1. The Veterinary Medicines Regulations 2005 SI 2745
These can be seen here
The VMDs own Guidance Notes can be seen at http://www.vmd.gov.uk/ under “Publications” then “Veterinary Medicines Guidance Notes”
2. The Supply of Relevant Veterinary Medicinal Products Order 2005 (SI 2005 no. 2751)
(the DTI order) can be seen here
3. Modifications to the RCVS Guide to professional conduct
Following agreement by RCVS Council at its meeting on 3 November 2005, the changes to the RCVS Guide to Professional Conduct to implement key recommendations from the Competition Commission's report have now been updated into the online Guide in four separate sections, as follows:
The information below attempts to pull some of the aspects of these provisions more immediately relevant to practicing veterinary surgeons together under a series of headings. Veterinary Surgeons should consult the full legislation as above for more detail
CLASSIFICATION
Classification of veterinary medicinal products (The Veterinary Medicines Regulations 2005 - Schedule 3)
1—(1) There shall be the following categories of authorised veterinary medicinal products—
(a) Prescription Only Medicine–Veterinarian (abbreviated to POM-V);
(b) Prescription Only Medicine–Veterinarian, Pharmacist, Suitably Qualified Person
(abbreviated to POM-VPS);
(c) Non-Food Animal–Veterinarian, Pharmacist, Suitably Qualified Person (abbreviated to
NFA-VPS);
(d) Authorised Veterinary Medicine - General Sales List (abbreviated to AVM-GSL).
SUPPLY
Retail supply of veterinary medicinal products (The Veterinary Medicines Regulations 2005 - Schedule 3)
3.—(1) This paragraph applies in relation to retail supply of veterinary medicinal products
(2) A veterinary medicinal product classified as POM-V may only be supplied by a veterinary
surgeon or a pharmacist and must be supplied in accordance with a prescription from a veterinary surgeon.
(3) A veterinary medicinal product classified as POM-VPS may only be supplied by—
(a) a veterinary surgeon;
(b) a pharmacist; or
(c) a suitably qualified person in accordance with paragraph 9.
and must be in accordance with a prescription from one of those persons.
(4) A veterinary medicinal product classified as NFA-VPS may be supplied without
prescription, but may only be supplied by —
(a) a veterinary surgeon;
(b) a pharmacist; or
(c) a suitably qualified person in accordance with paragraph 9.
(5) Any person supplying a veterinary medicinal product in accordance with a prescription may
only supply the product specified in that prescription.
(6) Any person who supplies a veterinary medicinal product classified as POM-V, POM-VPS or
NFA-VPS—
(a) must always advise on the safe administration of the veterinary medicinal product;
(b) must advise as necessary on any warnings or contra-indications on the label or package
leaflet;
(c) must be satisfied that the person who will use the product is competent to use it safely,
and intends to use it for a use for which it is authorised.
(7) There are no restrictions on the supply of AVM-GSL products.
(8) In this paragraph—
(a) “retail supply” means any supply other than to or from the holder of a wholesale dealer’s
authorisation, and whether or not for payment; and
(b) a person may supply a product irrespective of who owns it.
(9) It is an offence to fail to comply with this paragraph..
Supply (The Veterinary Medicines Regulations 2005)
27.—(1) It is an offence to supply an unauthorised veterinary medicinal product.
(2) This regulation does not apply to —
(a) a veterinary medicinal product prescribed by a veterinary surgeon under the cascade; or
(b) a product supplied in accordance with a certificate granted by the Secretary of State under
these Regulations.
(2) Any person who supplies a veterinary medicinal product that has passed its expiry date is
guilty of an offence.
(3) Any person who supplies a medicinal product authorised for human use for administration to
an animal (other than in accordance with a prescription from a veterinary surgeon for
administration under the cascade) is guilty of an offence.
ADMINISTRATION
Administration of the product (The Veterinary Medicines Regulations 2005)
8.—(1) It is an offence to administer a veterinary medicinal product to an animal unless—
(a) the product has a marketing authorisation authorising its administration in the United
Kingdom, and the administration is in accordance with that marketing authorisation; or
(b) it is administered in accordance with Schedule 4 (administration of a veterinary medicinal
product outside the terms a marketing authorisation). – ie the cascade
(2) It is an offence to administer a veterinary medicinal product to a food-producing animal
unless it was prescribed in accordance with Schedule 3 or is administered in accordance with
Schedule 4.
POSSESSION
Possession of an unauthorised veterinary medicinal product (The Veterinary Medicines Regulations 2005)
(4) Any person in possession of a veterinary medicinal product that was supplied to him other
than in accordance with Schedule 3 is guilty of an offence.
26.—(1) It is an offence to be in possession of an unauthorised veterinary medicinal product.
(2) This regulation does not apply to —
(a) a veterinary medicinal product imported in accordance with a certificate granted by the
Secretary of State under these Regulations;
(b) a veterinary medicinal product prescribed by a veterinary surgeon under the cascade;
(c) wholesale dealers if the possession is for re-export;
(d) a holder of a manufacturer’s authorisation or marketing authorisation if the intention is to
manufacture a veterinary medicinal product..(3) It is a defence for a person charged under paragraph (1) to prove that he was in possession of the veterinary medicinal product for the purposes of research or development of a veterinary medicinal product.
PRESCRIPTIONS
Prescriptions (The Veterinary Medicines Regulations 2005 - Schedule 3)
5.—(1) A veterinary surgeon who prescribes a veterinary medicinal product classified as
POM-V must first carry out a clinical assessment of the animal, and the animal must be under his care, and failure to do so is an offence.
(2) It is an offence to prescribe more than the minimum amount of a veterinary medicinal
product required for the treatment.
Form of prescription (Schedule 3)
6.—(1) A prescription may be oral or written, but must be written if the veterinary medicinal
product is not supplied by the person who has prescribed it.
(2) A written prescription must be in ink or other indelible format, and must include—
(a) the name and address of the person prescribing the product;
(b) the qualifications enabling the person to prescribe the product;
(c) the name and address of the owner or keeper;
(d) the species of animal, identification and number of the animals;
(e) the premises at which the animals are kept if this is different from the address of the
owner or keeper;
(f) the date of the prescription;
(g) the signature or other authentication of the person prescribing the product;
(h) the name and amount of the product prescribed;
(i) the dosage and administration instructions;
(j) any necessary warnings;
(k) the withdrawal period if relevant.
(3) A written prescription for a controlled drug as specified in the Misuse of Drugs Regulations
2001(a) is valid for three weeks.
(4) A written prescription for any other drug is valid for six months or such shorter period as
may be specified in the prescription.
(5) If the prescription is a repeatable prescription that does not specify the number of times the
product may be supplied, the prescription may only be repeated once.
Charging for prescriptions (DTI order)
DTI Order - The Supply of Relevant Veterinary Medicinal Products Order 2005 (SI 2005 no. 2751) http://www.opsi.gov.uk/si/si2005/20052751.htm
Relates to “relevant VMPs” which are in effect POM-V products.
Prescription fees and prohibition of discrimination
3. —(1) Subject to paragraph (2), during the relevant period a veterinary surgeon must not charge a client a fee for providing a prescription.
(2) During the relevant period a veterinary surgeon may pass on to his clients the costs incurred in providing prescriptions, provided that he does so in a manner that does not discriminate between clients to whom he gives prescriptions and clients to whom he does not.
(3) It shall be unlawful for a veterinary surgeon to discriminate between a client to whom he provides prescriptions and a client to whom he does not, in—
(a) the price he charges for a relevant veterinary medicinal product; and
(b) the fee he charges for supplying veterinary services other than giving a prescription.
(4) In paragraphs (1) and (2), "relevant period" means the period of 3 years beginning with the day on which this Order comes into force.
Provision of prescriptions (RCVS Guide to Professional Conduct)
Veterinary surgeons must: -
1. Ensure clients are able to obtain prescriptions, as appropriate.
(A veterinary surgeon may only prescribe Prescription Only Medicines, Category V,
(POM Vs) if the animal is under his or her care; a prescription may not be appropriate if the animal is an in-patient or immediate treatment is necessary.)
7. Advise clients, by means of a large and prominently displayed sign or signs (in the
waiting room or other appropriate area), with reference to the following:
· “Prescriptions are available from this practice.
· You may obtain Prescription Only Medicines, Category V, (POM Vs) from your veterinary surgeon OR ask for a prescription and obtain these medicines from another veterinary surgeon or a pharmacy.
· Your veterinary surgeon may prescribe POM Vs only for animals under his or her care.
· A prescription may not be appropriate if your animal is an in-patient or immediate treatment is necessary.
· You will be informed, on request, of the price of any medicine that may be prescribed for your animal.
· The general policy of this practice is to re-assess an animal requiring repeat prescriptions every xx months, but this may vary with individual circumstances. The standard charge for a re-examination is £ xx.
· The current prices for the ten POM Vs most commonly prescribed or supplied during XX ( a typical 3 month period) were:
[The ten drugs and prices listed.].
· Further information on the prices of medicines is available on request”
THE CASCADE
(The Veterinary Medicines Regulations 2005 - Schedule 4)
Administration of a veterinary medicinal product outside the terms of a marketing authorisation
Administration under the cascade
2.—(1) If there is no authorised veterinary medicinal product in the United Kingdom for a
condition the veterinary surgeon responsible for the animal may, to avoid unacceptable suffering, treat the animals concerned with the following (“the cascade”), cascaded in the following order—
(a) a veterinary medicinal product authorised in the United Kingdom for use with another
animal species, or for another condition in the same species; or
(b) if and only if there is no such product that is suitable, either—
(i) a medicinal product authorised in the United Kingdom for human use; or
(ii) a veterinary medicinal product not authorised in the United Kingdom but authorised
in another member State for use with any animal species (in the case of a food-producing
animal, it must be a food-producing species); or
(c) if and only if there is no such product that is suitable, a veterinary medicinal product
prepared extemporaneously by a pharmacist, a veterinary surgeon or a person holding a
manufacturing authorisation authorising the manufacture of that type of product.
(2) In the case of a veterinary medicinal product imported from another member State, if the
veterinary surgeon has not obtained a certificate from the Secretary of State under regulation 25(5) permitting him to import it, he must obtain a certificate from the Secretary of State before he administers it.
(3) For the purposes of this paragraph a food producing animal includes an animal belonging to
the equidae family unless it has been declared, in accordance with Commission
Decisions 93/623/EEC (establishing the identification document (passport) accompanying
registered equidae(a)) and 2000/68/EC (amending Decision 93/623/EEC and establishing the
identification of equidae for breeding and production(b)), as not being intended for slaughter for
human consumption.
(4) Any pharmacologically active substances included in a medicinal product administered to a
food-producing animal (NB not species) under the cascade must be listed in Annex I, II or III to Council Regulation (EEC) No. 2377/90.
Supply of veterinary medicinal products for use under the cascade (Schedule 3)
8.—(1) A veterinary medicinal product for use under the cascade must be prescribed by a
veterinary surgeon and may only be supplied by a veterinary surgeon or a pharmacist.
(2) Unless the veterinary surgeon who prescribed the veterinary medicinal product supplies the
product himself and administers it to the animal himself, the person supplying it must label it with at least the following information—
(a) the name and address of the dispensing pharmacy or veterinary surgery;
(b) the name of the veterinary surgeon who has prescribed the product;
(c) the name and address of the animal owner;
(d) the identification of the animal or group of animals;
(e) the date of dispensing;
(f) the expiry date of the product, if applicable;
(g) the name or description of the product which should include at least the name and
quantity of active ingredients;
(h) dosage and administration instructions;
(i) any special storage precautions;
(j) any necessary warnings for the user, target species, administration or disposal of the
product.
(3) It is an offence to fail to comply with this paragraph.
Withdrawal periods
3.—(1) A veterinary surgeon administering a veterinary medicinal product to a food-producing
animal under the cascade must specify an appropriate withdrawal period.
(2) The withdrawal period must ensure that, if there is a maximum residue limit specified for the
active substance in Council Regulation (EEC) No. 2377/90, the level of residue of the active
substance does not exceed that limit.
(3) In any event, unless the Secretary of State has specified in writing a different withdrawal
period for a particular veterinary medicinal product, the withdrawal period (irrespective of
whether or not a maximum residue limit is specified in Council Regulation (EEC) No. 2377/90)
must not be less than—
(a) 7 days for eggs;
(b) 7 days for milk;
(c) 28 days for meat from poultry and mammals including fat and offal;
(d) 500 degree days (c) for fish meat.
(4) In the case of homoeopathic veterinary medicinal products in which active principles figure
in Annex II to Council Regulation (EEC) No. 2377/90, the withdrawal period is zero.
Note – It is not clear at present if there in fact currently are any products in horses to which this 28 day withdrawal period will apply.
Treatment in exceptional circumstances
7.—(1) Where the health situation so requires, and where there is no suitable veterinary
medicinal product available either as an authorised product or under the cascade, a veterinary
surgeon may treat an animal with a veterinary medicinal product authorised in a third (ie non-EU) country; but if the veterinary surgeon has not obtained a certificate from the Secretary of State under regulation 25(5) permitting him to import it, he must obtain a certificate from the Secretary of State before he treats the animal.
(2) The certificate may be granted subject to any condition the Secretary of State thinks fit.
RECORDS
(The Veterinary Medicines Regulations 2005)
A. The Veterinary Surgeon
Records of products supplied on prescription
23.—(1) When any person permitted under these Regulations to supply veterinary medicinal
products classified as POM-V or POM-VPS receives or supplies any such veterinary medicinal
product he must keep all documents relating to the transaction, which must include—
(a) the date;
(b) the identity of the veterinary medicinal product;
(c) the quantity;
(d) the name and address of the supplier or recipient;
(e) if there is a written prescription, the name and address of the person who wrote the
prescription and a copy of the prescription.
(2) If the documents do not include this information he must make a record of the missing
information as soon as is reasonably practicable.
(3) As an alternative to paragraphs (1) and (2) he may make a record of all the information
required there provided that he does so as soon as is reasonably practicable.
(4) When he starts to use the veterinary medicinal product he must also record the batch number
and the date.
(5) He must keep the documentation and records for at least five years.
(6) It is an offence to fail to comply with this regulation.
Records of products administered to a food-producing animal under the cascade
24.—(1) A veterinary surgeon administering a veterinary medicinal product to a food-producing
animal under the cascade, or permitting another person to administer it under his responsibility,
must, as soon as is reasonably practicable, record—
(a) the date he examined the animals;
(b) the name and address of the owner;
(c) the identification and number of animals treated;
(d) the diagnosis;
(e) the trade name of the product if there is one;
(f) the manufacturer’s batch number shown on the product if there is one;
(g) the name and quantity of the active substances;
(h) the doses administered;
(i) the duration of treatment; and
(j) the withdrawal period..(2) He must keep the record for at least five years.
(3) It is an offence to fail to comply with this regulation.
Food-producing animals: records of administration by a veterinary surgeon
18.—(1) If a veterinary surgeon administers a veterinary medicinal product to a food-producing
animal he must either enter the following information himself in the keeper’s records or give it to
the keeper in writing (in which case the keeper must enter the following into his records)—
(a) the name of the veterinary surgeon;.
(b) the name of the product;
(c) the date of administration of the product;
(d) the amount of product administered;
(e) the identification of the animals treated;
(f) the withdrawal period.
(2) It is an offence to fail to comply with this regulation.
Annual audit (Schedule 3)
10.—(1) At least once a year every person entitled to supply a veterinary medicinal product on
prescription must carry out a detailed audit, and incoming and outgoing veterinary medicinal
products shall be reconciled with products currently held in stock, any discrepancies being
recorded..(2) It is an offence to fail to comply with this paragraph.
Veterinary surgeons should also consult the VMDs “Clarification Note on Record keeping for vets ” at http://www.vmd.gov.uk/general/r2001/ClarificationNote.pdf
B. Owners/Keepers of Food Producing Animals
Veterinary surgeons dealing with food producing animals (including horses declared as intended for human consumption or – in England - undeclared in their passport) may wish to be able to advise their owners or keepers of their new responsibilities under the Veterinary medicines Regulations 2005
Food-producing animals: proof of purchase of veterinary medicinal products
17.—(1) The owner or keeper of food-producing animals must keep proof of purchase of all
veterinary medicinal products acquired for those animals.
(2) It is an offence to fail to comply with this regulation.
Food-producing animals: records of administration by a veterinary surgeon
18.—(1) If a veterinary surgeon administers a veterinary medicinal product to a food-producing
animal he must either enter the following information himself in the keeper’s records or give it to
the keeper in writing (in which case the keeper must enter the following into his records)—
(a) the name of the veterinary surgeon;.
(b) the name of the product;
(c) the date of administration of the product;
(d) the amount of product administered;
(e) the identification of the animals treated;
(f) the withdrawal period.
(2) It is an offence to fail to comply with this regulation.
Food-producing animals: records of purchase and administration
19.—(1) When a veterinary medicinal product is bought for a food-producing animal the keeper
must record, at the time of purchase—
(a) the name of the product;
(b) the date of purchase;
(c) the quantity purchased;
(d) the withdrawal period;
(e) the name and address of the supplier.
(2) At the time of administration (unless the administration is by a veterinary surgeon in which
case the record must be in accordance with regulation 18) he must record—
(a) the name of the product;
(b) the date of administration;
(c) the quantity administered;
(d) the identity of the animals treated.
(3) If he disposes of it other than by treating an animal, he must record the date and route of
disposal.
(4) It is an offence to fail to comply with this regulation.
Food-producing animals: retention of records
20.—(1) The keeper must retain the proof of purchase and the record for at least five years
following the administration or other disposal of the product, irrespective of whether or not the
animals concerned are no longer in his possession or have been slaughtered or have died during
that period.
(2) It is an offence to fail to comply with this regulation.
ADVERTISING
(The Veterinary Medicines Regulations 2005)
Veterinary Surgeons may also wish to note the VMD’s “Advertising of Prescription Only Veterinary Medicinal Products - Clarification Note ” as seen at http://www.vmd.gov.uk/general/r2001/Advertising_Clarification_Note.pdf
Advertising the product
10.—(1) It is an offence to advertise a veterinary medicinal product if the advertisement is
misleading or contains any medicinal claim that is not in the summary of product characteristics.
(2) It is an offence to advertise a human medicine for administration to animals (including
sending a price list of or including human medicines to a veterinary surgeon or veterinary
practice).
(3) Paragraph (2) does not apply to the holder of a wholesale dealer’s authorisation who supplies
a list of human medicines, together with prices, to a veterinary surgeon for use under the cascade
provided that—
(a) the list is sent following a request from the veterinary surgeon to whom it is sent;
(b) the veterinary surgeon has specified the type of human medicinal product he wishes to
use, and the list is confined to human medicines of that type;
(c) the list states clearly that the product does not have a marketing authorisation as a
veterinary medicinal product, and may only be administered under the cascade; and
(d) it only includes human medicines that may be administered legally under the cascade.
Advertising of prescription products and products with psychotropic drugs or narcotics
11.—(1) It is an offence to advertise veterinary medicinal products that—
(a) are available on veterinary prescription only; or
(b) contain psychotropic drugs or narcotics.
(2) In the case of a product containing psychotropic drugs or narcotics, this does not apply to
advertisements aimed at veterinary surgeons.
(3) In the case of POM-V medicines, this does not apply to price lists, or to advertisements
aimed at veterinary surgeons, pharmacists or professional keepers of animals.
(4) In the case of POM-VPS medicines, this does not apply to price lists, or to advertisements
aimed at—
(a) veterinary surgeons;
(b) pharmacists;
(c) suitably qualified person registered in accordance with paragraph 9 of Schedule 3;
(d) other veterinary health care professionals;
(e) professional keepers of animals;
(f) owners or keepers of horses.
RCVS Guide to Professional Conduct
1. Subject to any legal restrictions, medicine prices may be published, but any publicity for
Prescription Only Medicines, Category V, must indicate that a veterinary surgeon may
only prescribe or supply such medicines lawfully for animals under his or her care (ref to
H5). In addition, a veterinary surgeon should only prescribe or supply medicines
appropriate to and only in sufficient quantity for the patient’s needs. The selection of an
appropriate veterinary medicine is a matter of clinical judgment for the prescribing
veterinary surgeon.”
PROVISION OF INFORMATION
(RCVS Guide to Professional Conduct)
2. Veterinary surgeons must: -
2. Subject to any legal restrictions, ensure there is adequate provision of information on medicine prices, including the current prices for the ten POM Vs most commonly prescribed during a recent and typical 3 month period, to provide clients with a fair and representative illustration of the practice’s medicines prices.
3. Provide the price of any POM V stocked or sold, to clients, or other legitimate enquirers, making reasonable requests.
4. If requested, inform clients of the price of any medicine to be prescribed or dispensed.
5. Where possible and relevant, inform clients of the frequency and charges regarding
further examinations of animals requiring repeat prescriptions.
6. Provide clients with an invoice that distinguishes the price of POM Vs from other
charges and, where practicable, provide clients with an invoice that distinguishes the
price of individual POM Vs.
7. Advise clients, by means of a large and prominently displayed sign or signs (in the
waiting room or other appropriate area), with reference to ….see above under “Prescriptions”
8. Provide new clients with a written version of the information set out in the sign or signs referred to in paragraph 7, which may be set out in a practice leaflet or client letter.
9. On a continuing basis, take reasonable steps to ensure that all clients are provided with a written version of the information set out in the sign or signs referred to in paragraph 7, which may be set out in a practice leaflet or client letter.
3. “All invoices should be itemised showing the amounts relating to goods and services provided by the practice. Fees for outside services and any charge for additional administration or other costs to the practice in arranging such services should also be shown separately. See Part 1, D, paragraph 7 for the invoicing of Prescription Only Medicines, Category V, (POM Vs).”
4. Part 2, B, Fees and Related Matters, Discussion of Fees
“Discussion should take place with the client, covering a range of reasonable treatment options and prognoses, and the likely charges (including ancillary or associated charges, such as those for medicines/anaesthetics and likely post operative care) in each case so as to ensure that the client is in a position to give informed consent. It is wise for any estimate to be put in writing and to cover the approximate overall charge for any procedure or treatment including VAT, pre and post operative checks, any diagnostic tests, etc. The owner should be warned that additional charges may arise if complications occur.”
IMPORTATION
(The Veterinary Medicines Regulations 2005)
Importation of authorised veterinary medicinal products (ie ones with a UK marketing authorisation)
9.—(1) It is an offence to import a veterinary medicinal product authorised for use in the United
Kingdom except in accordance with this regulation.
For UK authorised products…..
(5) A veterinary surgeon or a pharmacist may import any authorised veterinary medicinal
product.
(6) A suitably qualified person (in accordance with paragraph 9 of Schedule 3) may import any
authorised veterinary medicinal product that he is permitted to supply.
(7) There are no restrictions on the importation of an authorised veterinary medicinal product in
category AVM-GSL.
Importation of an unauthorised veterinary medicinal product (ie ones without a UK marketing authorisation)
25.—(1) It is an offence to import an unauthorised veterinary medicinal product except in
accordance with this regulation.
(5) A veterinary surgeon may import an unauthorised veterinary medicinal product that is
authorised in another member State if it is for the purpose of administration by him or under his
supervision under the cascade or administration in exceptional circumstances in accordance with
Schedule 4; the import must be in accordance with the appropriate certificate granted by the Secretary of State, and the product may be imported by the veterinary surgeon himself or by using a wholesale dealer or pharmacist as his agent.
(6) A wholesale dealer or a pharmacist may import an unauthorised veterinary medicinal
product for the purpose of storing it pending administration by a veterinary surgeon under the
cascade or administration in exceptional circumstances in accordance with Schedule 4 if—
(a) the veterinary medicinal product is authorised in another member State or a third country;
(b) the Secretary of State has issued a certificate certifying that—
(i) the disease or condition is such that the veterinary medicinal product is likely to be
needed as a matter of urgency for the treatment of an animal;
(ii) delay in administering the product will seriously affect the health or welfare of the
animal; and
(iii) there is no suitable veterinary medicinal product authorised in the United Kingdom;
and
(c) in the case of a wholesale dealer, the product is within the terms of his authorisation.
Also – as outlined above under the Cascade note that …
Treatment in exceptional circumstances (Schedule 4)
7.—(1) Where the health situation so requires, and where there is no suitable veterinary
medicinal product available either as an authorised product or under the cascade, a veterinary
surgeon may treat an animal with a veterinary medicinal product authorised in a third (ie non-EU) country; but if the veterinary surgeon has not obtained a certificate from the Secretary of State under regulation 25(5) permitting him to import it, he must obtain a certificate from the Secretary of State before he treats the animal.
(2) The certificate may be granted subject to any condition the Secretary of State thinks fit.
Alistair Barr 29.10.05