The Veterinary Medicines (Amendment etc.) Regulations 2024

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.”.

(1)

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