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.

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.

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.

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 but wish to obtain the medicine from another supplier (e.g. a pharmacy or another veterinary practice).

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).

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.

Requirements at the time of retail supply
Veterinary surgeons, pharmacists and SQPs, collectively known as registered qualified persons (RQPs), are entitled to prescribe veterinary medicinal products (VMPs). An RQP may only prescribe and/or supply the products that fall within the scope of the qualification and the registration they hold. It is the duty of the RQP to ensure that the statutory requirements associated with the prescription or supply of POM-V, POM-VPS and NFA-VPS are respected.

When an RQP prescribes a medicine classified as POM-V or POM-VPS, or supplies a medicine classified as NFA-VPS:

• Before doing so, the RQP must be satisfied that the person who will use the medicine is competent to do so safely, and intends to use it for a purpose for which it is authorized
• When doing so, the RQP must advise on its safe administration and on any necessary warnings or contraindications on the label or package leaflet (which are derived from the Summary of Product Characteristics, SPC). The SPC for products authorized in the UK can be found on the Veterinary Medicines Directorate (VMD) website
• The RQP must not prescribe (or in the case of an NFA-VPS product, supply) more than the minimum amount required for the immediate treatment, but it is a defence to show that:
  • The VMP prescribed or supplied was in a container specified in the marketing authorization
  • The marketing authorization does not permit smaller containers
  • The RQP is not a person authorized to break open the package before supply.

Labelling
The label information on the product is specifically authorized to provide the necessary information for the safe and effective use of the product. This includes warnings for the user and animal owner, so the label must not be obscured by any additional labelling or amendments made to the packaging.

A veterinary surgeon or pharmacist supplying a product against a written prescription may amend the authorized label in accordance with the prescription (for example, to change the dose). However, none of the other information on the outer packaging or the immediate container may be obscured. SQPs may only supply in accordance with the authorized label, except when supplying a product under a written prescription from a veterinary surgeon under the prescribing cascade.

Where a product is placed into a container which has not been authorized as part of the marketing authorization, such as tablets being supplied in a standard bottle with a child-resistant closure, sufficient written product information must still be provided in writing. It may be convenient to use a copy of the package leaflet, a copy of the SPC or a copy of the datasheet. Copies of all authorized SPCs are available on the VMD website. Many product datasheets can be accessed via the NOAH Compendium. 

Where a product is supplied under the cascade, there are additional labelling requirements to be met. These are summarized in the VMD Guidance Note 13.