Guidance on prescribing or supplying veterinary medicines including requirements for registration and inspection of premises.
Guidance for vets, pharmacists and suitably qualified persons (SQPs) on prescribing or supplying veterinary medicines including the requirements for the registration and inspection of premises.
Registered Qualified Persons (RQP)
Under the Veterinary Medicines Regulations (VMR) vets, pharmacists and SQPs, collectively known as RQPs, can prescribe or supply certain categories of authorised veterinary medicines that they are qualified and registered to supply.
The distribution categories for authorised medicines are:
- Prescription Only Medicine – Veterinarian (POM-V)
- Prescription Only Medicine – Veterinarian, Pharmacist, SQP (POM-VPS)
- Non-Food Animal – Veterinarian, Pharmacist, SQP (NFA-VPS)
- Authorised Veterinary Medicine – General Sales List (AVM-GSL)
The details and distribution categories for all medicines can be found on the Veterinary Medicines Directorate’s Product Information Database.
In addition to the above there is also an exemption in the VMR that allows products to be supplied legally without a marketing authorisation.
A POM-V medicine may only be supplied if it has been prescribed by a vet following a clinical assessment of the animal(s), which must be under their care. The VMR doesn’t define ‘clinical assessment’ or ‘under their care’ and vets should use their professional judgment to interpret what this means in individual cases. However the Royal College of Veterinary Surgeons (RCVS) has interpreted both phrases.
A client may ask for a written prescription if they want to buy the product from a supplier other than the prescribing vet. In either case, the prescribing vet must retain clinical responsibility for the treatment and the animal(s) under their care. A vet or pharmacist may supply POM-V products or products for use under the cascade (a provision in the VMR that allows a vet to prescribe medicines that would not otherwise be permitted) to non-clients but only against a valid written prescription from a vet registered with the RCVS.
The vet or pharmacist should use their specialist knowledge to check that the prescription matches their own understanding of the product. If they have any concerns about the prescription, they should contact the prescribing vet before supplying the medicine. Suppliers can refuse to supply against a prescription.
Products containing a new active substance will usually be categorised as POM-V.
A POM-VPS medicine may be prescribed by any RQP. A clinical assessment of the animal(s) does not have to be carried out when prescribing POM-VPS medicines and the animal doesn’t have to be under the RQP’s care. However, the RQP must have sufficient information about the animal and the condition to be treated to enable them to prescribe and supply the most appropriate product.
A customer may request a written prescription if they want to buy the product from a supplier other than the prescribing RQP. RQPs may supply POM-VPS medicines against a written prescription from another RQP.
Pharmacists and SQPs may supply a POM-VPS (or NFA-VPS and AVM-GSL) medicine for use under the cascade if prescribed by a vet against a written prescription.
A NFA-VPS medicine doesn’t have to be prescribed but it may only be supplied by an RQP, provided the requirements for supply are followed.
There are no legal restrictions on the retail supply of veterinary medicines classified as AVM-GSL.
Specific requirements: vets, pharmacists, SQPs
A vet may only prescribe and supply veterinary medicines (other than those classified as AVM-GSL) if they are registered with the RCVS.
Vets may only supply medicines from premises registered with the RCVS as a Veterinary Practice Premises (VPP).
For details of registration requirements under the VMR see the RCVS website.
Vets must ensure that they meet the legal requirements for prescribing and supplying POM-V, POM-VPS and NFA-VPS however the product is supplied (for example supply in a postal supply).
A vet supplying a veterinary medicine (other than one classified as AVM-GSL) must be present when it is handed over unless they:
- authorise each transaction individually before the product is supplied
- are satisfied that the person who hands it over is competent to do so
If the vet intends to delegate supply to other competent personnel, the supply must still be made from a registered VPP.
However, in exceptional circumstances, for example animal welfare reasons, a vet may instruct a wholesale dealer authorisation (WDA) holder to deliver medicines directly to the client’s premises.
A mobile treatment unit operated by a vet doesn’t require individual registration if it’s linked to a registered VPP. However, it will be inspected with the practice. Please also see the section on registering trade stands further down.
A mobile unit must be registered as a VPP in its own right if the sole purpose of the unit is to retail veterinary medicines, for example at agricultural shows. However, small quantities of veterinary medicines may be stored and supplied from a mobile unit if the veterinary practice has one at a show or an event.
The VMD strongly discourages the unprofessional practice of unsolicited visits to farms by vets specifically to sell veterinary medicines.
A registered pharmacist may only supply veterinary medicines (other than those classified as AVM-GSL) from premises:
- registered as a pharmacy with either the General Pharmaceutical Council (GPhC) or the Pharmaceutical Society of Northern Ireland (PSNI)
- registered as a VPP
- approved for the storage and supply of veterinary medicines by an SQP (see Suitably Qualified Persons)
A pharmacist supplying veterinary medicines (other than one classified as AVM-GSL) must be present when it is handed over, unless the pharmacist:
- authorises each transaction individually before the product is supplied
- is satisfied that the person who hands it over is competent to do so
A pharmacist must ensure that they meet the legal requirements for the prescribing and supplying POM-VPS, and NFA-VPS however the product is supplied (for example supply in a merchant’s store, postal supplies).
A pharmacist may prepare and supply an extemporaneous preparation,for example a medicine prepared especially for use under the cascade, against a written prescription from a vet. The product should be made using pharmacopoeia-compliant raw materials. The product should meet the requirements of the relevant general monographs of the pharmacopoeia. It may be supplied directly to the user.
Suitably Qualified Persons
SQPs may only supply veterinary medicines that they are qualified and registered to supply. For example an SQP registered in companion animals may only supply companion animal products.
SQPs must ensure that they meet the legal requirements for prescribing and supplying POM-VPS and NFA-VPS however the product is supplied (for example supply in a merchant’s store, postal supply, etc).
An SQP must comply with the Code of Practice for Suitably Qualified Persons. Information on how to become an SQP is available from the Animal Medicines Training Regulatory Authority (AMTRA) and VetSkill Ltd.
An SQP supplying a veterinary medicine (other than one classified as AVM-GSL) must do one of the following:
- hand over or despatch the product personally
- ensure that, when the product is handed over or despatched, the SQP is in a position to intervene if necessary
- check the product after it has been allocated for supply to a customer and be satisfied that the person handing over or dispatching it is competent to do so
SQPs may only supply from the following premises:
- premises approved as an SQP retailer
- a pharmacy registered with the GPhC or the PSNI
- a VPP registered with the RCVS
Approved SQP Premises
Each premise an SQP supplies medicines from must be approved separately. The premises are considered to be under the control of the business in whose name the approval is granted.
To be approved and retain that approval, each premise must have a registered SQP. Approved SQP retailers must notify the VMD of any proposed change to their registered SQP.
Domestic premises may be approved as SQP retailer premises if they meet the required criteria (a permanent building with a fixed address). For the purpose of approval and inspection, the part of the premises used for the retail supply of POM-VPS and NFA-VPS medicines must be made accessible to inspectors following reasonable notice.
If an SQP considers that the premises in which they’re operating no longer comply with the requirements of approval, they must immediately notify the VMD. This is necessary to ensure that the products are prescribed and supplied in accordance with the VMR and are stored correctly to maintain their safety and efficacy.
You can apply for registration of an SQP retailer premises using the application form and guidance on registering an SQP retailer premises.
Approval will only be granted following a satisfactory inspection.
SQP retailer distribution centres
A company’s distribution centre, to which POM-VPS or NFA-VPS veterinary medicines are delivered from a wholesale dealer for onward transfer to the companys’ own approved SQP retailer premises, should itself be approved as an SQP retailer premises.
The distribution centre should have a named SQP with overall responsibility for the intake, storage and transfer of POM-VPS products but that SQP doesn’t need to authorise each and every transfer to the company’s other approved retail premises.
If the distribution centre is used to store veterinary medicines for supply to third party companies, it will need a WDA.
The Register of Approved SQP Retailers Premises is published here.
Requirements for all RQPs
When prescribing a medicine classified as POM-V or POM-VPS or supplying a medicine classified as NFA-VPS, 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 an authorised purpose
- must advise on its safe administration and on any necessary warnings or contra-indications on the label or package leaflet
- must not prescribe (or, in the case of a NFA-VPS product, supply) more than the minimum amount required for the immediate treatment. However, it is a defence to show that:
- the veterinary medicine prescribed or supplied was in a container specified in the marketing authorisation (MA)
- the marketing authorisation does not permit smaller containers
- the RQP is not a person authorised to break open the package before supply
In order to meet the above requirements RQPs must satisfy themselves by all reasonable means that the customer is competent to use the product safely; and satisfy themselves that the product is suitable for the animal concerned. The following sets out VMD’s expectation of what information is likely to be necessary to be assessed by the RQP prior to supply taking place. It should be noted that this information does not necessarily need to be recorded – the information that must be kept when a veterinary medicinal product is supplied is detailed in Record keeping requirements for veterinary medicines.
For pets/companion animals the following in respect of each animal:
- No of animal(s)
- Weight (of each animal if more than one)
- Whether the animal is in general good health
- Whether the animal is pregnant or lactating
- Whether the animal is on any other medication
- Whether the customer knows how to use the product safely/effectively
- Whether the customer knows what the product is supposed to do
- Whether the customer has been provided with the warnings on the SPC
Food producing animals
As above and:
- What is the animals intended food use (milk/meat/eggs etc)
- Does the customer know the applicable withdrawal period
- In the case of sheep dip products, that they are satisfied that the person (or a person acting on his behalf) holds a Certificate of Competence in the Safe Use of Sheep Dips. The supply of sheep dip must be made in accordance with the legislative requirements, including, for OP dips, the supply of protective gloves and the laminated notice contained in the Regulations
- In the case of anthelmintic products for sheep and cattle, SQPs should follow the recommendations of Sustainable Control of Parasites in Sheep (SCOPS), and the Control of Worms Sustainably (COWS), respectively
- In the case of horses and other equidae, whether the animal has been declared as non-food producing in their horse passport
The requirements on the RQP are non-delegable and cannot be transferred to the customer. ‘Disclaimers’ that simply inform a customer that they must answer yes or no to a list of questions will not be considered by the VMD to meet this requirement.
Labelling at the time of retail supply
The label information on the product is specifically authorised to provide essential information for its safe and effective use. This includes warnings for the user and animal owner so it must not be obscured by any additional labelling or amendments made to the packaging.
A vet or pharmacist supplying a product against a written prescription may amend the authorised label to reflect the prescription (for example to change the dose). However, none of the other information on the outer packaging or the immediate container must be obscured. SQPs may only supply a product in accordance with the authorised label, except when supplying a product under the cascade against a written prescription from a vet.
If a product is placed into a container which hasn’t been authorised as part of the MA (for example tablets being supplied in a standard bottle with a child resistant closure) sufficient written information must still be provided to make sure the product is used safely.
There are additional labelling requirements for products supplied under the cascade.
Prescribing is the process of an RQP deciding, instructing and recording the treatment required for an animal. Prescriptions may be oral or in writing. RQPs can prescribe in accordance with the distribution categories for veterinary medicines for which they’re qualified.
A prescription product can only be supplied by an RQP working from a different business or premises from where the product was initially prescribed against a written prescription. However, a written prescription isn’t necessary when the prescribing RQP and supplying RQP are different but working on the same site, provided they interact in the transaction.
A prescription from a vet may be for an authorised veterinary medicine or for a product for use under the cascade.
If the prescription is not repeatable, it’s sensible for this to be stated on the prescription.
If the prescription has a section that states number of repeats, it’s recommended that this is crossed out by the prescriber if the prescription is not to be repeated.
No particular format is required for a written veterinary prescription. But they must include the following information:
- the name, address and telephone number of the person prescribing the product
- the qualifications enabling the person to prescribe the product. It is recommended to cite MRCVS or the SQP’s registration number
- the name and address of the owner or keeper
- identity (including the species) of the animal or group of animals
- the premises at which the animals are kept if this is different from the address of the owner or keeper
- the date of the prescription
- the signature or other authentication of the person prescribing the product
- the name and amount of the product prescribed
- the dosage and administration instructions
- any necessary warnings
- the withdrawal period (if relevant)
- a statement that it is prescribed under the cascade (if relevant)
It is a legal requirement for the prescriber to include all of the above information on the prescription. If any information is missing the prescription is not valid and no supply should be made agaist it.
An example of a vet’s prescription is available from the British Veterinary Association (BVA).
Prescription pads for SQPs are available from the Animal Health Distributors Association (AHDA).
Prescriptions are valid for up to 6 months from the date of signing unless the prescriber specifies a shorter period.
Prescriptions for Controlled Drugs (CDs)
There are specific requirements for prescriptions for CDs.
Anyone supplying a veterinary medicine against a written prescription must take reasonable steps to ensure the prescription is genuine. Anyone who alters a written prescription without authorisation to do so by the prescriber is committing an offence.
If an amendment (such as a typographic error) to a written prescription is necessary before a product can be supplied, then the prescriber may give the supplier permission to make an amendment on their behalf, and this action should be recorded.
If orders against faxed or electronic prescriptions are accepted then the supplier may need to check that each prescription is genuine.
Prescribers may choose to use methods such as stickers or serial numbers to help with this. If the supplier doubts the validity of a prescription then they should telephone the prescriber to check its validity.
Unless the use of electronic transmission for prescriptions is an agreed and familiar practice between the prescriber and supplier or it is needed urgently to avoid an animal suffering, the supplier should make sure they have the original hard copy prescription before supplying the medicine.
How to reduce or discourage unauthorised alterations
- placing a poster in the practice waiting room educating clients that it is an offence under the Veterinary Medicines Regulations (VMR) to alter a written prescription (Schedule 3 para 5(3))
- vets - use only the prescription template offered by the BVA or other reputable organisations
- SQP - use only the prescription template offered by AHDA
- RQP - use typed text rather than handwritten prescriptions
- RQP - write quantities as numbers and text
- RQP - initial and date any alterations to hard copy prescriptions
- RQP - include a sequential numbering system on prescriptions, where a unique identifier is added enabling suppliers to check with prescribers
- RQP - recommend clients obtain medicines from internet retailers who are accredited by the VMD’s Accredited Internet Retailer Scheme (AIRS)
- RQP - can email prescriptions directly to the dispensing business (if known)
See here for a list of accredited internet retailers.
- if the client is new, telephone the vet named on the prescription
- check the name and address of the vet or practice on the RCVS website (Not all veterinary premises are published on the RCVS website. If in any doubt contact the RCVS)
- check the name and address of the pharmacist on the GPhC or PSNI website
- check the List of SQPs and Register of Approved SQP Retailers Premises
- if the prescription is unclear or there are amendments check with the prescriber
- if you do dispense against faxed or emailed prescriptions ask for the original prescription
For online retailers:
- do not offer template electronic prescriptions on websites
- when a client adds a Prescription Only Medicine to their ‘basket’ or when proceeding to the checkout, include a warning that tampering with a prescription is an offence
- reporting instances of prescription misuse using this form.
Retail supply via the internet
The VMR apply to the sale of veterinary medicines on the internet in the same way as they do to ‘over the counter’ sales.
Internet retailers of veterinary medicines can apply to be accredited under the VMD’s Accredited Internet Retailer Scheme (AIRS). Retailers who meet the accreditation criteria will be able to display the VMD’s Internet Retailer logo on their website.
The GPhC operates an Internet Pharmacy Logo scheme to identify legitimate on line pharmacies so that the public can be sure they are purchasing safe and genuine medicines online.
Import and export of veterinary medicines
It is an offence to import a veterinary medicine that’s not authorised for use in the UK unless it’s under a suitable import certificate issued by the VMD. Details of the Special Import scheme.
The VMR allow the export of veterinary medicines, for more information see guidance on export certificates.
Vets and pharmacists may export medicines within the EU against prescriptions from vets in the European Economic Area (EEA) and Switzerland, provided that:
- they are satisfied the prescription for the product to be exported is valid
- the medicines will be used in the country where the prescription was written
Supply of sheep dip
A sheep dip can only be supplied to a person (or a person acting on his behalf) who holds a Certificate of Competence in the Safe Use of Sheep Dips showing that Parts 1 and 2 or units 1 and 2 of the assessment referred to in the Certificate have been satisfactorily completed, or NPTC Level 2 Award in the Safe Use of Sheep Dip.
The supplier must make a record of the Certificate number as soon as is reasonably practicable and keep it for at least three years.
When supplying a product containing an active substance that is an organophosphorus compound, the supplier must give the buyer a double sided laminated notice (unless the notice has been provided to the buyer within the previous twelve months and the supplier knows or has reasonable cause to believe that the buyer still has it).
The notice must be at least A4 size with a laminated transparent cover and must tell the user of the sheep dip:
- to read and act in accordance with the label, including instructions on measuring and diluting concentrate
- that sheep dip is absorbed through the skin
- always to wear the recommended protective clothing, including gloves, and have spare protective clothing available
- always to wash protective clothing before taking it off
- to direct any questions to the supplier or manufacturer
The notice must contain a diagram showing recommended protective clothing. In Wales the notice may be in Welsh as well as in English.
The supplier must also provide two pairs of gloves which must be non-lined, PVC or nitrile, heavy duty gauntlet style. They must be 0.5mm thick and at least 300mm long or provide demonstrably superior protection to the user than gloves of these specified measurements.
RQPs may supply POM-VPS medicines to farmers who are members of a buying group provided they fulfil the prescribing requirements of the VMR and the record keeping requirements detailed in Record-Keeping Requirements for Veterinary Medicines.
To comply with these requirements the RQP must have made contact with each member of the buying group and have knowledge of the animals to be treated.
The RQP may invoice the buying group provided the terms and conditions of the group make it clear that it is acting only as an agent of the individual member supplied with the POM-VPS medicine(s) and does not take ownership of the goods supplied at any time.
Veterinary medicines, apart from AVM-GSL and exemption products should not be offered or supplied via auctions, including on the internet.
Out of date products
It is illegal to supply a product (even if free of charge) after the expiry date shown on the pack. Any out of date products should be disposed of in accordance with the wording on the product literature.
Some products (for example injectables) once they’re opened must be discarded after a period of time stated on their packaging. This is due to EU and national legislative requirements to ensure the stability and safety of the product. The expiry date is usually 28 days after opening but it can be shorter or longer.
Emergency wholesale supply between authorised retailers
An authorised retailer of veterinary medicines may supply products they are qualified to supply to another authorised retailer to relieve a temporary supply shortage, without a WDA. This exemption from the VMR is intended to prevent shortages of available medicines causing animal welfare problems and should not be a regular occurance. It is not intended to exempt wholesale supply from the need for a WDA.
Trade stands can be registered as a VPP, SQP retailer premises or pharmacy at a trade show or exhibition for the retail supply of veterinary medicines provided that the stand is within a permanent building, such as an exhibition hall, with a specific address, and the relevant storage requirements of the medicines are met.
Supplying medicines for horses
See specific guidance on Horse Medicines and Horse Passports record keeping.
Inspection of retail premises
We inspect approved SQP retailer premises and VPPs (except those VPPs that are registered with the RCVS as Practice Standards Scheme (PSS) premises), to ensure they comply with the VMR.
Inspections are carried out on a risk basis; the higher the risk the more frequent the inspections. VPPs are inspected at least every four years. SQP retailers premises are inspected at least every four to six years depending on the medicines being supplied. The VMD will generally give retailers reasonable notice that they intend carrying out a routine inspection.
The Inspection Criteria for SQPs are set out in the SQPs’ Code of Practice
The Inspection Criteria for the SQP’s Retailers Premises
Inspectors are authorised under the VMR to:
- inspect the premises, organisational arrangements and procedures used in the storage and distribution of medicinal products
- interview key personnel named on the authorisation
- take samples
- examine any documentation or records relating to the manufacture, assembly, storage and distribution of veterinary medicines
Following an inspection, the inspector will give the retailer a report detailing any deficiencies (also referred to as non-compliances). For major and critical deficiencies, the inspector will request details of the measures that have been, or will be, taken to correct them.
The VMD categorises deficiencies as critical, major and other (minor). The report will also include recommendations; observations made by the inspector which, whilst not a legal requirement, would be considered good practice.
Minor (Other) Deficiencies:
- minor and poses no potential risk to human or animal health, or the environment
- does not indicate a significant deviation from the requirements of the VMR, Codes of Practice or Guidance
- cannot be classified as either critical or major because there is insufficient information to classify it as such
- non-critical but has produced, or has the potential to produce, a possible risk to human or animal health or the environment
- a major deviation from the requirements of the VMR
- a failure to carry out satisfactory procedures to ensure that products are manufactured, stored or distributed in accordance with their specific requirements
- a combination of more than six other (minor) deficiencies, none of which on their own may be major, but which may together represent a major deficiency and should be explained and reported as such
- other (minor) deficiencies that have been brought to the attention of the business on previous occasions but have not been resolved
- deficiencies that have produced, or have the potential to produce, a significant risk to human or animal health, or the environment
- a significant deviation from the requirements of the VMR through serious negligence or intent
Inspections are scheduled at intervals based on the number and type of deficiencies noted during an inspection, as follows:
|Inspection findings||Compliance rating||Max inspection interval in months by category|
|VPP, AM*||AM||AS, AJ, AC|
|6 or less minor, other||Good||48||60||72|
|>6 minor, 3 or less major||Acceptable||36||45||54|
|>3 minor, 5 or less major||Poor||24||30||36|
|6 or more major; any critical||Unacceptable||Follow up inspection as specified on Improvement Notice, then next scheduled inspection within 9 to 12 months|
Key to table:
|Category||Category name||Activity description|
|VPP||Veterinary Practice Premises||Premises registered with the RCVS as practice premises|
|AM*||Agricultural Merchant*||Approved retail supplier of veterinary medicinal products by SQPs, including the supply of vaccines and sheep dips|
|AM||Agricultural Merchant||Approved retail supplier of veterinary medicinal products by SQPs, with the exception of vaccines and sheep dips|
|AS||Horses & Companion Animals||Approved retail supplier of veterinary medicinal products for the treatment of horses and companion animals only by SQPs|
|AJ||Horses Only||Approved retail supplier of veterinary medicinal products for the treatment of horses only by SQPs|
|AC||Companion Animals Only||Approved retail supplier of veterinary medicinal products for the treatment of companion animals only by SQPs|
For the most serious deficiencies or failure to comply with the VMR, we may take formal action in accordance with our Enforcement Strategy. If we decide to suspend or revoke an approval, retailers have the right to appeal against that decision.