The Veterinary Medicines (Amendment etc.) Regulations 2024

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—

“Information with the application: general

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(1), 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.

Information with the application: format

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.

Information with the application: animal testing

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.

Information with the application: POM-VPS, NFA-VPS and AVM-GSL

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—

“Summary of product characteristics

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.		Name of the veterinary medicinal product, followed by its strength and pharmaceutical form.
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.		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.		Pharmacological information as regards—
	4.1	the ATCvet Code;
	4.2	pharmacodynamics;
	4.3	pharmacokinetics.
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.		Name of the holder of the marketing authorisation.
7.		Marketing authorisation number or numbers.
8.		Date of the first marketing authorisation.
9.		Date of the last revision of the summary of product characteristics.
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.		Information on the take-back schemes referred to in point 5.5 applicable to the veterinary medicinal product concerned.
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”;

(c) after sub-paragraph (2) insert—

“(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—

“Hybrid veterinary medicinal products

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.”;

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

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.”;

(c) in sub-paragraph (3) for “13” substitute “18”;

(d) omit sub-paragraph (4).

New paragraph 12A

37.  After paragraph 12 insert—

“Time limits – supplementary

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—

“Place of establishment of applicant

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.”.

(c) below the existing text (renumbered as sub-paragraph (2)) insert—

“(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—

“Withdrawal of application for marketing authorisation

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;”;

(c) after paragraph (f) insert—

“(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.”;

(c) after sub-paragraph (1) insert—

“(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.”;

(c) in the heading, at the beginning insert “Records and”.

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—

“Duration and validity of marketing authorisation

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—

“Variation procedure

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”;

(c) in the heading, after “suspension” insert “, revocation, etc”.

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—

“Temporary restrictions

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.

Restrictions in relation to immunological veterinary medicines

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—

“Labelling of immediate packaging of veterinary medicinal products

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—

“Labelling of the outer packaging of veterinary medicinal products

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—

“Labelling of small immediate packaging units of veterinary medicinal products

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—

“Package leaflet of veterinary medicinal products

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—

“Duties of marketing authorisation holder in relation to pharmacovigilance

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.

Duties of marketing authorisation holder in relation to signal management process

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.

Duties of qualified person (pharmacovigilance)

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.

Signal management process

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—

“Adverse events following administration of a veterinary medicinal product”.

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—

“Pharmacovigilance inspections by Secretary of State

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.

Powers of Secretary of State in relation to signal management process

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).

(1)

EUR 2009/470, amended by S.I. 2019/865 (itself amended by S.I. 2020/1461).