Law

The Veterinary Medicines (Amendment etc.) Regulations 2024

United Kingdom · regulation

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In force since 2024-05-17, as the publisher states.

Copy read on 2026-11-10. The page it was read from

Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.

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Contents: 210 provisions

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210 provisions

40 Amendment to paragraph 15

Omit paragraph 15 (similar immunological products).

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41 Amendment to paragraph 17

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. .

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42 Amendment to paragraph 18

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. .

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43 Amendment to paragraph 22

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. .

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44 New paragraph 22A

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. .

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45 Amendment to paragraph 24

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). .

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46 Amendment to paragraph 25

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”.

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47 Amendment to paragraph 26

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. .

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48 Amendment to paragraph 27

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. .

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49 Amendment to paragraph 28

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”.

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50 Amendment to paragraph 30

Omit paragraph 30 (control tests).

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51 Amendment to paragraph 31

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. .

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52 Amendment to paragraph 32

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. .

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53 Amendment to paragraph 33

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. .

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54 New paragraph 33A

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. .

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55 Amendment to paragraph 34

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), .

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56 Amendment to paragraph 35

Omit paragraph 35 (administrative variations).

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57 Amendment to paragraph 38

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”.

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58 Amendment to paragraph 39

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

Propose a change

59 Amendment to paragraph 41

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 .

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60 New paragraphs 41A and 41B

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. .

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61 Amendment to paragraph 48

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. .

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62 Amendment to paragraph 49

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. .

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63 Amendment to paragraph 50

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. .

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64 Amendment to paragraph 51

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. .

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65 Amendment to paragraph 52

Omit paragraph 52 (small containers other than ampoules).

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66 Amendment to paragraph 53

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 .

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67 Amendment to paragraph 55

Omit paragraph 55 (qualified person responsible for pharmacovigilance).

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

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). .

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69 Amendment to paragraph 57

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 .

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70 Amendment to paragraph 58

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

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71 Amendment to paragraph 59

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”.

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72 Amendment to paragraph 60

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. .

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73 New paragraphs 60A and 60B

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. .

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74 Amendment to paragraph 61

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, .

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75 Amendment to paragraph 63

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”.

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76 Amendment to paragraph 64

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; .

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77 Amendment to paragraph 65

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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78 Amendment to paragraph 68

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).

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79 Introduction

Schedule 2 to the 2013 Regulations (manufacture of veterinary medicinal products) is amended in accordance with this Part.

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