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The Veterinary Medicines Regulations 2006

Type Statutory-Instrument

Publication 2006-09-05

Last updated 2022-04-01

State In force

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Source legislation.gov.uk

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PART 7 — Labelling and package leaflets

Approval by the Secretary of State

44

When the Secretary of State issues the marketing authorisation he shall approve all containers, packaging, labels and package leaflets.

Reference to being authorised

45

A label and package leaflet of an authorised veterinary medicinal product may contain in legible characters the words “UK authorised veterinary medicinal product” or, if the marketing authorisation provides, other wording specified in the authorisation indicating that the product is authorised in the United Kingdom.

Language

46

(1) All labels and package leaflets must be in English, but may contain other languages provided that the information given is identical in all the languages.

(2) This requirement does not apply in the case of a product imported by a veterinary surgeon and administered by or under the supervision of that same veterinary surgeon.

Labelling with all the information on the immediate packaging

47

(1) If it is reasonably practicable to do so, the following must be provided on the immediate packaging, in legible characters—

(a) the name, strength and pharmaceutical form of the veterinary medicinal product;

(b) the name and strength of each active substance, and of any excipient if this is required under paragraph 2 of the summary of product characteristics;

(d) the batch number;

(e) the expiry date;

(f) the words “For animal treatment only” and if appropriate, “To be supplied only on veterinary prescription”;

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

(h) the marketing authorisation number;

(i) the name and address of the marketing authorisation holder or, if there is a distributor authorised in the marketing authorisation, that distributor;

(j) a suitably labelled space to record discard date (if relevant);

(k) the target species;

(l) the distribution category;

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

(n) storage instructions;

(o) the in-use shelf-life (if appropriate);

(p) for food-producing species, the withdrawal period for each species or animal product concerned;

(q) any warning specified in the marketing authorisation;

(r) disposal advice;

(s) full indications;

(t) dosage instructions;

(u) contra-indications;

(v) further information required in the marketing authorisation;

(w) if the product is one that requires a dose to be specified for the animal being treated, a space for this.

(2) If all this is on the immediate packaging, there is no need for any outer packaging or a package leaflet.

Products with immediate and outer packaging

48

(1) If it is not reasonably practicable to have all the information on the immediate packaging then this paragraph applies.

(2) The immediate packaging must have at least the following information—

(a) the name of the veterinary medicinal product, including its strength and pharmaceutical form;

(b) the name and proportion of each active substance, and of any excipient if knowledge of the excipient is needed for safety reasons;

(d) the batch number;

(e) the expiry date;

(f) the words “For animal treatment only” and if appropriate, “To be supplied only on veterinary prescription”;

(g) the words “Keep the container in the outer carton”.

(3) In addition, the immediate packaging must have as much of the information in paragraph 47 as is reasonably practicable, in the order set out in that paragraph.

(4) The outer packaging must contain all the information in paragraph 47 if it is reasonably practicable to do this, and if it is not reasonably practicable to do this a package leaflet must be supplied with the product in accordance with the following paragraph.

Package leaflets

49

(1) If it is not reasonably practicable to have all the information in paragraph 47 on the immediate packaging or all of this information on the outer packaging, there must be a package leaflet supplied with the product, containing all the information in paragraph 47 except for the batch number and the expiry date, and including the name of both the marketing authorisation holder and, if different, the name of the distributor named in the marketing authorisation.

(2) If there is a package leaflet, the immediate packaging and the outer packaging must both refer the user to it.

(3) A package leaflet shall relate solely to the veterinary medicinal product with which it is included.

(4) It must be written in terms that are comprehensible to the general public.

(5) Only a package leaflet approved in the marketing authorisation may be included with the veterinary medicinal product.

Ampoules

50

(1) In the case of ampoules or other unit dose forms, where the container cannot bear legibly the required information, only the following information must be shown on the immediate packaging—

(a) the name of the veterinary medicinal product;

(b) the name and strength of the active ingredient;

(d) the batch number;

(e) the expiry date;

(f) the words “For animal treatment only” and if appropriate, “To be supplied only on veterinary prescription”.

(2) The outer packaging must contain all the information in paragraph 47 if it is reasonably practicable to do this, and if it is not reasonably practicable to do this a package leaflet must be supplied with the product, except that the ampoule need not refer to the package leaflet.

Small containers other than ampoules

51

As regards small immediate packaging containing a single dose, other than ampoules, on which it is impossible to give the particulars mentioned in paragraph 47, all the information in paragraph 47 must appear on the outer packaging or outer packaging and package leaflet, but the immediate packaging must be labelled with the batch number and the expiry date and, if there is room, the other information in the preceding paragraph.

Homeopathic remedies

52

(1) A homeopathic remedy registered under these Regulations must be labelled in accordance with this paragraph.

(2) There must be no specific therapeutic indication on the labelling or in any information relating to it.

(3) The labelling (or labelling and package leaflet) must contain the following and no other information—

(a) the words “homeopathic remedy without approved therapeutic indications for veterinary use”;

(b) the scientific name of the stock or stocks followed by the degree of dilution, using the symbols of the pharmacopoeia used (if the homeopathic remedy is composed of more than one stock, the labelling may mention an invented name in addition to the scientific names of the stocks);

(d) the method and, if necessary, route of administration;

(e) the expiry date;

(f) the pharmaceutical form;

(g) the contents of the pack;

(h) any special storage precautions;

(i) the target species;

(j) any necessary special warnings;

(k) the batch number; and

(l) the registration number.

Variations

53

The Secretary of State may permit variations in the above in any individual marketing authorisation if this is necessary for public or animal health purposes or the protection of the environment.

PART 8 — Pharmacovigilance

Qualified persons responsible for pharmacovigilance

54

(1) A marketing authorisation holder must have permanently and continuously at his disposal an appropriately qualified person responsible for pharmacovigilance (“a qualified person (pharmacovigilance)”) who resides in a member State.

(2) It is an offence to fail to comply with this paragraph.

Duties relating to the qualified person

55

(1) The marketing authorisation holder must ensure that the qualified person (pharmacovigilance)—

(a) establishes and maintains a system that ensures that information about all suspected adverse reactions reported to the marketing authorisation holder is collected and collated in order to be accessible at least at one point in a member State;

(b) answers any request from the Secretary of State for the provision of additional information necessary for the evaluation of the benefits and risks afforded by a veterinary medicinal product fully and within any time limit imposed by the Secretary of State when he requested the information, including the volume of sales of the veterinary medicinal product concerned and, if available, details of prescriptions;

(c) provides to the Secretary of State any other information relevant to the evaluation of the benefits and risks afforded by a veterinary medicinal product, including appropriate information on post-marketing surveillance studies; and in this paragraph “post-marketing surveillance studies” means a pharmacoepidemiological study or a clinical trial carried out in accordance with the terms of the marketing authorisation, conducted with the aim of identifying and investigating a safety hazard relating to an authorised veterinary medicinal product.

(2) It is an offence to fail to comply with this paragraph.

Adverse reactions to a veterinary medicinal product administered in the United Kingdom

56

(1) A marketing authorisation holder must act in accordance with this paragraph if he learns of any suspected—

(a) serious adverse reaction;

(b) human adverse reaction; or

following the administration of the product in the United Kingdom.

(2) He must make a record of what happened.

(3) He must without delay and in any event within 15 days report it (electronically if this is practicable) to the Secretary of State.

(4) In addition, he must supply to the Secretary of State all relevant veterinary pharmacovigilance information in his possession relating to the reaction, giving a full description of the incident and a list of all the symptoms using internationally recognised veterinary and medical terminology[^f00023], either with the report or, if the information becomes available after the report has been sent, as soon after it becomes available as is reasonably practicable.

(5) In this and the following paragraph—

“human adverse reaction” means a reaction that is noxious and unintended and that occurs in a human being following exposure to a veterinary medicine;

“serious adverse reaction” means an adverse reaction that results in death, is life-threatening, results in significant disability or incapacity, is a congenital anomaly or birth defect, or that results in permanent or prolonged signs in the animals treated.

(6) It is an offence to fail to comply with this paragraph.

Adverse reactions to a veterinary medicinal product administered in a third country

57

(1) A marketing authorisation holder for a veterinary medicinal product authorised in the United Kingdom must act in accordance with this paragraph if he learns of any suspected—

(a) serious, unexpected adverse reaction (for these purposes a reaction is unexpected if its nature, severity or outcome is not consistent with the summary of the product characteristics);

(b) human adverse reaction; or

following the administration of the product in a third country.

(2) He must make a record of what happened.

(3) He must without delay and in any event within 15 days report the suspected reaction or transmission (electronically if this is practicable) to the Secretary of State, the competent authorities of all member States in which the product is authorised, and the Agency.

(4) In addition to the report, he must supply to the Secretary of State, the competent authorities of all other member States where the product is authorised and the Agency, the information required under paragraph 56(4) in the manner set out in that paragraph.

(5) It is an offence to fail to comply with this paragraph.

Periodic safety update reports

58

(1) The marketing authorisation holder must submit to the Secretary of State records of all adverse reactions (including nil reports) in the form of a periodic safety update report for each marketing authorisation in accordance with this paragraph, including a summary of each incident and a list of all the symptoms using internationally recognised veterinary and medical terminology.

(2) If the marketing authorisation holder has not yet placed a product on the market in the United Kingdom, he must submit a periodic safety update report immediately upon request of the Secretary of State and at least every six months after authorisation.

(3) Following the placing on the market in the United Kingdom, the marketing authorisation holder must submit a periodic safety update report to the Secretary of State immediately upon request and—

(a) at least every six months during the first two years following the initial placing on the market;

(b) once a year for the following two years; and

(4) Following the granting of a marketing authorisation, the marketing authorisation holder may apply to the Secretary of State to change the periods of notification.

(5) The periodic safety update report must include a scientific evaluation of the risk benefit balance of the veterinary medicinal product.

(6) The periodic safety update report must include—

(a) the volume of the product sold in each year covered by the report, calculated on an annual basis beginning 1st January;

(b) the number of adverse reactions for each year of the report;

(c) the ratio of adverse reactions to volume of product sold together with an explanation of the basis of the calculation;

(d) differentiation of data based on—

(i) target species (if the product is authorised for use in more than one species);

(ii) reaction type (such as serious, non-serious, human, suspected lack of efficacy, unauthorised use or other);

(iii) the country of origin of the report.

(7) If the product is indicated for more than one species, the information in sub-paragraph (6) must be based so far as is practicable on the estimated use of the product.

(8) Data relating to different formulations (either different dosage forms or different strengths) must be provided in separate reports.

(9) It is an offence to fail to comply with this paragraph.

Release of information by the marketing authorisation holder

59

(1) A marketing authorisation holder must not communicate information relating to pharmacovigilance concerns to the general public in relation to its authorised veterinary medicinal product without giving prior or simultaneous notification to the Secretary of State.

(2) The marketing authorisation holder must ensure that such information is presented objectively and is not misleading.

(3) It is an offence to fail to comply with this paragraph.

Action taken on account of pharmacovigilance

60

(1) Where, as a result of the evaluation of veterinary pharmacovigilance data, the Secretary of State considers that a marketing authorisation should be—

(a) suspended;

(b) revoked; or

(i) restrict the indications;

(ii) change the distribution category;

(iii) amend the dose;

(iv) add a contraindication; or

(v) add a new precautionary measure,

he shall forthwith inform the Agency, all other member States (irrespective of whether the product is authorised in another member State) and the marketing authorisation holder.

(2) If urgent action is necessary for protecting human or animal health, the Secretary of State may suspend the marketing authorisation of a veterinary medicinal product, but he must inform the Agency, the Commission and the other member States within one working day.

(3) If, following the opinion of the Agency, the Commission requests the Secretary of State to suspend, withdraw or vary the marketing authorisation, the Secretary of State shall comply with that request immediately on a temporary basis.

(4) The Secretary of State shall take final measures in accordance with the Decision of the Commission.

PART 9 — Homeopathic remedies

Meaning of “homeopathic remedy”

61

For the purposes of these Regulations, a homeopathic remedy is a veterinary medicinal product (which may contain a number of principles) prepared from homeopathic stocks in accordance with a homeopathic manufacturing procedure described in the European Pharmacopoeia[^f00024] or, if it is not described there, in a pharmacopoeia published by the British Pharmacopoeial Commission or by the competent authority of any member State.

Placing a homeopathic remedy on the market in accordance with a registration

62

(1) By way of derogation from the provisions of these Regulations requiring a marketing authorisation for a veterinary medicinal product, a homeopathic remedy may be placed on the market in accordance with a registration by the Secretary of State instead of in accordance with a marketing authorisation if it complies with this paragraph.

(2) It must not be an immunological product.

(3) The route of administration must be as described in the European Pharmacopoeia or, if it is not described there, by a pharmacopoeia currently used officially in any member State.

(4) There must be a sufficient degree of dilution to guarantee the safety of the product, and in any event it must not contain more than one part in 10,000 of the mother tincture.

(5) All other provisions relating to marketing authorisations apply in the same way to registrations of a homeopathic remedy.

Application for registration

63

(1) An applicant for registration must submit the following to the Secretary of State—

(a) the scientific name or other name of the homeopathic stock given in a pharmacopoeia, together with a statement of the various routes of administration, pharmaceutical forms and degree of dilution;

(b) a dossier describing how the homeopathic stock is obtained and controlled, and justifying its homeopathic nature, on the basis of an adequate bibliography;

(c) in the case of a product containing biological substances, a description of the measures taken to ensure the absence of pathogens;

(d) the manufacturing and control file for each pharmaceutical form and a description of the method of dilution and potentisation;

(e) a copy of the manufacturing authorisation for the product;

(f) copies of any registrations or authorisations obtained for the same homeopathic remedy in other member States;

(g) a mock-up of the outer packaging and immediate packaging;

(h) stability data;

(i) the proposed withdrawal period necessary to ensure that the provisions of Council Regulation (EEC) No. 2377/90 are complied with together with all necessary justification.

(2) These documents must demonstrate the pharmaceutical quality and the batch-to-batch homogeneity of the products concerned.

(3) In the case of a food-producing animal, if the applicant states in the application that the homeopathic remedy contains an active substance, or has been manufactured using an active substance, that substance must be one that appears in Annex II to Regulation (EEC) No. 2377/90 and complies with any requirements in that Annex relating to that substance.

(4) If a product is registered in another member State, the Secretary of State may waive some or all of the requirements of this paragraph if he is satisfied that it is reasonable to do so.

Procedure for registration

64

(1) The procedure for registration is the same as the procedure for granting a marketing authorisation in accordance with Part 3, except—

(a) the applicant is not required to provide proof of therapeutic effect;

(b) the product shall not have a summary of product characteristics;

(2) The procedure for variation, suspension and revocation is the same as for a marketing authorisation.

Products on the market before 1994

65

A homeopathic remedy that was on the market before 1st January 1994 may be placed on the market without being registered.

Classification

66

The registration must specify the classification of the homeopathic remedy, which must be one of the classifications specified for a veterinary medicinal product in Schedule 3.

SCHEDULE 2 — THE MANUFACTURE OF VETERINARY MEDICINAL PRODUCTS

PART 1 — Manufacturing authorisation

Application

1

An application for a manufacturing authorisation shall be made to the Secretary of State.

Time limits

2

(1) The Secretary of State shall process an application for a manufacturing authorisation within 90 days of receiving it.

(2) He shall process an application for a variation of a manufacturing authorisation within 30 days unless he notifies the applicant in writing that he is extending the time to 90 days.

Granting the authorisation

3

The Secretary of State shall grant a manufacturing authorisation if he is satisfied that the applicant has at his disposal suitable and sufficient premises, staff, technical equipment and facilities for the manufacture, control and storage of the products, and will comply with his duties under these Regulations.

The authorisation

4

(1) The manufacturing authorisation shall specify—

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

(b) the place where they are to be manufactured or controlled;

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

(e) the name of the qualified person 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.

Suspension or revocation of the authorisation

5

(1) The Secretary of State may suspend 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 his manufacturing authorisation;

(d) no longer has suitable premises or equipment.

(2) He may also suspend or revoke it if he is satisfied that the qualified person (manufacture) is not fulfilling his duties.

Representation to the Secretary of State

6

(1) A person may make representations against a refusal, suspension or revocation of a manufacturing authorisation to a person appointed for the purpose by the Secretary of State.

(2) The appointed person shall consider the representations and report in writing to the Secretary of State.

(3) The Secretary of State shall give written notification of his final determination and the reasons for it.

Inspection of premises

7

(1) The Secretary of State shall inspect the premises relating to a manufacturing authorisation on a regular basis to ensure compliance with good manufacturing practice.

(2) Within 90 days after an inspection, the Secretary of State shall issue a certificate of good manufacturing practice to the manufacturer if the inspection established that he is complying with the principles and guidelines on good manufacturing practice in accordance with Commission Directive 91/412/EEC laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products[^f00025].

(3) If an inspection is carried out at the request of the European Pharmacopoeia to establish compliance with a monograph, the Secretary of State shall issue a certificate of compliance with the monograph, if appropriate.

(4) The Secretary of State shall provide details of each certificate of good manufacturing practice that he issues to the Agency for entry into a database.

(5) If the outcome of the inspection is that the manufacturer does not comply with the principles and guidelines of good manufacturing practice, he shall provide details to the Agency for entry into the database.

Report following inspection

8

(1) After each inspection of manufacturing premises, the inspector shall 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 shall inform the inspected manufacturer of the content of such reports.

Duties on the holder of a manufacturing authorisation

9

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

(2) He must have permanently at his disposal the services of at least one qualified person (manufacture) who is on the register of qualified persons (manufacture) maintained by the Secretary of State.

(3) He must hold a current Certificate of Good Manufacturing Practice.

(4) He must have in place a system of Quality Assurance and Quality Control.

(5) He must give to the Secretary of State on request proof of all control tests 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.

(6) If he makes up a bulk package of veterinary medicinal products he 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.

(7) He 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 he requires it in writing.

Qualified persons for manufacture

10

(1) The Secretary of State may appoint as a qualified person (manufacture) any person who is—

(a) registered as a pharmaceutical chemist with the Royal Pharmaceutical Society of Great Britain or 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

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) if he is satisfied that he has the educational qualifications or practical experience to carry out the duties under this Schedule.

Refusal or revocation of appointment

11

(1) The Secretary of State may refuse or revoke an appointment if he is not satisfied that a person has fulfilled or will fulfil his duties.

(2) A person may make representations against a refusal or revocation to a person appointed for the purpose by the Secretary of State, and the procedure in paragraph 6 applies.

Duties on a qualified person

12

(1) The qualified person (manufacture) must ensure that each batch of veterinary medicinal product manufactured under his 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 a third country, including a product manufactured in a member State, the qualified person (manufacture) must ensure that, following importation, each production batch imported is fully tested in a member State, 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) The preceding paragraph does not apply where appropriate arrangements have been made by the European Community 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.

(5) It is an offence to fail to comply with this paragraph.

Register

13

The Secretary of State shall maintain and publish a register of holders of manufacturing authorisations and qualified persons (manufacture).

Test sites

14

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

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

(3) Authorisation and inspection of the premises are the same as for a manufacturing authorisation.

PART 2 — Authorisation of manufacturers of autogenous vaccines

Authorisation to manufacture autogenous vaccines

15

(1) The Secretary of State may authorise a person and premises to manufacture autogenous vaccines.

(2) In order to be authorised the premises must be under the supervision of—

(a) a veterinary surgeon, or

(b) a person who the Secretary of State is satisfied has sufficient qualifications and experience to manufacture the product safely.

(3) Before he authorises the premises, the Secretary of State must be satisfied that the production process will produce a consistent, safe product.

(4) The procedure for the suspension or revocation of the authorisation is the same as for the holder of a manufacturing authorisation.

(5) It is an offence to manufacture an autogenous vaccine other than in accordance with such an authorisation.

Types of authorisation

16

(1) The authorisation shall specify the products that may be manufactured.

(2) It shall either be for the production of a single batch of product or for on-going production of the products specified in the authorisation.

(3) If it is for a single batch the authorisation shall be time-limited.

(4) Only the products specified in the authorisation may be manufactured, and in the case of an authorisation for a single batch the product may only be manufactured before the expiry of the authorisation.

Labelling

17

(1) The operator of the premises must ensure that every container containing autogenous vaccine is labelled with—

(a) the name of the veterinary surgeon who ordered the vaccine;

(b) a precise description of the vaccine;

(d) the name of the authorisation holder and address of the authorised premises;

(e) the expiry date;

(f) any necessary warnings; and

(g) instructions for use.

(2) It is an offence to fail to comply with this paragraph.

Records

18

(1) The operator of the premises must, as soon as is reasonably practicable, record—

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

(b) the identity of the source animal;

(d) the date of supply to the veterinary surgeon.

(2) He must keep the records for at least five years.

(3) It is an offence to fail to comply with this paragraph.

Adverse reactions

19

(1) The authorised person must notify the Secretary of State of any adverse reactions to an autogenous vaccine of which he becomes aware within 15 days of learning of the reaction.

(2) It is an offence to fail to comply with this paragraph.

Inspection of premises

20

The Secretary of State shall inspect the authorised premises every two years.

PART 3 — Authorisation of blood banks

Authorisation of blood banks

21

(1) The Secretary of State may authorise blood banks for the collection, storage and supply of blood for the treatment of non-food-producing animals.

(2) In order to be authorised a blood bank must be under the supervision of—

(a) a veterinary surgeon named in the authorisation; or

(b) a person named in the authorisation who the Secretary of State is satisfied is suitably qualified to operate the blood bank.

(3) Before he authorises a blood bank, the Secretary of State must be satisfied—

(a) that the welfare of animals used in the collection of blood will be respected; and

(b) that the production process will produce a consistent, safe product.

(4) The procedure for the suspension or revocation of the authorisation is the same as for the holder of a manufacturing authorisation.

(5) Blood may only be collected under the supervision of a veterinary surgeon.

(6) It is an offence to operate a blood bank for treatment of animals other than in accordance with such an authorisation.

Supply and administration of blood from a blood bank

22

(1) The blood may only be supplied to a veterinary surgeon.

(2) It may only be administered by a veterinary surgeon or under his supervision.

(3) It may only be administered to non-food-producing animals.

(4) It is an offence to fail to comply with this paragraph.

Labelling

23

(1) The operator of a blood bank must ensure that every container used for the blood is labelled with—

(a) the identity of the donor animal;

(b) the date of collection;

(d) any necessary warnings; and

(e) the expiry date.

(2) It is an offence to fail to comply with this paragraph.

Records

24

(1) The operator of a blood bank must, as soon as is reasonably practicable, record—

(a) the date of collection;

(b) the identity of the donor animal;

(d) the expiry date; and

(e) the date the blood was used or, if it was supplied to another veterinary surgeon, the name of that veterinary surgeon and the date it was supplied.

(2) He must keep the records for at least five years.

(3) It is an offence to fail to comply with this paragraph.

Inspection of blood banks

25

The Secretary of State shall inspect a blood bank every two years.

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

Authorisation to manufacture products for administration under the cascade

26

(1) The Secretary of State may authorise a person and premises to manufacture an unauthorised veterinary medicinal product for administration under the cascade.

(2) In order to be authorised the premises must be under the supervision of a person who the Secretary of State is satisfied has sufficient qualifications and experience to manufacture the product safely.

(3) Before he authorises the premises, the Secretary of State must be satisfied that the production process will produce a safe product.

(4) The procedure for the suspension or revocation of the authorisation is the same as for the holder of a manufacturing authorisation.

(5) The authorisation shall specify what types of product it covers.

(6) It is an offence for the holder of an authorisation to manufacture a product other than in accordance with the authorisation.

Labelling

27

(1) The authorised person must ensure that, before a veterinary medicinal product is supplied, every container is labelled with—

(a) the name of the veterinary surgeon who ordered the veterinary medicinal product;

(b) a precise description of the veterinary medicinal product;

(d) the name of the authorisation holder and the address of the authorised premises;

(e) the expiry date;

(f) any necessary warnings; and

(g) instructions for use.

(2) It is an offence to fail to comply with this paragraph.

Records

28

(1) The authorised person must, as soon as is reasonably practicable, record—

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

(b) a precise description of the veterinary medicinal product;

(d) the expiry date; and

(e) the date of supply to the veterinary surgeon.

(2) He must keep the records for at least five years.

(3) It is an offence to fail to comply with this paragraph.

Adverse reaction

29

(1) The authorised person must notify the Secretary of State of any adverse reaction to a product manufactured by him within 15 days of learning of the reaction.

(2) It is an offence to fail to comply with this paragraph.

Inspection of premises

30

The Secretary of State shall inspect the authorised premises every two years.

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 shall specify the classification of the veterinary medicinal product when he grants the initial marketing authorisation.

(3) He 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 he grants the marketing authorisation the Secretary of State must classify the following as POM-V—

(a) products containing narcotic or psychotropic substances;

(b) products intended as treatments following a precise prior diagnosis.

(5) When he grants the marketing authorisation he must classify the following as POM-V or POM-VPS—

(a) (after 1st January 2007) 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.

Wholesale supply of veterinary medicinal products

2

(1) Only a holder of a marketing authorisation, the holder of a manufacturing authorisation or the holder of a wholesale dealer’s authorisation granted by the Secretary of State may supply a veterinary medicinal product wholesale, or be in possession of it for that purpose.

(2) They may only supply a veterinary medicinal product if their authorisation relates to that product, and they may only supply it to another person who may supply that product under these Regulations, either wholesale or retail.

(3) If the supply is to a suitably qualified person, it must be to the premises approved in accordance with paragraph 13.

(4) It is irrelevant whether or not the supply is for profit.

(5) This paragraph does not apply in relation to a retailer of veterinary medicinal products who supplies another retailer provided that in any one year the amount supplied by a retailer does not exceed five per cent in terms of value of turnover of veterinary medicinal products of that retailer.

(6) It is an offence to fail to comply with this paragraph.

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 any supply other than to or from the holder of a wholesale dealer’s authorisation, and whether or not for payment; and

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

(7) It is an offence to fail to comply with this paragraph.

Prescriptions by a veterinary surgeon

4

A veterinary surgeon who prescribes a veterinary medicinal product classified as POM-V must first carry out a clinical assessment of the animal, and the animal must be under his care, and failure to do so is an offence.

Prescriptions

5

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

(a) by the person who prescribed it, or

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

(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 satisfy himself that the prescription has been written and signed by a person entitled to prescribe the product; and

(3) It is an offence to fail to comply with this paragraph.

Written prescriptions

6

(1) A written prescription must include—

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

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

(d) the species of animal, identification and number of the animals;

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

(f) the date of the prescription;

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

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

(i) the dosage and administration instructions;

(j) any necessary warnings;

(k) the withdrawal period if relevant.

(2) A written prescription for a controlled drug as specified in the Misuse of Drugs Regulations 2001[^f00026] 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 a repeatable prescription that does not specify the number of times the product may be supplied, the prescription may only be repeated once.

Duties when a product is prescribed or supplied

7

(1) When a person prescribes a product classified as POM-V or POM-VPS, or supplies a product classified as NFA-VPS—

(a) before he does so, he 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 he does so, he must advise on its safe administration and on any warnings or contra-indications on the label or package leaflet; and

(c) he 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 for him to show that—

(i) the product prescribed or supplied by him 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) he is not a person authorised to break open the package before supply.

(2) It is an offence to fail to comply with this paragraph.

Supply by a pharmacist

8

(1) A pharmacist may only supply a veterinary medicinal product classified as POM-V, POM-VPS or NFA-VPS from premises registered as a pharmacy with the Royal Pharmaceutical Society of Great Britain or with the Pharmaceutical Society of Northern Ireland, or (in the case of a veterinary medicinal product classified as POM-VPS or NFA-VPS) from premises registered under paragraph 13.

(2) A pharmacist may supply a homeopathic remedy prepared extemporaneously by a pharmacist in a registered pharmacy (as well as any other homeopathic remedy that he is permitted to supply under these Regulations) provided that it is prepared in accordance with paragraph 61 of Schedule 1 for an individual customer.

(3) It is an offence to fail to comply with this paragraph.

Supply by a veterinary surgeon when he is not present

9

(1) A veterinary surgeon supplying a veterinary medicinal product need not be present when it is handed over, but if he is not present—

(a) he must authorise each transaction individually before the product is supplied;

(b) he must have satisfied himself that the person handing it over is competent to do so.

(2) It is an offence to fail to comply with this paragraph.

Supply of products for incorporation into feedingstuffs

10

(1) In the case of a veterinary medicinal product where the marketing authorisation specifies that it must be incorporated into feedingstuffs, the marketing authorisation holder, an authorised manufacturer of that product or an authorised wholesale dealer may supply it to—

(a) an approved premixture manufacturer; or

(b) a feedingstuffs manufacturer where the approval so permits.

(2) A veterinary surgeon, pharmacist or suitably qualified person who supplies a veterinary medicinal product for the purposes of incorporating it into a premixture or feedingstuff may only supply it to a person specified in paragraph 10(1)(a) or (b).

(3) In addition, an approved premixtures manufacturer or feedingstuffs manufacturer may supply a veterinary medicinal product to another approved premixtures manufacturer or feedingstuffs manufacturer provided that the amount supplied does not exceed five per cent in terms of value of veterinary medicinal product used annually.

(4) It is an offence to fail to comply with this paragraph.

Labelling at the time of retail supply

11

(1) If a veterinary medicinal product is supplied in a container specified in the marketing authorisation, it is an offence to supply it if any information on the outer packaging (or, if there is no outer packaging, the immediate packaging) is not clearly visible at the time of supply or has been changed in any way.

(2) Sub-paragraph (1) does not apply to a veterinary surgeon who amends a label, or a pharmacist who amends it in accordance with a prescription from a veterinary surgeon, provided that the unamended information remains clearly visible.

(3) If a veterinary medicinal product is supplied in a container other than that specified in the marketing authorisation, the person supplying the veterinary medicinal product must supply sufficient written information (which may include a copy of the summary of product characteristics or the package leaflet) to enable the product to be used safely, and failure to do so is an offence.

Supply of veterinary medicinal products for use under the cascade

12

(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 supplies the product himself and administers it to the animal himself, 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 or veterinary surgery supplying the veterinary medicinal product;

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

(d) the identification 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.

(3) It is an offence to fail to comply with this paragraph.

Supply by a suitably qualified person

13

(1) The Secretary of State shall 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) To become a suitably qualified person it is necessary to pass examinations specified by such a body, and to be registered with such a body.

(4) The supply of products permitted to be supplied by a suitably qualified person must take place from premises approved by the Secretary of State as being suitable for the storage and supply of veterinary medicinal products.

(5) A suitably qualified person must either—

(a) hand over or despatch the product himself;

(b) ensure that, when the product is handed over or despatched, he is in a position so that he can intervene if necessary; or

(c) check the product after it has been allocated for supply to a customer, and satisfy himself that the person handing over or dispatching it is competent to do so.

(6) If a suitably qualified person considers that the premises in which he is operating no longer comply with the approval granted by the Secretary of State, he must notify the Secretary of State without unreasonable delay, and failure to do so is an offence.

(7) The Secretary of State may issue a Code of Practice for suitably qualified persons, and a body recognised under this paragraph shall ensure that a suitably qualified person registered with it complies with the Code of Practice.

(8) The Secretary of State shall publish a list of—

(a) suitably qualified persons; and

(b) the trading names and the addresses of premises approved under this paragraph.

(9) The procedure for the suspension or revocation of the authorisation of the premises is the same as for the holder of a manufacturing authorisation.

Annual audit

14

(1) At least once a year every person entitled to supply a veterinary medicinal product on prescription must carry out a detailed audit, and incoming and outgoing veterinary medicinal products shall be reconciled with products currently held in stock, any discrepancies being recorded.

(2) It is an offence to fail to comply with this paragraph.

PART 2 — Requirements for a wholesale dealer’s authorisation

Application

15

An application for a wholesale dealer’s authorisation shall be made to the Secretary of State.

Time limits

16

The Secretary of State shall process an application for a wholesale dealer’s authorisation within 90 days of receiving it.

Granting the authorisation

17

(1) The Secretary of State shall grant a wholesale dealer’s authorisation if he is satisfied that this paragraph is complied with.

(2) The authorised site must be—

(a) weatherproof;

(b) secure and lockable;

(d) free from contaminants.

(3) If the veterinary medicinal products covered by the authorisation are subject to specific storage conditions, the site must be capable of fulfilling those requirements.

(4) The authorisation holder must—

(a) have at his disposal the services of technically competent staff; and

(b) have an effective emergency recall plan.

The authorisation

18

(1) The wholesale dealer’s authorisation shall specify—

(a) the types of veterinary medicinal products and pharmaceutical forms that may be dealt in;

(b) the place where they are to be stored;

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

(e) the name of the qualified person nominated to act under the Guidelines on Good Distribution Practice under paragraph 21.

(2) It may cover more than one site.

(3) It shall lapse if the holder does not deal in veterinary medicinal products for five years.

Suspension or revocation of the authorisation

19

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

(a) has not complied with these Regulations; or

(b) no longer has suitable premises or equipment.

Representations

20

(1) A person may make representations against a refusal, suspension or revocation of a wholesale dealer’s authorisation to a person appointed for the purpose by the Secretary of State.

(2) The appointed person shall consider the representations and report in writing to the Secretary of State.

(3) The Secretary of State shall give written notification of his final determination and the reasons for it.

Duties on the holder of a wholesale dealer’s authorisation

21

(1) The holder of a wholesale dealer’s authorisation must store veterinary medicinal products in accordance with the terms of the marketing authorisation for each product.

(2) He must comply with the Guidelines on Good Distribution Practice of Medicinal Products for Human Use[^f00027] as if the veterinary medicinal products were products for human use.

(3) He must carry out a detailed stock audit at least once a year.

(4) He must supply information and samples to the Secretary of State on demand.

(5) He must notify the Secretary of State if there are any changes to the information held by him.

(6) It is an offence to fail to comply with this paragraph.

PART 3 — Sheep dip

Supply of sheep dip

22

(1) If the veterinary medicinal product is a sheep dip of any type the provisions of this paragraph apply, and it is an offence to supply the product by retail other than in accordance with this paragraph.

(2) The supply must be to a person (or a person acting on his behalf) who holds a Certificate of Competence in the Safe Use of Sheep Dips showing that Parts 1 and 2 or units 1 and 2 of the assessment referred to in the Certificate have been satisfactorily completed and issued by—

(a) in England, Wales, and Northern Ireland by the National Proficiency Tests Council, or by NPTC Part of the City & Guilds Group; or

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

(3) The supplier must make a record of the Certificate 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 shall be at least A4 size with a laminated transparent cover, coloured and printed to scale on front and back substantially in accordance with the following two diagrams, except that in Wales it may be in Welsh as well as in English—

Use of sheep dip

23

(1) It is an offence to use sheep dip unless this is done by, or under the supervision and in the presence of, a person who holds a Certificate of Competence in the Safe Use of Sheep Dips showing that Parts 1 and 2 or units 1 and 2 of the assessment referred to in the Certificate have been satisfactorily completed and issued by—

(a) in England, Wales and Northern Ireland by the National Proficiency Tests Council, or by NPTC Part of the City & Guilds Group; or

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

(2) In the case of a person who has had practical experience of sheep dipping before 1st October 2006, this paragraph does not apply until 31st December 2008, and in any other case does not apply until 1st April 2007.

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 may either administer a veterinary medicinal product prescribed by him personally or may direct another person to do so under his responsibility.

(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 and only if there is no such product that is suitable, either—

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

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

(c) if and only if there is no such product that is suitable, a veterinary medicinal product prepared extemporaneously by a pharmacist, a veterinary surgeon or a person holding a manufacturing authorisation authorising the manufacture of that type of product.

(3) In the case of a veterinary medicinal product imported from another member State, if the veterinary surgeon has not obtained a certificate from the Secretary of State under regulation 25(5) permitting him to import it, he must obtain a certificate from the Secretary of State before he administers it.

(4) For the purposes of this paragraph a food-producing animal includes an animal belonging to the equidae family unless it has been declared, as not being intended for slaughter for human consumption in accordance with—

(a) the Horse Passports (England) Regulations 2004[^f00028];

(b) the Horse Passports Regulations (Northern Ireland) 2004[^f00029];

(d) the Horse Passports (Wales) Regulations 2005[^f00031].

(5) Any pharmacologically active substances included in a medicinal product administered to a food-producing animal under the cascade must be listed in Annex I, II or III to Council Regulation (EEC) No. 2377/90.

Withdrawal periods

2

(1) A veterinary surgeon administering a veterinary medicinal product to a food-producing animal under the cascade must specify an appropriate withdrawal period.

(2) The withdrawal period must ensure that, if there is a maximum residue limit specified for the active substance in Council Regulation (EEC) No. 2377/90, the level of residue of the active substance does not exceed that limit.

(3) In any event, unless the Secretary of State has specified in writing a different withdrawal period for a particular veterinary medicinal product, the withdrawal period (irrespective of whether or not a maximum residue limit is specified in Council Regulation (EEC) No. 2377/90) must not be less than—

(a) 7 days for eggs;

(b) 7 days for milk;

(d) 500 degree days[^f00032] for fish meat.

(4) In the case of a homeopathic remedy in which active principles figure in Annex II to Council Regulation (EEC) No. 2377/90, the withdrawal period is zero.

Immunological products for serious epizootic disease

3

(1) In the event of serious epizootic 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 after informing the Commission of the detailed conditions of use.

(2) He shall publicise any permit as he sees fit.

Immunological products for an imported or exported animal

4

If an animal is imported from, or exported to, a third 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 the third country.

Administration by veterinary surgeons from other member States

5

(1) Veterinary surgeons practising in another member State 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 member State 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 has acquainted himself with the Guide to Professional Conduct issued by the Royal College of Veterinary Surgeons[^f00033].

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

(3) He 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, the products administered, the dosage administered, the duration of treatment and the withdrawal period applied, and shall keep them in the United Kingdom for at least three years, and failure to comply with this sub-paragraph is an offence.

(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

6

(1) 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 a third country; but if the veterinary surgeon has not obtained a certificate from the Secretary of State under regulation 25(5) permitting him to import it, he must obtain a certificate from the Secretary of State before he treats the animal.

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

Administration of a homeopathic remedy

7

(1) A registered homeopathic remedy or a homeopathic remedy prepared and supplied by a pharmacist under paragraph 8 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 himself or under his responsibility—

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

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

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—

“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 (of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety[^f00034]) the competent authority is the Secretary of State.

(2) Any person who contravenes any of the following provisions of that Regulation is guilty of an offence—

(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 (of the European Parliament and the Council on additives for use in animal nutrition[^f00035]) the competent authority is the Secretary of State.

(2) When he grants an authorisation under Article 3(2) of that Regulation, the authorisation shall be in writing.

(3) It is an offence to be in possession of a specified feed additive, or a premixture 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 a third country.

(4) Any person who contravenes any of the following provisions of that Regulation is guilty of an offence—

(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

4

For the purposes of Regulation (EC) No. 882/2004 (of the European Parliament and the Council on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules[^f00036]) 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 (of the European Parliament and of the Council laying down requirements for feed hygiene[^f00037]) the competent authority is the Secretary of State.

(2) Any person who contravenes any of the following provisions of that Regulation is guilty of an offence—

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

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

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

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

(i) 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 and failure to do so is an offence.

(4) In the case of the refusal, suspension or revocation of an approval under the Regulation the representations procedure relating to a manufacturing authorisation in paragraph 6 of Schedule 2 applies.

Approval of manufacturers and distributors of feedingstuffs containing veterinary medicinal products

6

(1) It is an offence to incorporate a veterinary medicinal product into a premixture or feedingstuffs, or to act as a distributor of premixtures or feedingstuffs containing a veterinary medicinal product, without being approved to do so by the Secretary of State.

(2) The requirements of this paragraph do not apply in relation to a person who incorporates a veterinary medicinal product into feedingstuffs in domestic premises for feeding, on those premises—

(a) non-food-producing animals, or

(b) food-producing animals kept purely for domestic consumption.

(3) The provisions of Regulation (EC) No. 183/2005 apply to those producers and distributors in the same way as to persons approved under Article 9 of that Regulation.

(4) A manufacturer must ensure that, so far as is reasonably practicable, the veterinary medicinal product is evenly incorporated throughout the feedingstuffs and failure to do so is an offence.

(5) In the case of the refusal, suspension or revocation of an approval under this paragraph the representations procedure relating to a manufacturing authorisation in paragraph 6 of Schedule 2 applies.

Incorporation of a veterinary medicinal product into a premixture

7

(1) Any person who incorporates a veterinary medicinal product into a premixture—

(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 veterinary medicinal product does not contain the same active substance as any other additive.

(2) It is an offence to fail to comply with this paragraph.

Incorporation of a veterinary medicinal product into feedingstuffs

8

(1) Any person who incorporates a veterinary medicinal product (or a premixture containing a veterinary medicinal product) 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 veterinary medicinal product does not contain the same active substance as any other additive;

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

(d) must ensure that the daily dose of the veterinary medicinal product 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 supplementary feedingstuffs.

(2) It is an offence to fail to comply with this paragraph.

Additional record keeping requirements relating to veterinary medicinal products

9

(1) Any person who—

(a) incorporates a veterinary medicinal product into a premixture;

(b) incorporates a premixture containing a veterinary medicinal product into feedingstuffs; or

must make a daily record of— the types and quantities of all veterinary medicinal products (and specified feed additives, if any) and premixture used in the manufacturing process; and the quantity of feedingstuffs and premixture containing veterinary medicinal product manufactured that day.

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

(a) the types and quantities of all premixtures and feedingstuffs containing veterinary medicinal products bought and sold that day;

(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 veterinary medicinal product incorporated into the feedingstuffs; and

(f) the expiry date.

(4) Records must be kept for five years.

(5) It is an offence to fail to comply with this paragraph.

Labelling a premixture containing a veterinary medicinal product

10

(1) A premixture containing a veterinary medicinal product must be clearly and legibly labelled with the following—

(a) the words “MEDICATED PREMIXTURE” in upper case letters;

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

(d) the inclusion rate into the feedingstuffs (or, where liquid is to be incorporated into the final feedingstuffs, the words “typical inclusion rate but refer to the prescription for the exact inclusion rate” or equivalent wording);

(e) the level of the active ingredient in the final feedingstuffs;

(f) warnings and contra-indications;

(g) withdrawal period;

(h) the expiry date;

(i) any special storage instructions;

(j) where a prescription is required, a statement to this effect.

(2) If the premixture 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.

(3) It is an offence to supply such a premixture not labelled in accordance with this paragraph.

Labelling of feedingstuffs containing a specified feed additive

11

(1) Feedingstuffs containing a specified feed additive must be clearly and legibly labelled with the following—

(a) the name of the specified feed additive;

(b) the name and amount of the active substance (mg/kg) in the feedingstuffs;

(d) the expiry date;

(e) the name and approval number of the manufacturer or the distributor;

(f) any particulars concerning the proper use of the feedingstuffs specified in the authorisation of the specified feed additive.

(2) It is an offence to supply such feedingstuffs not labelled in accordance with this paragraph.

Labelling of feedingstuffs containing a veterinary medicinal product

12

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

(a) the words “MEDICATED FEEDINGSTUFFS” in upper case letters;

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

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

(e) warnings and contra-indications;

(f) the withdrawal period;

(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 prescription;

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

(2) It is an offence to supply feedingstuffs not labelled in accordance with this paragraph.

Supply of specified feed additives

13

(1) A manufacturer or distributor of specified feed additives may only supply them to a person approved to hold them in accordance with this Schedule.

(2) It is an offence to fail to comply with this paragraph.

Supply of premixture

14

(1) A manufacturer or distributor of a premixture may only supply it to a person approved to hold it in accordance with this Schedule.

(2) It is an offence to fail to comply with this paragraph.

Supply of feedingstuffs containing a veterinary medicinal product

15

(1) A manufacturer (if his approval so permits) or distributor of feedingstuffs containing a veterinary medicinal product may only supply those feedingstuffs to—

(a) a person approved to hold them in accordance with this Schedule, or

(b) in accordance with a prescription as specified in paragraph 22, a person who keeps animals.

(2) He must keep the prescription for five years.

(3) It is an offence to fail to comply with this paragraph.

Possession

16

(1) It is an offence for any person other than a person holding the appropriate approval under this Schedule to be in possession of any—

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

(b) premixtures containing such an additive or a veterinary medicinal product; or

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