The Veterinary Medicines Regulations 2013

PART 1U.K.Introduction

Title and commencementU.K.

1.  These Regulations may be cited as the Veterinary Medicines Regulations 2013 and come into force on 1st October 2013.

Definition of “veterinary medicinal product”, interpretation and scopeE+W+S

2.—(1) In these Regulations “veterinary medicinal product” means—

(a)any substance or combination of substances presented as having properties for treating or preventing disease in animals; or

(b)any substance or combination of substances that may be used in, or administered to, animals with a view either to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis [F1; or

(c)any substance or combination of substances that may be used for the purpose of euthanising an animal].

(2) In these Regulations—

[F2“active substance” means any substance or mixture of substances intended to be used in the manufacture of a veterinary medicinal product, that, when used in its production, is responsible for the activity of that veterinary medicinal product;

“adverse environmental event” means an event where a non-target organism, population or ecosystem is adversely affected as a result of exposure to a veterinary medicinal product, its active substances or its metabolites present in soil, water or animal remains;

“adverse event” means any observation in animals that occurs after any use of a veterinary medicinal product, whether or not considered to be product-related, that is unfavourable and unintended;]

F3...

[F2“advertising” means, in relation to veterinary medicinal products, the making of a representation in any form in connection with those products in order to promote their supply, distribution, sale, prescription or use and includes any action taken for this purpose by way of the supply of samples or by means of sponsorship, and “advertise” and “advertisement” are to be construed accordingly;]

F4...

“animal” means all animals other than man and includes birds, reptiles, fish, molluscs, crustacea and bees;

[F2“antibiotic” means any substance with a direct action on bacteria that is used for treatment or prevention of infections or infectious diseases;

“antimicrobial” means any substance with a direct action on micro-organisms that is used for treatment or prevention of infections or infectious diseases and includes antibiotics, antivirals, antifungals and antiprotozoals;

“antimicrobial resistance” means the ability of micro-organisms to survive or to grow in the presence of a concentration of an antimicrobial agent which is usually sufficient to inhibit or kill micro-organisms of the same species;

“ATCvet code” means, in relation to a veterinary medicinal product, the code issued in respect of that product by the World Health Organization Collaborating Centre for Drug Statistics Methodology, and published by that body in the ATCvet index;

“benefit-risk balance” means, in relation to a veterinary medicinal product, an evaluation of the positive effects of the veterinary medicinal product in relation to the following risks relating to the use of that product—

“biological substance” means a substance that is produced by or extracted from a biological source and that needs for its characterisation and the determination of its quality a combination of physical, chemical and biological testing, together with knowledge of the production process and its control;

“biological veterinary medicinal product” means a veterinary medicinal product where an active substance is a biological substance;]

“the cascade” has the meaning given in paragraph 1 of Schedule 4;

F3...

F4...

[F2“complementary feedingstuffs” means compound feed which has a high content of certain substances and which, by reason of its composition, is sufficient for a daily ration only if used in combination with other feed;

“complete feed” means compound feed which, by reason of its composition, is sufficient for a daily ration;

“compound feed” means a mixture of at least two feed additives for oral animal-feeding in the form of complete or complementary feed;

“daily ration” means the average total quantity of feedingstuffs, calculated on a moisture content of 12%, required daily by an animal of a given species, age category and yield, to satisfy all its nutritional needs;

“excipient” means any constituent of a veterinary medicinal product other than an active substance;]

F3...

[F2“feed additives” means substances, micro-organisms or preparations, other than feed material and intermediate feedingstuff, which are intentionally added to feed or water in order to perform, in particular, one or more of the functions mentioned in Schedule 5;

“feed materials” means products of vegetable or animal origin whose principal purpose is to meet animals’ nutritional needs, and which are intended for use in oral animal feed either directly, or after processing, or in the preparation of compound feed, or as a carrier of intermediate feedingstuffs;

“feedingstuff” means any substance or product, including additives, whether processed, partially processed or unprocessed, intended to be used for oral feeding to animals;

“generic veterinary medicinal product” means a veterinary medicinal product which has the same qualitative and quantitative composition of active substances and the same pharmaceutical form as a reference veterinary medicinal product;

“genetically modified organism” or “GMO” means a genetically modified organism for the purposes of the GMO Deliberate Release Regulations;

“GMO Deliberate Release Regulations” means—

“good distribution practice” means that part of quality assurance which ensures that products are consistently stored, supplied and controlled in accordance with the quality standards appropriate for their intended use and as required by the applicable marketing authorisation or product specifications;

“good manufacturing practice” means that part of quality assurance which ensures that products are consistently produced and controlled in accordance with the quality standards appropriate for their intended use and as required by the applicable marketing authorisation or product specifications;]

“horse passport” means [F5a passport issued in accordance with the provisions of Commission Regulation (EC) No 504/2008 implementing Council Directives 90/426/EEC and 90/427/EEC as regards] [F5an identification document which complies with Commission Implementing Regulation (EU) 2015/262 laying down rules pursuant to Council Directives 90/427/EEC and 2009/156/EC as regards the] methods for the identification of equidae(4);

[F2“human adverse event” means a reaction that is noxious and unintended and that occurs in a human being following exposure to a veterinary medicinal product;]

“immunological veterinary medicinal product” means a veterinary medicinal product [F6intended to be] administered to [F7an animal] in order to produce active or passive immunity or to diagnose [F8its state] of immunity;

[F2“improvement notice” has the meaning given in regulation 38(1);

“intermediate feedingstuffs” means a feed which is not ready to be directly fed to animals without further processing, consisting of a homogenous mixture of one or more of the following—

with feed materials or compound feed, exclusively intended to be used for the manufacture of a complete feed;

“lack of efficacy” means the apparent inability of an authorised veterinary medicinal product to have the expected efficacy in an animal, whether or not the product was used in accordance with the summary of product characteristics;

“limited market” means a market for one of the following types of veterinary medicinal product—

“manufacturing authorisation”, except as regards Schedule 7, has the meaning given in paragraph 1 of Schedule 2;

“medicated feedingstuffs” means a feed which is ready to be directly fed to animals without any further processing, consisting of a homogenous mixture of one or more medicinal premixes or intermediate feedingstuff with feed materials or compound feed;

“medicinal premix” means a veterinary medicinal product authorised for incorporation into feedingstuffs;

“metaphylactic purposes”, in relation to the administration of a veterinary medicinal product, means the administration of the veterinary medicinal product to a group of animals after a diagnosis of clinical disease in part of the group has been established, with the aim of treating the clinically sick animals and controlling the spread of the disease to animals in close contact and at risk and which may already be subclinically infected;

“novel therapy” means a veterinary medicinal product which is considered to be in a nascent field in veterinary medicine, including a product of a type not previously authorised, and “novel therapies” is to be construed accordingly;

“person responsible for release” and “PRR” have the meaning given in paragraph 16 of Schedule 2;

“pharmacologically equivalent” means containing an active substance in the same proportions, in the same dosage form and concentration (in the case of a liquid dose) and meeting the same or comparable standards in relation to the clinical needs of a patient at the time of use;

“pharmacovigilance” means the science and activities relating to the detection, assessment, understanding and prevention of suspected adverse events or any other problem related to a medicinal product;

“pharmacovigilance system master file” means a detailed description of the pharmacovigilance system used by the holder of the marketing authorisation in relation to one or more authorised veterinary medicinal products;

“principles of good laboratory practice” has the meaning given in regulation 2(1) of the Good Laboratory Practice Regulations 1999;

“prophylactic purposes”, in relation to the administration of a veterinary medicinal product, means the administration of the veterinary medicinal product to an animal or group of animals before clinical signs of disease in order to prevent the occurrence of disease or infection;

“qualified person (manufacture)”, in relation to a veterinary medicinal product, means a person appointed under paragraph 9 of Schedule 2 with responsibility for that product;

“qualified person (pharmacovigilance)” has the meaning given in paragraph 56(9) of Schedule 1;

“reference veterinary medicinal product” has the meaning given in paragraph 10(1) of Schedule 1;]

[F9“Regulation (EC) No 178/2002” means Regulation (EC) No 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety(2);]

[F10“Regulation (EC) No 1831/2003” means Regulation (EC) No 1831/2003 of the European Parliament and of the Council on additives for use in animal nutrition(3);]

F11...

[F12“Regulation (EC) No 183/2005” means Regulation (EC) No 183/2005 of the European Parliament and of the Council laying down requirements for feed hygiene(5);]

“Regulation (EC) No 470/2009 of the European Parliament and of the Council” means Regulation (EC) No 470/2009 of the European Parliament and of the Council laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin(5);

“Regulation (EC) No 767/2009 of the European Parliament and of the Council” means Regulation (EC) No 767/2009 of the European Parliament and of the Council on the placing on the market and use of feed in relation to feedingstuffs containing specified feed additives(6) [F13, as last amended by Regulation (EU) No 2017/2279];

[F14“Regulation (EU) 2017/625” means Regulation (EU) 2017/625 of the European Parliament and of the Council on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products;]

F3...

[F2“serious adverse event” means an adverse reaction that results in death, is life-threatening, results in significant disability or incapacity, is a congenital anomaly or birth defect, or that results in permanent or prolonged signs in the animals treated;

“signal management process” has the meaning given in paragraph 56C of Schedule 1;]

[F15“strength” means the content of active substances in a veterinary medicinal product, expressed quantitatively per dosage unit, per unit of volume or per unit of weight according to the pharmaceutical form;]

[F2“wholesale dealing” means all activities consisting of procuring, holding, supplying, distributing or exporting veterinary medicinal products whether for profit or not, but does not include retail supply of veterinary medicinal products to the public;

“wholesale qualified person” has the meaning given in paragraph 17(2)(d) of Schedule 3;

“withdrawal period” means the minimum period under normal conditions of use between the last administration of a veterinary medicinal product to an animal and the production of foodstuffs from that animal which is necessary to ensure that such foodstuffs do not contain residues in quantities harmful to public health]

[F16(2A) In these Regulations, a biological veterinary medicinal product is treated as a single product even when more than one solvent is used in the preparation of different preparations of the final product (which may be for administration by different routes or methods).]

F17(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F18(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(5) For the avoidance of doubt, these Regulations apply to veterinary medicinal products irrespective of whether or not there is other legislation controlling a product.

Definition of “veterinary medicinal product”, interpretation and scopeN.I.

2.—(1) In these Regulations “veterinary medicinal product” means—

(a)any substance or combination of substances presented as having properties for treating or preventing disease in animals; or

(b)any substance or combination of substances that may be used in, or administered to, animals with a view either to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.

(2) In these Regulations—

“adverse reaction” means a reaction to a veterinary medicinal product that is harmful and unintended and that occurs at doses normally used in animals for the prophylaxis, diagnosis or treatment of disease or to restore, correct or modify a physiological function;

“the Agency” means the European Medicines Agency established by Regulation (EC) No 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency(1);

“animal” means all animals other than man and includes birds, reptiles, fish, molluscs, crustacea and bees;

“the cascade” has the meaning given in paragraph 1 of Schedule 4;

“Commission Regulation (EC) No 1234/2008” means Commission Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products(2) [F91, as last amended by Regulation (EU) No 712/2012](1);

“Commission Regulation (EU) No 37/2010” means Commission Regulation (EU) No 37/2010 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin(3);

“extension variation” has the same meaning as “Extension of a marketing authorisation” in Article 2 of Commission Regulation EC No 1234/2008;

“horse passport” means a passport issued in accordance with the provisions of Commission Regulation (EC) No 504/2008 implementing Council Directives 90/426/EEC and 90/427/EEC as regards methods for the identification of equidae(4);

“immunological veterinary medicinal product” means a veterinary medicinal product administered to animals in order to produce active or passive immunity or to diagnose the state of immunity;

[F92“Regulation (EC) No 178/2002” means Regulation (EC) No 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety(2);]

[F93“Regulation (EC) No 1831/2003” means Regulation (EC) No 1831/2003 of the European Parliament and of the Council on additives for use in animal nutrition(3);]

F94...

[F95“Regulation (EC) No 183/2005” means Regulation (EC) No 183/2005 of the European Parliament and of the Council laying down requirements for feed hygiene(5);]

“Regulation (EC) No 470/2009 of the European Parliament and of the Council” means Regulation (EC) No 470/2009 of the European Parliament and of the Council laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin(5);

“Regulation (EC) No 767/2009 of the European Parliament and of the Council” means Regulation (EC) No 767/2009 of the European Parliament and of the Council on the placing on the market and use of feed in relation to feedingstuffs containing specified feed additives(6) [F96, as last amended by Regulation (EU) No 2017/2279];

[F97“Regulation (EU) 2017/625” means Regulation (EU) 2017/625 of the European Parliament and of the Council on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products;]

“risk-benefit balance” means an evaluation of the positive therapeutic effects of the veterinary medicinal product in relation to—

“strength” means the amount of active substances in a dosage unit or unit of volume or weight.

(3) In these Regulations references to types of variation are to those specified in Commission Regulation (EC) No 1234/2008;

(4) In these Regulations any reference to a member State is a reference to a member State of the European Union and Norway, Iceland and Liechtenstein.

(5) For the avoidance of doubt, these Regulations apply to veterinary medicinal products irrespective of whether or not there is other legislation controlling a product.

Products to which these Regulations do not applyU.K.

3.—(1) These Regulations do not apply to a veterinary medicinal product based on radio-active isotopes.

(2) They do not apply in relation to a product intended for administration in the course of a procedure licensed under the Animals (Scientific Procedures) Act 1986(7), except that, if the animals are to be put into the human food chain, the only products that may be administered to the animals are—

(a)authorised veterinary medicinal products administered in accordance with their marketing authorisation; or

(b)products administered in accordance with an animal test certificate granted under paragraph 9 of Schedule 4.

PART 2U.K.Authorised veterinary medicinal products

Placing a veterinary medicinal product on the marketE+W+S

4.—[F19(1) No person may place a veterinary medicinal product on the market unless the Secretary of State has—

(a)as regards a product to which Schedule 1B applies, issued a QNIG certificate in respect of that product;

(b)otherwise, granted a marketing authorisation in respect of that product.]

(2) No person may certify data in relation to an application for a marketing authorisation or in relation to an existing marketing authorisation if they know that those data are false, or do not believe that they are accurate.

(3) Schedule 1 (marketing authorisations) has effect.

[F20(4) Schedule 1A (converted EU marketing authorisations) has effect.]

[F21(5) Schedule 1B (Northern Ireland qualifying good marketing authorisations) has effect. ]

Placing a veterinary medicinal product on the marketN.I.

4.—(1) No person may place a veterinary medicinal product on the market unless that product has been granted a marketing authorisation by the Secretary of State or the Agency.

(2) No person may certify data in relation to an application for a marketing authorisation or in relation to an existing marketing authorisation if they know that those data are false, or do not believe that they are accurate.

(3) Schedule 1 (marketing authorisations) has effect.

Manufacture of veterinary medicinal productsU.K.

5.—(1) The holder of a marketing authorisation must ensure that every stage in the manufacture of the veterinary medicinal product is carried out by the manufacturer specified in the marketing authorisation(8).

(2) Schedule 2 (the manufacture of veterinary medicinal products) has effect.

[F22(3) “Manufacture” includes any part of the manufacture of a veterinary medicinal product until the finished product is ready for sale in its final form as specified in the marketing authorisation but does not include the manufacture of an ingredient or breaking open the package of a veterinary medicinal product(9).]

Marketing of products not in accordance with a marketing authorisationU.K.

6.  The holder of a marketing authorisation for a veterinary medicinal product is guilty of an offence if either the holder or the manufacturer supplies a product that is not completely in accordance with the marketing authorisation.

Classification, supply and possession of the productU.K.

7.—(1) Schedule 3 (classification and supply, wholesale dealers and sheep dip) has effect.

(2) No person may supply a veterinary medicinal product [F23(including a veterinary medicinal product which has been incorporated into a medicated feedingstuff or intermediate feedingstuff)] that has passed its expiry date.

(3) No person may open the package (including the outer package) of a veterinary medicinal product before it has been supplied to the final user, other than as permitted under Schedule 3.

(4) No person may supply an authorised human medicinal product for administration to an animal (other than a product supplied by a veterinary surgeon or in accordance with a written prescription from a veterinary surgeon that includes all the information specified in paragraph 6 of Schedule 3).

(5) No person may be in possession of a veterinary medicinal product that was supplied to that person other than in accordance with Schedule 3.

Administration of the productE+W+S

8.  No person may administer a veterinary medicinal product to an animal unless—

(a)the product has a marketing authorisation authorising its administration in the United Kingdom, and the administration is in accordance with that marketing authorisation; or

(b)it is administered in accordance with Schedule 4 (administration of a veterinary medicinal product outside the terms of a marketing authorisation) or Schedule 6 (exemptions for small pet animals).

Administration of the productN.I.

8.  No person may administer a veterinary medicinal product to an animal unless—

(a)the product has a marketing authorisation authorising its administration in [F98Northern Ireland], and the administration is in accordance with that marketing authorisation; or

(b)it is administered in accordance with Schedule 4 (administration of a veterinary medicinal product outside the terms of a marketing authorisation) or Schedule 6 (exemptions for small pet animals).

Importation of authorised veterinary medicinal productsE+W+S

9.—[F24(1) No person may import, or move into Great Britain from Northern Ireland, a veterinary medicinal product authorised for use in Great Britain except in accordance with this regulation.]

(2) A holder of a marketing authorisation for a veterinary medicinal product may import that veterinary medicinal product.

(3) A holder of a manufacturing authorisation may import a veterinary medicinal product to which that authorisation relates.

(4) An authorised wholesale dealer may import a veterinary medicinal product if—

(a)the authorisation covers the product; and

(b)the dealer has notified the holder of the marketing authorisation in writing before importation.

(5) A veterinary surgeon or a pharmacist may import any authorised veterinary medicinal product.

(6) A suitably qualified person (registered in accordance with paragraph 14 of Schedule 3) may import any authorised veterinary medicinal product that that person is permitted to supply.

(7) There are no restrictions on the importation of an authorised veterinary medicinal product in category AVM-GSL.

Importation of authorised veterinary medicinal productsN.I.

9.—(1) No person may import a veterinary medicinal product authorised for use in [F99Northern Ireland] except in accordance with this regulation.

(2) A holder of a marketing authorisation for a veterinary medicinal product may import that veterinary medicinal product.

(3) A holder of a manufacturing authorisation may import a veterinary medicinal product to which that authorisation relates.

(4) An authorised wholesale dealer may import a veterinary medicinal product if—

(a)the authorisation covers the product; and

(b)the dealer has notified the holder of the marketing authorisation in writing before importation.

(5) A veterinary surgeon or a pharmacist may import any authorised veterinary medicinal product.

(6) A suitably qualified person (registered in accordance with paragraph 14 of Schedule 3) may import any authorised veterinary medicinal product that that person is permitted to supply.

(7) There are no restrictions on the importation of an authorised veterinary medicinal product in category AVM-GSL.

Advertising the productE+W+S

10.—[F25(1) No person may issue an advertisement relating to a relevant substance unless that advertisement—

(a)is set out in such a way that it is clear that the message is an advertisement for the purpose of promoting the supply, sale, prescription, distribution or use of the substance;

(b)encourages responsible use of the substance while presenting its characteristics in an objective manner;

(c)contains no information which—

(i)is misleading;

(ii)is incompatible with the summary of product characteristics in relation to the substance;

(iii)might encourage improper use of the substance; or

(iv)where the relevant substance is a veterinary medicinal product, might suggest that the substance is a feedingstuff or a biocide.

(1A) No person may advertise a veterinary medicinal product, other than a product which is placed on the market in accordance with Schedule 6, unless—

(a)a marketing authorisation has been granted in respect of that product, and

(b)that authorisation is not currently suspended in accordance with paragraph 38 of Schedule 1.]

(2) No person may advertise an authorised human medicinal product for administration to animals (including sending a price list of, or including, authorised human medicinal products to a veterinary surgeon or veterinary practice).

(3) Paragraph (2) does not apply to the holder of a wholesale dealer’s authorisation who supplies a list of authorised human medicinal products, together with prices, to a veterinary surgeon for use under the cascade provided that—

(a)the list is sent following a request from the veterinary surgeon to whom it is sent; and

(b)the list states clearly that the product does not have a marketing authorisation as a veterinary medicinal product, and may only be prescribed and administered under the cascade.

[F26(4) In this regulation, subject to paragraph (5), “relevant substance” means—

(a)a veterinary medicinal product;

(b)a medicinal premix;

(c)an intermediate feedingstuff; or

(d)a compound feed.

(5) In this regulation, coccidiostats and histomonostats are not relevant substances.]

Advertising the productN.I.

10.—(1) No person may advertise a veterinary medicinal product if the advertisement is misleading or contains any medicinal claim that is not in the summary of product characteristics.

(2) No person may advertise an authorised human medicinal product for administration to animals (including sending a price list of, or including, authorised human medicinal products to a veterinary surgeon or veterinary practice).

(3) Paragraph (2) does not apply to the holder of a wholesale dealer’s authorisation who supplies a list of authorised human medicinal products, together with prices, to a veterinary surgeon for use under the cascade provided that—

(a)the list is sent following a request from the veterinary surgeon to whom it is sent; and

(b)the list states clearly that the product does not have a marketing authorisation as a veterinary medicinal product, and may only be prescribed and administered under the cascade.

[F27Inducements and hospitalityE+W+S

10A.—(1) Subject to paragraphs (2) and (4), where veterinary medicinal products are being promoted to persons qualified to prescribe or supply veterinary medicinal products, no person may supply, offer or promise to any person any gift, pecuniary advantage or benefit in kind unless it is inexpensive and relevant to the practice of veterinary medicine or pharmacy.

(2) The provisions of paragraph (1) do not prevent any person offering hospitality (including the payment of travelling or accommodation expenses) at events for purely professional or scientific purposes to persons qualified to prescribe or supply veterinary medicinal products, provided that—

(a)it is subordinate to the main scientific objective of the event; and

(b)it is offered only to animal health professionals.

(3) Subject to paragraph (4), no person may offer hospitality (including the payment of travelling or accommodation expenses) at a meeting or event held for the promotion of veterinary medicinal products unless—

(a)it is subordinate to the main purpose of the meeting or event, and

(b)the person to whom it is offered is an animal health professional.

(4) Nothing in this regulation affects measures or trade practices relating to prices, margins or discounts which were in existence on the date on which the Veterinary Medicines (Amendment, etc.) Regulations 2024 came into force.

(5) No person qualified to prescribe or supply veterinary medicinal products may solicit or accept any gift, pecuniary advantage, benefit in kind, hospitality or sponsorship prohibited by this regulation.]

Advertising of prescription products and products containing psychotropic drugs or narcoticsU.K.

11.—(1) No person may advertise a veterinary medicinal product that—

(a)is available on veterinary prescription only; or

(b)contains psychotropic drugs or narcotics.

(2) In the case of a product containing psychotropic drugs or narcotics, paragraph (1) does not apply to advertisements aimed at veterinary surgeons or pharmacists.

(3) Subject to paragraph (4) in the case of POM-V medicines, paragraph (1) does not apply to price lists, or to advertisements aimed at—

(a)veterinary surgeons;

(b)veterinary nurses;

(c)pharmacists; or

(d)professional keepers of animals.

(4) No person may advertise [F28antimicrobials] to professional keepers of animals.

(5) In the case of POM-VPS medicines, paragraph (1) does not apply to price lists, or to advertisements aimed at—

(a)veterinary surgeons;

(b)pharmacists;

(c)suitably qualified persons registered in accordance with paragraph 14 of Schedule 3;

(d)other veterinary health care professionals; or

(e)professional keepers of animals.

[F29(6) A person advertising a veterinary medicinal product must—

(a)include in that advertisement the statement “prescription decisions are for the person issuing the prescription alone”;

(b)ensure that all factual statements concerning the characteristics of the product in the advertisement are consistent with the summary of product characteristics submitted in respect of the product under Schedule 1, as amended.]

Defence of publication in the course of businessU.K.

12.  In proceedings for an offence under these Regulation 43(g), it is a defence for the person charged to prove—

(a)that that person’s business is to publish or arrange for the publication of advertisements, and

(b)that the advertisement was received in the ordinary course of business and the person charged did not know and had no reason to suspect that its publication would amount to an offence under these Regulations.

Wholesale dealingU.K.

13.  No person may buy a veterinary medicinal product, other than by retail or for the purposes of retail supply in accordance with Schedule 3, unless the buyer has a wholesale dealer’s authorisation granted by the Secretary of State under this regulation and Schedule 3.

FeedingstuffsU.K.

14.  Schedule 5 (medicated feedingstuffs and specified feed additives) has effect.

ExemptionsE+W+S

15.—(1) These Regulations do not apply to an inactivated autogenous vaccine that is manufactured, on the instructions of a veterinary surgeon, from pathogens or antigens obtained from an animal and used for the treatment of that animal.

(2) Schedule 1 and Part 1 of Schedule 2 do not apply in relation to an inactivated autogenous vaccine that is—

(a)manufactured by a person and in premises authorised in accordance with Part 2 of Schedule 2, on the instructions of a veterinary surgeon, from pathogens or antigens obtained from an animal; and

(b)used for the treatment of—

(i)other animals on the same site;

(ii)animals intended to be sent to those premises; or

(iii)animals on a site that receives animals from those premises.

(3) Schedule 1 and Part 1 of Schedule 2 do not apply in relation to—

(a)blood or blood constituents from a blood bank authorised in accordance with [F30Part 2] of Schedule 2;

(b)a product manufactured for administration under the cascade by a person and in premises authorised in accordance with [F31Part 2] of Schedule 2; or

(c)F32... stem cell products for use as an autologous treatment for [F33non-food producing animals] from an F32... collection centre authorised in accordance with [F34Part 2] of Schedule 2.

(4) Schedule 6 (exemptions for small pet animals) has effect.

ExemptionsN.I.

15.—(1) These Regulations do not apply to an inactivated autogenous vaccine that is manufactured, on the instructions of a veterinary surgeon, from pathogens or antigens obtained from an animal and used for the treatment of that animal.

(2) Schedule 1 and Part 1 of Schedule 2 do not apply in relation to an inactivated autogenous vaccine that is—

(a)manufactured by a person and in premises authorised in accordance with Part 2 of Schedule 2, on the instructions of a veterinary surgeon, from pathogens or antigens obtained from an animal; and

(b)used for the treatment of—

(i)other animals on the same site;

(ii)animals intended to be sent to those premises; or

(iii)animals on a site that receives animals from those premises.

(3) Schedule 1 and Part 1 of Schedule 2 do not apply in relation to—

(a)blood or blood constituents from a blood bank authorised in accordance with Part 3 of Schedule 2;

(b)a product manufactured for administration under the cascade by a person and in premises authorised in accordance with Part 4 of Schedule 2; or

(c)equine stem cell products for use as an autologous treatment for horses from an equine collection centre authorised in accordance with Part 5 of Schedule 2.

(4) Schedule 6 (exemptions for small pet animals) has effect.

FeesU.K.

16.  Schedule 7 (fees) has effect.

PART 3U.K.Records

Food-producing animals: proof of purchase of veterinary medicinal productsU.K.

17.  The keeper of a food-producing animal must keep proof of purchase of all veterinary medicinal products acquired for the animal (or, if they were not bought, documentary evidence of how they were acquired).

Food-producing animals: records of administration by a veterinary surgeonU.K.

18.  A veterinary surgeon who administers a veterinary medicinal product to a food-producing animal must [F35as soon as is reasonably practicable] either enter the following information personally in the keeper’s records or give it to the keeper in writing (in which case the keeper must enter the following into those records)—

(a)the name of the veterinary surgeon;

(b)the name of the product and the batch number;

(c)the date of administration of the product;

(d)the amount of product administered;

(e)the identification of the animals treated; and

(f)the withdrawal period.

Food-producing animals: records of acquisition and administrationU.K.

19.—(1) When a veterinary medicinal product is bought or otherwise acquired for a food-producing animal the keeper must, at the time, record—

(a)the name of the product and the batch number;

(b)the date of acquisition;

(c)the quantity acquired; and

(d)the name and address of the supplier.

(2) At the time of administration (unless the administration is by a veterinary surgeon in which case the record must be in accordance with regulation 18) the keeper must record—

(a)the name of the product;

(b)the date of administration;

(c)the quantity administered;

(d)the withdrawal period; and

(e)the identification of the animals treated.

(3) A keeper who disposes of any or all of the veterinary medicinal product other than by treating an animal must record—

(a)the date of disposal;

(b)the quantity of product involved; and

(c)how and where it was disposed of.

Food-producing animals: retention of recordsU.K.

20.  The keeper of a food-producing animal must keep the documentation on the acquisition of a veterinary medicinal product and the records relating to the product for at least five years following the administration or other disposal of the product, irrespective of whether or not the animal concerned is no longer in that keeper’s possession or has been slaughtered or has died during that period.

Records by a holder of a manufacturing authorisationE+W+S

21.—[F36(1) The holder of a manufacturing authorisation must record the following information in respect of any veterinary medicinal product supplied by the holder—

(a)the name of the veterinary medicinal product and marketing authorisation number if applicable;

(b)the pharmaceutical form and strength of the product;

(c)the quantity of product supplied;

(d)the batch number and expiry date;

(e)the date of the transaction under which the product was supplied;

(f)the company name and the permanent address or registered place of business of the recipient of the supply.]

(2) The holder must keep with the record all certification provided by the qualified person (manufacture) in relation to that batch.

(3) The holder must keep all records and certificates for at least five years from the date the veterinary medicinal product is placed on the market [F37or for one year after the date of expiry of the batch, whichever is the longer.].

Records by a holder of a manufacturing authorisationN.I.

21.—(1) A holder of a manufacturing authorisation must, as soon as is reasonably practicable, make a record of each batch of veterinary medicinal product manufactured, assembled or supplied, which must include—

(a)the name of the product;

(b)the quantity manufactured, assembled or supplied;

(c)the date of manufacture, assembly or supply;

(d)the batch number and expiry date; and

(e)in the case of supply, the name and address of the recipient.

(2) The holder must keep with the record all certification provided by the qualified person (manufacture) in relation to that batch.

(3) The holder must keep all records and certificates for at least five years from the date the veterinary medicinal product is placed on the market.

Records by a holder of a wholesale dealer’s authorisationE+W+S

22.  A holder of a wholesale dealer’s authorisation must record the following as soon as is reasonably practicable after each incoming or outgoing transaction (including disposal) relating to a veterinary medicinal product—

(a)the date F38... of the transaction,

(b)the name of the veterinary medicinal product,

[F39(ba)the pharmaceutical form and strength of the product;]

(c)the F40... batch number,

(d)the expiry date,

(e)the quantity, and

[F41(f)the company name and permanent address or registered place of business of—

(i)in respect of a purchase, the supplier, and

(ii)in respect of a sale, the recipient,]

and must keep the records for at least [F42five years].

Records by a holder of a wholesale dealer’s authorisationN.I.

22.  A holder of a wholesale dealer’s authorisation must record the following as soon as is reasonably practicable after each incoming or outgoing transaction (including disposal) relating to a veterinary medicinal product—

(a)the date and nature of the transaction,

(b)the name of the veterinary medicinal product,

(c)the manufacturer’s batch number,

(d)the expiry date,

(e)the quantity, and

(f)the name and address of the supplier or recipient,

and must keep the records for at least three years.

Records of the receipt or supply of prescription productsE+W+S

23.—[F43(1) Any person permitted under these Regulations to supply a veterinary medicinal product classified as POM-V or POM-VPS or prescribed under the cascade who receives or supplies any such veterinary medicinal product must keep all documents relating to the transaction which show—

(a)the date of the transaction under which the product was received or supplied;

(b)the name of the veterinary medicinal product;

(c)the pharmaceutical form and strength of the product;

(d)the batch number;

(e)the quantity of product received or supplied;

(f)the company name and the permanent address or registered place of business of—

(i)in respect of a purchase, the supplier;

(ii)in respect of a sale, the recipient;

(g)if there is a written prescription the name and contact details of the prescriber;

(h)the expiry date.

(1A) Where the duty in paragraph (1) applies in respect of a veterinary medicinal product for a non-food producing animal, the duty in respect of sub-paragraph (d) is satisfied by recording the batch number—

(a)on the date on which the batch is received, or

(b)on the date on which a veterinary medicinal product from the batch is first supplied.]

(2) If the documents do not include this information that person must make a record of the missing information as soon as is reasonably practicable following the transaction.

(3) As an alternative to paragraphs (1) and (2) that person may make a record of all the information required there provided that this is done as soon as is reasonably practicable following the transaction.

(4) The documentation and records must be kept for at least five years.

Records of the receipt or supply of prescription productsN.I.

23.—(1) Any person permitted under these Regulations to supply a veterinary medicinal product classified as POM-V or POM-VPS who receives or supplies any such veterinary medicinal product must keep all documents relating to the transaction that show—

(a)the date;

(b)the name of the veterinary medicinal product;

(c)the batch number (except that, in the case of a product for a non-food-producing animal, this need only be recorded either on the date of receipt of the batch or the date a veterinary medicinal product from the batch is first supplied);

(d)the quantity;

(e)the name and address of the supplier or recipient; and

(f)if there is a written prescription, the name and address of the person who wrote the prescription and a copy of the prescription.

(2) If the documents do not include this information that person must make a record of the missing information as soon as is reasonably practicable following the transaction.

(3) As an alternative to paragraphs (1) and (2) that person may make a record of all the information required there provided that this is done as soon as is reasonably practicable following the transaction.

(4) The documentation and records must be kept for at least five years.

Records of products administered to a food-producing animal under the cascadeU.K.

24.  A veterinary surgeon administering a veterinary medicinal product to food-producing animals under the cascade, or permitting another person to administer it under that veterinary surgeon’s responsibility, must, as soon as is reasonably practicable, record—

(a)the date of examination of the animals;

(b)the name and address of the owner;

(c)the identification and number of animals treated;

(d)the result of the veterinary surgeon’s clinical assessment;

(e)the trade name of the product if there is one;

(f)the manufacturer’s batch number shown on the product if there is one;

(g)the name and quantity of the active substances;

(h)the doses administered or supplied;

(i)the duration of treatment; and

(j)the withdrawal period,

and must keep the record for at least five years.

[F44Reporting of sales and usage data in relation to antibioticsE+W+S

24A.—(1) Where the Secretary of State serves a notice in writing on any person mentioned in paragraph (2) requiring that person to provide any information held by that person in relation to sales and usage of antibiotics from any records made for the purposes of these Regulations the person must provide that information.

(2) The persons are—

(a)the holder of a manufacturing authorisation;

(b)the holder of a marketing authorisation;

(c)the holder of a wholesale dealer’s authorisation;

(d)a keeper of food-producing animals;

(e)a feedingstuffs manufacturer;

(f)a veterinary surgeon.]

PART 4U.K.Unauthorised veterinary medicinal products

Importation of an unauthorised veterinary medicinal productE+W+S

25.—(1) No person may import or be concerned in the importation of an unauthorised veterinary medicinal product except in accordance with this regulation.

(2) A holder of a marketing authorisation may import an unauthorised veterinary medicinal product if it is for the purpose of the manufacture of a veterinary medicinal product for which the importer holds the marketing authorisation.

(3) A holder of a manufacturing authorisation may import an unauthorised veterinary medicinal product if it is for the manufacture of a veterinary medicinal product that the importer is permitted to manufacture.

(4) A holder of a wholesale dealer’s authorisation may import an unauthorised veterinary medicinal product for the purposes of re-export.

(5) A veterinary surgeon may import an unauthorised veterinary medicinal product that is authorised in another [F45country] if it is for the purpose of administration by that veterinary surgeon or under that veterinary surgeon’s responsibility under the cascade or administration in exceptional circumstances in accordance with Schedule 4; the import must be in accordance with the appropriate certificate granted by the Secretary of State, and the product may be imported by the veterinary surgeon personally or by using a wholesale dealer or pharmacist as an agent.

(6) A wholesale dealer or a pharmacist may import an unauthorised veterinary medicinal product for the purpose of storing it pending administration by a veterinary surgeon under the cascade or administration in exceptional circumstances in accordance with Schedule 4 if—

(a)the veterinary medicinal product is authorised in another F46... country;

(b)the Secretary of State has issued a certificate certifying that—

(i)the disease or condition is such that the veterinary medicinal product is likely to be needed as a matter of urgency for the treatment of an animal;

(ii)delay in administering the product will seriously affect the health or welfare of the animal; and

(iii)there is no suitable veterinary medicinal product authorised in [F47Great Britain]; and

(c)in the case of a wholesale dealer, the product is within the terms of the authorisation.

[F48(6A) A pharmacist may supply a product to which paragraph (6) applies to a veterinary surgeon for the purposes mentioned in that paragraph notwithstanding paragraph 2(1) of Schedule 3.]

(7) The holder of an animal test certificate granted under paragraph 9 of Schedule 4 may import anything specified in the animal test certificate in accordance with the conditions in that certificate.

(8) The Secretary of State may authorise in writing the importation of any product or substance for use under a licence granted under the Animals (Scientific Procedures) Act 1986.

[F49(9) For the purposes of this regulation, references to the import or importation of an unauthorised veterinary medical product include the movement of such a product into Great Britain from Northern Ireland.]

Importation of an unauthorised veterinary medicinal productN.I.

25.—(1) No person may import or be concerned in the importation of an unauthorised veterinary medicinal product except in accordance with this regulation.

(2) A holder of a marketing authorisation may import an unauthorised veterinary medicinal product if it is for the purpose of the manufacture of a veterinary medicinal product for which the importer holds the marketing authorisation.

(3) A holder of a manufacturing authorisation may import an unauthorised veterinary medicinal product if it is for the manufacture of a veterinary medicinal product that the importer is permitted to manufacture.

(4) A holder of a wholesale dealer’s authorisation may import an unauthorised veterinary medicinal product for the purposes of re-export.

(5) A veterinary surgeon may import an unauthorised veterinary medicinal product that is authorised in [F100a] member State if it is for the purpose of administration by that veterinary surgeon or under that veterinary surgeon’s responsibility under the cascade or administration in exceptional circumstances in accordance with Schedule 4; the import must be in accordance with the appropriate certificate granted by the Secretary of State, and the product may be imported by the veterinary surgeon personally or by using a wholesale dealer or pharmacist as an agent.

(6) A wholesale dealer or a pharmacist may import an unauthorised veterinary medicinal product for the purpose of storing it pending administration by a veterinary surgeon under the cascade or administration in exceptional circumstances in accordance with Schedule 4 if—

(a)the veterinary medicinal product is authorised in [F101a] member State or a third country;

(b)the Secretary of State has issued a certificate certifying that—

(i)the disease or condition is such that the veterinary medicinal product is likely to be needed as a matter of urgency for the treatment of an animal;

(ii)delay in administering the product will seriously affect the health or welfare of the animal; and

(iii)there is no suitable veterinary medicinal product authorised in [F102Northern Ireland]; and

(c)in the case of a wholesale dealer, the product is within the terms of the authorisation.

(7) The holder of an animal test certificate granted under paragraph 9 of Schedule 4 may import anything specified in the animal test certificate in accordance with the conditions in that certificate.

(8) The Secretary of State may authorise in writing the importation of any product or substance for use under a licence granted under the Animals (Scientific Procedures) Act 1986.

[F103(9) For the purpose of this regulation, references to import or importation of an unauthorised veterinary medicinal product include the movement of such a product from Great Britain to Northern Ireland.]

Possession of an unauthorised veterinary medicinal productE+W+S

26.—(1) No person may be in possession of an unauthorised veterinary medicinal product.

(2) No person may be in possession of an unauthorised veterinary medicinal product with the intention of supplying that product to another person.

(3) This regulation does not apply to—

(a)a veterinary medicinal product imported in accordance with a certificate granted by the Secretary of State under these Regulations;

(b)a product prescribed by a veterinary surgeon under the cascade;

(c)a holder of a manufacturing authorisation if the possession is for export;

(d)a holder of a wholesale dealer’s authorisation if the possession is for export or re-export; or

(e)a holder of a manufacturer’s authorisation or marketing authorisation if the intention is to manufacture a veterinary medicinal product.

(4) A veterinary surgeon who practises in both [F50Great Britain] and another [F51country] may hold veterinary medicinal products authorised in the other [F51country] provided that the amount held does not exceed the amount expected to be used in that [F51country].

(5) It is a defence for a person charged with failing to comply with paragraph (1) to prove that the product was for the purposes of research or development of a veterinary medicinal product.

(6) A veterinary surgeon may have possession of an authorised human medicinal product intended for administration to animals under the cascade, provided that the amount held does not exceed the amount expected to be used under the cascade.

Possession of an unauthorised veterinary medicinal productN.I.

26.—(1) No person may be in possession of an unauthorised veterinary medicinal product.

(2) No person may be in possession of an unauthorised veterinary medicinal product with the intention of supplying that product to another person.

(3) This regulation does not apply to—

(a)a veterinary medicinal product imported in accordance with a certificate granted by the Secretary of State under these Regulations;

(b)a product prescribed by a veterinary surgeon under the cascade;

(c)a holder of a manufacturing authorisation if the possession is for export;

(d)a holder of a wholesale dealer’s authorisation if the possession is for export or re-export; or

(e)a holder of a manufacturer’s authorisation or marketing authorisation if the intention is to manufacture a veterinary medicinal product.

[F104(4) A veterinary surgeon who practices in Northern Ireland and a member State may hold veterinary medicinal products authorised in the member State provided that the amount held does not exceed the amount expected to be used in that member State.]

(5) It is a defence for a person charged with failing to comply with paragraph (1) to prove that the product was for the purposes of research or development of a veterinary medicinal product.

(6) A veterinary surgeon may have possession of an authorised human medicinal product intended for administration to animals under the cascade, provided that the amount held does not exceed the amount expected to be used under the cascade.

Supply of an unauthorised veterinary medicinal productU.K.

27.—(1) No person may supply an unauthorised veterinary medicinal product.

(2) This regulation does not apply to—

(a)a veterinary medicinal product prescribed by a veterinary surgeon under the cascade; or

(b)a product supplied in accordance with a certificate granted by the Secretary of State under these Regulations.

(3) It is a defence for a person charged with failing to comply with paragraph (1) to prove that the supply was for the purposes of research or development of a veterinary medicinal product.

PART 5U.K.Miscellaneous provisions, enforcement and offences

The Veterinary Products CommitteeU.K.

28.—(1) There shall continue to be a Veterinary Products Committee.

(2) The Secretary of State may appoint members of the Committee from professional people who are eminent in their field, and any lay members as the Secretary of State sees fit.

(3) The function of the Committee is to provide scientific advice on any aspect of veterinary medicinal products asked for by the Secretary of State and to carry out any functions specified in these Regulations.

(4) The Secretary of State may pay members of the Committee such amounts as the Secretary of State may decide.

(5) The Secretary of State may consult the Committee at any time.

Veterinary Products Committee appeals procedureU.K.

29.—(1) The following procedure applies when any person receives a notification from the Secretary of State informing that person (the appellant) of a right to an appeal to the Veterinary Products Committee.

(2) The appellant must inform the Secretary of State of an intention to appeal within 28 days of the notification which is the subject of the appeal.

(3) The appeal may be written or oral, or both, at the choice of the appellant.

(4) The appellant may not present to the Committee any new data not available to the Secretary of State at the time of the original decision.

(5) The Committee must consider the appeal and any representations made by the Secretary of State, and report its findings in writing to the Secretary of State together with its recommendations.

(6) The Secretary of State must send a copy of the report to the appellant on request.

(7) The Secretary of State must consider the report and then form a provisional decision.

(8) The Secretary of State must then notify the provisional decision to the appellant, together with the reasons for it.

Appeals to an appointed personE+W+S

30.—(1) A person aggrieved by a provisional decision of the Secretary of State under regulation 29 [F52or a body aggrieved by a decision to suspend or revoke its recognition under paragraph 14(1) of Schedule 3] may appeal against the decision to a person appointed for the purpose by the Secretary of State in accordance with this regulation.

(2) So may an applicant for—

(a)a manufacturing authorisation;

[F53(aa)a variation to a manufacturing authorisation;]

(b)appointment as a Qualified Person for the purposes of a manufacturing authorisation;

(c)authorisation for a person or premises to manufacture autogenous vaccines;

(d)an authorisation of a blood bank;

(e)authorisation of a person and premises to manufacture an unauthorised veterinary medicinal product for administration under the cascade;

(f)authorisation of [F54a stem cell centre];

(g)a wholesale dealer’s authorisation;

[F55(ga)registration in relation to active substances]

(h)the [F56authorisation] of premises for the supply of POM-VPS or NFA-VPS veterinary medicinal products by a suitably qualified person,

if such an application is refused.

(3) A holder of any of the above authorisations [F57or appointments] may appeal against a suspension [F58, revocation] or compulsory variation in the same way.

(4) The appointed person must consider the appeal (but may not consider any new data not available to the Secretary of State at the time of the original decision) and any representations made by the Secretary of State and report in writing, with a recommended course of action, to the Secretary of State.

(5) The Secretary of State must then reach a final decision and notify the appellant, together with the reasons for it.

Appeals to an appointed personN.I.

30.—(1) A person aggrieved by a provisional decision of the Secretary of State under regulation 29 may appeal against the decision to a person appointed for the purpose by the Secretary of State in accordance with this regulation.

(2) So may an applicant for—

(a)a manufacturing authorisation;

(b)appointment as a Qualified Person for the purposes of a manufacturing authorisation;

(c)authorisation for a person or premises to manufacture autogenous vaccines;

(d)an authorisation of a blood bank;

(e)authorisation of a person and premises to manufacture an unauthorised veterinary medicinal product for administration under the cascade;

(f)authorisation of an equine stem cell centre;

(g)a wholesale dealer’s authorisation;

(h)the approval of premises for the supply of POM-VPS or NFA-VPS veterinary medicinal products by a suitably qualified person,

if such an application is refused.

(3) A holder of any of the above authorisations, appointment or approvals may appeal against a suspension or compulsory variation in the same way.

(4) The appointed person must consider the appeal (but may not consider any new data not available to the Secretary of State at the time of the original decision) and any representations made by the Secretary of State and report in writing, with a recommended course of action, to the Secretary of State.

(5) The Secretary of State must then reach a final decision and notify the appellant, together with the reasons for it.

ExportsE+W+S

31.—(1) No person may export a veterinary medicinal product for use in another [F59country] unless the veterinary medicinal product may be lawfully supplied or administered in that [F59country].

(2) If a veterinary medicinal product has been manufactured in accordance with a marketing authorisation, or if a product without a marketing authorisation has been manufactured under a manufacturing authorisation, and the product is intended for export F60..., the Secretary of State must, at the request of the exporter or the competent authorities of the country to which it is being exported, provide a certificate [F61that (as the case may be)—

(a)the manufacturer holds a manufacturing authorisation;

(b)the manufacturer holds a certificate of good manufacturing practice; or

(c)the product has been marketed under a marketing authorisation].

(3) When issuing the certificate the Secretary of State must take account of [F62any relevant administrative arrangements in relation to the form and content of such certificates which are in existence between the United Kingdom and the country to which the product is to be exported].

(4) If the veterinary medicinal product is authorised in the United Kingdom the Secretary of State must ensure that the exporter or the competent authorities of the [F63importing] country has access to the summary of product characteristics.

ExportsN.I.

31.—(1) No person may export a veterinary medicinal product for use in another [F105country] unless the veterinary medicinal product may be lawfully supplied or administered in that [F105country].

(2) If a veterinary medicinal product has been manufactured in accordance with a marketing authorisation, or if a product without a marketing authorisation has been manufactured under a manufacturing authorisation, and the product is intended for export outside the European Union, the Secretary of State must, at the request of the exporter or the competent authorities of the country to which it is being exported, provide a certificate to that effect.

(3) When issuing the certificate the Secretary of State must take account of the model certificates issued by the World Health Organization(10).

(4) If the veterinary medicinal product is authorised in the United Kingdom the Secretary of State must ensure that the exporter or the competent authorities of the third country has access to the summary of product characteristics.

Time limitsU.K.

32.—(1) In any provision in these Regulations requiring the Secretary of State to issue an authorisation within a set time, the clock does not start to run until the Secretary of State has checked that the application dossier is in accordance with these Regulations and has validated the application.

(2) In calculating the period during which the Secretary of State must issue any authorisation requires the clock is stopped when the Secretary of State requires an applicant to provide further data until all the further data required have been provided.

(3) The clock is also stopped during any period that the applicant is given to provide oral or written explanations [F64or to provide any sample].

(4) The Secretary of State may stop the clock pending payment of outstanding fees.

Appointment of inspectorsU.K.

33.  The Secretary of State must appoint inspectors for the purposes of the enforcement of these Regulations and in these Regulations “inspector” means an inspector appointed under this regulation or a veterinary inspector appointed under the Animal Health Act 1981(11).

Powers of entryE+W+S

34.—(1) An inspector may, on giving reasonable notice, and on producing a duly authenticated authorisation if required, enter any premises at any reasonable hour for the purpose of ensuring that the provisions of these Regulations are being complied with; and in this regulation “premises” includes any place, vehicle, trailer, container, stall, moveable structure, ship or aircraft.

(2) The requirement to give notice does not apply—

(a)where the entry is pursuant to any provision of an [F65enactment] which requires inspection without notice;

(b)where the requirement has been waived;

(c)where reasonable efforts to agree an appointment have failed;

(d)where an inspector has reasonable suspicion of a failure to comply with these Regulations; or

(e)in an emergency.

(3) Paragraph (1) does not apply in relation to any premises which are used wholly or mainly as a private dwelling, unless those premises, or any part of them, are F66... registered or authorised for the sale of veterinary medicines under paragraph 8, 10, 14(4) or 18 of Schedule 3 or for use as a feed business under paragraph 5(2)(e) or 7(2) of Schedule 5.

(4) Paragraphs (1) and (3) do not affect any right of entry conferred by a warrant issued by a justice of the peace.

[F67(5) An inspector may be accompanied by such other persons as the inspector considers necessary.]

(6) If a justice of the peace, on sworn information in writing, is satisfied that there are reasonable grounds for entry into any premises for the purposes of the enforcement of these Regulations, and either—

(a)admission has been refused, or a refusal is expected, and (in either case) that notice to apply for a warrant has been given to the occupier;

(b)asking for admission, or the giving of such a notice, would defeat the object of the entry;

(c)the case is one of urgency; or

(d)the premises are unoccupied or the occupier is temporarily absent,

the justice may by signed warrant authorise an inspector to enter the premises, if need be by reasonable force.

(7) A warrant under this regulation is valid for one month.

(8) An inspector who enters any unoccupied premises must leave them as effectively secured against unauthorised entry as they were before entry.

(9) An inspector may enter the premises of manufacturers of active substances used as starting materials for veterinary medicinal products, and the premises of the marketing authorisation holder.

F68(10) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(11) In this regulation, a reference to a justice of the peace —

(a)in Scotland includes a reference to the sheriff and to a magistrate; and

(b)in Northern Ireland, is a reference to a lay magistrate.

Powers of entryN.I.

34.—(1) An inspector may, on giving reasonable notice, and on producing a duly authenticated authorisation if required, enter any premises at any reasonable hour for the purpose of ensuring that the provisions of these Regulations are being complied with; and in this regulation “premises” includes any place, vehicle, trailer, container, stall, moveable structure, ship or aircraft.

(2) The requirement to give notice does not apply—

(a)where the entry is pursuant to any provision of an EU instrument which requires inspection without notice;

(b)where the requirement has been waived;

(c)where reasonable efforts to agree an appointment have failed;

(d)where an inspector has reasonable suspicion of a failure to comply with these Regulations; or

(e)in an emergency.

(3) Paragraph (1) does not apply in relation to any premises which are used wholly or mainly as a private dwelling, unless those premises, or any part of them, are approved, registered or authorised for the sale of veterinary medicines under paragraph 8, 10, 14(4) or 18 of Schedule 3 or for use as a feed business under paragraph 5(2)(e) or 7(2) of Schedule 5.

(4) Paragraphs (1) and (3) do not affect any right of entry conferred by a warrant issued by a justice of the peace.

(5) An inspector may be accompanied by—

(a)such other persons as the inspector considers necessary; F106...

F106(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(6) If a justice of the peace, on sworn information in writing, is satisfied that there are reasonable grounds for entry into any premises for the purposes of the enforcement of these Regulations, and either—

(a)admission has been refused, or a refusal is expected, and (in either case) that notice to apply for a warrant has been given to the occupier;

(b)asking for admission, or the giving of such a notice, would defeat the object of the entry;

(c)the case is one of urgency; or

(d)the premises are unoccupied or the occupier is temporarily absent,

the justice may by signed warrant authorise an inspector to enter the premises, if need be by reasonable force.

(7) A warrant under this regulation is valid for one month.

(8) An inspector who enters any unoccupied premises must leave them as effectively secured against unauthorised entry as they were before entry.

(9) An inspector may enter the premises of manufacturers of active substances used as starting materials for veterinary medicinal products, and the premises of the marketing authorisation holder.

(10) An inspector may carry out an inspection at the request of [F107a] member State, the European Commission or the Agency.

[F108(11) In this regulation, a reference to justice of the peace is a reference to a lay magistrate.]

Powers of an inspectorE+W+S

35.—(1) An inspector entering premises under the previous regulation may—

(a)inspect the premises, and any plant, machinery or equipment;

(b)search the premises;

(c)take samples;

[F69(ca)purchase prescription only veterinary medicines for the purpose of carrying out tests;

(cb)verify the destruction of a controlled drug listed in Schedule 2, 3 or 4 of the Misuse of Drugs Regulations 2001;]

(d)seize any computers and associated equipment;

(e)seize any veterinary medicinal product or any additive to which Schedule 5 applies, if it is not authorised in the United Kingdom;

(f)seize any [F70intermediate feedingstuff] or feedingstuff that contains a veterinary medicinal product or additive to which Schedule 5 applies that is not authorised in the United Kingdom;

(g)seize any veterinary medicinal product, any additive to which Schedule 5 applies, any [F71intermediate feedingstuff] or feedingstuff if—

(i)it has not been lawfully manufactured, incorporated or supplied in accordance with these Regulations;

(ii)it has been stored in a way that affects its safety, quality or efficacy; or

(iii)it is sold or offered for sale by a person not permitted to supply it under these Regulations;

(h)carry out any inquiries, examinations and tests;

(i)have access to, and inspect and copy or seize any documents or records (in whatever form they are held) relating to these Regulations; and

(j)have access to, inspect and check the operation of any computer and any associated apparatus or material that is or has been in use in connection with the records; and for this purpose may require any person having charge of, or otherwise concerned with the operation of, the computer, apparatus or material to afford such assistance as may reasonably be required and, where a record is kept by means of a computer, may require the records to be produced in a form in which they may be taken away.

[F72(2) The inspector may seize and retain an item appearing to the inspector to be an item mentioned in paragraph (1)(d) to (g) if the inspector reasonably believes that an offence under these Regulations is being or has been committed in relation to, or by means of, that item]

(3) An officer of any local authority who has entered premises exercising any statutory power of entry for the purposes of enforcing any legislation relating to food hygiene, feed hygiene or animal health, may inspect any records made under these Regulations (in whatever form they are held) relating to food-producing animals, and may remove them to enable them to be copied.

(4) Where an inspector has entered any premises and it is not reasonably practicable to determine at the time whether documents on those premises are relevant to these Regulations, the inspector may seize them to ascertain whether or not they are relevant.

Powers of an inspectorN.I.

35.—(1) An inspector entering premises under the previous regulation may—

(a)inspect the premises, and any plant, machinery or equipment;

(b)search the premises;

(c)take samples;

(d)seize any computers and associated equipment;

(e)seize any veterinary medicinal product or any additive to which Schedule 5 applies, if it is not authorised in the United Kingdom;

(f)seize any premixture or feedingstuff that contains a veterinary medicinal product or additive to which Schedule 5 applies that is not authorised in the United Kingdom;

(g)seize any veterinary medicinal product, any additive to which Schedule 5 applies, any premixture or feedingstuff if—

(i)it has not been lawfully manufactured, incorporated or supplied in accordance with these Regulations;

(ii)it has been stored in a way that affects its safety, quality or efficacy; or

(iii)it is sold or offered for sale by a person not permitted to supply it under these Regulations;

(h)carry out any inquiries, examinations and tests;

(i)have access to, and inspect and copy or seize any documents or records (in whatever form they are held) relating to these Regulations; and

(j)have access to, inspect and check the operation of any computer and any associated apparatus or material that is or has been in use in connection with the records; and for this purpose may require any person having charge of, or otherwise concerned with the operation of, the computer, apparatus or material to afford such assistance as may reasonably be required and, where a record is kept by means of a computer, may require the records to be produced in a form in which they may be taken away.

(2) The powers of seizure under sub-paragraph (1)(e), (f) and (g) include a power to seize anything which purports to be, or which an inspector reasonably believes to be, something the inspector is entitled to seize under these powers.

(3) An officer of any local authority who has entered premises exercising any statutory power of entry for the purposes of enforcing any legislation relating to food hygiene, feed hygiene or animal health, may inspect any records made under these Regulations (in whatever form they are held) relating to food-producing animals, and may remove them to enable them to be copied.

(4) Where an inspector has entered any premises and it is not reasonably practicable to determine at the time whether documents on those premises are relevant to these Regulations, the inspector may seize them to ascertain whether or not they are relevant.

Inspection of pharmaciesU.K.

36.  In relation to a pharmacy, all the powers of an inspector to enforce these Regulations may also be exercised by an officer of the General Pharmaceutical Council appointed for the purpose.

ObstructionU.K.

37.  No person may—

(a)intentionally obstruct any person acting in the execution of these Regulations;

(b)without reasonable cause, fail to give to any person acting in the execution of these Regulations any assistance or information that that person may reasonably require under these Regulations;

(c)furnish to any person acting in the execution of these Regulations any information knowing it to be false or misleading; or

(d)fail to produce a record when required to do so to any person acting in the execution of these Regulations.

Improvement noticesU.K.

38.—(1) An inspector who has reasonable grounds for believing that any person is failing to comply with these Regulations may serve a notice on that person (in these Regulations referred to as an “improvement notice”) that—

(a)states the inspector’s grounds for believing this;

(b)specifies the matters that constitute the failure to comply;

(c)specifies the measures that, in the inspector’s opinion, the person must take in order to secure compliance; and

(d)requires the person to take those measures, or measures at least equivalent to them, within the period (being not less than 14 days) specified in the notice.

[F73(1A) If the inspector considers that the matters constituting a person’s perceived failure to comply involve risks to animal or human health or of damage to the environment which are so serious that, until steps have been taken to reduce or remove that failure, one or more activity carried on by the person ought to be prohibited or restricted, the improvement notice must state—

(a)the activity which is to be prohibited or restricted;

(b)the reasons why such prohibition or restriction is considered appropriate;

(c)the time and date at which the prohibition or restriction is to take effect (which may be immediately after the notice is served);

(d)that the person must not carry out the activity in breach of the prohibition or restriction until—

(i)that person has provided evidence to the inspector that measures have been undertaken to secure compliance, and

(ii)the inspector has confirmed to that person that the notice is revoked.

(1B) Where the person on whom an improvement notice to which paragraph (1A) applies has been served provides evidence to the inspector that the measures specified in the notice (or measures at least equivalent to them) have been undertaken to secure compliance, and the inspector is satisfied that the measures have been satisfactorily performed, the inspector must revoke the notice and inform the person of this.]

(2) An improvement notice must state—

(a)the right of appeal to a magistrates’ court or to the sheriff; and

(b)the period within which such an appeal may be brought.

Appeals against improvement noticesE+W+S

39.—(1) Any person who is aggrieved by an improvement notice may appeal to a magistrates’ court or, in Scotland, to the sheriff.

(2) The procedure on an appeal to a magistrates’ court under paragraph (1) is by way of complaint, and the Magistrates’ Courts Act 1980(12) applies to the proceedings.

(3) An appeal to the sheriff under paragraph (1) is by summary application.

(4) The period within which an appeal may be brought is 28 days or the period specified in the improvement notice, whichever ends the earlier.

(5) A court may suspend an improvement notice pending an appeal.

Appeals against improvement noticesN.I.

39.—(1) Any person who is aggrieved by an improvement notice may appeal to a magistrates’ court F109....

(2) The procedure on an appeal to a magistrates’ court under paragraph (1) is by way of complaint, and the Magistrates’ Courts Act 1980(12) applies to the proceedings.

F110(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(4) The period within which an appeal may be brought is 28 days or the period specified in the improvement notice, whichever ends the earlier.

(5) A court may suspend an improvement notice pending an appeal.

Powers of a court on appealU.K.

40.  On an appeal against an improvement notice, the court may either cancel the notice or confirm it, with or without modification.

Seizure noticesE+W+S

41.—(1) An inspector must follow the procedures set out in this regulation when seizing anything under these Regulations.

(2) The inspector must serve on the person appearing to be in charge of the seized [F74item] a notice (referred to in these Regulations as a “seizure notice”)—

(a)giving the grounds for seizing the [F74item]; and

(b)informing that person of the rights under this regulation to make a claim, and the address for the service of the claim.

(3) An inspector who is not able to remove [F75items] seized immediately may mark the [F75items] in any way, and serve a notice on the person in charge of the [F75items] identifying them, and prohibiting the removal of the [F75items] from the premises until they are collected by an inspector, and no person other than an inspector may remove [F75items] identified under this paragraph from the premises.

(4) The person on whom the seizure notice was served or the owner of the seized [F76item] may, within 28 days of seizure, notify any claim that the [F76item] was not liable to seizure to the Secretary of State at the address specified in the seizure notice, setting out the grounds in full.

(5) If a notification of a claim is not received within 28 days, the Secretary of State may destroy the [F77item].

(6) If a notification of a claim is received within 28 days, then, unless the [F78item] seized is being held for the purposes of pending or contemplated criminal proceedings, or for a criminal investigation, the Secretary of State must either return the [F78item] or take proceedings for an order for the confirmation of the seizure notice and the destruction of the [F79item] in a magistrates’ court (or, in Scotland, the sheriff court), and if the court confirms the notice it must order its destruction.

(7) The procedure in a magistrates’ court under this regulation is by way of complaint, and the Magistrates’ Courts Act 1980 applies to the proceedings.

(8) The procedure before the sheriff is by summary application.

(9) The person on whom the seizure notice was served is liable for the costs of transport, storage for up to 28 days and destruction of the [F80item] seized unless a claim is made to a court and the court directs otherwise.

Seizure noticesN.I.

41.—(1) An inspector must follow the procedures set out in this regulation when seizing anything under these Regulations.

(2) The inspector must serve on the person appearing to be in charge of the seized product a notice (referred to in these Regulations as a “seizure notice”)—

(a)giving the grounds for seizing the product; and

(b)informing that person of the rights under this regulation to make a claim, and the address for the service of the claim.

(3) An inspector who is not able to remove products seized immediately may mark the products in any way, and serve a notice on the person in charge of the products identifying them, and prohibiting the removal of the products from the premises until they are collected by an inspector, and no person other than an inspector may remove products identified under this paragraph from the premises.

(4) The person on whom the seizure notice was served or the owner of the seized product may, within 28 days of seizure, notify any claim that the product was not liable to seizure to the Secretary of State at the address specified in the seizure notice, setting out the grounds in full.

(5) If a notification of a claim is not received within 28 days, the Secretary of State may destroy the product.

(6) If a notification of a claim is received within 28 days, then, unless the product seized is being held for the purposes of pending or contemplated criminal proceedings, or for a criminal investigation, the Secretary of State must either return the product or take proceedings for an order for the confirmation of the seizure notice and the destruction of the veterinary medicinal product in a magistrates’ court F111..., and if the court confirms the notice it must order its destruction.

(7) The procedure in a magistrates’ court under this regulation is by way of complaint, and the Magistrates’ Courts Act 1980 applies to the proceedings.

F112(8) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(9) The person on whom the seizure notice was served is liable for the costs of transport, storage for up to 28 days and destruction of the product seized unless a claim is made to a court and the court directs otherwise.

PublicationU.K.

42.—(1) The Secretary of State must publicise all improvement notices and seizure notices issued under these Regulations and the suspension or revocation of anything issued under these Regulations, and may do so in such manner as the Secretary of State sees fit.

(2) This does not apply in relation to a seizure notice issued to a common carrier who does not own the seized goods.

OffenceE+W+S

43.  It is an offence(13) to fail to comply with—

(a)regulation 4(1) or (2);

(b)regulation 5(1);

(c)regulation 7(2), (3), (4) or (5);

(d)regulation 8;

(e)regulation 9(1);

(f)regulation 10[F81(1), (1A)] or (2);

[F82(fa)regulation 10A(1), (3) or (5);]

(g)regulation 11(1) [F83or (4) or (6)];

(h)regulation 13;

(i)regulation 17;

(j)regulation 18

(k)regulation 19

(l)regulation 20

(m)regulation 21

(n)regulation 22

(o)regulation 23

(p)regulation 24;

[F84(pa)regulation 24A(1)]

(q)regulation 25(1);

(r)regulation 26(1), (2) or (6);

(s)regulation 27(1);

(t)regulation 31(1);

(u)regulation 37;

(v)an improvement notice issued under regulation 38; or

(w)regulation 41(3).

OffenceN.I.

43.  It is an offence(13) to fail to comply with—

(a)regulation 4(1) or (2);

(b)regulation 5(1);

(c)regulation 7(2), (3), (4) or (5);

(d)regulation 8;

(e)regulation 9(1);

(f)regulation 10(1) or (2);

(g)regulation 11(1);

(h)regulation 13;

(i)regulation 17;

(j)regulation 18

(k)regulation 19

(l)regulation 20

(m)regulation 21

(n)regulation 22

(o)regulation 23

(p)regulation 24;

(q)regulation 25(1);

(r)regulation 26(1), (2) or (6);

(s)regulation 27(1);

(t)regulation 31(1);

(u)regulation 37;

(v)an improvement notice issued under regulation 38; or

(w)regulation 41(3).

PenaltiesU.K.

44.—(1) [F85As regards England and Wales,] A person guilty of an offence under these Regulations is liable—

(a)on summary conviction, to a fine not exceeding the statutory maximum or to imprisonment for a term not exceeding six months or both, or

(b)on conviction on indictment, to a fine or to imprisonment for a term not exceeding two years or both.

[F86(1A) As regards Scotland, a person guilty of an offence under these Regulations is liable—

(a)on summary conviction, to a fine not exceeding the statutory maximum or to imprisonment for a term not exceeding 12 months or both, or

(b)on conviction on indictment, to a fine or to imprisonment for a term not exceeding two years or both.]

(2) Where a body corporate is guilty of an offence under these Regulations, and that offence is proved to have been committed with the consent or connivance of, or to have been attributable to any neglect on the part of—

(a)a qualified person appointed as such for the purposes of these Regulations;

(b)any director, manager, secretary or other similar person of the body corporate; or

(c)any person who was purporting to act in any such capacity,

that person is guilty of the offence as well as the body corporate.

(3) If an offence under these Regulations committed by a partnership is shown—

(a)to have been committed with the consent or connivance of a partner; or

(b)to be attributable to any neglect on their part,

the partner as well as the partnership is guilty of the offence and liable to be proceeded against and punished accordingly.

(4) For the purposes of paragraph (2) above, “director”, in relation to a body corporate whose affairs are managed by its members, means a member of the body corporate.

(5) Where an offence that has been committed by a Scottish partnership is proved to have been committed with the consent or connivance of, or to be attributable to any neglect on the part of, a partner, the partner as well as the partnership is guilty of the offence.

Northern IrelandE+W+S

F8745.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Northern IrelandN.I.

45.—(1) This regulation has effect in relation to the enforcement of these Regulations in Northern Ireland.

(2) The Department of Agriculture and Rural Development or the Department of Health, Social Services and Public Safety (or both Departments acting jointly) instead of the Secretary of State exercise the powers of the Secretary of State in—

(a)regulation 33 (appointment of inspectors);

(b)regulation 41 (seizure notices);

(c)regulation 42 (publication); and

(d)sub-paragraph (4) of paragraph 14 of Schedule 3 (approval of premises for suitably qualified persons).

(3) The Department of Agriculture and Rural Development is the competent authority for—

[F113(a)Regulation (EC) No 178/2002;]

[F114(b)Regulation (EC) No 1831/2003;]

[F115(c)Regulation (EU) 2017/625; and]

[F116(d)Regulation (EC) No 183/2005.]

(4) In relation to pharmacies, an officer of the Pharmaceutical Society of Northern Ireland appointed by the Society for the purpose has all the powers of an inspector to enforce these Regulations.

(5) In proceedings in a magistrates’ court relating to an improvement notice under regulation 38 or a seizure notice under regulation 41, the Magistrates’ Courts (Northern Ireland) Order 1981(14) applies.

ReviewE+W+S

46.—(1) Before the end of each review period, the Secretary of State must—

(a)carry out a review of these Regulations other than the fees provisions;

(b)set out the conclusions of the review in a report; and

(c)publish the report.

F88(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F89(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(4) The report must in particular—

(a)set out the objectives intended to be achieved by the regulatory system established by these Regulations, other than the fees provisions;

(b)assess the extent to which those objectives are achieved; and

(c)assess whether those objectives remain appropriate and, if so, the extent to which they could be achieved with a system that imposes less regulation.

(5) In this regulation—

(a)“review period” means the period of five years [F90ending on 31st December 2028], and, subject to paragraph (6), each successive period of five years thereafter; and

(b)“the fees provisions” means regulation 16 and Schedule 7.

(6) If a report under this regulation is published before the last day of the review period to which it relates, the following review period is to begin with the day on which that report is published.

ReviewN.I.

46.—(1) Before the end of each review period, the Secretary of State must—

(a)carry out a review of these Regulations other than the fees provisions;

(b)set out the conclusions of the review in a report; and

(c)publish the report.

(2) In carrying out the review the Secretary of State must, so far as is reasonable, have regard to how the EU instruments, or provisions of EU instruments, to which this regulation applies are implemented in F117... member States.

(3) The EU instruments, and provisions of EU instruments, to which this regulation applies are—

(a)Council Directive 90/167/EEC laying down conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the Community, so far it is not superseded by Regulation (EC) No 183/2005(15);

(b)Commission Directive 91/412/EEC laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products(16);

(c)Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products(17);

(d)Regulation (EC) No 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety, in so far as it applies to veterinary medicinal products used in feedingstuffs;

(e)Regulation (EC) No 1831/2003 of the European Parliament and of the Council on additives for use in animal nutrition, in so far as it applies to veterinary medicinal products used in feedingstuffs;

[F118(f)Regulation (EU) 2017/625;]

(g)Regulation (EC) No 183/2005 of the European Parliament and of the Council laying down requirements for feed hygiene, in so far as it applies to veterinary medicinal products used in feedingstuffs;

(h)Commission Regulation (EC) No 1234/2008(18);

(i)Regulation (EC) No 470/2009 of the European Parliament and of the Council(19);

(j)Article 8 of Regulation (EC) No 767/2009 of the European Parliament and of the Council, and Articles 15 and 17 of that Regulation as they refer to the labelling requirements for feedingstuffs containing specified feed additives(20); and

(k)Commission Regulation (EU) No 37/2010(21).

(4) The report must in particular—

(a)set out the objectives intended to be achieved by the regulatory system established by these Regulations, other than the fees provisions;

(b)assess the extent to which those objectives are achieved; and

(c)assess whether those objectives remain appropriate and, if so, the extent to which they could be achieved with a system that imposes less regulation.

(5) In this regulation—

(a)“review period” means the period of five years beginning with the day on which these Regulations come into force, and, subject to paragraph (6), each successive period of five years thereafter; and

(b)“the fees provisions” means regulation 16 and Schedule 7.

(6) If a report under this regulation is published before the last day of the review period to which it relates, the following review period is to begin with the day on which that report is published.

RevocationsU.K.

47.  The following Regulations are revoked—

(a)the Veterinary Medicines Regulations 2011(22); and

(b)the Veterinary Medicines (Amendment) Regulations 2012(23).