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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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(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 2001[^f00036] 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 paragraph[^f00037].

(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 [^f00040]).

(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 Surgeons[^f00041].

(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; ...

(ba) paragraph 6A;

(d) paragraph 9A.

SCHEDULE 5 — Medicated feedingstuffs and specified feed additives

Scope and interpretation

1

(1) This Schedule applies in relation to the following (referred to in this Schedule as “specified feed additives”) when used as feed additives—

(a) coccidiostats;

(b) histomonostats; and

(i) digestibility enhancers;

(ii) gut flora stabilisers; and

(iii) substances incorporated with the intention of favourably affecting the environment.

(2) It also applies in relation to the manufacture and placing on the market of feedingstuffs containing a veterinary medicinal product.

(3) In this Schedule—

“animal keeper” means any natural or legal person responsible for animals, whether on a permanent or a temporary basis;

“batch” means an identifiable quantity of feed determined to have common characteristics whether in relation to origin, variety, type of packaging, packer, consignor or labelling and, in the case of a production process, a unit of production from a single plant using uniform production parameters or a number of such units when produced in continuous order and stored together;

“cross-contamination” means contamination of a non-target feed with an active substance originating from the previous use of the relevant facilities or equipment;

“distributor” means a feed business operator distributing specified feed additives, intermediate feedingstuff or complete feed containing specified feed additives, or intermediate feedingstuff or complete feed containing medicinal premixes;

“feed business” means any undertaking whether for profit or not and whether public or private, carrying out any operation of production, manufacture, processing, storage, transport or distribution of feed including any producer producing, processing or storing feed for feeding to animals on their own holding;

“feed business operator” means any person responsible for ensuring that the requirements of this Schedule are met within the feed business under that person’s control;

“non-target feed” means feed, whether medicated or not which is not intended to contain a specific active substance;

“premises” means any unit of a feed business;

“premixture” means a mixture of a veterinary medicinal product or a specified feed additive with feedingstuffs materials, intended for further mixing with feedingstuffs before being fed to animals;

“zootechnical additive” means any additive used to maintain animals in good health or favourably affect their performance.

Enforcement of Regulation (EC) No 178/2002

2

(1) For the purposes of Regulation (EC) No 178/2002 the competent authority is the Secretary of State.

(2) No person may fail to comply with any of the following provisions of that Regulation—

(a) Article 11 (requirements relating to imports);

(b) Article 12 (requirements relating to exports);

(d) Article 16 so far as it prohibits misleading labelling, advertising or presentation of feedingstuffs;

(e) Article 18(2) and (3) (requirements of traceability) in so far as it relates to feed business operators; and

(f) Article 20 (responsibilities of feed business operators).

Enforcement of Regulation (EC) No 1831/2003

3

(1) For the purposes of Regulation (EC) No 1831/2003 the competent authority is the Secretary of State.

(2) An authorisation under Article 3(2) of that Regulation must be in writing.

(3) No person may possess a specified feed additive, or an intermediate feedingstuff or feedingstuffs containing a specified feed additive, unless the specified feed additive has been authorised under Regulation (EC) No 1831/2003 or is for export to another country.

(4) No person may fail to comply with any of the following provisions of that Regulation—

(a) Article 3(1) or Article 3(3) (the authorisation, conditions of use and labelling of specified feed additives);

(b) Article 12(1) or (2) (conditions relating to specified feed additives);

(d) Article 16(3) (additional labelling requirement);

(e) Article 16(4) (premixtures containing specified feed additives);

(f) Article 16(5) (packaging).

Enforcement of Regulation (EC) No 882/2004 Regulation (EU) 2017/625

4

For the purposes of Regulation (EU) 2017/625 the competent authority is the Secretary of State.

Enforcement of Regulation (EC) No 183/2005

5

(1) For the purposes of Regulation (EC) No 183/2005 the competent authority is the Secretary of State.

(2) No person may fail to comply with any of the following provisions of that Regulation—

(a) Article 5(2), (5) or (6) (specific obligations);

(b) Article 6(1) as read with (2) and (3) (HACCP system);

(d) Article 9(2) (official controls, notification and registration);

(e) Article 10(1) (approval of feed business establishments);

(f) Article 11 (prohibition on operating without approval or registration);

(g) Article 17(2) (exemption from on-site visits);

(h) Article 18(3) (declaration of compliance);

(i) Article 23(1) (conditions relating to imports from third countries);

(j) Article 25 (feedingstuffs produced for export to third countries).

(3) A manufacturer must ensure that, so far as is reasonably practicable, the active ingredient is evenly incorporated throughout the feedingstuffs.

(4) In the case of the refusal, suspension or revocation of an approval under the Regulation the appeals procedure relating to a manufacturing authorisation in regulation 30 applies.

Enforcement of Regulation (EC) No 767/2009

6

No person may contravene Article 8 of Regulation (EC) No 767/2009 of the European Parliament and of the Council in relation to feedingstuffs containing specified feed additives.

Approval of manufacturers and distributors of feedingstuffs containing veterinary medicinal products

7

(1) For the purposes of Directive 90/167/EEC laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the Community[^f00046] the competent authority is the Secretary of State.

(2) No person may incorporate a medicinal premix into an intermediate feedingstuff or feedingstuff, or act as a distributor of intermediate feedingstuffs or feedingstuffs containing a medicinal premix, without being authorised to do so by the Secretary of State.

(3) The conditions which govern authorisation of feed business premises under Regulation (EC) No 183/2005 laying down requirements for feed hygiene[^f00047] also govern authorisation of manufacturers and distributors under sub-paragraph (2).

(4) The Secretary of State shall conduct inspections of manufacturers and distributors authorised under sub-paragraph (2) basing the frequency of inspection on the risks associated with each premises’ history and the nature of the products handled at the premises.

(5) A manufacturer must ensure that, so far as is reasonably practical the medicinal premix is evenly incorporated and homogeneously dispersed throughout the feedingstuffs, taking into account the specific properties of the medicinal premix and the mixing technology employed.

(6) The provisions of this paragraph do not apply in relation to any person breeding or selling ornamental fish not intended for human consumption provided that the person does not use more than a total of 1kg of medicinal premix annually for that purpose.

(7) In the case of the refusal, suspension or revocation of an authorisation under this paragraph the appeals procedure relating to a manufacturing authorisation in regulation 30 applies.

Incorporation of a veterinary medicinal product into a premixture

8

Any person who incorporates a medicinal premix into an intermediate feedingstuff—

(a) must do so in accordance with the summary of product characteristics, and must take account of any interactions listed there; and

(b) must ensure that the medicinal premix does not contain the same active substance as any other additive.

Top dressing

9

No person may promote or label any veterinary medicinal product, or anything containing a veterinary medicinal product, as being suitable for top dressing (that is, sprinkling it on to feedingstuffs without thoroughly incorporating it) unless the summary of product characteristics specifically permits this use.

Incorporation of a veterinary medicinal product into feedingstuffs

10

Any person who incorporates a medicinal premix (or an intermediate feedingstuff) into feedingstuffs—

(a) must do so in accordance with the summary of product characteristics, and must take account of any interactions listed there;

(b) must ensure that the medicinal premix does not contain the same active substance as any other additive;

(c) must ensure that the medicinal premix is incorporated in accordance with its marketing authorisation (unless it has been prescribed under the cascade) and the medicated feedingstuff prescription;

(d) must ensure that the daily dose of the medicinal premix is contained in a quantity of medicated feedingstuffs corresponding to at least half the daily feedingstuffs ration of the animals treated or, in the case of ruminants, corresponding to at least half the daily requirements of non-mineral complementary feedingstuffs.

Additional record keeping requirements relating to medicinal premixes

11

(1) Any person who—

(a) incorporates a medicinal premix into an intermediate feedingstuff;

(b) incorporates an intermediate feedingstuff containing a medicinal premix into feedingstuffs; or

must make a daily record of—

(d) the types and quantities of all medicinal premixes (and specified feed additives, if any) and intermediate feedingstuffs used in the manufacturing process; and

(e) the quantity of feedingstuffs and intermediate feedingstuffs containing medicinal premix manufactured that day.

(2) An authorised distributor must make a daily record of—

(a) the types and quantities of all intermediate feedingstuffs and feedingstuffs containing medicinal premixes bought and sold that day; and

(b) the quantity held.

(3) A manufacturer and distributor must also record, as soon as reasonably practicable, for each consignment supplied—

(a) the date of delivery;

(b) the name and address of each consignee (or, in the case of a manufacturer supplying to a distributor, the name and address of the distributor);

(d) the quantity;

(e) the type of medicinal premix incorporated into the feedingstuffs; ...

(f) the expiry date ; and

(g) the batch number.

(4) Records must be kept for five years.

Labelling a premixture containing a veterinary medicinal product

12

(1) An intermediate feedingstuff containing a medicinal premix must be clearly and legibly labelled with the following—

(a) the words “INTERMEDIATE FEEDINGSTUFF” (or, if it is to be labelled as “complementary feedingstuffs” under legislation implementing Council Directive 79/373/EEC on the marketing of compound feedingstuffs[^f00048], “MEDICATED COMPLEMENTARY FEEDINGSTUFFS” ) in upper case letters;

(b) the proprietary name of the medicinal premix and the authorisation number;

(d) the range of acceptable inclusion rates of the intermediate feedingstuff into the final feedingstuffs, the range of acceptable levels of the active ingredients in the final feedingstuffs and the words “refer to the medicated feedingstuffs prescription for the exact inclusion rate” or equivalent wording;

(e) warnings and contra-indications;

(ea) a statement that the product must be used in accordance with its summary of product characteristics;

(eb) the contact details (including a free helpline number) for the supplier of the product;

(ec) the words “inappropriate disposal of this product poses a serious threat to the environment”;

(ed) in the case of a product containing an antibiotic, the words “inappropriate disposal of this product may contribute to antimicrobial resistance”;

(f) the withdrawal period, and a statement that, if the medicated feedingstuffs prescription requires a longer withdrawal period, that is the one that applies;

(g) the expiry date;

(h) any special storage instructions required by the marketing authorisation;

(i) where a medicated feedingstuffs prescription is required, a statement to this effect.

(2) If there is more than one medicinal premix used, the longest withdrawal period must be shown on the label.

(3) If the intermediate feedingstuff also contains a specified feed additive to which this Schedule applies it must also contain the information required under Article 16 of Regulation (EC) No 1831/2003[^f00049].

(4) No person may supply such an intermediate feedingstuff unless it is labelled in accordance with this paragraph.

Labelling of feedingstuffs containing a specified feed additive

13

No person may contravene the labelling requirements of Article 15 and Article 17 of Regulation (EC) No 767/2009 of the European Parliament and of the Council.

Labelling of feedingstuffs containing a medicinal premix

14

(1) Feedingstuffs containing a medicinal premix must be clearly and legibly labelled with the following—

(a) the words “MEDICATED COMPLETE FEED” in upper case letters, or where feedingstuffs are to be labelled as a complementary feedingstuff and intended to be fed to animals without further mixing with feed materials, the words “MEDICATED COMPLEMENTARY FEEDINGSTUFF”;

(b) the proprietary name, authorisation number and inclusion rate (kg/tonne or mg/kg) of the medicinal premix incorporated into the feedingstuffs;

(d) the species of animal for which the feedingstuffs are intended;

(e) warnings and contra-indications;

(ea) the contact details (including a free helpline number) for the supplier of the product;

(eb) the words “inappropriate disposal of this product poses a serious threat to the environment”;

(ec) in the case of a product containing an antibiotic, the words “inappropriate disposal of this product may contribute to antimicrobial resistance”;

(f) the withdrawal period, and a statement that, if the medicated feedingstuffs prescription requires a longer withdrawal period, that is the one that applies;

(fa) the batch number;

(g) the expiry date;

(h) any special storage instructions required by the marketing authorisation;

(i) a statement to the effect that the feedingstuffs must only be fed in accordance with its medicated feedingstuffs prescription;

(j) the name and authorisation number of the manufacturer or the distributor.

(2) If there is more than one medicinal premix used, the longest withdrawal period must be shown on the label.

(3) If the feedingstuff also contains a specified feed additive to which this Schedule applies it must also contain the information required by Articles 15 and 17 of Regulation (EC) No 767/2009 of the European Parliament and of the Council.

(4) No person may supply feedingstuffs containing a medicinal premix unless they are labelled in accordance with this paragraph.

Supply of specified feed additives

15

(1) No person other than the person who manufactured a specified feed additive or an authorised distributor may supply a specified feed additive.

(2) The person who manufactured the specified feed additive may only supply it to—

(a) an authorised distributor;

(b) an authorised intermediate feedingstuff manufacturer or an authorised complementary feedingstuffs manufacturer; or

(3) An authorised distributor may only supply it to—

(a) another authorised distributor;

(b) an authorised intermediate feedingstuff manufacturer or an authorised complementary feedingstuffs manufacturer; or

Supply of premixture

16

(1) No person other than the person who manufactured an intermediate feedingstuff or specified feed additive or an authorised distributor may supply an intermediate feedingstuff or specified feed additive.

(2) The person who manufactured the intermediate feedingstuff or specified feed additive may only supply it to—

(a) an authorised distributor; or

(b) a feedingstuff manufacturer authorised to incorporate that intermediate feedingstuff or specified feed additive.

(3) An authorised distributor may only supply it to—

(a) another authorised distributor; or

(b) a feedingstuff manufacturer authorised to incorporate that intermediate feedingstuff or specified feed additive.

Supply of a complementary feedingstuff

17

(1) No person other than—

(a) the person who manufactured a complementary feedingstuff containing a specified feed additive; or

(b) an authorised distributor

may supply a complementary feedingstuff containing a specified feed additive.

(2) The person who manufactured such complementary feedingstuff may only supply it to—

(a) an authorised distributor; or

(b) a feedingstuff manufacturer registered to incorporate that complementary feedingstuff or authorised to incorporate an intermediate feedingstuff.

(3) An authorised distributor may only supply it to—

(a) another authorised distributor, or

(b) a feedingstuff manufacturer registered to incorporate that complementary feedingstuff or authorised to incorporate an intermediate feedingstuff.

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

Supply of feedingstuffs containing a veterinary medicinal product

18

(1) No person other than the person who manufactured the feedingstuffs or an authorised distributor may supply feedingstuffs containing a medicinal premix.

(2) The person who manufactured the feedingstuff may only supply it to—

(a) an authorised distributor; or

(b) an animal keeper for feeding to those animals.

(3) A distributor may only supply it to—

(a) another authorised distributor; or

(b) an animal keeper for feeding to those animals.

(4) Supply to an animal keeper must be in accordance with a written medicated feedingstuff prescription as specified in the following paragraph.

(5) If a medicated feedingstuff prescription is for a period of longer than one month, the supplier may not provide more than one month’s supply at any one time.

(6) No manufacturer or distributor may supply a feedingstuff to anyone not specified in this paragraph, or otherwise than in accordance with this paragraph.

(7) The person supplying the feedingstuff must keep the medicated feedingstuff prescription for five years.

(8) Nothing in this paragraph prevents a commercial feed manufacturer from incorporating a medicinal premix with a feedingstuff in advance of receiving a written prescription for that feedingstuff.

Prescriptions for feedingstuffs containing a veterinary medicinal product

19

(1) A medicated feedingstuff prescription for feedingstuffs containing a medicinal premix must contain the following—

(a) the name and address of the person prescribing the product;

(b) the qualifications enabling the person to prescribe the product;

(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 keeper;

(ea) the diagnosed disease to be treated or prevented (in the case of immunological veterinary medicinal products or antiparasitics without antimicrobial effects);

(f) the date of the prescription;

(g) the signature or other authentication of the person prescribing the product;

(h) the name, active substance, amount of the product prescribed and inclusion rate of the medicinal premix and resulting inclusion rate of the active substance;

(i) the dosage and administration instructions;

(j) any necessary warnings;

(ja) a statement that the prescription may not be re-used;

(k) the withdrawal period;

(l) the manufacturer or the distributor of the feedingstuffs (who must be authorised for the purpose) , whichever is the supplier to the end user;

(m) if the validity exceeds one month, a statement that not more than 31 days’ supply may be provided at any time;

(n) the name, type and quantity of feedingstuffs to be used;

(na) the overall amount of feedingstuff to be supplied under the prescription;

(o) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(p) any special instructions;

(q) the percentage of the prescribed feedingstuffs to be added to the daily ration; and

(r) if it is prescribed under the cascade, a statement to that effect.

(2) It is valid for three months or such shorter period as may be specified in the medicated feedingstuff prescription.

(2A) In the case of a prescription to which sub-paragraph (1) applies which relates to an antibiotic, the time between a prescription being issued and the course of treatment starting must be no more than five working days.

(2B) Subject to paragraph 7A in Schedule 3, a prescription for a medicated feedingstuff containing a medicinal premix which includes an antibiotic may not be issued for prophylactic purposes.

(3) In relation to food-producing animals a medicated feedingstuffs prescription may not confer authority for more than one course of treatment.

Writing the prescription

20

(1) The person who writes the medicated feedingstuff prescription must—

(a) give a copy to the person incorporating the medicinal premix into the feedingstuffs or to the distributor of the feedingstuffs , whichever is the supplier to the end user;

(b) give one copy to the keeper of the animals to be treated;

(2) The person must be satisfied that—

(a) there is no undesirable interaction between the medicinal premix and any feed additive used in the feedingstuffs; and

(b) the active substance of the medicinal premix is not the same as an active substance in any feed additive used in the feedingstuffs.

(3) The person must prescribe a medicinal premix authorised for incorporation in feedingstuffs but may, if there is no medicinal premix authorised for a condition in a particular species—

(a) prescribe a medicinal premix authorised for another species or for another condition in the same species, and

(b) prescribe more than one medicinal premix,

provided all medicinal premixes prescribed are authorised for incorporation in feedingstuffs.

Possession

21

(1) No person other than a person holding the appropriate authorisation under this Schedule may be in possession of any—

(a) specified feed additive or medicinal premix to which this Schedule applies;

(b) intermediate feedingstuffs containing such an additive or a medicinal premix; or

(2) No person other than a manufacturer or distributor may be in possession of feedingstuffs incorporating a medicinal premix unless it has been supplied under a medicated feedingstuffs prescription.

Sampling and analysis

22

(1) If any enforcement action is taken under this Schedule based on a sample, that sample must have been taken and analysed in accordance with Regulation (EC) No 152/2009 laying down methods of sampling and analysis for the official control of feedingstuffs.

(2) Unless otherwise specified in the marketing authorisation, it is a defence if the active ingredient in the medicated feedingstuff sample is within the following tolerances—

Level of active ingredient specified on the label	Tolerance
≤500mg/kg	±30%
˃500mg/kg ≤5g/kg	±20%
˃5g/kg	±10%

(3) Unless otherwise specified in the Commission Regulation authorising the specified feed additive in question, it is a defence if the active ingredient of a specified feed additive in a feedingstuff sample is within the tolerances set out in Articles 11(5) and paragraph 2(e) of Annex IV to Regulation (EC) No 767/2009 of the European Parliament and of the Council.

Storage

23

No person may store a medicinal premix intended for incorporation into feedingstuffs, or an intermediate feedingstuff or feedingstuffs containing a medicinal premix, except in—

(a) a suitable storage area that is locked when not in use; or

(b) a hermetic container designed to store those products.

Packages and other containers

24

No person may place on the market feedingstuffs containing a medicinal premix except in packages or containers that are sealed in such a way that, when the package or container is opened, the seal is damaged.

Transport

25

(1) No person may transport feedingstuffs by road tankers or in bulk unless the labelling requirements are set out in a document accompanying the feedingstuffs, and the transporter must hand over details when delivering the feedingstuffs unless these have already been provided to the purchaser.

(2) Any person transporting feedingstuffs containing medicinal premixes or specified feed additives in road tankers or similar containers must ensure that the vehicle or container is cleaned before any re-use if this is necessary to prevent undesirable interaction or contamination.

(3) In the case of feedingstuffs containing a medicinal premix or specified feed additive the transporter must ensure that the vehicle is accompanied by documentation stating this.

(4) Any person operating an undertaking transporting feedingstuffs containing medicinal premixes or specified feed additives must give written instructions to drivers on how to load and unload vehicles so as to avoid cross-contamination, and take reasonable steps to ensure that the driver complies with those instructions.

Possession, placing on the market and use of feedingstuffs

26

(1) No person may possess, place on the market or feed to animals any feedingstuffs incorporating medicinal premixes or specified feed additives unless they have been incorporated in accordance with this Schedule.

(2) No person may feed to any animal, or buy, possess or supply for the purpose of feeding to any animal, any feedingstuff containing a medicinal premix or specified feed additive unless—

(a) that medicinal premix or specified feed additive is authorised for that species of animal and for the purpose for which it is used; or

(b) in the case of a medicinal premix, it was prescribed for that animal.

(2A) An animal keeper must ensure that any product to which this Schedule applies is appropriately stored in accordance with its authorisation.

(2B) An animal keeper must ensure in respect of any such product that—

(a) no cross-contamination occurs between products held by the keeper;

(b) no product contaminates any feedingstuff or feed material;

(d) a product is administered only to correctly identified animals mentioned on the medicated feedingstuffs prescription.

(2C) An animal keeper must comply with the withdrawal period in relation to any such product.

(3) This paragraph does not apply in relation to feedingstuffs if the medicinal premix has been incorporated in accordance with an animal test certificate or the feedingstuff has been imported in accordance with this Schedule.

Imports from third countries

27

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Trade between member States

28

No person may bring in from another country a feedingstuff containing a veterinary medicinal product unless—

(a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b) it only contains a veterinary medicinal product that has the same quantitative and qualitative composition as a medicinal premix authorised in Great Britain.

Import for incorporation into premixture or feedingstuffs for export

29

(1) A manufacturer of intermediate feedingstuffs or feedingstuffs who imports a veterinary medicinal product authorised in another ... country for the purposes of incorporating it into intermediate feedingstuffs or feedingstuffs for export does not commit an offence under regulation 43(q) (importation of an unauthorised veterinary medicinal product) or regulation 43(r) (possession of an unauthorised veterinary medicinal product)

(2) No person may place that intermediate feedingstuff or feedingstuff on the market in the United Kingdom once the veterinary medicinal product has been incorporated into it.

Animals on domestic premises

30

(1) The requirements of paragraph 7 (authorisation of manufacturers and distributors of feedingstuffs containing medicinal premix) do not apply in relation to a person who incorporates a medicinal premix into feedingstuffs in domestic premises for feeding, on those premises—

(a) non-food-producing animals; or

(b) food-producing animals provided that the animals or products from those animals are not sold or supplied commercially.

(2) Notwithstanding paragraphs 16 and 18 of this Schedule, a veterinary surgeon, a pharmacist or a suitably qualified person who is registered in accordance with paragraph 14 of Schedule 3 may be supplied with and may supply an intermediate feedingstuff containing a medicinal premix, or feedingstuffs containing a medicinal premix, to such a producer.

(3) The requirement for a written prescription does not apply in relation to such supply, but the provisions of Schedule 3 relating to supply of a veterinary medicinal product apply in relation to the supply of intermediate feedingstuffs and feedingstuffs in the same way as they apply to a veterinary medicinal product.

Offences

31

It is an offence to fail to comply with—

(a) paragraph 2(2);

(b) paragraph 3(3) or (4);

(d) paragraph 6;

(e) paragraph 7(2) or (5);

(f) paragraph 8;

(g) paragraph 9;

(h) paragraph 10;

(i) paragraph 11;

(j) paragraph 12(4);

(k) paragraph 13;

(l) paragraph 14(4);

(m) paragraph 15;

(n) paragraph 16;

(o) paragraph 17;

(p) paragraph 18;

(pa) paragraph 19;

(q) paragraph 20;

(r) paragraph 21;

(ra) paragraph 22A;

(s) paragraph 23;

(t) paragraph 24;

(u) paragraph 25;

(v) paragraph 26(1) , (2), (2A), (2B) or (2C);

(va) paragraph 26A;

(w) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(x) paragraph 28; or

(y) paragraph 29(2).

SCHEDULE 6 — Exemptions for small pet animals

Animals to which this Schedule applies

1

This Schedule applies in relation to veterinary medicinal products intended solely for the following animals kept exclusively as a pet—

(a) aquarium animals;

(b) cage birds;

(d) homing pigeons;

(e) rabbits;

(f) small rodents; and

(g) terrarium animals.

Placing on the market, importing and administering the product

2

A veterinary medicinal product intended solely for an animal to which this Schedule applies may be placed on the market, imported or administered without a marketing authorisation if it complies with this Schedule and the manufacturer appears on the register maintained under paragraph 3A.

Manufacture

3

(1) The product must have been manufactured by—

(a) the holder of a manufacturing authorisation if manufactured in Great Britain;

(b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(d) in the case of any other country, a manufacturer whose premises have been inspected and approved by an officer of the Secretary of State.

(2) Sub-paragraph (1)(d) does not apply where the United Kingdom has a formal agreement with the exporting country that includes mutual recognition of good manufacturing practice or where the Secretary of State is satisfied that the exporting country requires manufacturers of veterinary medicinal products to apply standards of good manufacturing practice which are at least equivalent to those in Great Britain.

Approval of the active substance

4

(1) The Secretary of State may approve an active substance for use in a veterinary medicinal product manufactured under this Schedule.

(2) The Secretary of State may not grant an approval if the active substance requires veterinary control.

(3) The approval must specify the species of animals for which it is approved, and may specify how the active substance or a product containing it is to be administered.

(4) The Secretary of State may suspend or revoke the approval (or limit it to a smaller number of species) if—

(a) it is demonstrated that the substance requires veterinary control;

(b) adverse events are reported making suspension or revocation necessary; or

(i) is carcinogenic;

(ii) is genotoxic; or

(iii) shows developmental toxicity (including teratogenicity).

(5) The procedure for the refusal, suspension or revocation of an approval under this paragraph is the same as the procedure for a marketing authorisation.

The product

5

(1) The active substance in the veterinary medicinal product must be approved under paragraph 4.

(2) The veterinary medicinal product must not be an antibiotic.

(3) It must not contain any narcotic or psychotropic substance.

(4) It must not be intended for treatments or pathological processes that require a precise prior diagnosis or the use of which may cause effects that impede or interfere with subsequent diagnostic or therapeutic measures.

Labelling

6

(1) The product must be clearly labelled as being exempt from the requirements of these Regulations in relation to a marketing authorisation.

(2) The labelling must show the following—

(a) the name of the veterinary product, including, if it is part of the name, its strength and pharmaceutical form;

(b) the authorisation number of the manufacturer;

(d) the route of administration;

(e) the batch number;

(f) the expiry date;

(g) the words “For animal treatment only”;

(h) the contents by weight, volume or number of dose units;

(i) the name and address of the manufacturer or distributor;

(j) the target species;

(k) the words “Keep out of reach of children”;

(l) storage instructions;

(m) the shelf-life after the immediate packaging has been opened for the first time;

(n) disposal advice;

(o) full indications, including—

(i) therapeutic indications;

(ii) contra-indications;

(iii) interaction with other medicines and other forms of interaction; and

(p) dosage instructions.

(3) If there is insufficient room on the label, the information may instead be in a package leaflet, but the leaflet must contain all the information in the preceding sub-paragraph other than the batch number and the expiry date, but the label on the product must contain at least the following—

(a) the name of the veterinary medicinal product;

(b) its active substance and its strength;

(d) the batch number;

(e) the expiry date; and

(f) the words “For animal treatment only”.

Administration

7

The method of administration must be oral or topical or (in the case of a product for fish) by addition to the water.

Pack size

8

The pack size must only be sufficient for a single course of treatment or, in the case of a veterinary medicinal product for aquarium fish, sufficient for a single course of treatment of no more than 7 administrations to an aquarium of25,000 litres.

Adverse reactions

9

(1) The manufacturer or importer of a veterinary medicinal product must—

(a) notify the Secretary of State within 15 days of learning of any serious adverse events; and

(b) make a record of each adverse event and serious adverse event on becoming aware of it and keep it for three years.

(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SCHEDULE 7 — Fees

PART 1 — Introduction

Interpretation

1

(1) In this Schedule—

“pharmaceutical product” means any veterinary medicinal product other than an immunological product or a biological veterinary medicinal product that is not immunological;

“simultaneous application” is an application in which, at the time an authorisation for a product is applied for, one or more additional applications are submitted for products that are identical to the first product except that—in the case of an immunological product, they have a lesser number of antigens than the first product, but only contain antigens contained in the first product; andin the case of a pharmaceutical product, they have different strengths of the active substance,...

(2) For the purposes of this Schedule “manufacturing authorisation” means the following activities—

(a) manufacture or import of an authorised veterinary medicinal product;

(b) manufacture of a product to which paragraph 2 of Schedule 6 relates;

(d) manufacture of—

(i) an autogenous vaccine;

(ii) a stem cell product; or

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