Legalize / United Kingdom / Statutory-Instrument

The Veterinary Medicines Regulations 2013

Type Statutory-Instrument

Publication 2013-08-06

Last updated 2024-05-17

State In force

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

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(4) Where the Secretary of State is not satisfied in relation to one or more of the matters mentioned in sub-paragraph (3), the Secretary of State may—

(a) reject the application; or

(b) grant a conditional manufacturing authorisation for a period specified by the Secretary of State until the deficiency has been addressed.

(5) The Secretary of State may extend the period for which a conditional manufacturing authorisation is granted under sub-paragraph (4)(b).

(6) Where a conditional manufacturing authorisation is granted under sub-paragraph (4)(b) and the deficiency is addressed within the specified period to the satisfaction of the Secretary of State, the authorisation continues to have effect without those conditions.

The authorisation

4

(1) The manufacturing authorisation must specify—

(a) the types of veterinary medicinal products and pharmaceutical forms that may be manufactured , controlled or imported;

(b) the name and address of the site where the products are to be manufactured or controlled, or to which they are to be imported;

(d) the address of the premises to which it relates;

(e) the names of all qualified persons nominated to act under this Schedule.

(2) It may specify that different activities must be carried out in different premises or parts of premises, and may require the holder of the manufacturing authorisation to restrict access to premises or parts of premises to persons carrying out activities there.

(3) The holder of a manufacturing authorisation must notify the Secretary of State, and if necessary apply for a variation of the authorisation, before making a material alteration to the premises or facilities used under the authorisation, or to the operations for which they are used.

Suspension, variation or revocation of the authorisation

5

(1) The Secretary of State may suspend, vary or revoke a manufacturing authorisation if the holder—

(a) has not complied with these Regulations;

(b) has manufactured a veterinary medicinal product not authorised by the manufacturing authorisation;

(d) no longer has suitable premises or equipment.

(e) has failed to carry out the activity specified in the authorisation for a period of five years or more; or

(f) has not paid any fee required under these Regulations

(2) The Secretary of State may also suspend, vary or revoke the authorisation on being satisfied that the qualified person (manufacture), the person responsible for quality control or the person with responsibility for production is not fulfilling that person’s duties under these Regulations.

(3) In particular, the Secretary of State may—

(a) suspend the manufacture or import of veterinary medicinal products;

(b) suspend, revoke or vary the manufacturing authorisation for one or more pharmaceutical forms;

(c) suspend, revoke or vary the manufacturing authorisation for one or more activities in one or more manufacturing sites.

Inspection of premises

6

(1) The Secretary of State must, from time to time, inspect sites authorised under paragraph 3, basing the frequency of the inspection on the risks associated with each site’s history and the nature of the products handled at the sites.

(2) Within 90 days after an inspection, the Secretary of State must issue a certificate of good manufacturing practice to the manufacturer if the inspection establishes that the manufacturer has complied with the requirements of these Regulations in respect of the site to which the inspection relates.

(2A) Where the Secretary of State does not consider that compliance is established after inspection in accordance with sub-paragraph (2), the Secretary of State must enter that fact in the register mentioned in paragraph 12(a).

(2B) The Secretary of State may carry out an inspection on a site occupied by a manufacturer established in a country other than the United Kingdom notwithstanding any arrangements that may have been entered into between the United Kingdom and that country.

(2C) The importer of a veterinary medicinal product must ensure before importation that the manufacturer of that product has—

(a) a valid certificate of good manufacturing practice issued by the Secretary of State; or

(b) an equivalent certificate issued by a regulatory authority—

(i) with which the Secretary of State has an agreement or arrangement for such purposes; or

(ii) which the Secretary of State considers to have demonstrated equivalent standards to those in the United Kingdom.

(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Report following inspection

7

(1) After each inspection of manufacturing premises, the inspector must make a written report to the Secretary of State on whether the principles and guidelines on good manufacturing practice and the conditions of these Regulations are being complied with.

(2) The Secretary of State must inform the inspected manufacturer of the content of such reports.

Duties on the holder of a manufacturing authorisation

8

(1) A holder of a manufacturing authorisation must ensure that the veterinary medicinal product is manufactured in accordance with the marketing authorisation.

(2) The holder must have permanently at the holder’s disposal the services of—

(a) staff complying with any legal requirements in relation to manufacture of veterinary medicinal products; and

(b) at least one qualified person (manufacture).

(2A) The holder must place at the disposal of any qualified person (manufacture) all necessary documents, premises and technical and other facilities in order to enable that person to discharge their duties as the qualified person.

(2B) Where any qualified person (manufacture) ceases to be available to provide services to the holder, the holder must give notice of the fact to the Secretary of State—

(a) at least 30 days in advance of the person’s ceasing to be so available; or

(b) where such notice is not possible, at the earliest opportunity.

(3) The holder must—

(a) comply with good manufacturing practice and have a valid certificate of good manufacturing practice;

(b) use as starting materials only active substances which have been manufactured in accordance with good manufacturing practice and distributed in accordance with good distribution practice for active substances;

(c) verify that each manufacturer, distributor or importer from whom the holder obtains active substances and to which paragraph 26 applies is registered with the Secretary of State under that paragraph;

(d) carry out audits based on a risk assessment in relation to the manufacturers, distributors and importers from which the holder obtains active substances;

(e) have in place a system of quality assurance and quality control; and

(f) give to the Secretary of State, on request, proof of any control test specified by the Secretary of State which has been carried out on the veterinary medicinal product or the constituents and intermediate products of the manufacturing process in accordance with the data submitted in support of the application for the marketing authorisation.

(3A) The holder of a manufacturing authorisation must inform the Secretary of State and the holder of any relevant marketing authorisation where the holder obtains information that veterinary medicinal products which fall within the scope of its manufacturing authorisation are falsified, or are suspected of being falsified, irrespective of whether those products were distributed within the legal supply chain or by illegal means.

(4) A holder who makes up a bulk package of veterinary medicinal products must ensure that the package is labelled, in a way that the label is clearly visible and legible, with—

(a) the name of the veterinary medicinal product, its strength as shown in the summary of product characteristics and its pharmaceutical form;

(b) the batch number;

(d) any storage requirements; and

(e) any other warning necessary for the safe handling of the package.

(5) A holder must keep an adequate number of representative samples of each batch of a veterinary medicinal product in stock at least until the expiry date of the batch, and must submit any such sample to the Secretary of State if required in writing to do so.

(6) A holder must keep detailed records of all veterinary medicinal products which the holder supplies.

Qualified persons for manufacture

9

(1) The Secretary of State may appoint as a qualified person (manufacture) any person (including the manufacturer of a veterinary medicinal product) who is—

(a) a member of the Royal Pharmaceutical Society or registered with the Pharmaceutical Society of Northern Ireland;

(b) a Chartered Chemist or a Fellow, Member or Associate Member of the Royal Society of Chemistry; or

(1A) For the purposes of sub-paragraph (1), a person has sufficient practical experience if they have been engaged in one or more of the activities mentioned in sub-paragraph (1B) for at least two years in the provision of services to the holder of a manufacturing authorisation.

(1B) For the purposes of sub-paragraph (1A) the activities are—

(a) quality assurance of medicinal products;

(b) qualitative analysis of medicinal products;

(1C) The Secretary of State may treat the reference in sub-paragraph (1A) to two years of practical experience as a reference to—

(a) one year, where the person’s formal course of study lasted for at least five years;

(b) six months, where the person’s formal course of study lasted for at least six years.

who qualified on the basis of a formal course of study lasting not less than three years full-time or equivalent and who has sufficient practical experience to carry out the duties under this Schedule.

(2) The Secretary of State may exceptionally appoint a person who is not a member of one of those institutions to act as a qualified person (manufacture) on being satisfied that that person has the educational qualifications or practical experience to carry out the duties under this Schedule.

Refusal or revocation of appointment

10

The Secretary of State may refuse , revoke, suspend or vary an appointment if the Secretary of State is not satisfied that a person has fulfilled or will fulfil duties under these Regulations.

Duties on a qualified person

11

(1) The qualified person (manufacture) must ensure that each batch of veterinary medicinal product manufactured under that person’s responsibility is manufactured and checked in compliance with these Regulations and in accordance with the data submitted in support of the application for the marketing authorisation.

(2) If a manufacturer imports a veterinary medicinal product from another country,..., the qualified person (manufacture) must ensure that, following importation, each production batch imported is fully tested ..., including a full qualitative analysis, a quantitative analysis of at least all the active substances and all the other tests or controls necessary to ensure the quality of a veterinary medicinal product is in accordance with the requirements of the marketing authorisation.

(3) Sub-paragraph (2) does not apply where the exporting country has demonstrated equivalent standards to those of the United Kingdom or where appropriate arrangements have been made ...with the exporting country to ensure that the manufacturer of the veterinary medicinal product applies standards of good manufacturing practice at least equivalent to those laid down in Commission Directive 91/412/EEC and to ensure that the controls in sub‑paragraph(2) have been carried out in the exporting country.

(4) At each stage of manufacture, including release for sale, the qualified person (manufacture) must certify in writing that all control tests required under the marketing authorisation have been carried out, and that the production batch complies with the marketing authorisation.

Register

12

The Secretary of State must maintain and publish a register of—

(a) holders of manufacturing authorisations; and

(b) qualified persons (manufacture) appointed under paragraph 9(2).

Test sites

13

(1) The Secretary of State may authorise a site to act as a test site to carry out contract testing for a holder of a manufacturing authorisation.

(2) The site must have a current certificate of good manufacturing practice.

(2A) The site must be specified in an existing manufacturing authorisation.

(3) Inspection of the site is the same as for a manufacturing authorisation.

PART 2 — Authorisation of autogenous vaccines, blood-banks, stem cell centres and products manufactured under the cascade

Authorisation to manufacture autogenous vaccines

14

(1) The Secretary of State may authorise a person to—

(a) manufacture—

(i) autogenous vaccines; or

(ii) an unauthorised veterinary medicinal product for administration under the cascade;

(b) collect, store and supply blood in connection with the treatment of non-food animals;

(c) collect, store and supply blood constituents obtained by the physical separation of donor blood into different fractions within a closed bag system, for the treatment of non-food animals; or

(d) collect, process and store stem cells for use as an autologous treatment in non-food animals,

and may authorise sites for the purpose of carrying out those activities by that person.

(2) A single authorisation under sub-paragraph (1) may confer permission to carry out the activities mentioned in both paragraph (b) and (c) of that sub-paragraph.

(3) In this paragraph, a “closed bag system” means a system in which the blood pack assembly is manufactured under clean conditions, sealed to the external environment and sterilised.

Types of authorisation

15

No person may carry out any activity mentioned in paragraph 14 otherwise than—

(a) in accordance with an authorisation mentioned in that paragraph; or

(b) pursuant to paragraph 1(2) of Schedule 4 (administration under the cascade).

Labelling

16

In order to be authorised the site mentioned in paragraph 14(1) must be under the supervision of a named person responsible for release (a “PRR”) who in the opinion of the Secretary of State has sufficient qualifications and experience to manufacture the product safely.

Records

17

(1) An applicant for authorisation under paragraph 14 must, at least two months before commencing an activity mentioned in that paragraph, submit the following to the Secretary of State—

(a) the name and address of the proposed holder of the authorisation;

(b) a description of the activity in which the applicant for authorisation proposes to be engaged;

(c) particulars (including the name and address) in relation to the site at which the relevant activity is to be carried out (whether in the occupation of the proposed holder or otherwise) and a description of the technical equipment on the site;

(d) particulars in relation to the qualifications and experience of the proposed PRR who will supervise the activities at the site.

(2) The application must include a declaration that the applicant will comply with the requirements of these Regulations and confirmation that the site is ready for inspection.

(3) Before granting an authorisation in relation to a site, the Secretary of State must be satisfied that the production process carried out there will produce a consistent, safe product and, in the case of a blood bank or a stem cell centre, that the welfare of the animals involved in the processes will be respected.

Adverse reactions

18

(1) No person may collect blood for the purposes of a non-food animal blood bank other than a veterinary surgeon or a person acting under the responsibility of a veterinary surgeon.

(2) The holder of an authorisation to carry out an activity under paragraph 14(1)(b) or (c) may only supply blood or blood constituents to a veterinary surgeon.

(3) No person other than a veterinary surgeon or someone acting under a veterinary surgeon’s responsibility may administer blood to a non-food producing animal.

(4) No person may administer blood to a food-producing animal.

Inspection of premises

19

(1) No person may collect stem cells for the purposes of treating animals other than a veterinary surgeon or a person acting under the responsibility of a veterinary surgeon.

(2) No person may collect stem cells from embryonic tissues.

(3) No person may administer any product grown from stem cells to a food-producing animal.

PART 3 — Authorisation of blood banks

Authorisation of blood banks

20

(1) Subject to sub-paragraph (2), no person may manufacture a product for administration under the cascade that is the pharmaceutical equivalent of an authorised veterinary medicinal product.

(2) The Secretary of State may authorise the manufacture of a product notwithstanding sub-paragraph (1) where there is difficulty in relation to the supply of the authorised veterinary medicinal product.

(3) The holder of an authorisation under paragraph 14(1)(a)(ii) may not supply a product manufactured in accordance with that sub-paragraph other than to a veterinary surgeon who has prescribed the product under the cascade.

(4) The holder of an authorisation under paragraph 14(1)(a)(ii) must—

(a) provide a list of products manufactured in accordance with that sub-paragraph to the Secretary of State annually or at the request of the Secretary of State;

(b) provide sales data for products supplied under sub-paragraph (3) at the request of the Secretary of State.

(5) For the purposes of this paragraph, a product is the pharmaceutical equivalent of an authorised veterinary medicinal product if—

(a) it has the same qualitative and quantitative composition in active substances; and

(b) it has the same pharmaceutical form.

Supply and administration of blood from a blood bank

21

The Secretary of State may by notice suspend, vary or revoke an authorisation under paragraph 14 if the Secretary of State is satisfied that—

(a) the holder of the authorisation no longer uses fit and proper processes;

(b) the site at which the activity takes place is not suitable;

(d) the PRR has not carried out adequately the PRR’s responsibilities under these Regulations;

(e) in the case of a person authorised under paragraph 14(1), that person has manufactured a veterinary medicinal product pursuant to that authorisation that is not within its scope;

(f) the holder has not conducted an activity relating to the authorisation for five years or more;

(g) the holder has not paid any fee required under these Regulations; or

(h) the holder has not complied with any other provision in these Regulations.

Labelling

22

(1) The holder of an authorisation under paragraph 14 must ensure that every container used is labelled with—

(a) a precise description of the product;

(b) the date on which the product was produced;

(d) the address of the site named under the authorisation and its authorisation number;

(e) the instructions for use;

(f) the expiry date;

(g) any necessary warnings;

(h) in the case of an autogenous vaccine or an unauthorised veterinary medicinal product for administration under the cascade, the name of the veterinary surgeon who ordered the product;

(i) in the case of blood or a stem cell product—

(i) the identification of the donor animal; and

(ii) the date of collection.

(2) In the case of blood or blood constituents there must be no specific therapeutic indication on the label or on any information related to the product.

(3) In the case of an unauthorised veterinary medicinal product for administration under the cascade the words “this veterinary medicinal product does not hold a marketing authorisation” must appear on the label.

Records

23

The holder of an authorisation under paragraph 14 must, as soon as is reasonably practicable after the product is supplied, in addition to the expiry date of the product, record the following—

(a) in the case of an unauthorised veterinary medicinal product for administration under the cascade—

(i) the name and address of the veterinary surgeon who ordered the veterinary medicinal product;

(ii) a precise description of the product;

(iii) the date of production;

(iv) the date of supply to the veterinary surgeon;

(b) in the case of stem cells or blood—

(i) the identification of the source animal;

(ii) the name of the veterinary surgeon who collected the product (or under whose responsibility it was collected);

(iii) the date of collection of the product;

(iv) the date that the product was used or if the product was supplied to another veterinary surgeon, the name and address of that veterinary surgeon and the date the product was supplied;

(i) the name and address of the veterinary surgeon who ordered the vaccine;

(ii) the identification of the source animal;

(iii) the date of supply to the veterinary surgeon,

and must keep the records for at least five years.

Inspection of premises

24

The holder of an authorisation under paragraph 14 must notify the Secretary of State of any adverse event in relation to a product produced by that person under that authorisation within 30 days of learning of the event.

PART 4 — Authorisation of manufacturers of products for administration under the cascade

Authorisation to manufacture products for administration under the cascade

25

The Secretary of State must inspect any site authorised under paragraph 14, basing the frequency of the inspection on the risks associated with each site’s history and the nature of the products handled at the site.

Labelling

26

(1) No person may manufacture, import or distribute an active substance unless the person is registered in the register maintained under sub-paragraph (2).

(2) The Secretary of State must establish and maintain a register of manufacturers, importers and distributors of active substances and the sites occupied by them for the purposes of manufacturing or holding active substances.

Records

27

(1) An applicant for registration under paragraph 26 must, at least two months before commencing an activity mentioned in paragraph 26(1) or, in the case of an existing manufacturer, within two months of the date on which this provision comes into force, submit the following to the Secretary of State—

(a) the name and address of the proposed registration holder;

(b) the name of the relevant active substance;

(d) particulars in relation to the site at which the relevant active substance is to be manufactured or held (as the case may be).

(2) Information may be submitted to the Secretary of State pursuant to sub-paragraph (1) prior to the date on which this provision comes into force, and in such a case—

(a) as regards an applicant for registration who is not an existing manufacturer, the relevant period of two months is to be treated as having started on the date of submission;

(b) as regards an applicant for registration who is an existing manufacturer, the information is to be treated as having been submitted within the relevant period of two months.

Adverse reactions

28

A manufacturer, importer or distributor of active substances must comply with good manufacturing practice or good distribution practice, as applicable.

Inspection of premises

29

(1) A person registered under paragraph 26 must immediately inform the Secretary of State on receipt of any new information that might adversely affect the quality and safety of the active substance.

(2) A person registered under paragraph 26 must immediately inform the Secretary of State of any prohibition or restriction in relation to the active substance imposed by the competent authorities of any country other than the United Kingdom in which the active substance is authorised.

PART 5 — Authorisation of equine stem cell centres

Authorisation of stem cell centres

30

The Secretary of State may, from time to time, inspect sites registered under paragraph 26, basing the frequency of the inspections on the risks associated with each site’s history and the nature of the substances handled at the site.

Supply and administration of stem cells

31

(1) After each inspection of a site for the purposes of this Part, the inspector must make a written report to the Secretary of State on whether the requirements in this Part are being complied with.

(2) The Secretary of State must inform the inspected registered person of the content of such reports.

Labelling

32

It is an offence to fail to comply with—

(a) paragraph 1;

(b) paragraph 4(3);

(d) paragraph 11;

(e) paragraph 15;

(f) paragraph 18;

(g) paragraph 19;

(h) paragraph 20(1), (3) or (4);

(i) paragraph 22;

(j) paragraph 23;

(k) paragraph 24;

(l) paragraph 26;

(m) paragraph 28;

(n) paragraph 29.

Records

33

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Inspection of premises

34

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Offences

35

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SCHEDULE 3 — Classification and supply, wholesale dealers and sheep dip

PART 1 — Classification and supply of authorised veterinary medicinal products

Classification of veterinary medicinal products

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);

(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;

(d) products for the purpose of euthanasia;

(e) products with a hormonal or thyrostatic function;

(f) products containing beta-agonists.

(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;

(d) new veterinary medicinal products containing an active substance that has not been included in an authorised veterinary medicinal product for five years;

(e) immunological veterinary medicinal products.

(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 event 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 antibiotics or anthelmintic substances even where the veterinary medicinal products containing those substances are used incorrectly.

Wholesale supply of veterinary medicinal products

2

(1) Only a 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) A person mentioned in sub-paragraph (1) may only supply a veterinary medicinal product if—

(a) the authorisation in question relates to that product, and

(b) the supply is to the holder of a manufacturing authorisation or is to another person who is entitled to supply that product under these Regulations, either wholesale or retail.

(3) If the supply is to a veterinary surgeon, a pharmacist or a suitably qualified person, it must be to premises registered (or authorised as the case may be) in accordance with paragraph 8(1), paragraph 10(1) or paragraph 14(4).

(4) It is immaterial 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 with such products for the purpose of alleviating a temporary supply shortage that could be detrimental to animal welfare.

(6) A wholesale dealer may break open any package (other than the immediate packaging) of a veterinary medicinal product.

Retail supply of veterinary medicinal products

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

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

(5) There are no restrictions on the supply of AVM-GSL products.

(6) In this paragraph—

(a) “retail supply” means a supply whether or not for payment to the owner or keeper of an animal for administration to that animal; and

(b) a person may supply a product irrespective of who owns it.

Prescriptions by a veterinary surgeon

4

(1) A veterinary surgeon who prescribes a veterinary medicinal product classified as POM-V or a veterinary medicinal product under the cascade must first carry out a clinical assessment of the animal, and the animal must be under that veterinary surgeon’s care.

(2) This does not apply in relation to the administration of such a product to a wild animal where the administration is authorised by the Secretary of State.

Prescriptions

5

(1) A prescription may be verbal or written, but a veterinary medicinal product classified as POM-V or POM-VPS or a veterinary medicinal product prescribed under the cascade may only be supplied—

(a) by the person who prescribed it;

(b) under a written prescription that complies with paragraph 6; or

(1A) Where a veterinary medicinal product is supplied in accordance with a prescription which is not a written prescription, the person who prescribes the product must make a record of the reason for prescribing the product.

(1B) A record made in accordance with sub-paragraph (1A) must be kept by the person mentioned in that sub-paragraph for a period of five years from the date on which the product is prescribed

(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

(3) No person may alter a written prescription unless authorised to do so by the person who signed it.

(4) No person may submit a written prescription to a retailer on more than one occasion where the prescription is not repeatable.

Written prescriptions

6

(1) A written prescription must include—

(a) the full name, address and contact details of the person prescribing the product, including that person’s professional registration number (if available);

(b) the full name, address and contact details of the animal owner or keeper;

(d) the premises at which the animals are kept if this is different from the address of the owner or keeper;

(e) the issue date;

(f) the signature or electronic signature of the prescriber;

(g) the name and amount of the product prescribed;

(h) the pharmaceutical form and strength of the product;

(i) as regards veterinary medicinal products that are antibiotics which are prescribed for prophylactic purposes or metaphylactic purposes (as the case may be), a statement to that effect;

(j) the dosage regimen;

(k) any warnings necessary to ensure the proper use, including, where relevant, to ensure prudent use of antimicrobials;

(l) the words “It is an offence under the Veterinary Medicines Regulations 2013 for a person to alter a written prescription unless authorised to do so by the person who signed it”;

(m) for food-producing animal species, the withdrawal period or a statement that the withdrawal period is equal to zero days; and

(n) if the prescription relates to a product prescribed under the cascade, a statement to that effect.

(1A) Subject to the professional obligations of a veterinary surgeon to ensure the health and welfare of animals under their care, a veterinary surgeon may only prescribe a veterinary medicinal product that is an antibiotic where satisfied that the circumstances set out in sub-paragraph (1B) apply.

(1B) For the purposes of sub-paragraph (1A) the circumstances are that the product is not—

(a) used routinely;

(b) used to compensate for poor hygiene, inadequate animal husbandry, or poor farm management practices; or

(2) A written prescription for a controlled drug as specified in Schedules 2 to 4 of the Misuse of Drugs Regulations 2001³² 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.

Duties when a product is prescribed or supplied

7

(1) A person who prescribes a veterinary medicinal product under the cascade or 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 a charge of failing to comply with this paragraph 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) A person who prescribes antimicrobials must ensure that the product is prescribed for the most limited period that is consistent with the risk to be addressed.

Supply by a veterinary surgeon from registered premises

8

(1) A veterinary surgeon may only supply a veterinary medicinal product from practice premises registered with the Royal College of Veterinary Surgeons as veterinary practice premises at which veterinary medicinal products are stored or supplied.

(2) This paragraph does not apply in relation to a veterinary medicinal product classified as AVM-GSL.

(3) The Royal College of Veterinary Surgeons must, on request, supply the Secretary of State with a copy of the register of veterinary practice premises.

(4) The Secretary of State must, from time to time, inspect premises registered under sub-paragraph (1), basing the frequency of the inspection on the risks associated with each premises’ history and the nature of the products handled at the premises.

(5) Where an inspection under sub-paragraph (4) reveals significant breaches of these Regulations the Secretary of State may require the Royal College of Veterinary Surgeons to remove the premises from the register maintained under sub-paragraph (1).

(6) Where the Secretary of State requires the removal of premises from the register the veterinary surgeon concerned may appeal using the procedure in regulation 30.

(7) Where premises have been removed from the register under sub-paragraph (5) they may not be re-registered without the approval of the Secretary of State.

(8) The Secretary of State may only grant approval under sub-paragraph (7) after a further inspection of the premises.

Supply by a veterinary surgeon

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.

(2) A veterinary surgeon or a person acting under a veterinary surgeon’s responsibility may open any package containing a veterinary medicinal product.

Supply by a pharmacist

10

(1) A pharmacist may only supply a veterinary medicinal product classified as POM-V, POM-VPS or NFA-VPS , or prescribed under the cascade, from—

(a) premises registered as a pharmacy with the General Pharmaceutical Council or with the Pharmaceutical Society of Northern Ireland;

(b) premises registered with the Royal College of Veterinary Surgeons 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 authorised 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 63 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.

Supply of a veterinary medicinal product for incorporation into feedingstuffs

11

(1) This paragraph applies in relation to the supply of a medicinal premix.

(2) ... An authorised manufacturer of the product or an authorised wholesale dealer may only supply such a medicinal premix to—

(a) a veterinary surgeon, pharmacist or, in the case of a product classified as POM-VPS, a suitably qualified person;

(b) an authorised intermediate feedingstuffs manufacturer; or

(c) an authorised feedingstuffs manufacturer if the approval permits the rate of incorporation specified on the label of that medicinal premix (if the manufacturer is the end-user the supply must be in accordance with a medicated feedingstuffs prescription).

(3) A veterinary surgeon, pharmacist or, in the case of a product classified as POM-VPS, a suitably qualified person may only supply such a medicinal premix to—

(a) an authorised intermediate feedingstuffs manufacturer; or

(b) an authorised feedingstuffs manufacturer if the authorisation permits the rate of incorporation specified on the label of that medicinal premix (if the manufacturer is the end user the supply must be in accordance with a prescription for medicated feedingstuffs).

(4) This paragraph does not apply in relation to a feedingstuffs manufacturer approved to incorporate a medicinal premix who supplies another such feedingstuffs manufacturer with medicinal premix where the purpose of that supply is to alleviate a temporary supply shortage that could be detrimental to animal welfare.

Labelling at the time of retail supply

12

(1) If a veterinary medicinal product is supplied in a container specified in the marketing authorisation, it must not be supplied 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.

Supply of veterinary medicinal products for use under the cascade

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 practice premises or authorised premises supplying the veterinary medicinal product;

(b) the name of the veterinary surgeon who has prescribed the product;

(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”.

Supply by a suitably qualified person

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;

(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) For the purposes of these Regulations, a suitably qualified person is a person who has passed examinations specified by such a body, and is registered with such a body as a suitably qualified person.

(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 authorised 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 General Pharmaceutical Council 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.

(5) A suitably qualified person who supplies a product classified as POM-VPS or NFA-VPS must be present when it is handed over unless the suitably qualified person—

(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.

(6) A suitably qualified person supplying products from premises authorised under this regulation by the Secretary of State who considers that the premises no longer comply with the authorisation must notify the Secretary of State without unreasonable delay.

(7) The Secretary of State may issue a Code of Practice for suitably qualified persons and bodies recognised under this paragraph, and a body recognised under this paragraph must take appropriate action in accordance with any disciplinary code that applies to that body if a suitably qualified person registered with it does not comply 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 authorised under this paragraph³³.

(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 authorisation of authorised premises on being satisfied that they are no longer suitable for the storage and supply of veterinary medicinal products.

(11) The Secretary of State must, from time to time, inspect premises authorised under sub-paragraph (4)(a) basing the frequency of the inspection on the risks associated with each premises’ history and the nature of the products handled at the premises.

(12) The Secretary of State may suspend or revoke recognition of a body mentioned in sub-paragraph (1) where the body fails to comply with a provision of any Code of Practice issued under this paragraph.

Annual audit

15

(1) At least once a year, a retailer of prescription only veterinary medicinal products must carry out a detailed audit of stock and compare the incoming and outgoing veterinary medicinal products recorded with products currently held and make a record of this audit.

(2) Where, as a result of the audit mentioned in sub-paragraph (1), the retailer identifies a discrepancy the retailer must make a record of the fact.

(3) The retailer must keep the records mentioned in sub-paragraphs (1) and (2) for a period of five years from the date of the audit and the Secretary of State may require the retailer to provide a copy of them at any time within that period.

PART 2 — Requirements for a wholesale dealer’s authorisation

Application

16

No person may carry out any wholesale dealing in veterinary medicinal products otherwise than in accordance with an authorisation granted under paragraph 18(2) (a “wholesale dealer’s authorisation”).

Time limits

17

(1) An application for a wholesale dealer’s authorisation (which must be submitted to the Secretary of State electronically) must include the matters mentioned in sub-paragraph (2).

(2) For the purposes of sub-paragraph (1) the matters are—

(a) the name of the person who will hold the wholesale dealer’s authorisation and that person’s address or registered place of business;

(b) the names and addresses of the sites from which wholesale dealing of veterinary medicinal products is to take place;

(i) weatherproof;

(ii) secure and lockable;

(iii) clean;

(iv) free from contaminants;

(v) designed with designated areas for the receipt of veterinary medicinal products; and

(vi) where the veterinary medicinal products for which the authorisation is sought are subject to specific storage requirements, capable of fulfilling those requirements;

(d) the name of the person nominated to act in accordance with good distribution practice (the “wholesale qualified person”);

(e) the qualifications and a description of the relevant experience of the wholesale qualified person;

(f) a description of the veterinary medicinal products proposed to be dealt in under the authorisation;

(g) evidence that the proposed holder of the authorisation has available to it the services of technically competent staff;

(h) evidence that the proposed holder of the authorisation has in place—

(i) an effective emergency recall plan; and

(ii) a quality system;

(i) a declaration that the applicant complies with good distribution practice and any relevant legislation;

(j) a declaration that any site mentioned in paragraph (b) is ready for inspection.

Granting the authorisation

18

(1) The Secretary of State must inspect the sites mentioned in paragraph 17(2)(b) within 90 days of validating the application.

(2) Where the Secretary of State is satisfied, following the inspection mentioned in sub-paragraph (1) that—

(a) the sites are suitable for the intended purposes; and

(b) the applicant has—

(i) suitable and sufficient staff and facilities for the storage of veterinary medicinal products; and

(ii) a documented quality system in place,

the Secretary of State must grant the wholesale dealer’s authorisation.

(3) Where the Secretary of State is not satisfied in relation to one or more of the matters mentioned in sub-paragraph (2), the Secretary of State may—

(a) reject the application; or

(b) grant a conditional wholesale dealer’s authorisation for a period specified by the Secretary of State until the deficiency has been addressed.

(4) The Secretary of State may extend the period for which a conditional wholesale dealer’s authorisation is granted under sub-paragraph (3)(b).

(5) Where a conditional wholesale dealer’s authorisation is granted under sub-paragraph (3)(b) and the deficiency is addressed within the specified period to the satisfaction of the Secretary of State, the authorisation continues to have effect without those conditions.

The authorisation

19

(1) The Secretary of State must, from time to time, inspect the sites from which wholesale dealing of veterinary medicinal products takes place pursuant to a wholesale dealer’s authorisation basing the frequency of the inspection on the risks associated with each site’s history and the nature of the products handled at the site.

(2) The Secretary of State may suspend, vary or revoke a wholesale dealer’s authorisation if, in respect of any one of the sites covered by that authorisation, the holder does not deal in veterinary medicinal products from that site for five years.

Suspension, variation or revocation of the authorisation

20

The Secretary of State may suspend, vary or revoke a wholesale dealer’s authorisation if the holder—

(a) has not complied with these Regulations; or

(b) no longer has suitable premises, equipment or technically competent staff

Duties on the holder of a wholesale dealer’s authorisation

21

The holder of a wholesale dealer’s authorisation must—

(a) store veterinary medicinal products in accordance with the terms of the marketing authorisation for each product;

(b) comply with good distribution practice;

(d) supply information and samples to the Secretary of State on demand ; and

(e) notify the Secretary of State (and in relation to paragraph (ii), the holder of the relevant marketing authorisation) where it has reason to suspect—

(i) a threat to the continued supply of a veterinary medicinal product;

(ii) that it has been offered veterinary medicinal products which are counterfeit.

PART 3 — Sheep dip

Supply of sheep dip

22

(1) A person who supplies by retail sheep dip which contains a veterinary medicinal product must supply it in accordance with this paragraph.

(2) The supply must be to a person (or a person acting on that person’s behalf) who is qualified to use it in accordance with paragraph 23.

(3) The supplier must make a record of that person’s certificate or award number as soon as is reasonably practicable, and keep it for at least three years.

(4) If the active ingredient of the veterinary medicinal product is an organophosphorus compound, the supplier must give to the buyer—

(a) a double-sided laminated notice meeting the specifications in the following sub-paragraph (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 available for use); and

(b) two pairs of gloves either as described in the notice or providing demonstrably superior protection to the proposed user against exposure to the dip than would be provided by gloves as so described.

(5) The notice must be at least A4 size with a laminated transparent cover and must tell the user of the sheep dip—

(a) to read and act in accordance with the label, including instructions on measuring and diluting concentrate;

(b) that sheep dip is absorbed through the skin;

(d) always to wash protective clothing before taking it off; and

(e) to direct any questions to the supplier or manufacturer.

(6) The notice must contain a diagram showing recommended protective clothing.

Use of sheep dip

23

(1) No person may use sheep dip which contains a veterinary medicinal product unless they hold, or they are acting under the supervision and in the presence of a person who holds, either—

(a) 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

(b) NPTC Level 2 Award in the Safe Use of Sheep Dip (QCF).

(2) The certificate must be issued—

(a) in England, Wales and Northern Ireland; by—

(i) the National Proficiency Tests Council;

(ii) NPTC Part of the City & Guilds Group; or

(iii) City and Guilds NPTC;

(b) in Scotland, by one of those organisations or the Scottish Skills Testing Service.

Offences

24

It is an offence to fail to comply with—

(a) paragraph 2;

(b) paragraph 3;

(ba) paragraph 3A;

(bb) paragraph 3B;

(bc) paragraph 3C;

(bd) paragraph 3D;

(be) paragraph 3E;

(d) paragraph 5;

(da) paragraph 6;

(e) paragraph 7;

(ea) paragraph 7A;

(f) paragraph 8(1);

(g) paragraph 9(1);

(h) paragraph 10;

(i) paragraph 11;

(j) paragraph 12(1) or (3);

(k) paragraph 13;

(l) paragraph 14(4), (5) or (6);

(m) paragraph 15;

(ma) paragraph 16;

(n) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(o) paragraph 21;

(oa) paragraph 21B;

(ob) paragraph 21C;

(oc) paragraph 21D;

(od) paragraph 21E;

(oe) paragraph 21F;

(p) paragraph 22; or

(q) paragraph 23(1).

SCHEDULE 4 — Administration of a veterinary medicinal product outside the terms of a marketing authorisation

Administration under the cascade

1

(1) A veterinary surgeon acting under this paragraph who prescribes a veterinary medicinal product may either administer it personally or may direct another person to do so under the responsibility of the veterinary surgeon.

(2) If there is no authorised veterinary medicinal product in the United Kingdom for a condition the veterinary surgeon responsible for the animal may, in particular to avoid unacceptable suffering, treat the animal 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 there is no such product that is suitable, either—

(i) a human medicinal product authorised in the United Kingdom; or

(ii) a veterinary medicinal product not authorised in the United Kingdom but authorised in another country for use with any animal species (in the case of a food-producing animal, it must be a food-producing species);or

(c) 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.

(3) In the case of a veterinary medicinal product imported from another country, if the veterinary surgeon has not obtained a certificate from the Secretary of State under regulation 25(5) permitting importation, the veterinary surgeon must obtain a certificate from the Secretary of State before administration.

(4) All substances included in a medicinal product administered to a food-producing animal under the cascade must be substances for which a maximum residue limit has been established under Regulation (EC) No 470/2009 of the European Parliament and of the Council or substances which do not fall within the scope of Regulation (EC) No 470/2009 of the European Parliament and of the Council.

(5) Where a substance mentioned in sub-paragraph (4) is administered, the maximum residue limits established in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council must be complied with.

Withdrawal periods

2

(1) A veterinary surgeon prescribing or 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—

(a) where there is a maximum residue limit established for the active substance for the treated species under Regulation (EC) No 470/2009 of the European Parliament and of the Council, the level of residue of the active substance does not exceed that limit; and

(b) where there is no maximum residue limit for the treated species established under Regulation (EC) No 470/2009 of the European Parliament and of the Council but one is established for the substance itself, the level of residue of the active substance does not exceed the level determined by reference to Commission Implementing Regulation (EU) 2018/470 on detailed rules on the maximum residue limit to be considered for control purposes for foodstuffs derived from animals which have been treated in the EU under Article 11 of Directive 2001/82/EC.

(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 has been established) must not be less than—

(a) for eggs—

(i) the longest withdrawal period in the summary of product characteristics for any species multiplied by a factor of 1.5; or

(ii) 14 days, if the product is not authorised for animals producing eggs for human consumption;

(b) for milk—

(i) the longest withdrawal period in the summary of product characteristics for any species multiplied by a factor of 1.5;

(ii) 7 days, if the veterinary medicinal product is not authorised for animals producing milk for human consumption; or

(iii) 1 day, if the medicinal product has a zero-hour withdrawal period;

(i) the longest withdrawal period provided in its summary of product characteristics for meat and offal, multiplied by a factor of 1.5;

(ii) 28 days if the veterinary medicinal product is not authorised for food-producing animals; or

(iii) 1 day, if the veterinary medicinal product has a zero-day withdrawal period;

(d) for aquatic species producing meat for human consumption—

(i) the longest withdrawal period for any of the aquatic species in the summary of product characteristics multiplied by a factor of 1.5 and expressed as degree-days;

(ii) if the medicinal product is authorised for food-producing terrestrial animal species, the longest withdrawal period for any of the food-producing animal species in the summary of product characteristics multiplied by a factor of 50 and expressed as degree-days; or

(iii) 25 degree-days if the highest withdrawal period for any animal species is zero.

(4) For the purposes of sub-paragraph (3)—

(a) if the calculation of a withdrawal period results in a fraction of days, the withdrawal period must be rounded to the nearest number of days, with any half of a day being rounded upwards;

(b) in relation to the calculation of the withdrawal period for milk, if the calculation of the period results in a milk withdrawal period not divisible by 12, the withdrawal period must be rounded up to the nearest multiple of 12 hours.

Administration to food-producing horses

3

(1) If there is no authorised veterinary medicinal product for a food-producing horse (as shown on its horse passport) and treatment under the cascade is unsuitable, substances may be administered in accordance with Commission Regulation (EC) No 122/2013 (establishing, in accordance with Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products, a list of substances essential for the treatment of equidae ³⁶).

(2) The person administering the substance must comply with Article 3(2) of Commission Regulation (EC) No 122/2013 (recording the details of the treatment in the animal’s passport).

Immunological products for serious epizootic disease or emerging disease

4

In the event of serious epizootic diseases or emerging diseases, the Secretary of State may permit in writing the administration of immunological veterinary medicinal products without a marketing authorisation, in the absence of a suitable medicinal product ... and may publicise any permit as the Secretary of State sees fit.

Immunological products for an imported or exported animal

5

If an animal is imported from, or exported to, another country, the Secretary of State may permit the administration to that animal of an immunological veterinary medicinal product that is not covered by a marketing authorisation in the United Kingdom but is authorised under the legislation of that other country.

Administration by veterinary surgeons from other countries

6

(1) Veterinary surgeons practising in another country with equivalent medicines regulation standards to those of the United Kingdom may bring into the United Kingdom and administer to animals small quantities of veterinary medicinal products that are not authorised for use in the United Kingdom if—

(a) the quantity does not exceed the requirements for the treatment of specific animals;

(b) the product is authorised in the country in which the veterinary surgeon is established;

(d) in the case of administration to food-producing animals, there is a veterinary medicinal product authorised in the United Kingdom that has the same qualitative and quantitative composition in terms of active substances;

(e) the veterinary surgeon is acquainted with the Code of Professional Conduct for veterinary surgeons issued by the Royal College of Veterinary Surgeons³⁷.

(2) The veterinary surgeon must only supply to the owner or keeper enough veterinary medicinal product to complete the treatment of animals concerned.

(3) The veterinary surgeon must—

(a) ensure that the withdrawal period specified on the label of the product is complied with, or the United Kingdom withdrawal period for the equivalent product authorised in the United Kingdom if this is longer than the one on the label; and

(b) keep detailed records of the animals treated, the diagnosis or clinical assessment, the products administered, the dosage administered, the duration of treatment and the withdrawal period applied, and must keep them in the United Kingdom for at least three years.

(4) The overall range and quantity of veterinary medicinal products carried by the veterinary surgeon must not exceed that generally required for the daily needs of good veterinary practice.

(5) This paragraph does not apply in relation to immunological veterinary medicinal products.

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 medicinal product authorised in another country; but a veterinary surgeon who has not obtained a certificate from the Secretary of State under regulation25(5) permitting importation must obtain a certificate from the Secretary of State before treating the animal.

(2) The certificate may be granted subject to any condition the Secretary of State thinks fit.

Administration of a homeopathic remedy

8

(1) A registered homeopathic remedy or a homeopathic remedy prepared and supplied by a pharmacist under paragraph 10 of Schedule 3 may be administered to an animal by anyone, subject to any restrictions specified in its registration.

(2) A homeopathic remedy that was on the market before 1st January 1994 may be administered by anyone.

(3) A veterinary surgeon may administer, either personally or under the veterinary surgeon’s responsibility—

(a) a homeopathic remedy authorised for human use, or

(b) a homeopathic remedy prepared extemporaneously by a veterinary surgeon, a pharmacist or a person holding a manufacturing authorisation authorising the manufacture of that type of product.

Administration under an animal test certificate

9

(1) A medicinal product may be administered in accordance with an animal test certificate granted for clinical trials by the Secretary of State.

(2) An application for an animal test certificate may be refused if this is necessary for the protection of animal or public health or the environment, and the animal test certificate may be varied, suspended or revoked in the same way as a marketing authorisation.

(3) The holder of an animal test certificate may not supply a product for administration that is not within the terms of the animal test certificate.

(4) The holder of an animal test certificate test who becomes aware of any adverse event following the administration of a product under an animal test certificate must report the reaction to the Secretary of State within 30 days of learning of it.

Offences

10

It is an offence to fail to comply with—

(za) paragraph 2;

(a) paragraph 3(2);

(b) paragraph 6; ...

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