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).
(2) The Secretary of State must specify the classification of the veterinary medicinal product when granting the initial marketing authorisation.
(3) The Secretary of State may change the classification after the marketing authorisation has been granted, either at the request of the marketing authorisation holder or in accordance with paragraph 37 of Schedule 1 (compulsory variation).
(4) When granting the marketing authorisation the Secretary of State must classify the following as POM-V—
(a)products containing narcotic or psychotropic substances;
(b)products intended for administration following a diagnosis or clinical assessment by a veterinary surgeon.
(5) When granting the marketing authorisation the Secretary of State must classify the following as POM-V or POM-VPS—
(a)products for food-producing animals;
(b)products in respect of which special precautions must be taken in order to avoid any unnecessary risk to—
(i)the target species;
(ii)the person administering the products to the animal; and
(iii)the environment;
(c)products that may cause effects that impede or interfere with subsequent diagnostic or therapeutic measures; and
(d)new veterinary medicinal products containing an active substance that has not been included in an authorised veterinary medicinal product for five years.
(6) The requirement in sub-paragraph (5)(a) relating to veterinary medicinal products for food-producing animals does not apply if all the following criteria are met—
(a)the administration of the veterinary medicinal product is restricted to formulations requiring no particular knowledge or skill in using the product;
(b)the veterinary medicinal product does not present a direct or indirect risk, even if administered incorrectly, to the animal or animals treated, to the person administering the product or to the environment;
(c)the summary of product characteristics of the veterinary medicinal product does not contain any warnings of potential serious side effects deriving from its correct use;
(d)neither the veterinary medicinal product nor any other product containing the same active substance has previously been the subject of frequent serious adverse reaction reporting;
(e)the summary of product characteristics does not refer to contra-indications related to other veterinary medicinal products commonly used without prescription;
(f)the veterinary medicinal product is not subject to special storage conditions;
(g)there is no risk for consumer safety as regards residues in food obtained from treated animals even where the veterinary medicinal products are used incorrectly; and
(h)there is no risk to human or animal health as regards the development of resistance to antimicrobials or anthelmintic substances even where the veterinary medicinal products containing those substances are used incorrectly.
2.—(1) Only a holder of a marketing authorisation, the holder of a manufacturing authorisation or the holder of a wholesale dealer’s authorisation granted by the Secretary of State may supply a veterinary medicinal product wholesale, or be in possession of it for that purpose.
(2) They may only supply a veterinary medicinal product if their authorisation relates to that product, and they may only supply it to another person who may supply that product under these Regulations, either wholesale or retail.
(3) If the supply is to a suitably qualified person, it must be to the premises approved in accordance with paragraph 14.
(4) It is irrelevant whether or not the supply is for profit.
(5) This paragraph does not apply in relation to a retailer of veterinary medicinal products who supplies another retailer provided that in any one year the amount supplied by a retailer does not exceed five per cent in terms of value of turnover of veterinary medicinal products of the retailer who supplies the product.
(6) A wholesale dealer may break open any package (other than the immediate packaging) of a veterinary medicinal product.
(7) It is an offence to fail to comply with this paragraph.
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 14,
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 14.
(5) There are no restrictions on the supply of AVM-GSL products.
(6) 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.
(7) It is an offence to fail to comply with this paragraph.
4.—(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 that veterinary surgeon’s care, and failure to do so is an offence.
(2) This does not apply in relation to treatment of a wild animal where the treatment is authorised by the Secretary of State.
5.—(1) A prescription may be oral or written, but a veterinary medicinal product classified as POM-V or POM-VPS may only be supplied—
(a)by the person who prescribed it;
(b)under a written prescription that complies with paragraph 6; or
(c)(in the case of POM-VPS) by a suitably qualified person in accordance with paragraph 14(5).
(2) A person supplying such a product under a written prescription—
(a)may only supply the product specified in that prescription;
(b)must take all reasonable steps to be satisfied that the prescription has been written and signed by a person entitled to prescribe the product; and
(c)must take all reasonable steps to ensure that it is supplied to the person named in the prescription.
(3) No person may alter a written prescription unless authorised to do so by the person who signed it.
(4) It is an offence to fail to comply with this paragraph.
6.—(1) A written prescription must include—
(a)the name, address and telephone number 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 identification (including the species) of the animal or group of animals to be treated;
(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; and
(l)if it is prescribed under the cascade, a statement to that effect.
(2) A written prescription for a controlled drug as specified in the Misuse of Drugs Regulations 2001(1) is valid for 28 days.
(3) A written prescription for any other drug is valid for six months or such shorter period as may be specified in the prescription.
(4) If the prescription is repeatable it must specify the number of times the veterinary medicinal product may be supplied.
7.—(1) A person who prescribes a product classified as POM-V or POM-VPS, or supplies a product classified as NFA-VPS—
(a)before doing so, must be satisfied that the person who will use the product is competent to do so safely, and intends to use it for a purpose for which it is authorised;
(b)when doing so, must advise on its safe administration and on any warnings or contra-indications on the label or package leaflet; and
(c)must not prescribe (or, in the case of a NFA-VPS product, supply) more than the minimum amount required for the treatment; but it is a defence to show that—
(i)the product prescribed or supplied was in a container specified in the marketing authorisation;
(ii)the manufacturer does not supply that veterinary medicinal product in a smaller container; and
(iii)the person prescribing or supplying is not a person authorised to break open the package before supply.
(2) It is an offence to fail to comply with this paragraph.
8.—(1) A veterinary surgeon who supplies a veterinary medicinal product from any practice premises not registered with the Royal College of Veterinary Surgeons under this paragraph as veterinary practice premises at which veterinary medicinal products are stored or supplied is guilty of an offence.
(2) This paragraph does not apply in relation to a veterinary medicinal product classified as AVM-GSL.
9.—(1) A veterinary surgeon supplying a veterinary medicinal product (other than one classified as AVM-GSL) must be present when it is handed over unless the veterinary surgeon—
(a)authorises each transaction individually before the product is supplied; and
(b)is satisfied that the person handing it over is competent to do so,
and it is an offence to supply other than in accordance with this paragraph.
(2) A veterinary surgeon or a person acting under a veterinary surgeon’s responsibility may open any package containing a veterinary medicinal product.
10.—(1) A pharmacist may only supply a veterinary medicinal product classified as POM-V, POM-VPS or NFA-VPS from—
(a)premises registered as a pharmacy with the Royal Pharmaceutical Society of Great Britain or with the Pharmaceutical Society of Northern Ireland;
(b)from 1st April 2009, premises registered under these Regulations as being premises from which a veterinary surgeon supplies veterinary medicinal products; or
(c)(in the case of a veterinary medicinal product classified as POM-VPS or NFA-VPS) from premises approved under paragraph 14.
(2) A pharmacist supplying a veterinary medicinal product (other than one classified as AVM-GSL) must be present when it is handed over unless the pharmacist—
(a)authorises each transaction individually before the product is supplied; and
(b)is satisfied that the person handing it over is competent to do so.
(3) A pharmacist may supply any veterinary medicinal product prepared in a pharmacy in accordance with the prescriptions of a pharmacopoeia and intended to be supplied directly to the end-user.
(4) A pharmacist may supply a homeopathic remedy prepared extemporaneously by a pharmacist in a registered pharmacy (as well as any other homeopathic remedy permitted to be supplied by a pharmacist under these Regulations) provided that it is prepared in accordance with paragraph 62 of Schedule 1 and intended to be supplied directly to the end user.
(5) A pharmacist may break open any package containing a veterinary medicinal product for the purposes of supply other than the immediate packaging of an injectable product.
(6) It is an offence to fail to comply with this paragraph.
11.—(1) This paragraph applies in relation to the supply of a veterinary medicinal product intended for incorporation into feedingstuffs.
(2) The marketing authorisation holder, an authorised manufacturer of the product or an authorised wholesale dealer may supply such a veterinary medicinal product to—
(a)a veterinary surgeon, pharmacist or, in the case of a product classified as POM-VPS, a suitably qualified person;
(b)an approved premixture manufacturer; or
(c)an approved feedingstuffs manufacturer if the approval permits the rate of incorporation specified on the label of that veterinary medicinal product (if the manufacturer is the end-user the supply must be in accordance with a prescription).
(3) A veterinary surgeon, pharmacist or, in the case of a product classified as POM-VPS, a suitably qualified person may supply such a veterinary medicinal product to—
(a)an approved premixture manufacturer; or
(b)an approved feedingstuffs manufacturer if the approval permits the rate of incorporation specified on the label of that veterinary medicinal product (if the manufacturer is the end user the supply must be in accordance with a prescription).
(4) In addition, an approved premixture manufacturer or an approved feedingstuffs manufacturer may supply such a veterinary medicinal product to another approved premixture manufacturer or approved feedingstuff manufacturer provided that the amount supplied does not exceed five per cent in terms of value of veterinary medicinal product incorporated annually by the person supplying the veterinary medicinal product.
(5) It is an offence to supply such a veterinary medicinal product other than in accordance with this paragraph.
12.—(1) If a veterinary medicinal product is supplied in a container specified in the marketing authorisation, it is an offence to supply it if any information on the outer packaging (or, if there is no outer packaging, the immediate packaging) is not clearly visible at the time of supply or has been changed in any way.
(2) Sub-paragraph (1) does not apply to a veterinary surgeon who amends a label, or a pharmacist who amends it in accordance with a prescription from a veterinary surgeon, provided that the unamended information remains clearly visible.
(3) If a veterinary medicinal product is supplied in a container other than that specified in the marketing authorisation, the person supplying the veterinary medicinal product must ensure that the container is suitably labelled and must supply sufficient written information (which may include a copy of the summary of product characteristics or the package leaflet) to enable the product to be used safely, and failure to do so is an offence.
13.—(1) A veterinary medicinal product supplied for administration under the cascade may only be supplied in accordance with a prescription from a veterinary surgeon.
(2) Unless the veterinary surgeon who prescribed the veterinary medicinal product both supplies the product and administers it to the animal in person, the person supplying it must label it (or ensure that it is labelled) with at least the following information—
(a)the name and address of the pharmacy, veterinary surgery or approved premises supplying the veterinary medicinal product;
(b)the name of the veterinary surgeon who has prescribed the product;
(c)the name and address of the animal owner;
(d)the identification (including the species) of the animal or group of animals;
(e)the date of supply;
(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;
(k)the withdrawal period, if relevant; and
(l)the words “Keep out of reach of children” and “For animal treatment only”.
(3) It is an offence to fail to comply with this paragraph.
14.—(1) The Secretary of State may recognise bodies that are suitable to maintain a register for suitably qualified persons to prescribe and supply veterinary medicinal products classified as POM-VPS and NFA-VPS.
(2) In order to recognise such a body, the Secretary of State must be satisfied that the body—
(a)has in place a system for ensuring that persons applying for registration have adequate training to act as a suitably qualified person under these Regulations;
(b)has adequate standards in deciding whether or not to register someone as a suitably qualified person;
(c)maintains a programme of continuing professional development for persons registered with it;
(d)operates an adequate appeal system if it intends to refuse to register anyone with appropriate qualifications or to remove anyone from the register.
(3) To become a suitably qualified person it is necessary to pass examinations specified by such a body, and to be registered with such a body.
(4) A suitably qualified person may only supply a veterinary medicinal product classified as POM-VPS, NFA-VPS or AVM-GSL, and may only supply it from—
(a)premises approved by the Secretary of State as being suitable for the storage and supply of veterinary medicinal products by a suitably qualified person;
(b)premises registered as a pharmacy with the Royal Pharmaceutical Society of Great Britain or with the Pharmaceutical Society of Northern Ireland; or
(c)practice premises registered under these Regulations as being premises from which a veterinary surgeon supplies veterinary medicinal products,
and it is an offence to supply other than from those premises.
(5) A suitably qualified person who supplies a product classified as POM-VPS or NFA-VPS must either—
(a)hand over or despatch the product personally;
(b)ensure that, when the product is handed over or despatched, the suitably qualified person is in a position to intervene if necessary; or
(c)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.
(6) A suitably qualified person supplying products from premises approved under this regulation by the Secretary of State who considers that the premises no longer comply with the approval must notify the Secretary of State without unreasonable delay, and failure to do so is an offence.
(7) The Secretary of State may issue a Code of Practice for suitably qualified persons, and a body recognised under this paragraph must ensure that a suitably qualified person registered with it complies with the Code of Practice.
(8) The Secretary of State must publish a list of—
(a)suitably qualified persons; and
(b)the trading names and the addresses of premises approved under this paragraph(2).
(9) A suitably qualified person may break open any package (other than the immediate packaging) of a veterinary medicinal product.
(10) The Secretary of State may suspend or revoke the approval of approved premises on being satisfied that they are no longer suitable for the storage and supply of veterinary medicinal products.
15.—(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 must be reconciled with products currently held in stock, any discrepancies being recorded.
(2) It is an offence to fail to comply with this paragraph.
S. I. 2001/3998; relevant amending instruments are S. I. 2003/1432 and 2005/1653.
Published at: http://www.vmd.gov.uk/Industry/QPAS/SQPs/htm.