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The Veterinary Medicines (Amendment etc.) Regulations 2024

Type Statutory-Instrument

Publication 2024-04-25

State In force

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

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Amendment to paragraph 68

78

In paragraph 68 (offences)—

(a) before sub-paragraph (a) insert—

(za) paragraph 22A(1);

(b) after sub-paragraph (d) insert—

(da) paragraph 28(4);

(d) omit sub-paragraph (i);

(e) after sub-paragraph (j) insert—

(ja) a restriction or requirement made under paragraph 41A; (jb) a prohibition made under paragraph 41B;

(f) omit sub-paragraph (k);

(g) after sub-paragraph (l) insert—

(la) paragraph 56A; (lb) paragraph 56B; (lc) paragraph 56C;

(h) omit sub-paragraph (n).

PART 4 — Amendments to Schedule 2 to the 2013 Regulations

Introduction

79

Schedule 2 to the 2013 Regulations (manufacture of veterinary medicinal products) is amended in accordance with this Part.

Amendment to paragraph 1

80

For paragraph 1 (application) substitute—

(1) (1) No person may carry out any activity mentioned in sub-paragraph (2) otherwise than in accordance with an authorisation granted under this Schedule (a “manufacturing authorisation”). (2) For the purposes of sub-paragraph (1) the activities are— (a) the manufacture of veterinary medicinal products (whether for use in Great Britain or another country); (b) the carrying out of any part of the manufacturing process or of bringing a veterinary medicinal product to its final state, including the processing, assembling, packaging or repackaging, labelling or relabelling, storing, sterilising or releasing for supply of a veterinary medicinal product; (c) the importation of any veterinary medicinal product for use in Great Britain.

Amendment to paragraph 2

81

For paragraph 2 (time limits) substitute—

(2) (1) An application for a manufacturing authorisation must be submitted to the Secretary of State electronically and 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 manufacturing authorisation and that person’s address or registered place of business; (b) the names and addresses of the sites (including any site where work is undertaken on behalf of the proposed holder under contract) where— (i) each stage of the manufacturing process or of bringing a veterinary medicinal product to its final state, including processing, assembling, packaging or repackaging, labelling or relabelling, storing or sterilising, is carried out; (ii) any imported products are held; or (iii) any control or batch release is carried out; (c) a description of the veterinary medicinal products or pharmaceutical forms proposed to be manufactured or imported under the authorisation; (d) the name of the proposed qualified person (manufacture) for the purposes of paragraph 9; (e) the name of the person proposed to have responsibility for quality control; (f) the qualifications and a description of the relevant experience of the person proposed to have responsibility for quality control; (g) the name of the person proposed to have responsibility for production; (h) the qualifications and a description of the relevant experience of the person proposed to have responsibility for production; (i) a declaration that the applicant complies with good manufacturing practice and any relevant legislation; and (j) a declaration that any site mentioned in paragraph (b) is ready for inspection.

Amendment to paragraph 3

82

For paragraph 3 (granting the authorisation) substitute—

(3) (1) The Secretary of State must process an application mentioned in paragraph 2 within 90 days of validating the application. (2) The Secretary of State must inspect the sites mentioned in paragraph 2(2)(b) within 90 days of validating the application. (3) The Secretary of State must grant the manufacturing authorisation if satisfied, following the inspection mentioned in sub-paragraph (2), that— (a) the sites are suitable for the intended purposes; (b) the applicant has— (i) suitable and sufficient staff, technical equipment and facilities for the proposed activities; and (ii) a documented quality management system in place. (4) Where the Secretary of State is not satisfied in relation to one or more of the matters mentioned in sub-paragraph (3), the Secretary of State may— (a) reject the application; or (b) grant a conditional manufacturing authorisation for a period specified by the Secretary of State until the deficiency has been addressed. (5) The Secretary of State may extend the period for which a conditional manufacturing authorisation is granted under sub-paragraph (4)(b). (6) Where a conditional manufacturing authorisation is granted under sub-paragraph (4)(b) and the deficiency is addressed within the specified period to the satisfaction of the Secretary of State, the authorisation continues to have effect without those conditions.

Amendment to paragraph 4

83

In paragraph 4(1) (authorisation)—

(a) in paragraph (a) after “be manufactured” insert “, controlled”;

(b) for paragraph (b) substitute—

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

New paragraph 4A

84

After paragraph 4 insert—

(4A) (1) The holder of a manufacturing authorisation must notify the Secretary of State, and apply for a variation of the authorisation, before— (a) making a material alteration to the premises or facilities used under the authorisation, or to the operations for which they are used; (b) changing the qualified person (manufacture), the person with responsibility for quality control or the person with responsibility for production. (2) The Secretary of State must process an application under sub-paragraph (1) within 30 days of receiving it unless the Secretary of State notifies the applicant in writing that the time has been extended to 90 days. (3) The Secretary of State must grant the application under sub-paragraph (1) if satisfied in respect of the matters in paragraph 3(3) as regards the proposed variation. (4) The Secretary of State may inspect any site to which the manufacturing authorisation or proposed variation relates in connection with the application. (5) Where the Secretary of State is not satisfied for the purposes of sub-paragraph (3), the Secretary of State may— (a) reject the application; or (b) grant a conditional variation to the manufacturing authorisation for a period specified by the Secretary of State until the deficiency has been addressed. (6) The Secretary of State may extend the period for which a conditional variation to the marketing authorisation is granted under sub-paragraph (5)(b). (7) Where a conditional variation to the manufacturing authorisation is granted under sub-paragraph (5)(b) and the deficiency is addressed within the specified period to the satisfaction of the Secretary of State, the authorisation continues to have effect as so varied without those conditions.

Amendment to paragraph 5

85

In paragraph 5 (suspension, variation or revocation of authorisation)—

(a) in sub-paragraph (1)—

(i) after paragraph (c) omit “or”;

(ii) at the end insert—

(e) has failed to carry out the activity specified in the authorisation for a period of five years or more; or (f) has not paid any fee required under these Regulations

(b) for sub-paragraph (2) substitute—

(2) The Secretary of State may also suspend, vary or revoke the authorisation on being satisfied that the qualified person (manufacture), the person responsible for quality control or the person with responsibility for production is not fulfilling that person’s duties under these Regulations. (3) In particular, the Secretary of State may— (a) suspend the manufacture or import of veterinary medicinal products; (b) suspend, revoke or vary the manufacturing authorisation for one or more pharmaceutical forms; (c) suspend, revoke or vary the manufacturing authorisation for one or more activities in one or more manufacturing sites.

Amendment to paragraph 6

86

In paragraph 6 (inspection of premises)—

(a) in sub-paragraph (1)—

(i) for “premises” (in the first and the third place it appears) substitute “sites”;

(ii) for “registered” substitute “authorised”;

(iii) for “premises’ history” substitute “site’s history”;

(b) for sub-paragraph (2) substitute—

(2) Within 90 days after an inspection, the Secretary of State must issue a certificate of good manufacturing practice to the manufacturer if the inspection establishes that the manufacturer has complied with the requirements of these Regulations in respect of the site to which the inspection relates. (2A) Where the Secretary of State does not consider that compliance is established after inspection in accordance with sub-paragraph (2), the Secretary of State must enter that fact in the register mentioned in paragraph 12(a). (2B) The Secretary of State may carry out an inspection on a site occupied by a manufacturer established in a country other than the United Kingdom notwithstanding any arrangements that may have been entered into between the United Kingdom and that country. (2C) The importer of a veterinary medicinal product must ensure before importation that the manufacturer of that product has— (a) a valid certificate of good manufacturing practice issued by the Secretary of State; or (b) an equivalent certificate issued by a regulatory authority— (i) with which the Secretary of State has an agreement or arrangement for such purposes; or (ii) which the Secretary of State considers to have demonstrated equivalent standards to those in the United Kingdom.

Amendment to paragraph 8

87

In paragraph 8 (duties on holder of manufacturing authorisation)—

(a) for sub-paragraph (2) substitute—

(2) The holder must have permanently at the holder’s disposal the services of— (a) staff complying with any legal requirements in relation to manufacture of veterinary medicinal products; and (b) at least one qualified person (manufacture). (2A) The holder must place at the disposal of any qualified person (manufacture) all necessary documents, premises and technical and other facilities in order to enable that person to discharge their duties as the qualified person. (2B) Where any qualified person (manufacture) ceases to be available to provide services to the holder, the holder must give notice of the fact to the Secretary of State— (a) at least 30 days in advance of the person’s ceasing to be so available; or (b) where such notice is not possible, at the earliest opportunity.

(b) for sub-paragraph (3) substitute—

(3) The holder must— (a) comply with good manufacturing practice and have a valid certificate of good manufacturing practice; (b) use as starting materials only active substances which have been manufactured in accordance with good manufacturing practice and distributed in accordance with good distribution practice for active substances; (c) verify that each manufacturer, distributor or importer from whom the holder obtains active substances and to which paragraph 26 applies is registered with the Secretary of State under that paragraph; (d) carry out audits based on a risk assessment in relation to the manufacturers, distributors and importers from which the holder obtains active substances; (e) have in place a system of quality assurance and quality control; and (f) give to the Secretary of State, on request, proof of any control test specified by the Secretary of State which has been carried out on the veterinary medicinal product or the constituents and intermediate products of the manufacturing process in accordance with the data submitted in support of the application for the marketing authorisation. (3A) The holder of a manufacturing authorisation must inform the Secretary of State and the holder of any relevant marketing authorisation where the holder obtains information that veterinary medicinal products which fall within the scope of its manufacturing authorisation are falsified, or are suspected of being falsified, irrespective of whether those products were distributed within the legal supply chain or by illegal means.

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

New paragraphs 8A and 8B

88

After paragraph 8 insert—

(8A) (1) A holder of a manufacturing authorisation must ensure that the veterinary medicinal product is manufactured in accordance with this paragraph, whether the manufacturing is performed by the holder or another person. (2) The manufacturing operations must be conducted in accordance with a written methodology, to be known as the “pharmaceutical quality system” or “PQS”. (3) The PQS must be— (a) clear; (b) systematically reviewed from time to time in the light of experience; and (c) capable of consistently manufacturing veterinary medicinal products which are of the required quality and which meet the requirements of the relevant marketing authorisation. (4) The critical steps of the manufacturing process set out in the PQS must be validated. (5) Any significant amendments to the PQS must be validated. (6) The PQS must provide for— (a) appropriately qualified and trained personnel; (b) adequate premises and space; (c) suitable equipment and access to services; (d) suitable materials, containers and labelling; (e) relevant procedures and instructions; (f) suitable storage and transport; (g) investigation into complaints and defects. (7) The PQS must provide for any significant deviations from its provisions to be— (a) fully recorded, and (b) investigated, with appropriate corrective and preventative action implemented. (8) The holder of a manufacturing authorisation must ensure that records of the manufacturing process, including distribution, are kept in a comprehensible and accessible form until the later of— (a) the date which is five years after the date on which the veterinary medicinal product is placed on the market; (b) the date which is one year after the expiry date of the batch of veterinary medicinal product. (9) In this paragraph, a process (or part of a process) is “validated” if scientific evidence is assembled which demonstrates that it is capable of consistently delivering expected results. (8B) (1) The holder of a manufacturing authorisation must comply with any requirement by the Secretary of State to recall a veterinary medicinal product and must record the details of the recall operation. (2) The holder of a manufacturing authorisation must record any veterinary medicinal product which is— (a) recalled (whether or not the holder physically receives the recalled product); or (b) discovered to be counterfeit. (3) Where any veterinary medicinal product is recalled and physically received, the qualified person (manufacture) must assess the recalled product in order to determine whether— (a) the product has been stored (including during transport) in accordance with the summary of product characteristics; (b) the product is a genuine product and not counterfeit. (4) Where the qualified person (manufacture) determines that a recalled veterinary medicinal product does not satisfy sub-paragraph (3)(a) or (b), or where it is not possible for the qualified person (manufacture) to determine whether the product does so, the product may not be re-sold. (5) The qualified person (manufacture) must record any assessment and determination made under sub-paragraphs (3) and (4). (6) Any veterinary medicinal products which may not be re-sold must be identified, held separately and destroyed and the holder of a manufacturing authorisation must develop a suitable procedure to set out the steps to be taken in accordance with this sub-paragraph. (7) The holder of a manufacturing authorisation must keep any information recorded under this paragraph for five years.

Amendment to paragraph 9

89

In paragraph 9 (qualified person for manufacture)—

(a) in sub-paragraph (1), after “any person” insert “(including the manufacturer of a veterinary medicinal product)”;

(b) after sub-paragraph (1) insert—

(1A) For the purposes of sub-paragraph (1), a person has sufficient practical experience if they have been engaged in one or more of the activities mentioned in sub-paragraph (1B) for at least two years in the provision of services to the holder of a manufacturing authorisation. (1B) For the purposes of sub-paragraph (1A) the activities are— (a) quality assurance of medicinal products; (b) qualitative analysis of medicinal products; (c) quantitative analysis of active substances. (1C) The Secretary of State may treat the reference in sub-paragraph (1A) to two years of practical experience as a reference to— (a) one year, where the person’s formal course of study lasted for at least five years; (b) six months, where the person’s formal course of study lasted for at least six years.

Amendment to paragraph 10

90

In paragraph 10 (refusal or revocation of appointment)—

(a) for “or revoke” substitute “, revoke, suspend or vary”;

(b) for the heading substitute—

Amendment to paragraph 13

91

In paragraph 13 (test sites)—

(a) in sub-paragraph (1) for “premises” substitute “a site”;

(b) in sub-paragraph (2) for “premises” substitute “site”;

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

(d) in sub-paragraph (3) for “Authorisation and inspection of the premises are” substitute “Inspection of the site is”.

Amendment to Parts 2 to 5

92

For Parts 2 to 5 substitute—

(14) (1) The Secretary of State may authorise a person to— (a) manufacture— (i) autogenous vaccines; or (ii) an unauthorised veterinary medicinal product for administration under the cascade; (b) collect, store and supply blood in connection with the treatment of non-food animals; (c) collect, store and supply blood constituents obtained by the physical separation of donor blood into different fractions within a closed bag system, for the treatment of non-food animals; or (d) collect, process and store stem cells for use as an autologous treatment in non-food animals, and may authorise sites for the purpose of carrying out those activities by that person. (2) A single authorisation under sub-paragraph (1) may confer permission to carry out the activities mentioned in both paragraph (b) and (c) of that sub-paragraph. (3) In this paragraph, a “closed bag system” means a system in which the blood pack assembly is manufactured under clean conditions, sealed to the external environment and sterilised. (15) No person may carry out any activity mentioned in paragraph 14 otherwise than— (a) in accordance with an authorisation mentioned in that paragraph; or (b) pursuant to paragraph 1(2) of Schedule 4 (administration under the cascade). (16) In order to be authorised the site mentioned in paragraph 14(1) must be under the supervision of a named person responsible for release (a “PRR”) who in the opinion of the Secretary of State has sufficient qualifications and experience to manufacture the product safely. (17) (1) An applicant for authorisation under paragraph 14 must, at least two months before commencing an activity mentioned in that paragraph, submit the following to the Secretary of State— (a) the name and address of the proposed holder of the authorisation; (b) a description of the activity in which the applicant for authorisation proposes to be engaged; (c) particulars (including the name and address) in relation to the site at which the relevant activity is to be carried out (whether in the occupation of the proposed holder or otherwise) and a description of the technical equipment on the site; (d) particulars in relation to the qualifications and experience of the proposed PRR who will supervise the activities at the site. (2) The application must include a declaration that the applicant will comply with the requirements of these Regulations and confirmation that the site is ready for inspection. (3) Before granting an authorisation in relation to a site, the Secretary of State must be satisfied that the production process carried out there will produce a consistent, safe product and, in the case of a blood bank or a stem cell centre, that the welfare of the animals involved in the processes will be respected. (18) (1) No person may collect blood for the purposes of a non-food animal blood bank other than a veterinary surgeon or a person acting under the responsibility of a veterinary surgeon. (2) The holder of an authorisation to carry out an activity under paragraph 14(1)(b) or (c) may only supply blood or blood constituents to a veterinary surgeon. (3) No person other than a veterinary surgeon or someone acting under a veterinary surgeon’s responsibility may administer blood to a non-food producing animal. (4) No person may administer blood to a food-producing animal. (19) (1) No person may collect stem cells for the purposes of treating animals other than a veterinary surgeon or a person acting under the responsibility of a veterinary surgeon. (2) No person may collect stem cells from embryonic tissues. (3) No person may administer any product grown from stem cells to a food-producing animal. (20) (1) Subject to sub-paragraph (2), no person may manufacture a product for administration under the cascade that is the pharmaceutical equivalent of an authorised veterinary medicinal product. (2) The Secretary of State may authorise the manufacture of a product notwithstanding sub-paragraph (1) where there is difficulty in relation to the supply of the authorised veterinary medicinal product. (3) The holder of an authorisation under paragraph 14(1)(a)(ii) may not supply a product manufactured in accordance with that sub-paragraph other than to a veterinary surgeon who has prescribed the product under the cascade. (4) The holder of an authorisation under paragraph 14(1)(a)(ii) must— (a) provide a list of products manufactured in accordance with that sub-paragraph to the Secretary of State annually or at the request of the Secretary of State; (b) provide sales data for products supplied under sub-paragraph (3) at the request of the Secretary of State. (5) For the purposes of this paragraph, a product is the pharmaceutical equivalent of an authorised veterinary medicinal product if— (a) it has the same qualitative and quantitative composition in active substances; and (b) it has the same pharmaceutical form. (21) The Secretary of State may by notice suspend, vary or revoke an authorisation under paragraph 14 if the Secretary of State is satisfied that— (a) the holder of the authorisation no longer uses fit and proper processes; (b) the site at which the activity takes place is not suitable; (c) the equipment is not suitable; (d) the PRR has not carried out adequately the PRR’s responsibilities under these Regulations; (e) in the case of a person authorised under paragraph 14(1), that person has manufactured a veterinary medicinal product pursuant to that authorisation that is not within its scope; (f) the holder has not conducted an activity relating to the authorisation for five years or more; (g) the holder has not paid any fee required under these Regulations; or (h) the holder has not complied with any other provision in these Regulations. (22) (1) The holder of an authorisation under paragraph 14 must ensure that every container used is labelled with— (a) a precise description of the product; (b) the date on which the product was produced; (c) the name and address of the authorisation holder; (d) the address of the site named under the authorisation and its authorisation number; (e) the instructions for use; (f) the expiry date; (g) any necessary warnings; (h) in the case of an autogenous vaccine or an unauthorised veterinary medicinal product for administration under the cascade, the name of the veterinary surgeon who ordered the product; (i) in the case of blood or a stem cell product— (i) the identification of the donor animal; and (ii) the date of collection. (2) In the case of blood or blood constituents there must be no specific therapeutic indication on the label or on any information related to the product. (3) In the case of an unauthorised veterinary medicinal product for administration under the cascade the words “this veterinary medicinal product does not hold a marketing authorisation” must appear on the label. (23) The holder of an authorisation under paragraph 14 must, as soon as is reasonably practicable after the product is supplied, in addition to the expiry date of the product, record the following— (a) in the case of an unauthorised veterinary medicinal product for administration under the cascade— (i) the name and address of the veterinary surgeon who ordered the veterinary medicinal product; (ii) a precise description of the product; (iii) the date of production; (iv) the date of supply to the veterinary surgeon; (b) in the case of stem cells or blood— (i) the identification of the source animal; (ii) the name of the veterinary surgeon who collected the product (or under whose responsibility it was collected); (iii) the date of collection of the product; (iv) the date that the product was used or if the product was supplied to another veterinary surgeon, the name and address of that veterinary surgeon and the date the product was supplied; (c) in the case of an autogenous vaccine— (i) the name and address of the veterinary surgeon who ordered the vaccine; (ii) the identification of the source animal; (iii) the date of supply to the veterinary surgeon, and must keep the records for at least five years. (24) The holder of an authorisation under paragraph 14 must notify the Secretary of State of any adverse event in relation to a product produced by that person under that authorisation within 30 days of learning of the event. (25) The Secretary of State must inspect any site authorised under paragraph 14, basing the frequency of the inspection on the risks associated with each site’s history and the nature of the products handled at the site.

New Part 2A and Part 2B

93

After Part 2 (as substituted by the previous regulation) insert—

(26) (1) No person may manufacture, import or distribute an active substance unless the person is registered in the register maintained under sub-paragraph (2). (2) The Secretary of State must establish and maintain a register of manufacturers, importers and distributors of active substances and the sites occupied by them for the purposes of manufacturing or holding active substances. (27) (1) An applicant for registration under paragraph 26 must, at least two months before commencing an activity mentioned in paragraph 26(1) or, in the case of an existing manufacturer, within two months of the date on which this provision comes into force, submit the following to the Secretary of State— (a) the name and address of the proposed registration holder; (b) the name of the relevant active substance; (c) a description of the activity proposed to be engaged in in relation to the relevant active substance; and (d) particulars in relation to the site at which the relevant active substance is to be manufactured or held (as the case may be). (2) Information may be submitted to the Secretary of State pursuant to sub-paragraph (1) prior to the date on which this provision comes into force, and in such a case— (a) as regards an applicant for registration who is not an existing manufacturer, the relevant period of two months is to be treated as having started on the date of submission; (b) as regards an applicant for registration who is an existing manufacturer, the information is to be treated as having been submitted within the relevant period of two months. (28) A manufacturer, importer or distributor of active substances must comply with good manufacturing practice or good distribution practice, as applicable. (29) (1) A person registered under paragraph 26 must immediately inform the Secretary of State on receipt of any new information that might adversely affect the quality and safety of the active substance. (2) A person registered under paragraph 26 must immediately inform the Secretary of State of any prohibition or restriction in relation to the active substance imposed by the competent authorities of any country other than the United Kingdom in which the active substance is authorised. (30) The Secretary of State may, from time to time, inspect sites registered under paragraph 26, basing the frequency of the inspections on the risks associated with each site’s history and the nature of the substances handled at the site. (31) (1) After each inspection of a site for the purposes of this Part, the inspector must make a written report to the Secretary of State on whether the requirements in this Part are being complied with. (2) The Secretary of State must inform the inspected registered person of the content of such reports. (32) It is an offence to fail to comply with— (a) paragraph 1; (b) paragraph 4(3); (c) paragraph 8; (d) paragraph 11; (e) paragraph 15; (f) paragraph 18; (g) paragraph 19; (h) paragraph 20(1), (3) or (4); (i) paragraph 22; (j) paragraph 23; (k) paragraph 24; (l) paragraph 26; (m) paragraph 28; (n) paragraph 29.

PART 5 — Amendments to Schedule 3 to the 2013 Regulations

Introduction

94

Schedule 3 to the 2013 Regulations (classification and supply, wholesale dealers and sheep dip) is amended in accordance with this Part.

Amendment to paragraph 1

95

In paragraph 1 (classification of veterinary medicinal products)—

(a) in sub-paragraph (4) at the end insert—

(c) products containing an antimicrobial; (d) products for the purpose of euthanasia; (e) products with a hormonal or thyrostatic function; (f) products containing beta-agonists

(b) in sub-paragraph (5)—

(i) at the end of paragraph (c) omit “and”;

(ii) at the end insert—

(e) immunological veterinary medicinal products.

(i) in paragraph (d) for “adverse reaction” substitute “adverse event”;

(ii) in paragraph (h) for “antimicrobials” substitute “antibiotics”.

Amendment to paragraph 2

96

In paragraph 2 (wholesale supply of veterinary medicinal products)—

(a) in sub-paragraph (1) omit “of a marketing authorisation, the holder”;

(b) in sub-paragraph (2)(b) after “the supply” insert “is to the holder of a manufacturing authorisation or”;

(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).

Amendment to paragraph 3

97

In paragraph 3(6) (retail supply of veterinary medicinal products) for paragraph (a) substitute—

(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

New paragraphs 3A, 3B, 3C, 3D and 3E

98

After paragraph 3 insert—

(3A) (1) Subject to sub-paragraph (2) a person mentioned in paragraph 2(1) or 3(2) may not supply a veterinary medicinal product for promotional purposes. (2) Subject to sub-paragraph (3), the person may supply samples of product labelled in a way that clearly identifies them as such to— (a) sales representatives who are responsible for promoting the product; or (b) those entitled to supply the product during sponsored events. (3) Sub-paragraph (2) does not apply in relation to a product containing an antimicrobial substance. (3B) (1) No person may supply or offer to supply a veterinary medicinal product classified as POM-V, POM-VPS or NFA-VPS by means of the internet to persons in Great Britain unless the person— (a) is established within Great Britain; (b) has an address within Great Britain; and (c) appears on the register maintained under sub-paragraph (2). (2) The Secretary of State must establish, maintain and publish on a website a register of persons who supply veterinary medicinal products by means of the internet. (3C) (1) An applicant for registration under paragraph 3B must, at least two months before commencing the activity mentioned in paragraph 3B(1) (or in the case of an existing supplier of veterinary medicinal products by means of the internet within two months of the date on which this provision comes into force), submit to the Secretary of State the name and the address within Great Britain of the proposed registration holder. (2) Information may be submitted to the Secretary of State pursuant to sub-paragraph (1) prior to the date on which this provision comes into force, and in such a case— (a) as regards an applicant for registration who is not an existing supplier of veterinary medicinal products by means of the internet, the relevant period of two months is to be treated as having started on the date of submission; (b) as regards an applicant for registration who is an existing supplier of veterinary medicinal products by means of the internet, the information is to be treated as having been submitted within the relevant period of two months. (3D) Where a person offers to supply a veterinary medicinal product by means of the internet, that person must make available on each part of the website where the product is offered— (a) the statement “registered internet retailer of veterinary medicines”; (b) the contact details of the Secretary of State; and (c) a link to the published register. (3E) A retailer of veterinary medicinal products must store (including during transport) a veterinary medicinal product in accordance with the terms of any specific instructions on the label of the product and in accordance with the relevant summary of product characteristics.

Amendment to paragraph 4

99

In paragraph 4(1) (prescriptions by veterinary surgeon) after “POM-V” insert “or a veterinary medicinal product under the cascade”.

Amendment to paragraph 5

100

In paragraph 5 (prescriptions)—

(a) in sub-paragraph (1)—

(i) for “oral” substitute “verbal”;

(ii) after “POM-VPS” insert “or a veterinary medicinal product prescribed under the cascade”;

(b) after sub-paragraph (1) insert—

(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

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

Amendment to paragraph 6

101

In paragraph 6 (written prescriptions) for sub-paragraph (1) substitute—

(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; (c) the identification (including the species) of the animal or group of animals to be treated; (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 (c) used to promote growth or increase yield.

Amendment to paragraph 7

102

In paragraph 7 (duties when a product is prescribed or supplied)—

(a) the existing text is renumbered as sub-paragraph (1);

(b) in that sub-paragraph after “who prescribes” insert “a veterinary medicinal product under the cascade or”;

(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.

New paragraph 7A

103

After paragraph 7 insert—

(7A) (1) Subject to sub-paragraphs (2) and (3) a veterinary surgeon may not prescribe a veterinary medicinal product which is an antibiotic for prophylactic purposes. (2) Without prejudice to paragraph 6(1A), a veterinary surgeon may only prescribe a veterinary medicinal product which is an antibiotic for administration to an animal for prophylactic purposes in exceptional circumstances where the risk of an infection or of an infectious disease is very high and where the consequences of not prescribing the product are likely to be severe. (3) Subject to sub-paragraph (2), a veterinary surgeon may only prescribe a veterinary medicinal product which is an antibiotic for administration to a group of animals for prophylactic purposes where the circumstances set out in sub-paragraph (4) apply. (4) For the purposes of sub-paragraph (3) the circumstances are that— (a) the rationale for prescribing the product to the group of animals is clearly recorded by the veterinary surgeon prescribing it; and (b) a management review is carried out by a veterinary surgeon at, or as soon as reasonably practicable after, administration of the product in order to identify factors and implement measures for the purpose of eliminating the need for any future such administration. (5) A veterinary surgeon who prescribes a veterinary medicinal product which is an antibiotic must make a record of the satisfaction of the relevant conditions for the purposes of its use in accordance with this paragraph and keep that documentation for at least five years.

Amendment to paragraph 10

104

In paragraph 10(1) (supply by a pharmacist)—

(a) in the words before paragraph (a), after “NFA-VPS” insert “, or prescribed under the cascade,”;

(b) in paragraph (c) for “approved” substitute “authorised”.

Amendment to paragraph 11

105

In paragraph 11 (supply for incorporation into feedingstuffs)—

(a) for “approved”, in each place it occurs, substitute “authorised”;

(b) in sub-paragraph (1) for “veterinary medicinal product intended for incorporation into feedingstuffs” substitute “medicinal premix”;

(i) for “veterinary medicinal product”, in both places it occurs, substitute “medicinal premix”;

(ii) in the words before paragraph (a) omit “The marketing authorisation holder,”;

(iii) in paragraph (b) for “premixture” substitute “intermediate feedingstuffs”;

(iv) in paragraph (c) for “prescription” substitute “medicated feedingstuffs prescription”;

(d) in sub-paragraph (3)—

(i) for “veterinary medicinal product”, in both places it occurs, substitute “medicinal premix”;

(ii) in paragraph (a) for “premixture” substitute “intermediate feedingstuffs”;

(iii) in paragraph (b)—

(aa) for “approval” substitute “authorisation”;

(bb) after “a prescription” insert “for medicated feedingstuffs”;

(e) for sub-paragraph (4) substitute—

(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.

(f) in the heading for “veterinary medicinal product for incorporation into feedingstuffs” substitute “medicinal premix”.

Amendment to paragraph 13

106

In paragraph 13(2)(a) (supply for use under the cascade)—

(a) for “veterinary surgery” substitute “veterinary practice premises”;

(b) for “approved” substitute “authorised”.

Amendment to paragraph 14

107

In paragraph 14 (supply by suitably qualified person)—

(a) for “approved”, in each place it occurs, substitute “authorised”;

(b) for “approval”, in each place it occurs, substitute “authorisation”;

(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.

(d) in sub-paragraph (7), after “suitably qualified persons” insert “and bodies recognised under this paragraph”;

(e) after sub-paragraph (10) insert—

(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.

Amendment to paragraph 15

108

For paragraph 15 (annual audit) substitute—

(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.

Amendment to paragraph 16

109

For paragraph 16 (application) substitute—

(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”).

Amendment to paragraph 17

110

For paragraph 17 (time limits) substitute—

(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; (c) evidence that the sites mentioned in paragraph (b) are— (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.

Amendment to paragraph 18

111

For paragraph 18 (granting authorisation) substitute—

(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.

Amendment to paragraph 19

112

For paragraph 19 (authorisation) substitute—

(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.

New paragraph 19A

113

After paragraph 19 insert—

(19A) (1) The holder of a wholesale dealer’s authorisation must notify the Secretary of State, and apply for a variation of the authorisation, before making a material alteration to the premises or facilities used under the authorisation or the operations for which the premises or facilities are used or where there is a change in the personnel carrying out the role of wholesale qualified person. (2) The Secretary of State must process an application under sub-paragraph (1) within 30 days of receiving it unless the Secretary of State notifies the applicant in writing that the time has been extended to 90 days. (3) The Secretary of State must grant the application under sub-paragraph (1) if satisfied in respect of the matters in paragraph 18(2) as regards the proposed variation. (4) The Secretary of State may inspect any site to which the wholesale dealer’s authorisation or proposed variation relates in connection with the application. (5) Where the Secretary of State is not satisfied for the purposes of sub-paragraph (3), the Secretary of State may— (a) reject the application; or (b) grant a conditional variation to the wholesale dealer’s authorisation for a period specified by the Secretary of State until the deficiency has been addressed. (6) The Secretary of State may extend the period for which a conditional variation to the wholesale dealer’s authorisation is granted under sub-paragraph (5)(b). (7) Where a conditional variation to the wholesale dealer’s authorisation is granted under sub-paragraph (5)(b) and the deficiency is addressed within the specified period to the satisfaction of the Secretary of State, the authorisation continues to have effect as so varied without those conditions.

Amendment to paragraph 20

114

For paragraph 20(b) (suspension, variation or revocation of authorisation) substitute—

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

Amendment to paragraph 21

115

In paragraph 21 (duties on holder of wholesale dealer’s authorisation)—

(a) for sub-paragraph (b) substitute—

(b) comply with good distribution practice;

(b) omit sub-paragraph (c) (and the “and” following it);

; 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

New paragraphs 21A, 21B, 21C, 21D, 21E and 21F

116

After paragraph 21 (and immediately before the heading for Part 3) insert—

(21A) The Secretary of State must establish, maintain and publish on a website a register of authorised wholesale dealers and their sites. (21B) (1) This paragraph applies in relation to wholesale supply of veterinary medicinal products. (2) The holder of a wholesale dealer’s authorisation must ensure that a document accompanies each consignment of veterinary medicinal products specifying— (a) the name of the veterinary medicinal product; (b) the strength and pharmaceutical form; (c) the date on which the veterinary medicinal product was supplied; (d) the quantity of product supplied; (e) the batch number; (f) the expiry date; (g) the name and address of the wholesale dealer supplying the product; (h) the means by which the product was transported and the required conditions of storage; (i) the name of the person to whom the product was supplied and the address to which it is to be delivered. (3) The holder of a wholesale dealer’s authorisation must make a record of the information mentioned in sub-paragraph (2) and must keep it for at least five years. (21C) (1) The holder of a wholesale dealer’s authorisation must comply with any requirement by the Secretary of State to recall a veterinary medicinal product and must record the details of the recall operation. (2) The holder of a wholesale dealer’s authorisation must record any veterinary medicinal product which is— (a) recalled (whether or not the holder physically receives the recalled product); (b) discovered to be counterfeit; or (c) returned. (3) Where any veterinary medicinal product is recalled or returned and physically received, the wholesale qualified person must assess the product received in order to determine whether the product has been stored (including during transport) in accordance with the summary of product characteristics. (4) Where a recalled or returned veterinary medicinal product has not been stored (including during transport) in accordance with the summary of product characteristics or where it is not possible for the wholesale qualified person to determine whether the product has been stored in accordance with the summary of product characteristics, the product may not be re-sold. (5) Any veterinary medicinal products which may not be re-sold must be identified, held separately and destroyed and the holder of a wholesale dealer’s authorisation must develop a suitable procedure to set out the steps to be taken in accordance with this sub-paragraph. (6) The holder of a wholesale dealer’s authorisation must keep any information recorded under this paragraph for five years. (21D) (1) At least once a year, the holder of a wholesale dealer’s authorisation must carry out a detailed audit of stock and compare the incoming and outgoing veterinary medicinal products recorded with products currently held and record the results of the audit in written form. (2) Where, as a result of the audit mentioned in sub-paragraph (1), the holder identifies a discrepancy the holder must— (a) make a record of that fact, (b) conduct an investigation for the purpose of discovering the cause of the discrepancy, and (c) maintain records of that investigation. (3) The holder 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 holder to provide a copy of them at any time within that period. (21E) Where the holder of a wholesale dealer’s authorisation contracts out any wholesale dealing activities to another such holder, the arrangement must record in writing the responsibilities of each party in relation to their respective roles in the supply process and, in particular, in connection with the recall of a veterinary medicinal product under paragraph 21C. (21F) (1) The holder of a wholesale dealer’s authorisation must have in place a self-inspection programme which ensures that every aspect of its business is inspected at least once a year in order to ensure that it is complying with good distribution practice. (2) Where, as a result of the self-inspection mentioned in sub-paragraph (1), the holder identifies any non-compliance the holder must— (a) make a record of that fact, (b) conduct an investigation for the purpose of discovering the cause of the non-compliance, and (c) maintain records of that investigation. (3) The holder must keep the records mentioned in sub-paragraph (2) for a period of five years from the date of the audit and the Secretary of State may require the holder to provide a copy of them at any time within that period.

Amendment to paragraph 23

117

In paragraph 23(1) (use of sheep dip) for the words from the beginning to “holds either” substitute “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”.

Amendment to paragraph 24

118

In paragraph 24 (offences)—

(a) after sub-paragraph (b) insert—

(ba) paragraph 3A; (bb) paragraph 3B; (bc) paragraph 3C; (bd) paragraph 3D; (be) paragraph 3E;

(b) after sub-paragraph (d) insert—

(da) paragraph 6;

(ea) paragraph 7A;

(d) after sub-paragraph (m) insert—

(ma) paragraph 16;

(e) omit sub-paragraph (n);

(f) after sub-paragraph (o) insert—

(oa) paragraph 21B; (ob) paragraph 21C; (oc) paragraph 21D; (od) paragraph 21E; (oe) paragraph 21F;

PART 6 — Amendments to Schedule 4 to the 2013 Regulations

Introduction

119

Schedule 4 to the 2013 Regulations (administration outside terms of marketing authorisation) is amended in accordance with this Part.

Amendment to paragraph 1

120

In paragraph 1 (administration under the cascade)—

(a) in sub-paragraph (4)—

(i) for the words “Any pharmacologically active substances” substitute “All substances”;

(ii) at the end insert “or substances which do not fall within the scope of Regulation (EC) No 470/2009 of the European Parliament and of the Council”;

(b) after sub-paragraph (4) insert—

(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.

Amendment to paragraph 2

121

In paragraph 2 (withdrawal periods)—

(a) for sub-paragraph (2) substitute—

(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[^f00011].

(b) in sub-paragraph (3)—

(i) for paragraph (a) substitute—

(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;

(ii) for paragraph (b) substitute—

(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;

(iii) for paragraph (c) substitute—

(c) for meat and offal from food-producing mammals, poultry and farmed game-birds— (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;

(iv) for paragraph (d) substitute—

(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.

Amendment to paragraph 4

122

In paragraph 4 (immunological products for serious epizootic disease)—

(a) after “epizootic diseases” insert “or emerging diseases”;

(b) in the heading at the end insert “or emerging disease”.

New paragraph 6A

123

After paragraph 6 (administration by veterinary surgeons from other countries) insert—

(6A) (1) An autogenous vaccine may only be administered to animals in exceptional circumstances where no suitable immunological veterinary medicinal product has been authorised in relation to the target species and indication. (2) Where a vaccine is used in accordance with sub-paragraph (1) it must be administered in accordance with a prescription under the cascade.

Amendment to paragraph 9

124

In paragraph 9 (administration under animal test certificate)—

(a) in sub-paragraph (1) for “research purposes” substitute “clinical trials”;

(b) in sub-paragraph (4)—

(i) for “serious adverse reaction” substitute “adverse event”;

(ii) for “15 days” substitute “30 days”.

New paragraph 9A

125

After paragraph 9 insert—

(9A) A person must not promote or facilitate any purported use of the cascade which is not in accordance with this Schedule.

Amendment to paragraph 10

126

In paragraph 10 (offences)—

(a) before sub-paragraph (a) insert—

(za) paragraph 2;

(b) in sub-paragraph (b) omit “or”;

(ba) paragraph 6A;

(d) in sub-paragraph (c) for “(4).” substitute “(4); or”;

(e) after sub-paragraph (c) insert—

(d) paragraph 9A.

PART 7 — Amendments to Schedule 5 to the 2013 Regulations

Introduction

127

Schedule 5 to the 2013 Regulations (medicated feedingstuffs and specified feed additives) is amended in accordance with this Part.

Amendment to paragraph 1

128

In paragraph 1(3) (interpretation)—

(a) omit the definition of “premixture”;

(b) at the appropriate place insert—

“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;

Amendment to paragraph 3

129

In paragraph 3(3) (enforcement of Regulation (EC) No 1831/2003) for “a premixture” substitute “an intermediate feedingstuff”.

Amendment to paragraph 7

130

In paragraph 7 (approval of manufacturers and distributors of feedingstuffs containing veterinary medicinal products)—

(a) in sub-paragraph (2)—

(i) for “veterinary medicinal product”, in each place it occurs, substitute “medicinal premix”;

(ii) for “a premixture” substitute “an intermediate feedingstuff”;

(iii) for “premixtures” substitute “intermediate feedingstuffs”;

(iv) for “approved” substitute “authorised”;

(b) in sub-paragraph (3)—

(i) for “approval”, in both places it occurs, substitute “authorisation”;

(ii) for “establishments” substitute “premises”;

(d) for sub-paragraph (5) substitute—

(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.

(e) in sub-paragraph (6) for “veterinary medicinal product” substitute “medicinal premix”;

(f) in sub-paragraph (7) for “approval” substitute “authorisation”;

(g) in the heading—

(i) for “Approval” substitute “Authorisation”;

(ii) for “veterinary medicinal products” substitute “medicinal premixes”.

Amendment to paragraph 8

131

In paragraph 8 (incorporation of veterinary medicinal product into premixture)—

(a) for “veterinary medicinal product”, in both places it occurs, substitute “medicinal premix”;

(b) for “a premixture” substitute “an intermediate feedingstuff”;

(c) in the heading for “veterinary medicinal product into a premixture” substitute “medicinal premix into an intermediate feedingstuff”.

Amendment to paragraph 10

132

In paragraph 10 (incorporation of veterinary medicinal product into feedingstuffs)—

(a) for “veterinary medicinal product”, in each place it occurs other than the occurrence dealt with in sub-paragraph (b), substitute “medicinal premix”;

(b) for “a premixture containing a veterinary medicinal product” substitute “an intermediate feedingstuff”;

(d) in the heading for “veterinary medicinal product” substitute “medicinal premix”.

Amendment to paragraph 11

133

In paragraph 11 (additional record keeping requirements)—

(a) in sub-paragraph (1)—

(i) in paragraph (a)—

(aa) for “veterinary medicinal product” substitute “medicinal premix”;

(bb) for “a premixture” substitute “an intermediate feedingstuff”;

(ii) in paragraph (b)—

(aa) for “a premixture” substitute “an intermediate feedingstuff”;

(bb) for “veterinary medicinal product” substitute “medicinal premix”;

(iii) in paragraph (c) for “veterinary medicinal product” substitute “medicinal premix”;

(iv) in paragraph (d)—

(aa) for “veterinary medicinal products” substitute “medicinal premixes”;

(bb) for “premixture” substitute “intermediate feedingstuffs”;

(v) in paragraph (e)—

(aa) for “premixture” substitute “intermediate feedingstuffs”;

(bb) for “veterinary medicinal product” substitute “medicinal premix”;

(b) in sub-paragraph (2)—

(i) for “approved” substitute “authorised”;

(ii) for “premixtures” substitute “intermediate feedingstuffs”;

(iii) for “veterinary medicinal products” substitute “medicinal premixes”;

(i) in paragraph (c) for “premixture” substitute “intermediate feedingstuffs”;

(ii) in paragraph (e) for “veterinary medicinal product” substitute “medicinal premix”;

(iii) after paragraph (e) omit “and”;

(iv) after paragraph (f) insert—

; and (g) the batch number.

(d) in the heading for “veterinary medicinal products” substitute “medicinal premixes”.

Amendment to paragraph 12

134

In paragraph 12 (labelling a premixture containing veterinary medicinal product)—

(a) in sub-paragraph (1)—

(i) in the words before paragraph (a)—

(aa) for “A premixture” substitute “An intermediate feedingstuff”;

(bb) for “veterinary medicinal product” substitute “medicinal premix”;

(ii) in paragraph (a) for “MEDICATED PREMIXTURE” substitute “INTERMEDIATE FEEDINGSTUFF”;

(iii) in paragraph (b) for “veterinary medicinal product” substitute “medicinal premix”;

(iv) in paragraph (c) for “premixture” substitute “intermediate feedingstuff”;

(v) in paragraph (d)—

(aa) for “premixture” substitute “intermediate feedingstuff”;

(bb) for “prescription” substitute “medicated feedingstuffs prescription”;

(vi) after paragraph (e) insert—

(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”;

(vii) in paragraph (f) for “prescription” substitute “medicated feedingstuffs prescription”;

(viii) in paragraph (h) at the end insert “required by the marketing authorisation”;

(ix) in paragraph (i) for “prescription” substitute “medicated feedingstuffs prescription”;

(b) in sub-paragraph (2) for “veterinary medicinal product” substitute “medicinal premix”;

(d) in sub-paragraph (4) for “a premixture” substitute “an intermediate feedingstuff”;

(e) in the heading—

(i) for “a premixture” substitute “an intermediate feedingstuff”;

(ii) for “veterinary medicinal product” substitute “medicinal premix”.

Amendment to paragraph 14

135

In paragraph 14 (labelling of feedingstuffs containing veterinary medicinal product)—

(a) in sub-paragraph (1)—

(i) for “veterinary medicinal product”, in each place it occurs, substitute “medicinal premix”;

(ii) after paragraph (e) insert—

(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”;

(iii) in paragraph (f) for “prescription” substitute “medicated feedingstuffs prescription”;

(iv) after paragraph (f) insert—

(fa) the batch number;

(v) in paragraph (i) for “prescription” substitute “medicated feedingstuffs prescription”;

(vi) in paragraph (j) for “approval” substitute “authorisation”;

(b) in sub-paragraph (2) for “veterinary medicinal product” substitute “medicinal premix”;

(d) in the heading for “veterinary medicinal product” substitute “medicinal premix”.

Amendment to paragraph 15

136

In paragraph 15 (supply of specified feed additives)—

(a) for “approved”, in each place it occurs, substitute “authorised”;

(b) in sub-paragraph (2)(b) for “premixture” substitute “intermediate feedingstuff”;

Amendment to paragraph 16

137

In paragraph 16 (supply of premixture)—

(a) for “approved”, in each place it occurs, substitute “authorised”;

(b) in sub-paragraph (1) for “a premixture”, in both places it occurs, substitute “an intermediate feedingstuff or specified feed additive”;

(c) in sub-paragraph (2) for “premixture”, in both places it occurs, substitute “intermediate feedingstuff or specified feed additive”;

(d) in sub-paragraph (3) for “premixture” substitute “intermediate feedingstuff or specified feed additive”;

(e) in the heading for “premixture” substitute “intermediate feedingstuff or specified feed additive”.

Amendment to paragraph 17

138

In paragraph 17 (supply of complementary feedingstuff)—

(a) for “approved”, in each place it occurs, substitute “authorised”;

(b) in sub-paragraph (2)(b) for “a premixture” substitute “an intermediate feedingstuff”;

(d) omit sub-paragraph (4).

Amendment to paragraph 18

139

In paragraph 18 (supply of feedingstuffs containing veterinary medicinal product)—

(a) for “approved”, in each place it occurs, substitute “authorised”;

(b) in sub-paragraph (1) for “veterinary medicinal product” substitute “medicinal premix”;

(d) in sub-paragraph (3)(b) for “a person who keeps animals” substitute “an animal keeper”;

(e) in sub-paragraph (4)—

(i) for “a person who keeps animals” substitute “an animal keeper”;

(ii) for “prescription” substitute “medicated feedingstuff prescription”;

(f) in sub-paragraph (5) for “prescription” substitute “medicated feedingstuff prescription”;

(g) in sub-paragraph (7) for “prescription” substitute “medicated feedingstuff prescription”;

(h) after sub-paragraph (7) insert—

(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.

(i) in the heading for “veterinary medicinal product” substitute “medicinal premix”.

Amendment to paragraph 19

140

In paragraph 19 (prescriptions for feedingstuffs containing veterinary medicinal product)—

(a) in sub-paragraph (1)—

(i) for “prescription” substitute “medicated feedingstuff prescription”;

(ii) for “veterinary medicinal product”, in both places it occurs, substitute “medicinal premix”;

(iii) after paragraph (e) insert—

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

(iv) for paragraph (h) substitute—

(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;

(v) after paragraph (j) insert—

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

(vi) in paragraph (l)—

(aa) for “approved” substitute “authorised”;

(bb) at the end insert “, whichever is the supplier to the end user”;

(vii) after paragraph (n) insert—

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

(viii) omit paragraph (o);

(b) in sub-paragraph (2) for “prescription” substitute “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.

(d) for sub-paragraph (3) substitute—

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

(e) in the heading—

(i) for “Prescriptions” substitute “Medicated feedingstuff prescriptions”;

(ii) for “veterinary medicinal product” substitute “medicinal premix”.

Amendment to paragraph 20

141

In paragraph 20 (writing the prescription)—

(a) in sub-paragraph (1)—

(i) in the words before paragraph (a) for “prescription” substitute “medicated feedingstuff prescription”;

(ii) in paragraph (a)—

(aa) for “veterinary medicinal product” substitute “medicinal premix”;

(bb) at the end insert “, whichever is the supplier to the end user”;

(b) in sub-paragraph (2) for “veterinary medicinal product”, in both places it occurs, substitute “medicinal premix”;

(i) for “veterinary medicinal product”, in each place it occurs, substitute “medicinal premix”;

(ii) for “veterinary medicinal products” substitute “medicinal premixes”;

(d) in the heading for “prescription” substitute “medicated feedingstuff prescription”.

Amendment to paragraph 21

142

In paragraph 21 (possession)—

(a) in sub-paragraph (1)—

(i) in the words before paragraph (a) for “approval” substitute “authorisation”;

(ii) in paragraph (a) for “veterinary medicinal product” substitute “medicinal premix”;

(iii) in paragraph (b)—

(aa) for “premixtures” substitute “intermediate feedingstuffs”;

(bb) for “veterinary medicinal product” substitute “medicinal premix”;

(iv) in paragraph (c) for “such an additive or a veterinary medicinal product” substitute “a medicinal premix”;

(b) in sub-paragraph (2)—

(i) for “veterinary medicinal product” substitute “medicinal premix”;

(ii) for “prescription” substitute “medicated feedingstuffs prescription”.

Amendment to paragraph 22

143

In paragraph 22 (sampling and analysis), in sub-paragraph (2) for the table substitute—

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

New paragraph 22A

144

After paragraph 22 insert—

(22A) (1) A feed business operator must ensure that cross-contamination of non-target feeds is as low as is reasonably achievable. (2) A feed business operator must analyse samples of non-target feeds in order to determine whether cross-contamination into non-target feed has occurred. (3) Where as a result of the process mentioned in sub-paragraph (2) it is determined that a cross-contamination rate has occurred which is 1% or more but less than 3% compared to the authorised maximum content, the feed business operator must make a record of this cross-contamination. (4) Where as a result of the process mentioned in sub-paragraph (2) it is determined that a cross-contamination rate has occurred of 3% or more compared to the authorised maximum content, the feed business operator must conduct an investigation in order to discover the cause of the occurrence and make a record of the fact and any conclusions. (5) The feed business operator must keep the records under sub-paragraphs (3) and (4) for at least five years. (6) Upon request of the Secretary of State, the feed business operator must provide any information in the feed business operator’s possession relating to the matters mentioned in this paragraph.

Amendment to paragraph 23

145

In paragraph 23 (storage)—

(a) for “veterinary medicinal product”, in both places it occurs, substitute “medicinal premix”;

(b) for “a premixture” substitute “an intermediate feedingstuff”.

Amendment to paragraph 24

146

In paragraph 24 (packages and other containers) for “veterinary medicinal product” substitute “medicinal premix”.

Amendment to paragraph 25

147

In paragraph 25 (transport)—

(a) in sub-paragraph (2) for “veterinary medicinal products” substitute “medicinal premixes”;

(b) in sub-paragraph (3) for “veterinary medicinal product” substitute “medicinal premix or specified feed additive”;

Amendment to paragraph 26

148

In paragraph 26 (possession, placing on market and use of feedingstuffs)—

(a) in sub-paragraph (1) for “veterinary medicinal products” substitute “medicinal premixes”;

(b) in sub-paragraph (2), for “veterinary medicinal product”, in each place it occurs, substitute “medicinal premix”;

(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; (c) no product escapes into the environment; and (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.

(d) in sub-paragraph (3) for “veterinary medicinal product” substitute “medicinal premix”.

New paragraph 26A

149

After paragraph 26 insert—

(26A) No person may feed medicated feedingstuffs which have passed their expiry date to an animal.

Amendment to paragraph 28

150

In paragraph 28(b) (trade) for “veterinary medicinal product”, in the second place it occurs, substitute “medicinal premix”.

Amendment to paragraph 29

151

In paragraph 29 (import for incorporation into premixture or feedingstuffs for export)—

(a) in sub-paragraph (1) for “premixture”, in both places it occurs, substitute “intermediate feedingstuffs”;

(b) in sub-paragraph (2) for “premixture” substitute “intermediate feedingstuff”;

Amendment to paragraph 30

152

In paragraph 30 (animals on domestic premises)—

(a) in sub-paragraph (1)—

(i) for “approval” substitute “authorisation”;

(ii) for “veterinary medicinal product”, in both places it occurs, substitute “medicinal premix”;

(b) in sub-paragraph (2)—

(i) for “a premixture” substitute “an intermediate feedingstuff”;

(ii) for “veterinary medicinal product”, in both places it occurs, substitute “medicinal premix”;

Amendment to paragraph 31

153

In paragraph 31 (offences)—

(a) after sub-paragraph (p) insert—

(pa) paragraph 19;

(b) after sub-paragraph (r) insert—

(ra) paragraph 22A;

(d) after sub-paragraph (v) insert—

(va) paragraph 26A;

PART 8 — Amendments to Schedule 6 to the 2013 Regulations

Introduction

154

Schedule 6 to the 2013 Regulations (exemptions for small pet animals) is amended in accordance with this Part.

Amendment to paragraph 2

155

In paragraph 2 (placing on market, import and administration) at the end insert “and the manufacturer appears on the register maintained under paragraph 3A”.

Amendment to paragraph 3

156

In paragraph 3 (manufacture) for sub-paragraph (2) substitute—

(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.

New paragraphs 3A and 3B

157

After paragraph 3 insert—

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