The Veterinary Medicines (Amendment etc.) Regulations 2024

(51) (1) Subject to sub-paragraphs (5) and (7), a package leaflet must be supplied with each veterinary medicinal product. (2) The package leaflet must provide the following information— (a) the name and address of the marketing authorisation holder and of the manufacturer and, where applicable, the distributor; (b) the name of the veterinary medicinal product, followed by its strength and pharmaceutical form; (c) the qualitative and quantitative composition of any active substance; (d) the target species, the dosage for each species, the method and route of administration and if necessary, advice on the correct administration; (e) the indications for use; (f) the contra-indications and adverse events; (g) if applicable, the withdrawal period for each species, even if such a period is zero; (h) special storage precautions, if any; (i) information essential for safety or health protection, including any special precautions relating to use and any other warnings; (j) the words “use take-back schemes for the disposal of any unused veterinary medicinal product or associated waste materials in accordance with local requirements and with any applicable national collection schemes”; (k) the marketing authorisation number; (l) contact details for the marketing authorisation holder or its representative, as appropriate, for the reporting of suspected adverse events; (m) classification of the veterinary medicinal product as referred to in the summary of product characteristics. (3) Providing that it complies with the marketing authorisation, the package leaflet may include additional information concerning distribution, possession or any necessary precaution required, provided that this information is not promotional in character. (4) The package leaflet must be in legible form and designed to be clear and understandable, in terms that are comprehensible to the general public. (5) Only a package leaflet approved in the marketing authorisation may be published or included with the veterinary medicinal product. (6) The Secretary of State may require the information set out in sub-paragraph (2) to be made available in written form or electronically, or both. (7) Where the Secretary of State requires the leaflet to be made available electronically— (a) an electronic package information leaflet which includes the information required by this paragraph must be provided in place of a leaflet in written form; (b) the packaging of the veterinary medicinal product must include— (i) a statement that the information which must be included on a package leaflet is provided electronically; (ii) any necessary electronic link in order to access the relevant part of the website where the electronic package information leaflet is to be found; (iii) a statement that a copy of the information in written form may be obtained on request; and (iv) instructions on how to obtain such a copy. (8) Any information required by this paragraph to be provided on a package leaflet in written form may be otherwise provided on the packaging of the veterinary medicinal product.

Amendment to paragraph 52

65

Omit paragraph 52 (small containers other than ampoules).

Amendment to paragraph 53

66

In paragraph 53(3) (homeopathic remedies)—

• (a) for paragraph (c) substitute—

(c) the name or company name and the permanent address or registered place of business of the registration holder and of the manufacturer

• (b) after paragraph (k) omit “and”;

• (c) after paragraph (l) insert “and”;

• (d) at the end insert—

(m) the withdrawal period, where applicable

Amendment to paragraph 55

67

Omit paragraph 55 (qualified person responsible for pharmacovigilance).

Amendment to paragraph 56 and new paragraphs 56A, 56B and 56C

68

For paragraph 56 (duties related to qualified person) substitute—

(56) (1) The marketing authorisation holder is responsible for pharmacovigilance in relation to a veterinary medicinal product for which it holds a marketing authorisation and must continuously evaluate, by appropriate means, the benefit-risk balance of this veterinary medicinal product and, if necessary, take appropriate measures to address any risk presented by the product. (2) A marketing authorisation holder must carry out the signal management process mentioned in paragraph 56C in relation to any veterinary medicinal product for which it holds an authorisation. (3) A marketing authorisation holder must comply with best practice in good veterinary pharmacovigilance practice. (4) A marketing authorisation holder must establish and maintain a system for collecting, collating and evaluating information in relation to suspected adverse events in respect of any veterinary medicinal product for which it holds an authorisation. (5) Subject to sub-paragraph (6), a marketing authorisation holder must establish and maintain one or more pharmacovigilance system master files describing in detail the pharmacovigilance system with respect to its authorised veterinary medicinal products. (6) For each veterinary medicinal product, the marketing authorisation holder must not establish and maintain more than one pharmacovigilance system master file. (7) A marketing authorisation holder must establish and maintain an adequate and effective local system for the purpose of receiving reports of suspected adverse events. (8) The system mentioned in sub-paragraph (7) must be staffed by personnel trained for this purpose who are able to communicate in English. (9) A marketing authorisation holder must designate not more than one qualified person responsible for pharmacovigilance (a “qualified person (pharmacovigilance)”) in relation to each pharmacovigilance system master file whose services are available permanently and continuously. (10) Where the pharmacovigilance functions or the functions of the qualified person for pharmacovigilance are performed by a third party, any such arrangement must be specified in detail in the pharmacovigilance system master file and within appropriate pharmacovigilance agreements. (11) A marketing authorisation holder may introduce urgent safety restrictions where evidence comes to the attention of the holder of a risk posed to human or animal health or to the environment from the use of the product. (12) Where a marketing authorisation holder takes any action under sub-paragraph (11) the holder must inform the Secretary of State no later than the following working day of the reasons for the action. (13) A marketing authorisation holder must establish and maintain an adequate and effective quality management system for the performance of its pharmacovigilance activities. (14) The Secretary of State may at any time by notice require a marketing authorisation holder to provide a copy of the pharmacovigilance system master file. (15) A marketing authorisation holder who is given notice under sub-paragraph (14) must comply with the requirement within seven days of receipt of the notice. (56A) (1) A marketing authorisation holder must carry out the signal management process mentioned in paragraph 56C on reports received (whether those reports derive from the United Kingdom or any other country) in relation to any veterinary medicinal product for which it holds an authorisation. (2) The marketing authorisation holder must record on an annual basis the results of the signal management process mentioned in paragraph 56C in relation to the product. (3) Where, as a result of the carrying out of the signal management process, a new risk or a change in the benefit-risk balance of the product is identified, the marketing authorisation holder must notify the Secretary of State promptly and in any event within 30 days of such identification. (4) Where the signal management process identifies the necessity for a variation in an authorisation the marketing authorisation holder must submit an application for such a variation to the Secretary of State promptly. (56B) A qualified person (pharmacovigilance) must— (a) establish and maintain a system which ensures that all suspected adverse events which are brought to the attention of the marketing authorisation holder in relation to a veterinary medicinal product are collected and recorded; (b) monitor the performance of each product which is the subject of a marketing authorisation, apply the signal management process mentioned in paragraph 56C and ensure that any relevant requirements in accordance with the process are carried out; (c) maintain the pharmacovigilance system master file for each such product; (d) provide to the Secretary of State any information relevant to detecting a change to the benefit-risk balance of a veterinary medicinal product including the results of any study or clinical trial carried out in relation to the product; (e) communicate the fact that a regulatory measure has been taken in a country other than the United Kingdom as a consequence of pharmacovigilance data and the nature of such measure to the Secretary of State within 30 days of the receipt of such information, if no equivalent to that regulatory measure has already been taken in the United Kingdom; (f) answer fully and promptly any request from the Secretary of State for the provision of additional information necessary for the evaluation of the benefit-risk balance of that product; (g) monitor the pharmacovigilance system and ensure that, if required, an appropriate preventative or corrective action plan is prepared and implemented on behalf of the marketing authorisation holder through the use of audits and routine monitoring; (h) following any action taken in accordance with paragraph (g), ensure that any relevant amendments are made to the pharmacovigilance system master file; (i) liaise with the Secretary of State in relation to any pharmacovigilance inspection carried out under paragraph 60A; (j) ensure that any person employed by the marketing authorisation holder who is engaged in pharmacovigilance receives ongoing training which is relevant to that person’s duties. (56C) (1) For the purposes of these Regulations, “signal management process” means a process for performing active surveillance of pharmacovigilance data for veterinary medicinal products in order to assess the pharmacovigilance data and determine whether there is any change to the benefit-risk balance of those veterinary medicinal products, with a view to detecting risks to animal or public health or protection of the environment. (2) A signal management process must consist of tasks of signal detection, validation, confirmation, analysis and prioritisation, assessment and recommendation for action. (3) A signal management process must be capable of identifying, at a minimum, in relation to a product— (a) a sudden and unexpected increase in the number of adverse events; (b) an unexpected increase in the frequency of a known clinical sign; (c) a new clinical sign; (d) reports in scientific literature of any of the matters mentioned in paragraphs (a) to (c).

Amendment to paragraph 57

69

In paragraph 57 (adverse reactions to product administered in UK)—

• (a) in sub-paragraph (1)—

• (i) in paragraph (a) for “serious adverse reaction” substitute “adverse event in respect of an animal”;

• (ii) in paragraph (b)—

• (aa) for “adverse reaction” substitute “adverse event”;

• (bb) omit “or”;

• (iii) after paragraph (c) (and immediately before the words “following the administration”) insert—

(d) occurrence of an adverse environmental event, or (e) lack of efficacy,

• (iv) omit “in the United Kingdom”;

• (b) after sub-paragraph (1) insert—

(1A) A marketing authorisation holder must also act in accordance with this paragraph where— (a) after the end of the withdrawal period a product of animal origin is found to include a pharmacologically active substance or marker residue exceeding the maximum residue limit established in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council; or (b) there is evidence in published scientific literature of an adverse event in connection with the product.

• (c) in sub-paragraph (3) for “15” substitute “30”;

• (d) in sub-paragraph (4) for “reaction” substitute “event”;

• (e) after sub-paragraph (4) insert—

(4A) The Secretary of State may require the marketing authorisation holder— (a) to collect specific pharmacovigilance data (in addition to the data mentioned in sub-paragraph (4)) and submit those data to the Secretary of State; and (b) to carry out specific post-marketing surveillance studies. (4B) Where the Secretary of State exercises the power mentioned in sub-paragraph (4A), the Secretary of State must— (a) state the reason for the requirement; and (b) state the time by which, or the period during which, the requirement must be complied with.

• (f) omit sub-paragraph (5);

• (g) for the heading substitute—

Amendment to paragraph 58

70

Omit paragraph 58 (adverse reactions to product administered outside UK).

Amendment to paragraph 59

71

In paragraph 59 (periodic safety update reports)—

• (a) in sub-paragraph (1)—

• (i) for “records of all adverse reactions (including nil reports)” substitute “a summary of pharmacovigilance activity”;

• (ii) for “a periodic safety update report” substitute “an annual benefit-risk report”;

• (iii) omit the words from “, including” to the end;

• (b) omit sub-paragraph (2);

• (c) in sub-paragraph (3)—

• (i) for “the United Kingdom” substitute “Great Britain”;

• (ii) for “periodic safety update report” substitute “benefit-risk report”;

• (iii) for the words from “request and—” to the end of the sub-paragraph substitute “request and, in any event, once in the course of every year during the period of validity of the authorisation”;

• (d) in sub-paragraph (4) for “periods of notification” substitute “submission dates for the annual benefit-risk reports”;

• (e) for sub-paragraph (5) substitute—

(5) The report must include a statement regarding the benefit-risk balance of the veterinary medicinal product.

• (f) for sub-paragraph (6) substitute—

(6) The annual benefit-risk report must include— (a) the volume of the product sold in the United Kingdom and in other countries in the period covered by the report, with the volume of the product sold in the United Kingdom in each calendar year identified; (b) the notification of signals detected during the reporting period following pharmacovigilance activity in the United Kingdom or a country other than the United Kingdom for which further regulatory actions are required (including a summary of the regular review of adverse events carried out during the year); and (c) where it appears from the observed data that there is cause for concern in relation to the safety of the product, recommendations on the need for further intervention by the Secretary of State.

• (g) omit sub-paragraphs (7) and (8);

• (h) in the heading for “Periodic safety update” substitute “Annual benefit-risk”.

Amendment to paragraph 60

72

In paragraph 60 (release of information by marketing authorisation holder)—

• (a) in sub-paragraph (1) after “concerns to” insert “veterinary surgeons or”;

• (b) at the end insert—

(3) For the purposes of this paragraph “information” includes any information contained in advertising material.

New paragraphs 60A and 60B

73

After paragraph 60 insert—

(60A) (1) The Secretary of State must, from time to time, inspect the pharmacovigilance systems of marketing authorisation holders for the purpose of verifying compliance with the provisions of this Schedule in relation to pharmacovigilance. (2) The frequency of inspections under sub-paragraph (1) must be based on the risks associated with each marketing authorisation holder’s history and the nature of the products included in their pharmacovigilance system. (3) Within 90 days after an inspection, the Secretary of State must issue an inspection report to the holder of the marketing authorisation if the inspection established compliance with best practice in good veterinary pharmacovigilance practice. (60B) The Secretary of State may decide to perform a targeted signal management process for a given veterinary medicinal product or a group of veterinary medicinal products.

Amendment to paragraph 61

74

In paragraph 61(1) (action taken on account of pharmacovigilance)—

• (a) after “a marketing authorisation” insert “, or a group of marketing authorisations containing the same active substance,”;

• (b) in paragraph (c)—

• (aa) after sub-paragraph (iv) omit “or”;

• (bb) after sub-paragraph (v) insert—

or (vi) implement a risk management plan,

Amendment to paragraph 63

75

In paragraph 63 (placing homeopathic remedy on market in accordance with registration)—

• (a) in sub-paragraph (2) after “immunological” insert “or, subject to sub-paragraph (2A), a biological”;

• (b) after sub-paragraph (2) insert—

(2A) Sub-paragraph (2) does not apply in relation to a homeopathic remedy which is derived from plants.

• (c) in sub-paragraph (3) after “must be” insert “either topical or oral and must be”.

Amendment to paragraph 64

76

In paragraph 64(1) (application for registration)—

• (a) in paragraph (a) after “stock” insert “or stocks”;

• (b) in paragraph (b)—

• (i) after “stock is” insert “, or stocks are,”;

• (ii) for “its” substitute “their”;

• (iii) for “nature” substitute “use”;

• (c) in paragraph (f) omit “or authorisations”;

• (d) for paragraph (g) substitute—

(g) the text which is to appear on the package leaflet, outer packaging and immediate packaging of the homeopathic remedy;

• (e) for paragraph (h) substitute—

(h) any relevant data concerning the stability of the homeopathic remedy;

Amendment to paragraph 65

77

In paragraph 65 (procedure for registration) at the end insert—

(3) The Secretary of State must ensure that the procedure for granting a registration in relation to a homeopathic remedy is completed within a maximum of 210 days after the submission of the application.

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);

• (c) omit sub-paragraph (f);

• (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.

• (c) in the heading for “Suspension, variation or revocation” substitute “Suspension, revocation etc”.

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.

• (c) for the heading substitute “Good manufacturing practice certificates and inspection of sites”.

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.

• (c) after sub-paragraph (5) insert—

(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”;

• (c) after sub-paragraph (2) insert—

(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.

• (c) in sub-paragraph (6)—

• (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”;

• (c) for sub-paragraph (3) substitute—

(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

• (c) after paragraph (3) insert—

(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”;

• (c) after that sub-paragraph insert—

(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”;

• (c) in sub-paragraph (2)—

• (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”;

• (c) for sub-paragraph (5) substitute—

(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);

• (c) in sub-paragraph (d), at the end insert—

; 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