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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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Made: 25th April 2024

Coming into force: 17th May 2024

A draft of this instrument has been laid before Parliament and approved by a resolution of each House of Parliament in accordance with section 47(3) and (6)(a) of the Act.

PART 1 — Introduction

Citation, commencement and extent

1

(1) These Regulations may be cited as the Veterinary Medicines (Amendment etc.) Regulations 2024 and come into force 21 days after the day on which they are made.

(2) These Regulations extend to England and Wales and Scotland.

Interpretation

2

In these Regulations, “the 2013 Regulations” means the Veterinary Medicines Regulations 2013[^f00002].

PART 2 — Amendments to Parts 1 to 5 of the 2013 Regulations

Introduction

3

Parts 1 to 5 of the 2013 Regulations are amended in accordance with this Part.

Amendment to regulation 2

4

In regulation 2 (interpretation)—

(a) in paragraph (1), in the definition of “veterinary medicinal product”, at the end insert—

; or (c) any substance or combination of substances that may be used for the purpose of euthanising an animal

(b) in paragraph (2)—

(i) at the appropriate places in alphabetical order insert—

“active substance” means any substance or mixture of substances intended to be used in the manufacture of a veterinary medicinal product, that, when used in its production, is responsible for the activity of that veterinary medicinal product;

“adverse environmental event” means an event where a non-target organism, population or ecosystem is adversely affected as a result of exposure to a veterinary medicinal product, its active substances or its metabolites present in soil, water or animal remains;

“adverse event” means any observation in animals that occurs after any use of a veterinary medicinal product, whether or not considered to be product-related, that is unfavourable and unintended;

“advertising” means, in relation to veterinary medicinal products, the making of a representation in any form in connection with those products in order to promote their supply, distribution, sale, prescription or use and includes any action taken for this purpose by way of the supply of samples or by means of sponsorship, and “advertise” and “advertisement” are to be construed accordingly;

“antibiotic” means any substance with a direct action on bacteria that is used for treatment or prevention of infections or infectious diseases;

“antimicrobial” means any substance with a direct action on micro-organisms that is used for treatment or prevention of infections or infectious diseases and includes antibiotics, antivirals, antifungals and antiprotozoals;

“antimicrobial resistance” means the ability of micro-organisms to survive or to grow in the presence of a concentration of an antimicrobial agent which is usually sufficient to inhibit or kill micro-organisms of the same species;

“ATCvet code” means, in relation to a veterinary medicinal product, the code issued in respect of that product by the World Health Organization Collaborating Centre for Drug Statistics Methodology, and published by that body in the ATCvet index[^f00003];

“benefit-risk balance” means, in relation to a veterinary medicinal product, an evaluation of the positive effects of the veterinary medicinal product in relation to the following risks relating to the use of that product— any risk to human or animal health relating to the quality, safety or efficacy of the veterinary medicinal product; any risk of undesirable effects on the environment; or any risk relating to the development of resistance;

“biological substance” means a substance that is produced by or extracted from a biological source and that needs for its characterisation and the determination of its quality a combination of physical, chemical and biological testing, together with knowledge of the production process and its control;

“biological veterinary medicinal product” means a veterinary medicinal product where an active substance is a biological substance;

“complementary feedingstuffs” means compound feed which has a high content of certain substances and which, by reason of its composition, is sufficient for a daily ration only if used in combination with other feed;

“complete feed” means compound feed which, by reason of its composition, is sufficient for a daily ration;

“compound feed” means a mixture of at least two feed additives for oral animal-feeding in the form of complete or complementary feed;

“daily ration” means the average total quantity of feedingstuffs, calculated on a moisture content of 12%, required daily by an animal of a given species, age category and yield, to satisfy all its nutritional needs;

“excipient” means any constituent of a veterinary medicinal product other than an active substance;

“feed additives” means substances, micro-organisms or preparations, other than feed material and intermediate feedingstuff, which are intentionally added to feed or water in order to perform, in particular, one or more of the functions mentioned in Schedule 5;

“feed materials” means products of vegetable or animal origin whose principal purpose is to meet animals’ nutritional needs, and which are intended for use in oral animal feed either directly, or after processing, or in the preparation of compound feed, or as a carrier of intermediate feedingstuffs;

“feedingstuff” means any substance or product, including additives, whether processed, partially processed or unprocessed, intended to be used for oral feeding to animals;

“generic veterinary medicinal product” means a veterinary medicinal product which has the same qualitative and quantitative composition of active substances and the same pharmaceutical form as a reference veterinary medicinal product;

“genetically modified organism” or “GMO” means a genetically modified organism for the purposes of the GMO Deliberate Release Regulations;

“GMO Deliberate Release Regulations” means— as regards England, the Genetically Modified Organisms (Deliberate Release) Regulations 2002[^f00004]; as regards Scotland, the Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002[^f00005]; as regards Wales, the Genetically Modified Organisms (Deliberate Release) (Wales) Regulations 2002[^f00006];

“good distribution practice” means that part of quality assurance which ensures that products are consistently stored, supplied and controlled in accordance with the quality standards appropriate for their intended use and as required by the applicable marketing authorisation or product specifications;

“good manufacturing practice” means that part of quality assurance which ensures that products are consistently produced and controlled in accordance with the quality standards appropriate for their intended use and as required by the applicable marketing authorisation or product specifications;

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

“improvement notice” has the meaning given in regulation 38(1);

“intermediate feedingstuffs” means a feed which is not ready to be directly fed to animals without further processing, consisting of a homogenous mixture of one or more of the following— a medicinal premix; a specified feed additive, with feed materials or compound feed, exclusively intended to be used for the manufacture of a complete feed;

“lack of efficacy” means the apparent inability of an authorised veterinary medicinal product to have the expected efficacy in an animal, whether or not the product was used in accordance with the summary of product characteristics;

“limited market” means a market for one of the following types of veterinary medicinal product— a veterinary medicinal product for the treatment or prevention of diseases that occur infrequently or in limited geographical areas; a veterinary medicinal product for an animal species other than cattle, sheep for meat production, pigs, chickens, dogs or cats;

“manufacturing authorisation”, except as regards Schedule 7, has the meaning given in paragraph 1 of Schedule 2;

“medicated feedingstuffs” means a feed which is ready to be directly fed to animals without any further processing, consisting of a homogenous mixture of one or more medicinal premixes or intermediate feedingstuff with feed materials or compound feed;

“medicinal premix” means a veterinary medicinal product authorised for incorporation into feedingstuffs;

“metaphylactic purposes”, in relation to the administration of a veterinary medicinal product, means the administration of the veterinary medicinal product to a group of animals after a diagnosis of clinical disease in part of the group has been established, with the aim of treating the clinically sick animals and controlling the spread of the disease to animals in close contact and at risk and which may already be subclinically infected;

“novel therapy” means a veterinary medicinal product which is considered to be in a nascent field in veterinary medicine, including a product of a type not previously authorised, and “novel therapies” is to be construed accordingly;

“person responsible for release” and “PRR” have the meaning given in paragraph 16 of Schedule 2;

“pharmacologically equivalent” means containing an active substance in the same proportions, in the same dosage form and concentration (in the case of a liquid dose) and meeting the same or comparable standards in relation to the clinical needs of a patient at the time of use;

“pharmacovigilance” means the science and activities relating to the detection, assessment, understanding and prevention of suspected adverse events or any other problem related to a medicinal product;

“pharmacovigilance system master file” means a detailed description of the pharmacovigilance system used by the holder of the marketing authorisation in relation to one or more authorised veterinary medicinal products;

“principles of good laboratory practice” has the meaning given in regulation 2(1) of the Good Laboratory Practice Regulations 1999[^f00007];

“prophylactic purposes”, in relation to the administration of a veterinary medicinal product, means the administration of the veterinary medicinal product to an animal or group of animals before clinical signs of disease in order to prevent the occurrence of disease or infection;

“qualified person (manufacture)”, in relation to a veterinary medicinal product, means a person appointed under paragraph 9 of Schedule 2 with responsibility for that product;

“qualified person (pharmacovigilance)” has the meaning given in paragraph 56(9) of Schedule 1;

“reference veterinary medicinal product” has the meaning given in paragraph 10(1) of Schedule 1;

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

“signal management process” has the meaning given in paragraph 56C of Schedule 1;

“wholesale dealing” means all activities consisting of procuring, holding, supplying, distributing or exporting veterinary medicinal products whether for profit or not, but does not include retail supply of veterinary medicinal products to the public;

“wholesale qualified person” has the meaning given in paragraph 17(2)(d) of Schedule 3;

“withdrawal period” means the minimum period under normal conditions of use between the last administration of a veterinary medicinal product to an animal and the production of foodstuffs from that animal which is necessary to ensure that such foodstuffs do not contain residues in quantities harmful to public health

(ii) in the definition of “immunological veterinary medicinal product”—

(aa) after “a veterinary medicinal product” insert “intended to be”;

(bb) for “animals” substitute “an animal”;

(cc) for “the state” substitute “its state”;

(iii) for the definition of “strength” substitute—

“strength” means the content of active substances in a veterinary medicinal product, expressed quantitatively per dosage unit, per unit of volume or per unit of weight according to the pharmaceutical form;

(iv) omit the definitions of “adverse reaction”, “Commission Regulation (EC) No 1234/2008”, “extension variation” and “risk-benefit balance”;

(2A) In these Regulations, a biological veterinary medicinal product is treated as a single product even when more than one solvent is used in the preparation of different preparations of the final product (which may be for administration by different routes or methods).

(d) omit paragraph (3).

Amendment to regulation 5

5

In regulation 5 (manufacture of veterinary medicinal products) omit paragraph (3).

Amendment to regulation 7

6

In regulation 7(2) (prohibition of supply past expiry date) after “veterinary medicinal product” insert “(including a veterinary medicinal product which has been incorporated into a medicated feedingstuff or intermediate feedingstuff)”.

Amendment to regulation 10

7

In regulation 10 (advertising)—

(a) for paragraph (1) substitute—

(1) No person may issue an advertisement relating to a relevant substance unless that advertisement— (a) is set out in such a way that it is clear that the message is an advertisement for the purpose of promoting the supply, sale, prescription, distribution or use of the substance; (b) encourages responsible use of the substance while presenting its characteristics in an objective manner; (c) contains no information which— (i) is misleading; (ii) is incompatible with the summary of product characteristics in relation to the substance; (iii) might encourage improper use of the substance; or (iv) where the relevant substance is a veterinary medicinal product, might suggest that the substance is a feedingstuff or a biocide. (1A) No person may advertise a veterinary medicinal product, other than a product which is placed on the market in accordance with Schedule 6, unless— (a) a marketing authorisation has been granted in respect of that product, and (b) that authorisation is not currently suspended in accordance with paragraph 38 of Schedule 1.

(b) at the end insert—

(4) In this regulation, subject to paragraph (5), “relevant substance” means— (a) a veterinary medicinal product; (b) a medicinal premix; (c) an intermediate feedingstuff; or (d) a compound feed. (5) In this regulation, coccidiostats and histomonostats are not relevant substances.

New regulation 10A

8

After regulation 10 insert—

(10A) (1) Subject to paragraphs (2) and (4), where veterinary medicinal products are being promoted to persons qualified to prescribe or supply veterinary medicinal products, no person may supply, offer or promise to any person any gift, pecuniary advantage or benefit in kind unless it is inexpensive and relevant to the practice of veterinary medicine or pharmacy. (2) The provisions of paragraph (1) do not prevent any person offering hospitality (including the payment of travelling or accommodation expenses) at events for purely professional or scientific purposes to persons qualified to prescribe or supply veterinary medicinal products, provided that— (a) it is subordinate to the main scientific objective of the event; and (b) it is offered only to animal health professionals. (3) Subject to paragraph (4), no person may offer hospitality (including the payment of travelling or accommodation expenses) at a meeting or event held for the promotion of veterinary medicinal products unless— (a) it is subordinate to the main purpose of the meeting or event, and (b) the person to whom it is offered is an animal health professional. (4) Nothing in this regulation affects measures or trade practices relating to prices, margins or discounts which were in existence on the date on which the Veterinary Medicines (Amendment, etc.) Regulations 2024 came into force. (5) No person qualified to prescribe or supply veterinary medicinal products may solicit or accept any gift, pecuniary advantage, benefit in kind, hospitality or sponsorship prohibited by this regulation.

Amendment to regulation 11

9

In regulation 11 (advertising of prescription products, etc.)—

(a) in paragraph (4) for “anti-microbials” substitute “antimicrobials”;

(b) at the end insert—

(6) A person advertising a veterinary medicinal product must— (a) include in that advertisement the statement “prescription decisions are for the person issuing the prescription alone”; (b) ensure that all factual statements concerning the characteristics of the product in the advertisement are consistent with the summary of product characteristics submitted in respect of the product under Schedule 1, as amended.

Amendment to regulation 15

10

In regulation 15(3) (exemptions)—

(a) in sub-paragraph (a), for “Part 3” substitute “Part 2”;

(b) in sub-paragraph (b), for “Part 4” substitute “Part 2”;

(i) omit “equine” in both places it occurs;

(ii) for “horses” substitute “non-food producing animals”;

(iii) for “Part 5” substitute “Part 2”.

Amendment to regulation 18

11

In regulation 18 (records of administration) after “food-producing animal must” insert “as soon as is reasonably practicable”.

Amendment to regulation 21

12

In regulation 21 (records by a holder of a manufacturing authorisation)—

(a) for paragraph (1) substitute—

(1) The holder of a manufacturing authorisation must record the following information in respect of any veterinary medicinal product supplied by the holder— (a) the name of the veterinary medicinal product and marketing authorisation number if applicable; (b) the pharmaceutical form and strength of the product; (c) the quantity of product supplied; (d) the batch number and expiry date; (e) the date of the transaction under which the product was supplied; (f) the company name and the permanent address or registered place of business of the recipient of the supply.

(b) in paragraph (3) at the end insert “or for one year after the date of expiry of the batch, whichever is the longer.”.

Amendment to regulation 22

13

In regulation 22 (records by a holder of a wholesale dealer’s authorisation)—

(a) in paragraph (a) omit “and nature”;

(b) after paragraph (b) insert—

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

(d) for paragraph (f) substitute—

(f) the company name and permanent address or registered place of business of— (i) in respect of a purchase, the supplier, and (ii) in respect of a sale, the recipient,

(e) for “three years” substitute “five years”.

Amendment to regulation 23

14

For regulation 23(1) (records of the receipt or supply of prescription products) substitute—

(1) Any person permitted under these Regulations to supply a veterinary medicinal product classified as POM-V or POM-VPS[^f00008] or prescribed under the cascade who receives or supplies any such veterinary medicinal product must keep all documents relating to the transaction which show— (a) the date of the transaction under which the product was received or supplied; (b) the name of the veterinary medicinal product; (c) the pharmaceutical form and strength of the product; (d) the batch number; (e) the quantity of product received or supplied; (f) the company name and the permanent address or registered place of business of— (i) in respect of a purchase, the supplier; (ii) in respect of a sale, the recipient; (g) if there is a written prescription the name and contact details of the prescriber; (h) the expiry date. (1A) Where the duty in paragraph (1) applies in respect of a veterinary medicinal product for a non-food producing animal, the duty in respect of sub-paragraph (d) is satisfied by recording the batch number— (a) on the date on which the batch is received, or (b) on the date on which a veterinary medicinal product from the batch is first supplied.

New regulation 24A

15

After regulation 24 (records of products administered to a food-producing animal under the cascade) insert—

(24A) (1) Where the Secretary of State serves a notice in writing on any person mentioned in paragraph (2) requiring that person to provide any information held by that person in relation to sales and usage of antibiotics from any records made for the purposes of these Regulations the person must provide that information. (2) The persons are— (a) the holder of a manufacturing authorisation; (b) the holder of a marketing authorisation; (c) the holder of a wholesale dealer’s authorisation; (d) a keeper of food-producing animals; (e) a feedingstuffs manufacturer; (f) a veterinary surgeon.

Amendment to regulation 25

16

In regulation 25 (importation of an unauthorised veterinary medicinal product) after paragraph (6) insert—

(6A) A pharmacist may supply a product to which paragraph (6) applies to a veterinary surgeon for the purposes mentioned in that paragraph notwithstanding paragraph 2(1) of Schedule 3.

Amendment to regulation 30

17

In regulation 30 (appeals to an appointed person)—

(a) in paragraph (1), after “regulation 29” insert “or a body aggrieved by a decision to suspend or revoke its recognition under paragraph 14(1) of Schedule 3”;

(b) in paragraph (2)—

(i) after sub-paragraph (a) insert—

(aa) a variation to a manufacturing authorisation;

(ii) in sub-paragraph (f), for “an equine stem cell centre” substitute “a stem cell centre”;

(iii) after sub-paragraph (g) insert—

(ga) registration in relation to active substances

(iv) in sub-paragraph (h), for “approval” substitute “authorisation”;

(i) for “, appointment or approvals” substitute “or appointments”;

(ii) after “suspension” insert “, revocation”.

Amendment to regulation 31

18

In regulation 31 (exports)—

(a) in paragraph (2), for “to that effect” substitute—

that (as the case may be)— (a) the manufacturer holds a manufacturing authorisation; (b) the manufacturer holds a certificate of good manufacturing practice; or (c) the product has been marketed under a marketing authorisation

(b) in paragraph (3), for the words from “the model certificates” to the end substitute “any relevant administrative arrangements in relation to the form and content of such certificates which are in existence between the United Kingdom and the country to which the product is to be exported”.

Amendment to regulation 32

19

In regulation 32(3) (time limits) at the end insert “or to provide any sample”.

Amendment to regulation 34

20

In regulation 34(3) (powers of entry) omit “approved,”.

Amendment to regulation 35

21

In regulation 35 (powers of an inspector)—

(a) in paragraph (1)—

(i) after sub-paragraph (c) insert—

(ca) purchase prescription only veterinary medicines for the purpose of carrying out tests; (cb) verify the destruction of a controlled drug listed in Schedule 2, 3 or 4 of the Misuse of Drugs Regulations 2001[^f00009];

(ii) in sub-paragraph (f) for “premixture” substitute “intermediate feedingstuff”;

(iii) in sub-paragraph (g) for “premixture” substitute “intermediate feedingstuff”;

(b) for paragraph (2) substitute—

(2) The inspector may seize and retain an item appearing to the inspector to be an item mentioned in paragraph (1)(d) to (g) if the inspector reasonably believes that an offence under these Regulations is being or has been committed in relation to, or by means of, that item

Amendment to regulation 38

22

In regulation 38 (improvement notices), after paragraph (1) insert—

(1A) If the inspector considers that the matters constituting a person’s perceived failure to comply involve risks to animal or human health or of damage to the environment which are so serious that, until steps have been taken to reduce or remove that failure, one or more activity carried on by the person ought to be prohibited or restricted, the improvement notice must state— (a) the activity which is to be prohibited or restricted; (b) the reasons why such prohibition or restriction is considered appropriate; (c) the time and date at which the prohibition or restriction is to take effect (which may be immediately after the notice is served); (d) that the person must not carry out the activity in breach of the prohibition or restriction until— (i) that person has provided evidence to the inspector that measures have been undertaken to secure compliance, and (ii) the inspector has confirmed to that person that the notice is revoked. (1B) Where the person on whom an improvement notice to which paragraph (1A) applies has been served provides evidence to the inspector that the measures specified in the notice (or measures at least equivalent to them) have been undertaken to secure compliance, and the inspector is satisfied that the measures have been satisfactorily performed, the inspector must revoke the notice and inform the person of this.

Amendment to regulation 41

23

In regulation 41(seizure notices)—

(a) in paragraph (2) for “product”, in both places it occurs, substitute “item”;

(b) in paragraph (3) for “products”, in each place it occurs, substitute “items”;

(d) in paragraph (5) for “product” substitute “item”;

(e) in paragraph (6)—

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

(ii) for “product”, in both places it occurs, substitute “item”;

(f) in paragraph (9) for “product” substitute “item”.

Amendment to regulation 43

24

In regulation 43 (offences)—

(a) in paragraph (f) for “(1)” substitute “(1), (1A)”;

(b) after paragraph (f) insert—

(fa) regulation 10A(1), (3) or (5);

(d) after paragraph (p) insert—

(pa) regulation 24A(1)

Amendment to regulation 44

25

In regulation 44 (penalties)—

(a) in paragraph (1), at the beginning insert “As regards England and Wales,”;

(b) after paragraph (1) insert—

(1A) As regards Scotland, a person guilty of an offence under these Regulations is liable— (a) on summary conviction, to a fine not exceeding the statutory maximum or to imprisonment for a term not exceeding 12 months or both, or (b) on conviction on indictment, to a fine or to imprisonment for a term not exceeding two years or both.

Amendment to regulation 46

26

In regulation 46 (review)—

(a) omit paragraphs (2) and (3);

(b) in paragraph (5), for “beginning with the day on which these Regulations come into force” substitute “ending on 31st December 2028”.

PART 3 — Amendments to Schedule 1 to the 2013 Regulations

Introduction

27

Schedule 1 to the 2013 Regulations (marketing authorisations in Great Britain) is amended in accordance with this Part.

Amendment to paragraph 2

28

For paragraph 2 (information with the application) substitute—

(2) (1) An application must include the matters mentioned in sub-paragraph (2) and— (a) where the veterinary medicinal product is an antimicrobial, the matters mentioned in sub-paragraph (4); (b) subject to sub-paragraph (6), where the product is to be administered to a food-producing animal and is a product containing pharmacologically active substances that are not permitted under Regulation (EC) No 470/2009 of the European Parliament and of the Council[^f00010], the matter mentioned in sub-paragraph (5); (c) where the product contains or consists of genetically modified organisms, the matters mentioned in sub-paragraph (7). (2) For the purposes of sub-paragraph (1) the matters are— (a) the name of the person who will hold the marketing authorisation and that person’s address or registered place of business; (b) the name and the address or registered place of business of— (i) the manufacturer of the finished product; (ii) any importer of the finished product; (iii) the manufacturer of any active substances involved at each stage of the manufacture; (c) the name and address of the sites where— (i) each stage of the manufacture is carried out; (ii) any imported products are held; or (iii) any control or batch release is carried out; (d) the nature of the marketing authorisation being applied for, and the provisions in Part 2 of Schedule 1 which are relevant to the application; (e) in relation to the veterinary medicinal product— (i) the name and the ATCvet code; (ii) a description of the active substances within the product and, if applicable, a description of any diluent; (iii) the strength of the product, or, in the case of an immunological veterinary medicinal product or a biological veterinary medicinal product that is not immunological, the biological activity, potency or titre; (iv) the pharmaceutical form of the product; (v) the route of administration; (vi) a description of the target species; (f) a document showing that the manufacturer is authorised to produce veterinary medicinal products or a certificate of good manufacturing practice issued by the Secretary of State or equivalent certification issued by an authority recognised by the Secretary of State for that purpose, together with a description of the manufacturing process for the active substances and finished product which falls within scope of that authorisation or certificate; (g) the reference number and a summary of the pharmacovigilance system master file in relation to the product and, where appropriate, the risk management plan that the applicant will put in place; (h) the proposed summary of product characteristics; (i) a description of the final presentation, the packaging and labelling of the product; (j) the proposed text of the information to be included on the immediate packaging, the outer packaging and the information leaflet accompanying the product; (k) details of any country where— (i) a marketing authorisation has been granted or revoked in relation to the product; (ii) a marketing authorisation has been submitted or refused; (l) a summary of product characteristics included in the terms of any marketing authorisation granted by another country; (m) technical documentation demonstrating the quality, safety and efficacy of the product; (n) a report (a “critical expert report”) on the quality, safety and efficacy of the product. (3) For the purposes of sub-paragraph (2)(n), each critical expert report must— (a) be prepared with regard to the state of scientific knowledge at the time of the application; (b) include an evaluation of each test and trial referred to in the application, addressing all aspects relevant to quality, safety and efficacy, with detailed results and precise bibliographic references (including copies of the referenced material); (c) where technical documentation within sub-paragraph (2)(m) is referenced, include precise cross-references; (d) be signed and dated by the author, and include details of the author’s educational background, training and occupational experience, and the author’s professional relationship with the applicant. (4) For the purposes of sub-paragraph (1)(a), the matters are— (a) information on the direct or indirect risks to public or animal health or to the environment arising from use of the antimicrobial product in animals; (b) information about the methods of mitigating the development of antimicrobial resistance as a result of the use of the product. (5) For the purposes of sub-paragraph (1)(b), the matter is a document certifying that a valid application for the establishment of maximum residue levels has been submitted to the Secretary of State. (6) Sub-paragraph (1)(b) does not apply in respect of a veterinary medicinal product which— (a) is for administration to a horse that has been declared on its horse passport as not intended for slaughter for human consumption, and (b) includes an active substance that has been classified under Article 14 of Regulation (EC) No 470/2009 of the European Parliament and of the Council as prohibited for use in food-producing animals. (7) For the purposes of sub-paragraph (1)(c) the matters are— (a) a copy of the written consent to the deliberate release into the environment of the genetically modified organisms for research and development purposes issued under the GMO Deliberate Release Regulations; (b) the complete technical file containing the information provided in respect of the application for that consent under the GMO Deliberate Release Regulations; (c) the environmental risk assessment provided in respect of the application for that consent under the GMO Deliberate Release Regulations; (d) the results of any investigations performed for the purposes of research or development. (8) In assembling the application for an authorisation under this Schedule, the applicant must— (a) take into account the most up-to-date veterinary medicinal knowledge and scientific guidelines relating to the quality, safety and efficacy of veterinary medicinal products (including relevant monographs of the European Pharmacopoeia and British Pharmacopoeia); (b) include in the application all information which is relevant to the evaluation of the veterinary medicinal product to which it relates, whether favourable or unfavourable to the product (including information relating to any incomplete or abandoned study or trial); (c) ensure that the application supports, by reference to specific studies and trials, each claim made by the applicant with regard to the properties, effects and uses of the veterinary medicinal product to which it relates; (d) otherwise ensure the accuracy of the information in the application. (9) For the purposes of sub-paragraph (8)(c), pharmacological, toxicological, residue and pre-clinical studies and clinical trials must be carried out in conformity with the principles of good laboratory practice, where applicable. (2A) (1) An application must be submitted electronically. (2) Subject to sub-paragraph (3), the application must be structured as a single dossier in four parts— (a) Part 1 (administrative information); (b) Part 2 (pharmaceutical quality (physicochemical, biological or microbiological) data); (c) Part 3 (safety documentation, including safety and residue tests); (d) Part 4 (efficacy documentation, including pre-clinical studies and clinical trials). (3) An application concerning the release of GMOs must set out the environmental risk assessment in respect of that release as a separate document, and that assessment must be presented in accordance with the following provision of the GMO Deliberate Release Regulations— (a) as regards England or Scotland, regulation 6; (b) as regards Wales, regulation 7. (2B) (1) Where information to be included in an application under paragraph 2(8) includes information concerning experiments on animals, this paragraph applies in respect of that information. (2) The application must state whether the information was obtained from an experiment conducted in accordance with the requirements in sub-paragraph (4). (3) The Secretary of State must, in assessing the application, disregard any information to which this paragraph applies which was not obtained from an experiment conducted in accordance with the requirements in sub-paragraph (4). (4) The requirements are— (a) the experiment was conducted in accordance with a detailed written protocol prepared in advance; (b) the experiment was designed to use the minimum number of animals and cause the least pain, suffering or lasting harm, and there was no satisfactory alternative in vitro test available to be used which would have reduced these impacts; (c) informed consent to the experiment and its consequences (including as regards disposal of treated animals and the taking of produce from treated animals) was obtained in writing from the owner of the animal before the animal was first treated under the experiment; (d) the welfare of the animals was subject to veterinary supervision throughout the experiment. (2C) (1) Where an applicant proposes, under paragraph 2(2)(d), that a marketing authorisation be granted on the basis that the veterinary medicinal product is classified as POM-VPS, NFA-VPS or AVM-GSL, the requirements in this paragraph apply. (2) The application must include a document which sets out a detailed justification for the suitability of such classification, having regard to— (a) animal safety (both as regards treated animals and other animals); (b) public health; and (c) environmental safety.

Amendment to paragraph 3

29

For paragraph 3 (summary of product characteristics) substitute—

(3) (1) Subject to sub-paragraph (2), the summary of product characteristics required under paragraph 2(2)(h) must include the following information in the order indicated below—

1.	1.	Name of the veterinary medicinal product, followed by its strength and pharmaceutical form.
2.	2.	Qualitative and quantitative composition of the active substances and qualitative composition of excipients and other constituents stating their common name or their chemical description and their quantitative composition, if that information is essential for proper administration of the veterinary medicinal product.
3.	3.	Clinical information as regards—
	3.1	target species;
	3.2	indications for use for each target species;
	3.3	contra-indications;
	3.4	special warnings;
	3.5	special precautions for use, including in particular special precautions for safe use in the target species, special precautions to be taken by the person administering the veterinary medicinal product to the animals and special precautions for the protection of the environment;
	3.6	frequency and seriousness of adverse events;
	3.7	use during pregnancy, lactation or lay;
	3.8	interaction with other medicinal products and other forms of interaction;
	3.9	administration route and dosage;
	3.10	symptoms of overdose and, where applicable, emergency procedures and antidotes in the event of overdose;
	3.11	special restrictions for use;
	3.12	special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance;
	3.13	if applicable, withdrawal periods, even if such periods are zero.
4.	4.	Pharmacological information as regards—
	4.1	the ATCvet Code;
	4.2	pharmacodynamics;
	4.3	pharmacokinetics.
5.	5.	Pharmaceutical particulars as regards—
	5.1	major incompatibilities;
	5.2	shelf-life, where applicable after reconstitution of the medicinal product or after the immediate packaging has been opened for the first time;
	5.3	special precautions for storage;
	5.4	nature and composition of immediate packaging;
	5.5	requirement to use take-back schemes for veterinary medicinal products for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products and, if appropriate, additional precautions regarding hazardous waste disposal of unused veterinary medicinal products or waste materials derived from the use of such products.
6.	6.	Name of the holder of the marketing authorisation.
7.	7.	Marketing authorisation number or numbers.
8.	8.	Date of the first marketing authorisation.
9.	9.	Date of the last revision of the summary of product characteristics.
10.	10.	If applicable, the statement—
	10.1	“marketing authorisation granted for a limited market and therefore assessment based on customised requirements for documentation”; or
	10.2	“marketing authorisation in exceptional circumstances and therefore assessment based on customised requirements for documentation”.
11.	11.	Information on the take-back schemes referred to in point 5.5 applicable to the veterinary medicinal product concerned.
12.	12.	Classification of the veterinary medicinal product.

(2) In the case of an immunological veterinary medicinal product or a biological veterinary medicinal product that is not immunological, in place of the information at points 4, 4.1, 4.2 and 4.3, the summary of product characteristics must include immunological information.

Amendment to paragraph 5

30

Omit paragraph 5 (time limits for applications).

Amendment to paragraph 7

31

In paragraph 7 (bibliographic application)—

(a) in sub-paragraph (1), for the words from “if the active” to the end substitute “if the applicant demonstrates that the active substances of the veterinary medicinal product have been in well-established veterinary use for at least 10 years, that their efficacy is documented and that they provide an acceptable level of safety”;

(b) after sub-paragraph (1) insert—

(1A) Sub-paragraph (1) does not apply to applications for— (a) biological (including immunological) veterinary medicinal products; (b) novel therapies.

Amendment to paragraph 8

32

In paragraph 8 (application for a product using a new combination of active substances)—

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

(b) after that text insert—

(2) Notwithstanding sub-paragraph (1) the applicant must provide a sound scientific justification based on valid therapeutic principles for the combination of active substances, including clinical data, which demonstrates the need for and contribution of all active substances at the moment of treatment.

Amendment to paragraph 10

33

In paragraph 10 (application for a pharmacologically equivalent medicinal product)—

(a) in sub-paragraph (1)—

(i) at the beginning insert “Subject to sub-paragraphs (2A), (9) and (10) and paragraph 10A,”;

(ii) for “pharmacologically equivalent to a” substitute “a generic of a”;

(iii) at the end add “(“the reference veterinary medicinal product”), provided that the applicant provides data demonstrating the matters referred to in sub-paragraph (2)”;

(b) in sub-paragraph (2)—

(i) for “pharmacologically equivalent to” substitute “a generic of”;

(ii) in paragraph (b) after “pharmaceutical form” insert “as the reference product”;

(iii) for paragraph (c) substitute—

(c) bioequivalence with the reference product has been demonstrated

(2A) Sub-paragraph (1) does not apply to applications for biological (including immunological) veterinary medicinal products.

(d) in sub-paragraph (5) after “Agency” insert “or the Secretary of State”;

(e) omit sub-paragraph (6);

(f) after sub-paragraph (6) insert—

(7) For the purposes of these Regulations, subject to sub-paragraph (8), the summary of product characteristics of a generic veterinary medicinal product must be essentially similar to the summary of product characteristics for the reference product. (8) The requirement in sub-paragraph (7) does not apply in relation to those parts of the summary of product characteristics of the reference product that refer to indications or pharmaceutical forms which are covered by patents at the time when the generic veterinary medicinal product is authorised. (9) Notwithstanding sub-paragraph (1), in respect of generic veterinary medicinal products intended to be administered by intramuscular, subcutaneous or transdermal routes, the applicant must provide— (a) administration site target animal tolerance data; (b) in respect of products intended for administration to food-producing species only, residues depletion data from the site of administration. (10) Notwithstanding sub-paragraph (1), in respect of generic veterinary medicinal products containing antimicrobial or antiparasitic substances, the applicant must provide all available data (including published data) on the current level of resistance, together with a review of that data as it relates to target pathogens to the active substances concerned. (11) An applicant must provide an environmental risk assessment for a generic veterinary medicinal product where— (a) the marketing authorisation for the reference veterinary medicinal product was granted before 1st October 2005, and (b) no marketing authorisation has been granted since 1st October 2005 in respect of a veterinary medicinal product which has the same active substance and pharmaceutical form as the reference veterinary medicinal product, and which is indicated for use in the same target species when administered at the same or a higher total dose, unless the Secretary of State holds an environmental risk assessment for the reference veterinary medicinal product and has confirmed this to the applicant.

(g) in the heading for “pharmacologically equivalent” substitute “generic veterinary”.

New paragraph 10A

34

After paragraph 10 insert—

(10A) An applicant for a marketing authorisation must provide the results of relevant pre-clinical studies or clinical trials where— (a) bioavailability studies are not capable of demonstrating bioequivalence between the veterinary medicinal product for which the authorisation is sought and a reference veterinary medicinal product for the purposes of paragraph 10; or (b) the veterinary medicinal product for which the authorisation is sought is not pharmacologically equivalent to a reference veterinary medicinal product for the purposes of paragraph 10 as a result of a difference in relation to— (i) the active substance or substances contained in the product; (ii) the strength of the product; (iii) the indications for use of the product; (iv) the pharmaceutical form of the product; (v) the route of administration of the product; (vi) the withdrawal period for the product.

Amendment to paragraph 11

35

In paragraph 11 (time limits for marketing authorisations – pharmacologically equivalent products)—

(a) in sub-paragraph (1) for “pharmacologically equivalent” substitute “generic veterinary medicinal”;

(b) for sub-paragraph (3) substitute—

(3) The product may not be placed on the market until the end of the longest of the following periods which is relevant— (a) subject to sub-paragraph (3A), 10 years in the case of a veterinary medicinal product authorised for major species; (b) 18 years in the case of a veterinary medicinal product authorised for bees; and (c) 14 years for a veterinary medicinal product authorised for all other species. (3A) Where the product— (a) is intended for administration to a major species; and (b) contains an active substance which is an antimicrobial which has not been an active substance in a veterinary medicinal product previously subject to a marketing authorisation in Great Britain, the period mentioned in sub-paragraph (3)(a) is 14 years. (3B) Where a patent in relation to a reference product has lapsed, the summary of product characteristics of the relevant generic product must be updated in order to include the protected information. (3C) Where, as a result of a variation to an existing marketing authorisation a product is accorded a new marketing authorisation number any relevant protection period applies in relation to that product. (3D) In this regulation “major species” means cattle, sheep (for meat production), pigs, chickens, dogs and cats.

Amendment to paragraph 12

36

In paragraph 12 (extension of time limits)—

(a) omit sub-paragraph (1);

(b) for sub-paragraph (2) substitute—

(2) Subject to sub-paragraph (2B), if a person submits an application for a marketing authorisation or for a variation to a marketing authorisation for a product, and within five years of the original marketing authorisation being granted, the marketing authorisation is extended to include an additional major species or a new antimicrobial product, the relevant protection period is extended by one year for each additional major species added to the marketing authorisation. (2A) Subject to sub-paragraph (2B), if a person submits an application for a marketing authorisation mentioned in sub-paragraph (2) and the marketing authorisation is extended to include an additional minor species, the relevant protection period is extended by four years. (2B) Sub-paragraphs (2) and (2A) do not apply where the application to extend the marketing authorisation is made fewer than three years before the expiration of the protection period.

(d) omit sub-paragraph (4).

New paragraph 12A

37

After paragraph 12 insert—

(12A) (1) Subject to sub-paragraph (3), a study, residue test or pre-clinical study in relation to the establishment of residue limits submitted by an applicant in relation to an application for a marketing authorisation or a variation of a marketing authorisation may not be used for any other such application or variation until the period of five years from that submission has elapsed. (2) Subject to sub-paragraph (3), a study, residue test or preclinical study submitted by an applicant for a marketing authorisation or a variation in a marketing authorisation which demonstrates a reduction in antimicrobial resistance in relation to a reference product may not be used for any other such application until a period of four years in addition to the relevant protection period has elapsed. (3) Sub-paragraphs (1) and (2) do not apply where an applicant has obtained a written authorisation to access a study, residue test or pre-clinical study mentioned in the relevant sub-paragraph.

Amendment to paragraph 13

38

Omit paragraph 13 (parallel imports).

Amendment to paragraph 14

39

Omit paragraph 14(4) (specific batch control scheme).

Amendment to paragraph 15

40

Omit paragraph 15 (similar immunological products).

Amendment to paragraph 17

41

In paragraph 17 (time limits)—

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

(b) after the renumbered sub-paragraph (1) insert—

(2) Sub-paragraph (1) does not apply where a simultaneous assessment of the application is being conducted by the Secretary of State and the relevant authority in another country.

Amendment to paragraph 18

42

For paragraph 18 (place of establishment of applicant) substitute—

(18) Only an applicant established in the United Kingdom or in a country which the Secretary of State considers to have demonstrated equivalent standards to those in the United Kingdom may be granted (or hold) a marketing authorisation or a veterinary homeopathic registration.

Amendment to paragraph 22

43

In paragraph 22 (grant of marketing authorisation)—

(a) the existing text is renumbered as sub-paragraph (2);

(b) above that text insert—

(22) (1) The Secretary of State must, before granting a marketing authorisation— (a) verify that the data submitted complies with the requirements set out in these Regulations; (b) assess the application and data submitted in respect of the veterinary medicinal product; and (c) reach a conclusion in relation to the benefit-risk balance of granting a marketing authorisation in respect of the veterinary medicinal product.

(3) The Secretary of State must set out any terms and conditions in connection with placing the product on the market when granting a marketing authorisation. (4) Where the marketing authorisation relates to a veterinary medicinal product that contains an antimicrobial the Secretary of State may require the holder of the marketing authorisation to conduct post-authorisation studies in order to ensure that the benefit-risk balance remains positive in relation to the development of antimicrobial resistance.

New paragraph 22A

44

After paragraph 22 insert—

(22A) (1) Where an applicant for a marketing authorisation withdraws the application before the Secretary of State has produced an assessment of the dossier under paragraph 21 the applicant must give written reasons for so doing. (2) Where an applicant withdraws an application for a marketing authorisation in the circumstances mentioned in sub-paragraph (1) the Secretary of State must publish— (a) the fact that the application has been withdrawn; and (b) a summary of the reasons for withdrawal.

Amendment to paragraph 24

45

In paragraph 24(2) (refusal of a marketing authorisation)—

(a) in paragraph (b) for “risk-benefit balance” substitute “benefit-risk balance”;

(b) for paragraph (c) substitute—

(c) the applicant has not provided sufficient evidence of the efficacy of the product in relation to the target species;

(g) the veterinary medicinal product is a veterinary medicinal product which contains an antimicrobial which is presented for use in order to promote the growth of treated animals or to increase yields from treated animals; (h) the risk for public health in case of development of antimicrobial resistance or antiparasitic resistance outweighs the benefits of the veterinary medicinal product to animal health; (i) the risks to public or animal health or to the environment are not sufficiently addressed; (j) the qualitative or quantitative composition of the veterinary medicinal product is not as stated in the application; (k) the active substance within the veterinary medicinal product meets the criteria for being considered persistent, bio-accumulative and toxic and the veterinary medicinal product is intended to be used in food-producing animals (except where it is demonstrated that the active substance is essential to prevent or control a serious risk to animal health).

Amendment to paragraph 25

46

In paragraph 25 (publication following the grant of a marketing authorisation)—

(a) after sub-paragraph (3) insert—

(4) Where the Secretary of State refuses to grant a marketing authorisation or suspends or revokes an authorisation the Secretary of State must publish that fact. (5) Where the Secretary of State varies a marketing authorisation in relation to the summary of product characteristics the Secretary of State must publish the terms of the variation.

(b) in the heading after “grant” insert “, refusal, suspension, variation or revocation”.

Amendment to paragraph 26

47

In paragraph 26 (marketing authorisations in exceptional circumstances)—

(a) in sub-paragraph (1)(a), after “further data” insert “, taking into account the benefit of the immediate availability on the market of the veterinary medicinal product in comparison to the risks”;

(b) in sub-paragraph (1)(b), after “limited market” insert “, taking into account the benefit in relation to public or animal health of the availability of the product on the market in comparison to the risks.”;

(1A) An exceptional marketing authorisation may be granted subject to such further conditions, including any restrictions, as the Secretary of State considers appropriate.

Amendment to paragraph 27

48

In paragraph 27 (provisions of samples and expertise)—

(a) in sub-paragraph (1) at the end insert “and to provide the results of any control tests carried out in relation to such materials or the finished product in accordance with the methods to be used under the terms of the marketing authorisation”;

(b) after sub-paragraph (2) insert—

(3) The Secretary of State may require an applicant for a marketing authorisation to provide samples of a veterinary medicinal product for testing. (4) The samples mentioned in sub-paragraph (3) may be used— (a) to test the veterinary medicinal product and its constituents at any stage of development of the product in order to ensure that the control methods used by the manufacturer are satisfactory; and (b) to verify that, where a veterinary medicinal product is intended for administration to a food-producing animal, the means used for residue detection in relation to pharmacologically active substances are satisfactory.

Amendment to paragraph 28

49

In paragraph 28 (supply of information)—

(a) for “risk-benefit balance”, in both places it occurs, substitute “benefit-risk balance”;

(b) after sub-paragraph (3) insert—

(4) A marketing authorisation holder must retain all of the original documents from every clinical trial from which data was derived in support of the application for authorisation under this Schedule, and in support of any variation of the authorisation (whether granted or otherwise), for at least five years from the date on which the authorisation ceases.

Amendment to paragraph 30

50

Omit paragraph 30 (control tests).

Amendment to paragraph 31

51

In paragraph 31 (placing on the market), after sub-paragraph (2) insert—

(2A) A holder of a marketing authorisation who identifies a shortage of the veterinary medicinal product must notify the Secretary of State as soon as is reasonably practicable. (2B) For the purposes of sub-paragraph (2A) a shortage of a veterinary medicinal product occurs when supply does not meet demand at a national level within the United Kingdom.

Amendment to paragraph 32

52

For paragraph 32 (duration and validity of marketing authorisation) substitute—

(32) Subject to any power of revocation provided under these Regulations a marketing authorisation is valid indefinitely.

Amendment to paragraph 33

53

In paragraph 33 (variation of marketing authorisation)—

(a) omit sub-paragraph (1);

(b) for sub-paragraph (3) substitute—

(3) An application for a variation under paragraph (2) may only relate to— (a) a single variation, which may relate to one or more marketing authorisations, or (b) one or more variations to a single marketing authorisation.

New paragraph 33A

54

After paragraph 33 insert—

(33A) (1) Subject to sub-paragraphs (2) and (6), an application for a variation must be submitted to the Secretary of State electronically. (2) Sub-paragraph (1) does not apply where the application is an emergency application. (3) The application must contain— (a) a description of the proposed variation; (b) information in relation to any of the matters referred to in paragraph 2 which are relevant to the proposed variation; (c) details of any marketing authorisation which may be affected by the proposed variation; and (d) where the proposed variation requires consequential variations to the terms of the marketing authorisation, a description of those variations. (4) The Secretary of State must produce an assessment of the application. (5) The Secretary of State may require the applicant to provide additional information during the assessment process. (6) Where the Secretary of State is satisfied that it is not necessary for the application to contain certain information for the purposes of conducting an assessment, having regard to the risks involved with the proposed variation, the Secretary of State may waive the requirement to provide that information under sub-paragraph (3) (and the requirement in sub-paragraph (4) does not apply in respect of that information). (7) The Secretary of State must send a copy of the assessment mentioned in sub-paragraph (4) to the applicant. (8) Having assessed the application, the Secretary of State must— (a) amend the authorisation to correspond with the proposed variation; or (b) reject the proposed variation. (9) Where the Secretary of State amends the authorisation in accordance with sub-paragraph (8)(a) the Secretary of State must notify the applicant in writing. (10) The Secretary of State must ensure that the determination of an application for a variation of a marketing authorisation is completed within a maximum of 180 days after the submission of the application.

Amendment to paragraph 34

55

In paragraph 34 (refusal of variation to marketing authorisation)—

(a) omit sub-paragraph (1);

(b) for sub-paragraph (3)(b) substitute—

(b) the Secretary of State produced an assessment in respect of the variation under paragraph 33A(4),

Amendment to paragraph 35

56

Omit paragraph 35 (administrative variations).

Amendment to paragraph 38

57

In paragraph 38 (suspension of marketing authorisation: grounds)—

(a) for sub-paragraph (1) substitute—

(1) If the Secretary of State is satisfied at any time that the benefit-risk balance of a veterinary medicinal product is not positive or is insufficient to ensure food safety, the Secretary of State may— (a) suspend the marketing authorisation; (b) require the holder of the marketing authorisation to submit an application for its variation; (c) revoke the marketing authorisation.

(b) for sub-paragraph (3) substitute—

(3) The Secretary of State may take the steps set out in sub-paragraph (1)(a), (b) and (c) on being satisfied at any time that— (a) information given in the application documents is incorrect; (b) any control tests required have not been carried out; (c) changes have been made to the manufacturing process without the authority of the Secretary of State; (d) any information required to be supplied to the Secretary of State has not been so supplied; (e) the holder of the marketing authorisation has failed to comply with the requirements of these Regulations; (f) the pharmacovigilance system in relation to a veterinary medicinal product is inadequate; (g) in the case of a generic authorisation, the reference product is updated to show a reduction in antimicrobial resistance; (h) the qualified person (pharmacovigilance) has failed to comply with the requirements of these Regulations

Amendment to paragraph 39

58

In paragraph 39 (suspension of marketing authorisation: procedure) omit sub-paragraph (4).

Amendment to paragraph 41

59

In paragraph 41 (prohibiting supply of veterinary medicinal products) for sub-paragraph (1) substitute—

(1) The Secretary of State may prohibit the supply of a veterinary medicinal product or require the recall of the product at any time on being satisfied that— (a) the benefit-risk balance of the veterinary medicinal product is not positive; (b) the qualitative or quantitative composition of the veterinary medicinal product is not as stated in the summary of product characteristics; (c) the recommended withdrawal period is insufficient to ensure food safety; (d) the required control tests have not been carried out; or (e) the incorrect labelling of the product might lead to a serious risk to human or animal health

New paragraphs 41A and 41B

60

After paragraph 41 (and in Part 5) insert—

(41A) Where urgent action is necessary for protecting human or animal health or the environment, the Secretary of State may, on a temporary basis— (a) restrict the supply of a veterinary medicinal product; (b) restrict the use of a veterinary medicinal product; (c) suspend the authorisation of a veterinary medicinal product; (d) require the holder of a marketing authorisation for a veterinary medicinal product to submit an application for variation of the authorisation. (41B) The Secretary of State may prohibit the manufacture, importation, distribution, supply or use of immunological veterinary medicines in any part of Great Britain where— (a) the administration of the product to an animal interferes with the implementation of a programme for the diagnosis, control or eradication of animal disease; (b) the administration of the product to an animal causes difficulty in relation to the certifying of absence of disease in live animals or contamination of foodstuffs or other products from treated animals; or (c) the strains of disease agents in relation to which the product is intended to confer immunity are largely absent from the territory concerned.

Amendment to paragraph 48

61

For paragraph 48 (labelling with all information on immediate packaging) substitute—

(48) (1) Subject to paragraph 50, the following information must be provided on the immediate packaging of a veterinary medicinal product— (a) the name of the product, followed by its strength and pharmaceutical form; (b) a statement of the active substances expressed qualitatively and quantitatively per unit or according to the form of administration for a particular volume or weight, using their common names; (c) the batch number, preceded by the word “Lot”; (d) the name or company name or logo of the marketing authorisation holder; (e) the target species; (f) the expiry date, in the format ‘mm/yyyy’, preceded by the abbreviation “Exp.”; (g) special storage precautions, if any; (h) the route of administration; (i) if applicable, the withdrawal period, even if such period is zero. (2) Where there is no outer packaging for the product, the information set out in paragraph 49 must be included on the immediate packaging of the veterinary medicinal product. (3) The information referred to in paragraph (1) must appear in easily legible and clearly comprehensible characters, or in abbreviations or pictograms.

Amendment to paragraph 49

62

For paragraph 49 (products with immediate and outer packaging) substitute—

(49) (1) The following information must be provided on any outer packaging of a veterinary medicinal product— (a) the information referred to in paragraph 48(1); (b) the contents by weight, volume or number of the immediate packaging units of the veterinary medicinal product; (c) a warning that the veterinary medicinal product must be kept out of the sight and reach of children; (d) a warning that the veterinary medicinal product is “for animal treatment only”; (e) a recommendation to read the package leaflet, if there is one; (f) in the case of a veterinary medicinal product not subject to a veterinary prescription, the indication for use; (g) the marketing authorisation number. (2) The information referred to in sub-paragraph (1) must appear in easily legible and clearly comprehensible characters, or in abbreviations or pictograms.

Amendment to paragraph 50

63

For paragraph 50 (package leaflets) substitute—

(50) (1) Where the immediate packaging units of a veterinary medicinal product are too small to include in a legible form all of the information set out in paragraph 48, the immediate packaging must instead provide the following information— (a) the name of the veterinary medicinal product; (b) the quantitative particulars of the active substances contained in the product; (c) the batch number, preceded by the word “Lot”; (d) the expiry date, in the form ‘mm/yyyy’, preceded by the abbreviation “Exp”. (2) The immediate packaging units mentioned in sub-paragraph (1) must be packed within outer packaging which provides the information required by paragraph 49.

Amendment to paragraph 51

64

For paragraph 51 (ampoules) substitute—

(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”;

(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.

(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);

(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.

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”;

(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.

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