The Veterinary Medicines Regulations 2013

PART 1U.K.Application for a marketing authorisation

Application for a marketing authorisationU.K.

1.  An application under these Regulations for a marketing authorisation for a veterinary medicinal product must be made to the Secretary of State.

[F3Information with the application: generalE+W+S

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, 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 applicationN.I.

2.—(1) An application must include all necessary administrative information, and all scientific documentation necessary for demonstrating the safety, quality and efficacy of the product.

(2) In particular, the applicant must provide all the data required in Annex I to Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products(1), generated in accordance with that Annex.

(3) The application must contain the following information—

(a)the name of the person who will hold the marketing authorisation, that person’s address and, if different, the name and address of all the manufacturers involved in each stage of the manufacture, and the sites where the manufacture will take place;

(b)the name of the veterinary medicinal product, which may be either—

(i)an invented name provided that this is not liable to be confused with the common name of the product or the international non-proprietary name (INN) recommended by the World Health Organization; or

(ii)a common or scientific name accompanied by a trademark or the name of the marketing authorisation holder;

(c)the qualitative and quantitative particulars of all the constituents of the veterinary medicinal product, including its INN recommended by the World Health Organization, where an INN exists, or its chemical name;

(d)a description of the method of manufacture;

(e)all therapeutic indications, contra-indications and adverse reactions;

(f)the dosage for each species of animal for which the veterinary medicinal product is intended, its pharmaceutical form, method and route of administration and proposed shelf life;

(g)any proposed precautionary and safety measures to be taken when storing the veterinary medicinal product, administering it to animals or disposing of waste, together with an indication of potential risks that the veterinary medicinal product might pose to the environment, to human or animal health or to plants, together with the reasons;

(h)in the case of medicinal products intended for food‑producing species, the proposed withdrawal period necessary to ensure that the maximum residue limits specified in Regulation (EC) No 470/2009 of the European Parliament and of the Council are not exceeded;

(i)a description of the testing methods to be used during manufacture;

(j)the results of—

(i)pharmaceutical (physico-chemical, biological or microbiological) tests;

(ii)safety tests and residue tests;

(iii)pre-clinical and clinical trials;

(iv)tests assessing the potential risks to the environment from the product;

(k)a detailed description of the pharmacovigilance system and, where appropriate, the risk management system that the applicant will put in place;

(l)a summary of the product characteristics, mock-ups of all proposed packaging and the proposed package leaflet, if any;

(m)a document showing that the manufacturer is authorised to produce veterinary medicinal products;

(n)copies (which must be updated if there are any changes while the application is being considered) of—

(i)any marketing authorisation obtained in [F6a] member State or in a third country for the relevant veterinary medicinal product, and a list of any F7... member States in which an application for authorisation of the product has been submitted;

(ii)if the product is already authorised outside the United Kingdom, the summary of product characteristics for each authorisation;

(iii)any decision to refuse authorisation, whether in the Community or a third country and the reasons for that decision;

(o)proof that the applicant has the services of a qualified person responsible for pharmacovigilance (referred to in these Regulations as a qualified person (pharmacovigilance)) and has the necessary means for the notification of any adverse reaction suspected of occurring either in the Community or in a third country;

(p)if the veterinary medicinal product is intended for food-producing species and contains one or more pharmacologically active substances not yet included for the species in question in Commission Regulation (EU) No 37/2010, a document certifying that a valid application for the establishment of maximum residue limits has been submitted to the Agency in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council.

(4) All documents relating to the results of tests or trials must be accompanied by a detailed and critical expert report that has been drafted and signed by a person with the requisite technical or professional qualifications and that has a brief curriculum vitae of the person signing the report attached to it.

(5) In the case of immunological products, the applicant must submit a description of the methods used to establish that the manufacturing process will consistently produce a veterinary medicinal product that is in accordance with the marketing authorisation.

[F3Information with the application: formatE+W+S

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 testingE+W+S

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-GSLE+W+S

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.]

[F4Summary of product characteristicsE+W+S

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—

(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.]

Summary of product characteristicsN.I.

3.  The summary of product characteristics required under the preceding paragraph must include the following information, set out in the same format—

Supply of a copy of the summary of product characteristicsU.K.

4.  A holder of a marketing authorisation must supply a copy of the summary of product characteristics to any person on demand.

Time limits for applications for products for use in food-producing animalsE+W+S

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Time limits for applications for products for use in food-producing animalsN.I.

5.  In the case of a veterinary medicinal product for food-producing animals, a marketing authorisation may not be applied for until at least six months after a valid application has been made for the establishment of a maximum residue limit in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council.