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The Veterinary Medicines Regulations 2013

Type Statutory-Instrument

Publication 2013-08-06

Last updated 2024-05-17

State In force

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

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(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Similar immunological products

15

Where an immunological veterinary medicinal product is pharmacologically equivalent to a reference product other than differences in raw materials or in the manufacturing process, the results of the appropriate pre-clinical tests or clinical trials must be provided, but the applicant need not provide the results of safety tests or residue tests.

Marketing a product authorised in another country

16

Where the health situation so requires, the Secretary of State may authorise the placing on the market of a veterinary medicinal product that has been authorised in another country.

PART 3 — Grant of a marketing authorisation

Time limits

17

(1) The Secretary of State must ensure that the procedure for granting an authorisation for a veterinary medicinal product is completed within a maximum of 210 days after the submission of the application.

(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.

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.

Procedure

19

The Secretary of State may require the applicant to provide additional information or to generate additional data, including laboratory testing, or may require the applicant to provide samples of any medicinal product, its starting materials and intermediate products or other constituent materials for testing in a laboratory.

Products authorised in another member State

20

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Assessment reports

21

The Secretary of State must produce an assessment of the dossier, consisting of an evaluation of the results of the pharmaceutical, safety and residue tests and the pre-clinical and clinical trials of the veterinary medicinal product concerned, and any additional related information.

Grant of a marketing authorisation

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.

(2) When granting a marketing authorisation, the Secretary of State must inform the applicant of the summary of product characteristics that has been approved, and the distribution category of the product.

(3) The Secretary of State must set out any terms and conditions in connection with placing the product on the market when granting a marketing authorisation.

(4) Where the marketing authorisation relates to a veterinary medicinal product that contains an antimicrobial the Secretary of State may require the holder of the marketing authorisation to conduct post-authorisation studies in order to ensure that the benefit-risk balance remains positive in relation to the development of antimicrobial resistance.

Marketing authorisations for food-producing species

23

(1) The Secretary of State must not grant a marketing authorisation for a veterinary medicinal product for food-producing species unless maximum residue limits have been established under Regulation (EC) No 470/2009 of the European Parliament and of the Council in respect of all its pharmacologically active substances ....

(2) This does not apply in the case of a marketing authorisation for a veterinary medicinal product for administration to a horse that has been declared on its horse passport as not intended for slaughter for human consumption; but in this case the product must not include 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.

Refusal of a marketing authorisation

24

(1) The Secretary of State must refuse to grant a marketing authorisation if the application does not comply with these Regulations.

(2) In addition, the Secretary of State must refuse to grant it if—

(a) the data submitted with the application are inadequate;

(b) the benefit-risk balance of the veterinary medicinal product is unfavourable;

(d) the withdrawal period proposed by the applicant is not long enough to ensure food safety, or is insufficiently substantiated;

(e) the veterinary medicinal product is for a prohibited use;

(f) the way that the product will be used will have an unnecessarily undesirable effect on the environment.

(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).

(3) The Secretary of State may refuse to grant a marketing authorisation—

(a) if there is ... legislation pending that is incompatible with the requested authorisation; or

(b) if additional data have been requested and those data are not provided within such time limit as may be stipulated.

(4) If the Secretary of State, on the grounds of safety, quality or efficacy, intends to refuse an application, or proposes to grant a marketing authorisation that is different from the one applied for, the Secretary of State must notify the applicant accordingly, and the applicant may appeal to the Veterinary Products Committee.

Publication following the grant of a marketing authorisation

25

(1) On granting a marketing authorisation the Secretary of State must publish—

(a) the notice granting the marketing authorisation;

(b) the summary of the product characteristics;

(c) the assessment report that has already been prepared but with any commercially confidential or personal information deleted.

(2) The Secretary of State must update the assessment report whenever new information that is of importance and relates to the quality, safety or efficacy of the veterinary medicinal product becomes available.

(3) The Secretary of State must send a copy of the assessment report, and any update, to the holder of the marketing authorisation before publication to enable the holder to make representations concerning any confidential or personal information that may be in it, and may specify a date by which representations must be made.

(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.

Marketing authorisations in exceptional circumstances

26

(1) In exceptional circumstances, and if there is no other product with a full marketing authorisation for the indicated condition in the target species, the Secretary of State may grant an exceptional marketing authorisation consisting of—

(a) a provisional marketing authorisation subject to a requirement for the applicant to provide further data , taking into account the benefit of the immediate availability on the market of the veterinary medicinal product in comparison to the risks; or

(b) a limited marketing authorisation for a product with a limited market , taking into account the benefit in relation to public or animal health of the availability of the product on the market in comparison to the risks..

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

(2) The Secretary of State must reassess each provisional or limited marketing authorisation annually.

Provisions of samples and expertise

27

(1) The Secretary of State may require a marketing authorisation holder to provide, at any time and at any stage of the manufacturing process, samples of starting materials or the veterinary medicinal product for testing 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.

(2) At the request of the Secretary of State, the marketing authorisation holder must provide technical expertise to facilitate any analysis of the product.

(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.

Supply of information

28

(1) A marketing authorisation holder must immediately inform the Secretary of State on receipt of any new information that might adversely affect the benefit-risk balance of the veterinary medicinal product.

(2) The holder must immediately inform the Secretary of State of any prohibition or restriction imposed by the competent authorities of any country in which the veterinary medicinal product is authorised.

(3) The Secretary of State may at any time require the marketing authorisation holder to provide data relating to the benefit-risk balance.

(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.

Duties on the holder of a marketing authorisation relating to an immunological product

29

(1) Before placing an immunological product on the market the holder of the marketing authorisation must notify the Secretary of State asking for written approval to do so.

(2) If notified under sub-paragraph (1) the Secretary of State must give or refuse a written approval as soon as is reasonably practicable.

(3) No person may place an immunological product on the market without a written approval issued by the Secretary of State ....

Control tests

30

The holder of a marketing authorisation must give to the Secretary of State on demand evidence that the holder has carried out all control tests required under the marketing authorisation, and the results of those tests.

Placing on the market

31

(1) A holder of a marketing authorisation must notify the Secretary of State when the veterinary medicinal product is first placed on the market in the United Kingdom, and the date on which it was placed on the market.

(2) A holder of a marketing authorisation who removes the veterinary medicinal product from the market in the United Kingdom must notify the Secretary of State at least two months (or a shorter period in exceptional circumstances) before doing so.

(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.

(3) Upon request by the Secretary of State, the marketing authorisation holder must provide—

(a) all data relating to the volume of sales of the veterinary medicinal product by the holder; and

(b) any data in the holder’s possession relating to the number of prescriptions written for the product and the total volume supplied under those prescriptions.

Duration and validity of a marketing authorisation

32

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

PART 4 — Variations of marketing authorisations on the application of the holder

Variation of a marketing authorisation

33

(1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(2) The holder of a marketing authorisation may apply to the Secretary of State for a variation of that marketing authorisation.

(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.

(4) The Secretary of State, when granting a variation of a veterinary medicinal product, may (unless there are exceptional circumstances necessary to protect human or animal health or the environment) specify transitional measures to enable products produced in accordance with the previous authorisation to continue to be marketed for the transitional period.

Refusal of a variation of a marketing authorisation

34

(1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(2) The grounds on which the Secretary of State may refuse an application for a variation of a marketing authorisation are those set out in paragraph 24 of this Schedule (refusal of a marketing authorisation).

(3) The Secretary of State must give written reasons for refusing to grant a variation; and if—

(a) those reasons are on the grounds of safety, quality or efficacy; and

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

the applicant may appeal to the Veterinary Products Committee.

Administrative variations

35

(1) The holder of a marketing authorisation may apply for a minor change in a marketing authorisation to be made without the Secretary of State considering any scientific data (an “administrative variation”).

(2) If the Secretary of State grants an administrative variation, and subsequently establishes that this should have been a variation requiring consideration of scientific data, the Secretary of State may notify the marketing authorisation holder, require the holder to submit an application for a variation enabling data to be assessed and revoke the administrative variation.

Changes after a marketing authorisation has been issued

36

After a marketing authorisation has been issued, the holder must take account of scientific and technical progress in manufacturing and control methods, and apply to the Secretary of State for any variation in the marketing authorisation that may be required to enable that veterinary medicinal product to be manufactured and checked by means of generally accepted scientific methods.

Compulsory variation

37

(1) If the Secretary of State decides, for any of the reasons for suspending a marketing authorisation specified in paragraph 38, or because the classification of a veterinary medicinal product should be changed, that a variation to a marketing authorisation is necessary, the Secretary of State must by a notification in writing to the holder of the marketing authorisation require that person to apply for a variation of the marketing authorisation, giving reasons for requiring the application to be made.

(2) The notification may specify a time limit within which the marketing authorisation holder must apply for the variation.

(3) If the variation is on the grounds of safety, quality or efficacy, the applicant may, within 28 days of the notification, appeal to the Veterinary Products Committee.

(4) If the marketing authorisation holder fails to apply for the variation within that time limit the Secretary of State may suspend or revoke the marketing authorisation.

PART 5 — Suspension, etc. of a marketing authorisation

Suspension of a marketing authorisation: grounds

38

(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;

(2) The Secretary of State may also suspend a marketing authorisation on being satisfied that a marketing authorisation holder has failed to make an application for a variation to take account of scientific and technical progress in manufacturing and control methods to enable the veterinary medicinal product to be manufactured and checked by means of generally accepted scientific methods.

(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;

(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

Suspension of a marketing authorisation: procedure

39

(1) If a marketing authorisation is suspended the Secretary of State must notify the holder immediately, and, unless the Secretary of State directs otherwise, the suspension has immediate effect, and continues in effect unless the marketing authorisation is reinstated.

(2) If the suspension is on the grounds of safety, quality or efficacy, the holder may, within 28 days of the notification, appeal to the Veterinary Products Committee.

(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Revocation

40

The Secretary of State may revoke any marketing authorisation that has been suspended for more than 28 days unless there is a current appeal to the Veterinary Products Committee, and may publicise a revocation in such manner as the Secretary of State sees fit.

Prohibiting the supply of veterinary medicinal products

41

(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;

(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

(2) The prohibition on supply and the requirement for recall may be confined to specific production batches.

(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART 6 — Mutual recognition and multiple applications

Application for a marketing authorisation where one already exists in a member State

42

(1) If a veterinary medicinal product has already received a marketing authorisation in a member State at the time of application, and the holder of the marketing authorisation applies for a marketing authorisation in Northern Ireland, the following procedure (“the mutual recognition procedure”) applies.

(2) The applicant must submit to the Secretary of State a dossier identical to the one submitted to the competent authority of the member State in which the veterinary medicinal product has been authorised (“the reference member State”).

(3) If there is a marketing authorisation current in more than one member State the applicant must identify which member State is acting as the reference member State.

(4) An applicant applying in more than one member State must supply the Secretary of State with a list of all the States in which the applicant is applying.

(5) The Secretary of State must obtain an assessment report from the reference member State and, where appropriate, an explanation of any extension of the period of data protection.

(6) Within 90 days after receipt of the assessment report, the Secretary of State must, subject to the following provisions, either—

(a) approve the assessment report, the summary of product characteristics, the labelling and the package leaflet, and inform the reference member State accordingly; or

(b) notify the reference member State that they have not been approved, and provide the reference member State with a detailed statement of the reasons.

(7) The Secretary of State may only refuse an application on the grounds of serious risk to human or animal health or the environment.

(8) If the assessment report, the summary of product characteristics, the labelling and the package leaflet are approved, the Secretary of State must ensure that a decision whether or not to grant a marketing authorisation can be made within 30 days of the approval.

(9) If the Secretary of State is notified by the reference member State that—

(a) not all member States concerned have within 90 days approved the assessment report, summary of product characteristics, labelling or package leaflet; and

(b) the reference member State has sent a detailed statement of the reasons to the other member States involved in the application, the applicant and the coordination group for action in accordance with Article 33(3) of Directive 2001/82/EC,

the Secretary of State must within 30 days comply with the decision of the coordination group or, if the coordination group refers the matter to the Agency, the decision of the Commission.

(10) The Secretary of State may grant the marketing authorisation even though not all member States have agreed to grant it, but must revoke or vary the authorisation if this is necessary to comply with the decision of the Commission when it is received.

Application in another member State

43

(1) When the Secretary of State has granted a marketing authorisation for a veterinary medicinal product and is notified by the marketing authorisation holder that the marketing authorisation holder has applied to have that veterinary medicinal product authorised in a member State, the Secretary of State must prepare an assessment report for the product within 90 days of the notification and send it to the member State or States concerned.

(2) If the other member State (or, if there is more than one, all of them) agrees with the assessment report, the summary of product characteristics, the labelling and the package leaflet the Secretary of State need take no further action.

(3) If not all the other member States concerned so agree within a further 90 days the Secretary of State must send a detailed statement setting out why they have disagreed to the other member States, the applicant and the coordination group for action in accordance with Article 33(3) of Directive 2001/82/EC.

(4) The Secretary of State must within 30 days comply with the decision of the coordination group or, if the coordination group refers the matter to the Agency, the decision of the Commission.

Application for a marketing authorisation in multiple member States where a marketing authorisation does not exist in any member State

44

(1) If an applicant wishes to apply for a marketing authorisation in more than one member State, and a marketing authorisation does not exist in any member State for the product (“the decentralised procedure”), the applicant must—

(a) apply simultaneously in all the relevant member States;

(b) submit a dossier to the Secretary of State that is identical to the dossier being submitted to all the other member States;

(d) nominate one of them to act as the reference member State to prepare a draft assessment report and drafts of the summary of product characteristics, labelling and package leaflet for consideration by the other member States (“the concerned member States”).

(2) If the United Kingdom is the reference member State, the Secretary of State must prepare a draft assessment report and drafts of the summary of product characteristics, labelling and package leaflet within 120 days of the receipt of a valid application and must send them to the other concerned member States and to the applicant.

(3) If the United Kingdom is not the reference member State, within 90 days after receipt of the assessment report and drafts of the summary of product characteristics, labelling and package leaflet from the reference member State, the Secretary of State must, subject to the following provisions, either—

(a) approve the assessment report, the summary of product characteristics, the labelling and the package leaflet, and inform the reference member State accordingly; or

(b) notify the reference member State that the Secretary of State will not approve it, and provide the reference member State with a detailed statement of the reasons.

(4) The Secretary of State may only refuse an application on the grounds of serious risk to human or animal health or the environment.

(5) If all the member States involved agree the assessment report, the summary of product characteristics, the labelling and the package leaflet within 90 days, the Secretary of State must ensure that a decision whether or not to grant a marketing authorisation can be made within 30 days.

(6) If, within 90 days, not all the member States have agreed the assessment report, summary of product characteristics, labelling and package leaflet on grounds of a potential serious risk to human or animal health or to the environment, the Secretary of State (if the United Kingdom is the reference member State) must send a detailed statement of the reasons to the other member States involved in the application, the applicant, and the coordination group to act in accordance with Article 33(3) of Directive 2001/82/EC.

(7) If reference has been made to the coordination group by any member State, the Secretary of State must within 30 days comply with the decision of the coordination group or, if the coordination group refers the matter to the Agency, the decision of the Commission.

(8) If the Secretary of State wishes to do so, the Secretary of State may grant the marketing authorisation even though not all member States have agreed to grant it, but must revoke or vary the authorisation if this is necessary to comply with the decision of the Commission when it is received.

PART 7 — Labelling and package leaflets

Approval by the Secretary of State

45

The Secretary of State, when issuing a marketing authorisation, must approve all containers, packaging, labels and package leaflets.

Reference to being authorised

46

A label and package leaflet of an authorised veterinary medicinal product may contain in legible characters the words “UK authorised veterinary medicinal product” or, if the marketing authorisation provides, other wording specified in the authorisation indicating that the product is authorised in the United Kingdom.

Language

47

(1) All labels and package leaflets must be in English, but may contain other languages provided that the information given is identical in all the languages.

(2) This requirement does not apply in the case of a product imported by a veterinary surgeon and administered by or under the responsibility of that same veterinary surgeon.

Labelling with all the information on the immediate packaging

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;

(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.

Products with immediate and outer packaging

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;

(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.

Package leaflets

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;

(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.

Ampoules

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;

(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.

Small containers other than ampoules

52

As regards small immediate packaging containing a single dose, other than ampoules, on which it is impossible to give the required information, all the required information must appear on the outer packaging or outer packaging and package leaflet, but the immediate packaging must be labelled with the batch number and the expiry date and, if there is room, the other information in the preceding paragraph.

Homeopathic remedies

53

(1) A homeopathic remedy registered under these Regulations must be labelled in accordance with this paragraph.

(2) There must be no specific therapeutic indication on the labelling or in any information relating to it.

(3) The labelling (or labelling and package leaflet) must contain the following and no other information—

(a) the words “homeopathic remedy without approved therapeutic indications for veterinary use”;

(b) the scientific name of the stock or stocks followed by the degree of dilution, using the symbols of the pharmacopoeia used (if the homeopathic remedy is composed of more than one stock, the labelling may mention an invented name in addition to the scientific names of the stocks);

(c) the name or company name and the permanent address or registered place of business of the registration holder and of the manufacturer

(d) the method and, if necessary, route of administration;

(e) the expiry date;

(f) the pharmaceutical form;

(g) the contents of the pack;

(h) any special storage precautions;

(i) the target species;

(j) any necessary special warnings;

(k) the batch number; ...

(l) the registration number; and

(m) the withdrawal period, where applicable.

Variations

54

The Secretary of State may permit variations in the above in any individual marketing authorisation if this is necessary for public or animal health purposes or the protection of the environment.

PART 8 — Pharmacovigilance

Qualified persons responsible for pharmacovigilance

55

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Duties relating to the qualified person

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.

Adverse reactions to a veterinary medicinal product administered in the United Kingdom

57

(1) A marketing authorisation holder must act in accordance with this paragraph on learning of any suspected—

(a) adverse event in respect of an animal;

(b) human adverse event; ...

(d) occurrence of an adverse environmental event, or

(e) lack of efficacy,

following the administration of the product ....

(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.

(2) The holder must make a record of what happened.

(3) The holder must without delay and in any event within 30 days report it (electronically if this is practicable) to the Secretary of State.

(4) In addition, the holder must supply to the Secretary of State all relevant veterinary pharmacovigilance information that the holder possesses relating to the event, giving a full description of the incident and a list of all the symptoms using internationally recognised veterinary and medical terminology, either with the report or, if the information becomes available after the report has been sent, as soon after it becomes available as is reasonably practicable.

(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.

(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Adverse reactions to a veterinary medicinal product administered in another country

58

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Periodic safety update reports

59

(1) The marketing authorisation holder must submit to the Secretary of State a summary of pharmacovigilance activity in the form of an annual benefit-risk report for each marketing authorisation in accordance with this paragraph ....

(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3) Following the placing on the market in Great Britain, the marketing authorisation holder must submit a benefit-risk report to the Secretary of State immediately upon request and, in any event, once in the course of every year during the period of validity of the authorisation.

(4) Following the granting of a marketing authorisation, the marketing authorisation holder may apply to the Secretary of State to change the submission dates for the annual benefit-risk reports.

(5) The report must include a statement regarding the benefit-risk balance of the veterinary medicinal product.

(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.

(7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(8) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Release of information by the marketing authorisation holder

60

(1) A marketing authorisation holder must not communicate information relating to pharmacovigilance concerns to veterinary surgeons or the general public in relation to its authorised veterinary medicinal product without giving prior or simultaneous notification to the Secretary of State.

(2) The marketing authorisation holder must ensure that such information is presented objectively and is not misleading.

(3) For the purposes of this paragraph “information” includes any information contained in advertising material.

Action taken on account of pharmacovigilance

61

(1) Where, as a result of the evaluation of veterinary pharmacovigilance data, the Secretary of State considers that a marketing authorisation , or a group of marketing authorisations containing the same active substance, should be—

(a) suspended;

(b) revoked; or

(i) restrict the indications;

(ii) change the distribution category;

(iii) amend the dose;

(iv) add a contraindication; ...

(v) add a new precautionary measure, or

(vi) implement a risk management plan,

the Secretary of State must forthwith inform ... and the marketing authorisation holder.

(2) If urgent action is necessary for protecting human or animal health, the Secretary of State may suspend the marketing authorisation of a veterinary medicinal product....

(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART 9 — Homeopathic remedies

Meaning of “homeopathic remedy”

62

For the purposes of these Regulations, a homeopathic remedy is a veterinary medicinal product (which may contain a number of principles) prepared from homeopathic stocks in accordance with a homeopathic manufacturing procedure described in the European Pharmacopoeia[^f00034] or, if it is not described there, in a pharmacopoeia published by the British Pharmacopoeial Commission ....

Placing a homeopathic remedy on the market in accordance with a registration

63

(1) By way of derogation from the provisions of these Regulations requiring a marketing authorisation for a veterinary medicinal product, a homeopathic remedy may be placed on the market in accordance with a registration by the Secretary of State instead of in accordance with a marketing authorisation if it complies with this paragraph.

(2) It must not be an immunological or, subject to sub-paragraph (2A), a biological product.

(2A) Sub-paragraph (2) does not apply in relation to a homeopathic remedy which is derived from plants.

(3) The route of administration must be either topical or oral and must be as described in the European Pharmacopoeia....

(4) There must be a sufficient degree of dilution to guarantee the safety of the product, and in any event it must not contain more than one part in 10,000 of the mother tincture.

(5) All other provisions relating to marketing authorisations apply in the same way to registrations of a homeopathic remedy.

Application for registration

64

(1) An applicant for registration must submit the following to the Secretary of State—

(a) the scientific name or other name of the homeopathic stock or stocks given in a pharmacopoeia, together with a statement of the various routes of administration, pharmaceutical forms and degree of dilution;

(b) a dossier describing how the homeopathic stock is , or stocks are, obtained and controlled, and justifying their homeopathic use, on the basis of an adequate bibliography;

(c) in the case of a product containing biological substances, a description of the measures taken to ensure the absence of pathogens;

(d) the manufacturing and control file for each pharmaceutical form and a description of the method of dilution and potentisation;

(e) a copy of the manufacturing authorisation for the product;

(f) copies of any registrations ... obtained for the same homeopathic remedy...;

(g) the text which is to appear on the package leaflet, outer packaging and immediate packaging of the homeopathic remedy;

(h) any relevant data concerning the stability of the homeopathic remedy;

(i) the proposed withdrawal period necessary to ensure that the provisions of Regulation (EC) No 470/2009 of the European Parliament and of the Council are complied with together with all necessary justification.

(2) These documents must demonstrate the pharmaceutical quality and the batch-to-batch homogeneity of the products concerned.

(3) In the case of a food-producing animal, if the applicant states in the application that the homeopathic remedy contains an active substance, or has been manufactured using an active substance, that substance must be one for which a maximum residue limit has been established under Regulation (EC) No 470/2009 of the European Parliament and of the Council.

(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Procedure for registration

65

(1) The procedure for registration is the same as the procedure for granting a marketing authorisation in accordance with Part 3, except—

(a) the applicant is not required to provide proof of efficacy;

(b) the product is not required to have a summary of product characteristics;

(2) The procedure for variation, suspension and revocation is the same as for a marketing authorisation.

(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.

Products on the market before 1994

66

A homeopathic remedy that was on the market before 1st January 1994 may be placed on the market without being registered.

Classification

67

The registration must specify the classification of the homeopathic remedy, which must be one of the classifications specified for a veterinary medicinal product in Schedule 3.

Offences

68

It is an offence to fail to comply with—

(za) paragraph 22A(1);

(a) a requirement made under paragraph 27(1);

(b) a request made under paragraph 27(2);

(d) a requirement made under paragraph 28(3);

(da) paragraph 28(4);

(e) paragraph 29(3);

(f) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(g) paragraph 31(1) or (2);

(h) a request made under paragraph 31(3);

(i) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(j) a prohibition or requirement made under paragraph 41(1);

(ja) a restriction or requirement made under paragraph 41A;

(jb) a prohibition made under paragraph 41B;

(k) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(l) paragraph 56;

(la) paragraph 56A;

(lb) paragraph 56B;

(lc) paragraph 56C;

(m) paragraph 57;

(n) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(o) paragraph 59; or

(p) paragraph 60.

SCHEDULE 2 — The manufacture of veterinary medicinal products

PART 1 — Manufacturing authorisations

Application

1

(1) No person may carry out any activity mentioned in sub-paragraph (2) otherwise than in accordance with an authorisation granted under this Schedule (a “manufacturing authorisation”).

(2) For the purposes of sub-paragraph (1) the activities are—

(a) the manufacture of veterinary medicinal products (whether for use in Great Britain or another country);

(b) the carrying out of any part of the manufacturing process or of bringing a veterinary medicinal product to its final state, including the processing, assembling, packaging or repackaging, labelling or relabelling, storing, sterilising or releasing for supply of a veterinary medicinal product;

Time limits

2

(1) An application for a manufacturing authorisation must be submitted to the Secretary of State electronically and must include the matters mentioned in sub-paragraph (2).

(2) For the purposes of sub-paragraph (1) the matters are—

(a) the name of the person who will hold the manufacturing authorisation and that person’s address or registered place of business;

(b) the names and addresses of the sites (including any site where work is undertaken on behalf of the proposed holder under contract) where—

(i) each stage of the manufacturing process or of bringing a veterinary medicinal product to its final state, including processing, assembling, packaging or repackaging, labelling or relabelling, storing or sterilising, is carried out;

(ii) any imported products are held; or

(iii) any control or batch release is carried out;

(c) a description of the veterinary medicinal products or pharmaceutical forms proposed to be manufactured or imported under the authorisation;

(d) the name of the proposed qualified person (manufacture) for the purposes of paragraph 9;

(e) the name of the person proposed to have responsibility for quality control;

(f) the qualifications and a description of the relevant experience of the person proposed to have responsibility for quality control;

(g) the name of the person proposed to have responsibility for production;

(h) the qualifications and a description of the relevant experience of the person proposed to have responsibility for production;

(i) a declaration that the applicant complies with good manufacturing practice and any relevant legislation; and

(j) a declaration that any site mentioned in paragraph (b) is ready for inspection.

Granting the authorisation

3

(1) The Secretary of State must process an application mentioned in paragraph 2 within 90 days of validating the application.

(2) The Secretary of State must inspect the sites mentioned in paragraph 2(2)(b) within 90 days of validating the application.

(3) The Secretary of State must grant the manufacturing authorisation if satisfied, following the inspection mentioned in sub-paragraph (2), that—

(a) the sites are suitable for the intended purposes;

(b) the applicant has—

(i) suitable and sufficient staff, technical equipment and facilities for the proposed activities; and

(ii) a documented quality management system in place.

(4) Where the Secretary of State is not satisfied in relation to one or more of the matters mentioned in sub-paragraph (3), the Secretary of State may—

(a) reject the application; or

(b) grant a conditional manufacturing authorisation for a period specified by the Secretary of State until the deficiency has been addressed.

(5) The Secretary of State may extend the period for which a conditional manufacturing authorisation is granted under sub-paragraph (4)(b).

(6) Where a conditional manufacturing authorisation is granted under sub-paragraph (4)(b) and the deficiency is addressed within the specified period to the satisfaction of the Secretary of State, the authorisation continues to have effect without those conditions.

The authorisation

4

(1) The manufacturing authorisation must specify—

(a) the types of veterinary medicinal products and pharmaceutical forms that may be manufactured , controlled or imported;

(b) the name and address of the site where the products are to be manufactured or controlled, or to which they are to be imported;

(d) the address of the premises to which it relates;

(e) the names of all qualified persons nominated to act under this Schedule.

(2) It may specify that different activities must be carried out in different premises or parts of premises, and may require the holder of the manufacturing authorisation to restrict access to premises or parts of premises to persons carrying out activities there.

(3) The holder of a manufacturing authorisation must notify the Secretary of State, and if necessary apply for a variation of the authorisation, before making a material alteration to the premises or facilities used under the authorisation, or to the operations for which they are used.

Suspension, variation or revocation of the authorisation

5

(1) The Secretary of State may suspend, vary or revoke a manufacturing authorisation if the holder—

(a) has not complied with these Regulations;

(b) has manufactured a veterinary medicinal product not authorised by the manufacturing authorisation;

(d) no longer has suitable premises or equipment.

(e) has failed to carry out the activity specified in the authorisation for a period of five years or more; or

(f) has not paid any fee required under these Regulations

(2) The Secretary of State may also suspend, vary or revoke the authorisation on being satisfied that the qualified person (manufacture), the person responsible for quality control or the person with responsibility for production is not fulfilling that person’s duties under these Regulations.

(3) In particular, the Secretary of State may—

(a) suspend the manufacture or import of veterinary medicinal products;

(b) suspend, revoke or vary the manufacturing authorisation for one or more pharmaceutical forms;

(c) suspend, revoke or vary the manufacturing authorisation for one or more activities in one or more manufacturing sites.

Inspection of premises

6

(1) The Secretary of State must, from time to time, inspect sites authorised under paragraph 3, basing the frequency of the inspection on the risks associated with each site’s history and the nature of the products handled at the sites.

(2) Within 90 days after an inspection, the Secretary of State must issue a certificate of good manufacturing practice to the manufacturer if the inspection establishes that the manufacturer has complied with the requirements of these Regulations in respect of the site to which the inspection relates.

(2A) Where the Secretary of State does not consider that compliance is established after inspection in accordance with sub-paragraph (2), the Secretary of State must enter that fact in the register mentioned in paragraph 12(a).

(2B) The Secretary of State may carry out an inspection on a site occupied by a manufacturer established in a country other than the United Kingdom notwithstanding any arrangements that may have been entered into between the United Kingdom and that country.

(2C) The importer of a veterinary medicinal product must ensure before importation that the manufacturer of that product has—

(a) a valid certificate of good manufacturing practice issued by the Secretary of State; or

(b) an equivalent certificate issued by a regulatory authority—

(i) with which the Secretary of State has an agreement or arrangement for such purposes; or

(ii) which the Secretary of State considers to have demonstrated equivalent standards to those in the United Kingdom.

(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Report following inspection

7

(1) After each inspection of manufacturing premises, the inspector must make a written report to the Secretary of State on whether the principles and guidelines on good manufacturing practice and the conditions of these Regulations are being complied with.

(2) The Secretary of State must inform the inspected manufacturer of the content of such reports.

Duties on the holder of a manufacturing authorisation

8

(1) A holder of a manufacturing authorisation must ensure that the veterinary medicinal product is manufactured in accordance with the marketing authorisation.

(2) The holder must have permanently at the holder’s disposal the services of—

(a) staff complying with any legal requirements in relation to manufacture of veterinary medicinal products; and

(b) at least one qualified person (manufacture).

(2A) The holder must place at the disposal of any qualified person (manufacture) all necessary documents, premises and technical and other facilities in order to enable that person to discharge their duties as the qualified person.

(2B) Where any qualified person (manufacture) ceases to be available to provide services to the holder, the holder must give notice of the fact to the Secretary of State—

(a) at least 30 days in advance of the person’s ceasing to be so available; or

(b) where such notice is not possible, at the earliest opportunity.

(3) The holder must—

(a) comply with good manufacturing practice and have a valid certificate of good manufacturing practice;

(b) use as starting materials only active substances which have been manufactured in accordance with good manufacturing practice and distributed in accordance with good distribution practice for active substances;

(c) verify that each manufacturer, distributor or importer from whom the holder obtains active substances and to which paragraph 26 applies is registered with the Secretary of State under that paragraph;

(d) carry out audits based on a risk assessment in relation to the manufacturers, distributors and importers from which the holder obtains active substances;

(e) have in place a system of quality assurance and quality control; and

(f) give to the Secretary of State, on request, proof of any control test specified by the Secretary of State which has been carried out on the veterinary medicinal product or the constituents and intermediate products of the manufacturing process in accordance with the data submitted in support of the application for the marketing authorisation.

(3A) The holder of a manufacturing authorisation must inform the Secretary of State and the holder of any relevant marketing authorisation where the holder obtains information that veterinary medicinal products which fall within the scope of its manufacturing authorisation are falsified, or are suspected of being falsified, irrespective of whether those products were distributed within the legal supply chain or by illegal means.

(4) A holder who makes up a bulk package of veterinary medicinal products must ensure that the package is labelled, in a way that the label is clearly visible and legible, with—

(a) the name of the veterinary medicinal product, its strength as shown in the summary of product characteristics and its pharmaceutical form;

(b) the batch number;

(d) any storage requirements; and

(e) any other warning necessary for the safe handling of the package.

(5) A holder must keep an adequate number of representative samples of each batch of a veterinary medicinal product in stock at least until the expiry date of the batch, and must submit any such sample to the Secretary of State if required in writing to do so.

(6) A holder must keep detailed records of all veterinary medicinal products which the holder supplies.

Qualified persons for manufacture

9

(1) The Secretary of State may appoint as a qualified person (manufacture) any person (including the manufacturer of a veterinary medicinal product) who is—

(a) a member of the Royal Pharmaceutical Society or registered with the Pharmaceutical Society of Northern Ireland;

(b) a Chartered Chemist or a Fellow, Member or Associate Member of the Royal Society of Chemistry; or

(1A) For the purposes of sub-paragraph (1), a person has sufficient practical experience if they have been engaged in one or more of the activities mentioned in sub-paragraph (1B) for at least two years in the provision of services to the holder of a manufacturing authorisation.

(1B) For the purposes of sub-paragraph (1A) the activities are—

(a) quality assurance of medicinal products;

(b) qualitative analysis of medicinal products;

(1C) The Secretary of State may treat the reference in sub-paragraph (1A) to two years of practical experience as a reference to—

(a) one year, where the person’s formal course of study lasted for at least five years;

(b) six months, where the person’s formal course of study lasted for at least six years.

who qualified on the basis of a formal course of study lasting not less than three years full-time or equivalent and who has sufficient practical experience to carry out the duties under this Schedule.

(2) The Secretary of State may exceptionally appoint a person who is not a member of one of those institutions to act as a qualified person (manufacture) on being satisfied that that person has the educational qualifications or practical experience to carry out the duties under this Schedule.

Refusal or revocation of appointment

10

The Secretary of State may refuse , revoke, suspend or vary an appointment if the Secretary of State is not satisfied that a person has fulfilled or will fulfil duties under these Regulations.

Duties on a qualified person

11

(1) The qualified person (manufacture) must ensure that each batch of veterinary medicinal product manufactured under that person’s responsibility is manufactured and checked in compliance with these Regulations and in accordance with the data submitted in support of the application for the marketing authorisation.

(2) If a manufacturer imports a veterinary medicinal product from another country,..., the qualified person (manufacture) must ensure that, following importation, each production batch imported is fully tested ..., including a full qualitative analysis, a quantitative analysis of at least all the active substances and all the other tests or controls necessary to ensure the quality of a veterinary medicinal product is in accordance with the requirements of the marketing authorisation.

(3) Sub-paragraph (2) does not apply where the exporting country has demonstrated equivalent standards to those of the United Kingdom or where appropriate arrangements have been made ...with the exporting country to ensure that the manufacturer of the veterinary medicinal product applies standards of good manufacturing practice at least equivalent to those laid down in Commission Directive 91/412/EEC and to ensure that the controls in sub‑paragraph(2) have been carried out in the exporting country.

(4) At each stage of manufacture, including release for sale, the qualified person (manufacture) must certify in writing that all control tests required under the marketing authorisation have been carried out, and that the production batch complies with the marketing authorisation.

Register

12

The Secretary of State must maintain and publish a register of—

(a) holders of manufacturing authorisations; and

(b) qualified persons (manufacture) appointed under paragraph 9(2).

Test sites

13

(1) The Secretary of State may authorise a site to act as a test site to carry out contract testing for a holder of a manufacturing authorisation.

(2) The site must have a current certificate of good manufacturing practice.

(2A) The site must be specified in an existing manufacturing authorisation.

(3) Inspection of the site is the same as for a manufacturing authorisation.

PART 2 — Authorisation of autogenous vaccines, blood-banks, stem cell centres and products manufactured under the cascade

Authorisation to manufacture autogenous vaccines

14

(1) The Secretary of State may authorise a person to—

(a) manufacture—

(i) autogenous vaccines; or

(ii) an unauthorised veterinary medicinal product for administration under the cascade;

(b) collect, store and supply blood in connection with the treatment of non-food animals;

(c) collect, store and supply blood constituents obtained by the physical separation of donor blood into different fractions within a closed bag system, for the treatment of non-food animals; or

(d) collect, process and store stem cells for use as an autologous treatment in non-food animals,

and may authorise sites for the purpose of carrying out those activities by that person.

(2) A single authorisation under sub-paragraph (1) may confer permission to carry out the activities mentioned in both paragraph (b) and (c) of that sub-paragraph.

(3) In this paragraph, a “closed bag system” means a system in which the blood pack assembly is manufactured under clean conditions, sealed to the external environment and sterilised.

Types of authorisation

15

No person may carry out any activity mentioned in paragraph 14 otherwise than—

(a) in accordance with an authorisation mentioned in that paragraph; or

(b) pursuant to paragraph 1(2) of Schedule 4 (administration under the cascade).

Labelling

16

In order to be authorised the site mentioned in paragraph 14(1) must be under the supervision of a named person responsible for release (a “PRR”) who in the opinion of the Secretary of State has sufficient qualifications and experience to manufacture the product safely.

Records

17

(1) An applicant for authorisation under paragraph 14 must, at least two months before commencing an activity mentioned in that paragraph, submit the following to the Secretary of State—

(a) the name and address of the proposed holder of the authorisation;

(b) a description of the activity in which the applicant for authorisation proposes to be engaged;

(c) particulars (including the name and address) in relation to the site at which the relevant activity is to be carried out (whether in the occupation of the proposed holder or otherwise) and a description of the technical equipment on the site;

(d) particulars in relation to the qualifications and experience of the proposed PRR who will supervise the activities at the site.

(2) The application must include a declaration that the applicant will comply with the requirements of these Regulations and confirmation that the site is ready for inspection.

(3) Before granting an authorisation in relation to a site, the Secretary of State must be satisfied that the production process carried out there will produce a consistent, safe product and, in the case of a blood bank or a stem cell centre, that the welfare of the animals involved in the processes will be respected.

Adverse reactions

18

(1) No person may collect blood for the purposes of a non-food animal blood bank other than a veterinary surgeon or a person acting under the responsibility of a veterinary surgeon.

(2) The holder of an authorisation to carry out an activity under paragraph 14(1)(b) or (c) may only supply blood or blood constituents to a veterinary surgeon.

(3) No person other than a veterinary surgeon or someone acting under a veterinary surgeon’s responsibility may administer blood to a non-food producing animal.

(4) No person may administer blood to a food-producing animal.

Inspection of premises

19

(1) No person may collect stem cells for the purposes of treating animals other than a veterinary surgeon or a person acting under the responsibility of a veterinary surgeon.

(2) No person may collect stem cells from embryonic tissues.

(3) No person may administer any product grown from stem cells to a food-producing animal.

PART 3 — Authorisation of blood banks

Authorisation of blood banks

20

(1) Subject to sub-paragraph (2), no person may manufacture a product for administration under the cascade that is the pharmaceutical equivalent of an authorised veterinary medicinal product.

(2) The Secretary of State may authorise the manufacture of a product notwithstanding sub-paragraph (1) where there is difficulty in relation to the supply of the authorised veterinary medicinal product.

(3) The holder of an authorisation under paragraph 14(1)(a)(ii) may not supply a product manufactured in accordance with that sub-paragraph other than to a veterinary surgeon who has prescribed the product under the cascade.

(4) The holder of an authorisation under paragraph 14(1)(a)(ii) must—

(a) provide a list of products manufactured in accordance with that sub-paragraph to the Secretary of State annually or at the request of the Secretary of State;

(b) provide sales data for products supplied under sub-paragraph (3) at the request of the Secretary of State.

(5) For the purposes of this paragraph, a product is the pharmaceutical equivalent of an authorised veterinary medicinal product if—

(a) it has the same qualitative and quantitative composition in active substances; and

(b) it has the same pharmaceutical form.

Supply and administration of blood from a blood bank

21

The Secretary of State may by notice suspend, vary or revoke an authorisation under paragraph 14 if the Secretary of State is satisfied that—

(a) the holder of the authorisation no longer uses fit and proper processes;

(b) the site at which the activity takes place is not suitable;

(d) the PRR has not carried out adequately the PRR’s responsibilities under these Regulations;

(e) in the case of a person authorised under paragraph 14(1), that person has manufactured a veterinary medicinal product pursuant to that authorisation that is not within its scope;

(f) the holder has not conducted an activity relating to the authorisation for five years or more;

(g) the holder has not paid any fee required under these Regulations; or

(h) the holder has not complied with any other provision in these Regulations.

Labelling

22

(1) The holder of an authorisation under paragraph 14 must ensure that every container used is labelled with—

(a) a precise description of the product;

(b) the date on which the product was produced;

(d) the address of the site named under the authorisation and its authorisation number;

(e) the instructions for use;

(f) the expiry date;

(g) any necessary warnings;

(h) in the case of an autogenous vaccine or an unauthorised veterinary medicinal product for administration under the cascade, the name of the veterinary surgeon who ordered the product;

(i) in the case of blood or a stem cell product—

(i) the identification of the donor animal; and

(ii) the date of collection.

(2) In the case of blood or blood constituents there must be no specific therapeutic indication on the label or on any information related to the product.

(3) In the case of an unauthorised veterinary medicinal product for administration under the cascade the words “this veterinary medicinal product does not hold a marketing authorisation” must appear on the label.

Records

23

The holder of an authorisation under paragraph 14 must, as soon as is reasonably practicable after the product is supplied, in addition to the expiry date of the product, record the following—

(a) in the case of an unauthorised veterinary medicinal product for administration under the cascade—

(i) the name and address of the veterinary surgeon who ordered the veterinary medicinal product;

(ii) a precise description of the product;

(iii) the date of production;

(iv) the date of supply to the veterinary surgeon;

(b) in the case of stem cells or blood—

(i) the identification of the source animal;

(ii) the name of the veterinary surgeon who collected the product (or under whose responsibility it was collected);

(iii) the date of collection of the product;

(iv) the date that the product was used or if the product was supplied to another veterinary surgeon, the name and address of that veterinary surgeon and the date the product was supplied;

(i) the name and address of the veterinary surgeon who ordered the vaccine;

(ii) the identification of the source animal;

(iii) the date of supply to the veterinary surgeon,

and must keep the records for at least five years.

Inspection of premises

24

The holder of an authorisation under paragraph 14 must notify the Secretary of State of any adverse event in relation to a product produced by that person under that authorisation within 30 days of learning of the event.

PART 4 — Authorisation of manufacturers of products for administration under the cascade

Authorisation to manufacture products for administration under the cascade

25

The Secretary of State must inspect any site authorised under paragraph 14, basing the frequency of the inspection on the risks associated with each site’s history and the nature of the products handled at the site.

Labelling

26

(1) No person may manufacture, import or distribute an active substance unless the person is registered in the register maintained under sub-paragraph (2).

(2) The Secretary of State must establish and maintain a register of manufacturers, importers and distributors of active substances and the sites occupied by them for the purposes of manufacturing or holding active substances.

Records

27

(1) An applicant for registration under paragraph 26 must, at least two months before commencing an activity mentioned in paragraph 26(1) or, in the case of an existing manufacturer, within two months of the date on which this provision comes into force, submit the following to the Secretary of State—

(a) the name and address of the proposed registration holder;

(b) the name of the relevant active substance;

(d) particulars in relation to the site at which the relevant active substance is to be manufactured or held (as the case may be).

(2) Information may be submitted to the Secretary of State pursuant to sub-paragraph (1) prior to the date on which this provision comes into force, and in such a case—

(a) as regards an applicant for registration who is not an existing manufacturer, the relevant period of two months is to be treated as having started on the date of submission;

(b) as regards an applicant for registration who is an existing manufacturer, the information is to be treated as having been submitted within the relevant period of two months.

Adverse reactions

28

A manufacturer, importer or distributor of active substances must comply with good manufacturing practice or good distribution practice, as applicable.

Inspection of premises

29

(1) A person registered under paragraph 26 must immediately inform the Secretary of State on receipt of any new information that might adversely affect the quality and safety of the active substance.

(2) A person registered under paragraph 26 must immediately inform the Secretary of State of any prohibition or restriction in relation to the active substance imposed by the competent authorities of any country other than the United Kingdom in which the active substance is authorised.

PART 5 — Authorisation of equine stem cell centres

Authorisation of stem cell centres

30

The Secretary of State may, from time to time, inspect sites registered under paragraph 26, basing the frequency of the inspections on the risks associated with each site’s history and the nature of the substances handled at the site.

Supply and administration of stem cells

31

(1) After each inspection of a site for the purposes of this Part, the inspector must make a written report to the Secretary of State on whether the requirements in this Part are being complied with.

(2) The Secretary of State must inform the inspected registered person of the content of such reports.

Labelling

32

It is an offence to fail to comply with—

(a) paragraph 1;

(b) paragraph 4(3);

(d) paragraph 11;

(e) paragraph 15;

(f) paragraph 18;

(g) paragraph 19;

(h) paragraph 20(1), (3) or (4);

(i) paragraph 22;

(j) paragraph 23;

(k) paragraph 24;

(l) paragraph 26;

(m) paragraph 28;

(n) paragraph 29.

Records

33

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Inspection of premises

34

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Offences

35

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SCHEDULE 3 — Classification and supply, wholesale dealers and sheep dip

PART 1 — Classification and supply of authorised veterinary medicinal products

Classification of veterinary medicinal products

1

(1) There shall be the following categories of authorised veterinary medicinal products—

(a) Prescription Only Medicine–Veterinarian (abbreviated to POM-V);

(b) Prescription Only Medicine–Veterinarian, Pharmacist, Suitably Qualified Person (abbreviated to POM-VPS);

(d) Authorised Veterinary Medicine–General Sales List (abbreviated to AVM-GSL).

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