has a narrow safety margin requiring above average care in its use
• It is government policy to demand professional control at a high level (for example, antimicrobials and Controlled Drugs).

All medicines previously classified as POM and a small number of P medicines were automatically reclassified as POM-V on 30 October 2005.

Small Animal Exemption Scheme
Medicines for use in certain pet species (aquarium fish, cage birds, ferrets, homing pigeons, rabbits, small rodents and terrarium animals), the active ingredient of which has been declared by the Secretary of State as not requiring veterinary control, may be marketed under the SAES.

These medicines are exempt from the requirement for a marketing authorization and therefore are not required to prove safety, quality or efficacy, but must be manufactured to the same standards as authorized medicines and are subject to pharmacovigilance reporting. These medicines do not have a legal distribution category, but may be considered for sale and supply purposes to be equivalent to AVM-GSL.

Labelling
To allow manufacturers to update packaging (inner, outer and leaflet, for each pack size) and obtain approval from the Veterinary Medicines Directorate, manufacturers were permitted to continue to release medicine batches for sale and supply labelled in accordance with the ‘old’ categories until 30 October 2008.

Sale and supply by wholesalers and retailers (including veterinary surgeons) of medicines with the old-style label is legal: as some medicines have multi-year shelf-lives, the old abbreviations will continue to appear on the labels of medicines for some time; nonetheless the new legal categories apply.

All authorized medicines must include the distribution category on the box label.
SAES medicines must include a reference to the Scheme on the label.