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The Veterinary Medicines Regulations 2013

Type Statutory-Instrument

Publication 2013-08-06

Last updated 2024-05-17

State In force

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

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Made: 6th August 2013

Laid before Parliament: 20th August 2013

Coming into force: 1st October 2013

The Secretary of State makes these Regulations in exercise of the powers conferred by section 2(2) of the European Communities Act 1972 and by section 56(1) of the Finance Act 1973.

PART 1 — Introduction

Title and commencement

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 scope

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 ; or

(2) In these Regulations—

“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;

“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;

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

“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—any risk to human or animal health relating to the quality, safety or efficacy of the veterinary medicinal product;any risk of undesirable effects on the environment; orany risk relating to the development of resistance;

“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;

“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;

“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—as regards England, the Genetically Modified Organisms (Deliberate Release) Regulations 2002;as regards Scotland, the Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002;as regards Wales, the Genetically Modified Organisms (Deliberate Release) (Wales) Regulations 2002;

“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 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 an 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[^f00008];

“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 intended to be administered to an animal in order to produce active or passive immunity or to diagnose its state of immunity;

“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—a medicinal premix;a specified feed additive,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—a veterinary medicinal product for the treatment or prevention of diseases that occur infrequently or in limited geographical areas;a veterinary medicinal product for an animal species other than cattle, sheep for meat production, pigs, chickens, dogs or cats;

“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;

“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[^f00006];

“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[^f00007];

“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[^f00009];

“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[^f00009];

“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[^f00010] , as last amended by Regulation (EU) No 2017/2279;

“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;

“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;

“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;

“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

(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).

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

(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.

Products to which these Regulations do not apply

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[^f00011], 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 2 — Authorised veterinary medicinal products

Placing a veterinary medicinal product on the market

4

(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.

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

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

Manufacture of veterinary medicinal products

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[^f00012].

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

(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[^f00013].

Marketing of products not in accordance with a marketing authorisation

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 product

7

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

(2) No person may supply a veterinary medicinal product (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 product

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).

Importation of authorised veterinary medicinal products

9

(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.

Advertising the product

10

(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;

(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.

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

(a) a veterinary medicinal product;

(b) a medicinal premix;

(d) a compound feed.

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

Advertising of prescription products and products containing psychotropic drugs or narcotics

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;

(d) professional keepers of animals.

(4) No person may advertise antimicrobials 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;

(d) other veterinary health care professionals; or

(e) professional keepers of animals.

(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 business

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 dealing

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.

Feedingstuffs

14

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

Exemptions

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 2 of Schedule 2;

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

(c) ... stem cell products for use as an autologous treatment for non-food producing animals from an ... collection centre authorised in accordance with Part 2 of Schedule 2.

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

Fees

16

Schedule 7 (fees) has effect.

PART 3 — Records

Food-producing animals: proof of purchase of veterinary medicinal products

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 surgeon

18

A veterinary surgeon who administers a veterinary medicinal product to a food-producing animal must as 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;

(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 administration

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;

(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;

(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

Food-producing animals: retention of records

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 authorisation

21

(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;

(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 or for one year after the date of expiry of the batch, whichever is the longer..

Records by a holder of a wholesale dealer’s authorisation

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 ... of the transaction,

(b) the name of the veterinary medicinal product,

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

(d) the expiry date,

(e) the quantity, and

(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 five years.

Records of the receipt or supply of prescription products

23

(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;

(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 products administered to a food-producing animal under the cascade

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;

(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.

PART 4 — Unauthorised veterinary medicinal products

Importation of an unauthorised veterinary medicinal product

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 country 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 ... 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 Great Britain;and

(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.

(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.

Possession of an unauthorised veterinary medicinal product

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;

(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 Great Britain and another country may hold veterinary medicinal products authorised in the other country provided that the amount held does not exceed the amount expected to be used in that country.

(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 product

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 5 — Miscellaneous provisions, enforcement and offences

The Veterinary Products Committee

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 procedure

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 person

30

(1) A person aggrieved by a provisional decision of the Secretary of State under regulation 29 or 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;

(aa) a variation to a manufacturing authorisation;

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

(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 a stem cell centre;

(g) a wholesale dealer’s authorisation;

(ga) registration in relation to active substances

(h) the authorisation 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 or appointments may appeal against a suspension , 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.

Exports

31

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

(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 ..., 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 that (as the case may be)—

(a) the manufacturer holds a manufacturing authorisation;

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

(3) When issuing the certificate the Secretary of State must take account of any 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 importing country has access to the summary of product characteristics.

Time limits

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 or to provide any sample.

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

Appointment of inspectors

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[^f00015].

Powers of entry

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 enactment which requires inspection without notice;

(b) where the requirement has been waived;

(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 ... 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 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;

(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) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(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 an inspector

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;

(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 intermediate 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 intermediate 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.

(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.

Inspection of pharmacies

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.

Obstruction

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 notices

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;

(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.

(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 notices

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[^f00016] 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.

Powers of a court on appeal

40

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

Seizure notices

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 item a notice (referred to in these Regulations as a “seizure notice”)—

(a) giving the grounds for seizing the item; 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 items seized immediately may mark the items in any way, and serve a notice on the person in charge of the items identifying them, and prohibiting the removal of the items from the premises until they are collected by an inspector, and no person other than an inspector may remove items identified under this paragraph from the premises.

(4) The person on whom the seizure notice was served or the owner of the seized item may, within 28 days of seizure, notify any claim that the item 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 item.

(6) If a notification of a claim is received within 28 days, then, unless the item 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 item or take proceedings for an order for the confirmation of the seizure notice and the destruction of the item 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 item seized unless a claim is made to a court and the court directs otherwise.

Publication

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.

Offence

43

It is an offence[^f00017] to fail to comply with—

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

(b) regulation 5(1);

(d) regulation 8;

(e) regulation 9(1);

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

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

(g) regulation 11(1) or (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;

(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).

Penalties

44

(1) As 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.

(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

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 Ireland

45

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

Review

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

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

(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 ending 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.

Revocations

47

The following Regulations are revoked—

(a) the Veterinary Medicines Regulations 2011[^f00030]; and

(b) the Veterinary Medicines (Amendment) Regulations 2012[^f00031].

SCHEDULE 1 — Marketing authorisations in Great Britain in Northern Ireland

PART 1 — Application for a marketing authorisation

Application for a marketing authorisation

1

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

Information with the application

2

(1) An application must include the matters mentioned in sub-paragraph (2) and—

(a) where the veterinary medicinal product is an antimicrobial, the matters mentioned in sub-paragraph (4);

(b) subject to sub-paragraph (6), where the product is to be administered to a food-producing animal and is a product containing pharmacologically active substances that are not permitted under Regulation (EC) No 470/2009 of the European Parliament and of the Council, the matter mentioned in sub-paragraph (5);

(c) where the product contains or consists of genetically modified organisms, the matters mentioned in sub-paragraph (7).

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

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

(b) the name and the address or registered place of business of—

(i) the manufacturer of the finished product;

(ii) any importer of the finished product;

(iii) the manufacturer of any active substances involved at each stage of the manufacture;

(i) each stage of the manufacture is carried out;

(ii) any imported products are held; or

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

(d) the nature of the marketing authorisation being applied for, and the provisions in Part 2 of Schedule 1 which are relevant to the application;

(e) in relation to the veterinary medicinal product—

(i) the name and the ATCvet code;

(ii) a description of the active substances within the product and, if applicable, a description of any diluent;

(iii) the strength of the product, or, in the case of an immunological veterinary medicinal product or a biological veterinary medicinal product that is not immunological, the biological activity, potency or titre;

(iv) the pharmaceutical form of the product;

(v) the route of administration;

(vi) a description of the target species;

(f) a document showing that the manufacturer is authorised to produce veterinary medicinal products or a certificate of good manufacturing practice issued by the Secretary of State or equivalent certification issued by an authority recognised by the Secretary of State for that purpose, together with a description of the manufacturing process for the active substances and finished product which falls within scope of that authorisation or certificate;

(g) the reference number and a summary of the pharmacovigilance system master file in relation to the product and, where appropriate, the risk management plan that the applicant will put in place;

(h) the proposed summary of product characteristics;

(i) a description of the final presentation, the packaging and labelling of the product;

(j) the proposed text of the information to be included on the immediate packaging, the outer packaging and the information leaflet accompanying the product;

(k) details of any country where—

(i) a marketing authorisation has been granted or revoked in relation to the product;

(ii) a marketing authorisation has been submitted or refused;

(l) a summary of product characteristics included in the terms of any marketing authorisation granted by another country;

(m) technical documentation demonstrating the quality, safety and efficacy of the product;

(n) a report (a “critical expert report”) on the quality, safety and efficacy of the product.

(3) For the purposes of sub-paragraph (2)(n), each critical expert report must—

(a) be prepared with regard to the state of scientific knowledge at the time of the application;

(b) include an evaluation of each test and trial referred to in the application, addressing all aspects relevant to quality, safety and efficacy, with detailed results and precise bibliographic references (including copies of the referenced material);

(d) be signed and dated by the author, and include details of the author’s educational background, training and occupational experience, and the author’s professional relationship with the applicant.

(4) For the purposes of sub-paragraph (1)(a), the matters are—

(a) information on the direct or indirect risks to public or animal health or to the environment arising from use of the antimicrobial product in animals;

(b) information about the methods of mitigating the development of antimicrobial resistance as a result of the use of the product.

(5) For the purposes of sub-paragraph (1)(b), the matter is a document certifying that a valid application for the establishment of maximum residue levels has been submitted to the Secretary of State.

(6) Sub-paragraph (1)(b) does not apply in respect of a veterinary medicinal product which—

(a) is for administration to a horse that has been declared on its horse passport as not intended for slaughter for human consumption, and

(b) includes an active substance that has been classified under Article 14 of Regulation (EC) No 470/2009 of the European Parliament and of the Council as prohibited for use in food-producing animals.

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

(a) a copy of the written consent to the deliberate release into the environment of the genetically modified organisms for research and development purposes issued under the GMO Deliberate Release Regulations;

(b) the complete technical file containing the information provided in respect of the application for that consent under the GMO Deliberate Release Regulations;

(c) the environmental risk assessment provided in respect of the application for that consent under the GMO Deliberate Release Regulations;

(d) the results of any investigations performed for the purposes of research or development.

(8) In assembling the application for an authorisation under this Schedule, the applicant must—

(a) take into account the most up-to-date veterinary medicinal knowledge and scientific guidelines relating to the quality, safety and efficacy of veterinary medicinal products (including relevant monographs of the European Pharmacopoeia and British Pharmacopoeia);

(b) include in the application all information which is relevant to the evaluation of the veterinary medicinal product to which it relates, whether favourable or unfavourable to the product (including information relating to any incomplete or abandoned study or trial);

(c) ensure that the application supports, by reference to specific studies and trials, each claim made by the applicant with regard to the properties, effects and uses of the veterinary medicinal product to which it relates;

(d) otherwise ensure the accuracy of the information in the application.

(9) For the purposes of sub-paragraph (8)(c), pharmacological, toxicological, residue and pre-clinical studies and clinical trials must be carried out in conformity with the principles of good laboratory practice, where applicable.

Summary of product characteristics

3

(1) Subject to sub-paragraph (2), the summary of product characteristics required under paragraph 2(2)(h) must include the following information in the order indicated below—

1.	1.	Name of the veterinary medicinal product, followed by its strength and pharmaceutical form.
2.	2.	Qualitative and quantitative composition of the active substances and qualitative composition of excipients and other constituents stating their common name or their chemical description and their quantitative composition, if that information is essential for proper administration of the veterinary medicinal product.
3.	3.	Clinical information as regards—
	3.1	target species;
	3.2	indications for use for each target species;
	3.3	contra-indications;
	3.4	special warnings;
	3.5	special precautions for use, including in particular special precautions for safe use in the target species, special precautions to be taken by the person administering the veterinary medicinal product to the animals and special precautions for the protection of the environment;
	3.6	frequency and seriousness of adverse events;
	3.7	use during pregnancy, lactation or lay;
	3.8	interaction with other medicinal products and other forms of interaction;
	3.9	administration route and dosage;
	3.10	symptoms of overdose and, where applicable, emergency procedures and antidotes in the event of overdose;
	3.11	special restrictions for use;
	3.12	special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance;
	3.13	if applicable, withdrawal periods, even if such periods are zero.
4.	4.	Pharmacological information as regards—
	4.1	the ATCvet Code;
	4.2	pharmacodynamics;
	4.3	pharmacokinetics.
5.	5.	Pharmaceutical particulars as regards—
	5.1	major incompatibilities;
	5.2	shelf-life, where applicable after reconstitution of the medicinal product or after the immediate packaging has been opened for the first time;
	5.3	special precautions for storage;
	5.4	nature and composition of immediate packaging;
	5.5	requirement to use take-back schemes for veterinary medicinal products for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products and, if appropriate, additional precautions regarding hazardous waste disposal of unused veterinary medicinal products or waste materials derived from the use of such products.
6.	6.	Name of the holder of the marketing authorisation.
7.	7.	Marketing authorisation number or numbers.
8.	8.	Date of the first marketing authorisation.
9.	9.	Date of the last revision of the summary of product characteristics.
10.	10.	If applicable, the statement—
	10.1	“marketing authorisation granted for a limited market and therefore assessment based on customised requirements for documentation”; or
	10.2	“marketing authorisation in exceptional circumstances and therefore assessment based on customised requirements for documentation”.
11.	11.	Information on the take-back schemes referred to in point 5.5 applicable to the veterinary medicinal product concerned.
12.	12.	Classification of the veterinary medicinal product.

(2) In the case of an immunological veterinary medicinal product or a biological veterinary medicinal product that is not immunological, in place of the information at points 4, 4.1, 4.2 and 4.3, the summary of product characteristics must include immunological information.

Supply of a copy of the summary of product characteristics

4

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

Time limits for applications for products for use in food-producing animals

5

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

PART 2 — Derogations from some of the requirements in Part 1

Scope

6

This Part provides for applications for marketing authorisations in which not all the information required in Part 1 is required, but for the avoidance of doubt any applicant may apply for a marketing authorisation using Part 1 if the applicant wishes to do so.

Bibliographic application

7

(1) An applicant for a marketing authorisation need not provide the results of safety tests, residue tests, pre-clinical trials or clinical trials if the applicant demonstrates that the active substances of the veterinary medicinal product have been in well-established veterinary use for at least 10 years, that their efficacy is documented and that they provide an acceptable level of safety.

(1A) Sub-paragraph (1) does not apply to applications for—

(a) biological (including immunological) veterinary medicinal products;

(b) novel therapies.

(2) The applicant may use any publicly available document.

(3) If an applicant makes use of scientific literature to obtain authorisation for a food-producing species, and submits, in respect of the same medicinal product and with a view to obtaining authorisation for another food-producing species, new residue studies, together with further clinical trials, a third party may not use those studies or trials in an application for a pharmacologically equivalent product for a period of threeyears from the grant of the authorisation for the additional species.

Application for a product using a new combination of active substances

8

(1) If an application is for a veterinary medicinal product containing active substances already used in an authorised veterinary medicinal product but not previously used in that combination in a veterinary medicinal product, the applicant need not provide the safety and efficacy data for the individual active substances.

(2) Notwithstanding sub-paragraph (1) the applicant must provide a sound scientific justification based on valid therapeutic principles for the combination of active substances, including clinical data, which demonstrates the need for and contribution of all active substances at the moment of treatment.

Application using existing data

9

If the Secretary of State has granted a marketing authorisation, the Secretary of State may, with the permission of the holder, use the data submitted in support of that marketing authorisation when assessing an application for another marketing authorisation.

Application for a pharmacologically equivalent medicinal product

10

(1) Subject to sub-paragraphs (2A), (9) and (10) and paragraph 10A, an applicant need not provide the results of safety tests, residue tests, pre-clinical trials or clinical trials if the applicant can demonstrate that the veterinary medicinal product is a generic of a veterinary medicinal product already authorised in the United Kingdom (“the reference veterinary medicinal product”), provided that the applicant provides data demonstrating the matters referred to in sub-paragraph (2).

(2) For the purposes of this paragraph a product is a generic of an existing product if—

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

(b) it has the same pharmaceutical form as the reference product; and

(2A) Sub-paragraph (1) does not apply to applications for biological (including immunological) veterinary medicinal products.

(3) For the purposes of this paragraph—

(a) the different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance are considered to be the same active substance, unless they differ significantly in properties with regard to safety or efficacy; and

(b) if they do differ significantly in properties with regard to efficacy or safety, additional information intended to provide proof of the safety or efficacy of the various salts, esters or derivatives of an authorised active substance must be supplied by the applicant.

(4) Different immediate-release oral pharmaceutical forms are regarded as the same pharmaceutical form.

(5) Bioavailability studies are not required if the bioequivalence guidelines produced by the European Medicines Agency or the Secretary of State exempt the product.

(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(7) For the purposes of these Regulations, subject to sub-paragraph (8), the summary of product characteristics of a generic veterinary medicinal product must be essentially similar to the summary of product characteristics for the reference product.

(8) The requirement in sub-paragraph (7) does not apply in relation to those parts of the summary of product characteristics of the reference product that refer to indications or pharmaceutical forms which are covered by patents at the time when the generic veterinary medicinal product is authorised.

(9) Notwithstanding sub-paragraph (1), in respect of generic veterinary medicinal products intended to be administered by intramuscular, subcutaneous or transdermal routes, the applicant must provide—

(a) administration site target animal tolerance data;

(b) in respect of products intended for administration to food-producing species only, residues depletion data from the site of administration.

(10) Notwithstanding sub-paragraph (1), in respect of generic veterinary medicinal products containing antimicrobial or antiparasitic substances, the applicant must provide all available data (including published data) on the current level of resistance, together with a review of that data as it relates to target pathogens to the active substances concerned.

(11) An applicant must provide an environmental risk assessment for a generic veterinary medicinal product where—

(a) the marketing authorisation for the reference veterinary medicinal product was granted before 1st October 2005, and

(b) no marketing authorisation has been granted since 1st October 2005 in respect of a veterinary medicinal product which has the same active substance and pharmaceutical form as the reference veterinary medicinal product, and which is indicated for use in the same target species when administered at the same or a higher total dose,

unless the Secretary of State holds an environmental risk assessment for the reference veterinary medicinal product and has confirmed this to the applicant.

Time limits for marketing authorisations granted under the procedure for a pharmacologically equivalent product

11

(1) This paragraph establishes the time limits relating to granting a marketing authorisation under the procedure for a generic veterinary medicinal product.

(2) An application for a marketing authorisation cannot be made until two years before the product may be placed on the market in accordance with this paragraph.

(3) The product may not be placed on the market until the end of the longest of the following periods which is relevant—

(a) subject to sub-paragraph (3A), 10 years in the case of a veterinary medicinal product authorised for major species;

(b) 18 years in the case of a veterinary medicinal product authorised for bees; and

(3A) Where the product—

(a) is intended for administration to a major species; and

(b) contains an active substance which is an antimicrobial which has not been an active substance in a veterinary medicinal product previously subject to a marketing authorisation in Great Britain,

the period mentioned in sub-paragraph (3)(a) is 14 years.

(3B) Where a patent in relation to a reference product has lapsed, the summary of product characteristics of the relevant generic product must be updated in order to include the protected information.

(3C) Where, as a result of a variation to an existing marketing authorisation a product is accorded a new marketing authorisation number any relevant protection period applies in relation to that product.

(3D) In this regulation “major species” means cattle, sheep (for meat production), pigs, chickens, dogs and cats.

(4) Time limits in this paragraph are calculated from the first grant of the marketing authorisation for the reference product.

Extension of time limits

12

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

(2) Subject to sub-paragraph (2B), if a person submits an application for a marketing authorisation or for a variation to a marketing authorisation for a product, and within five years of the original marketing authorisation being granted, the marketing authorisation is extended to include an additional major species or a new antimicrobial product, the relevant protection period is extended by one year for each additional major species added to the marketing authorisation.

(2A) Subject to sub-paragraph (2B), if a person submits an application for a marketing authorisation mentioned in sub-paragraph (2) and the marketing authorisation is extended to include an additional minor species, the relevant protection period is extended by four years.

(2B) Sub-paragraphs (2) and (2A) do not apply where the application to extend the marketing authorisation is made fewer than three years before the expiration of the protection period.

(3) The total period may not exceed 18years.

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

Parallel imports

13

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

Specific batch control scheme

14

(1) Where a veterinary medicinal product (other than a biological veterinary medicinal product) has been granted a marketing authorisation or an animal test certificate, and any starting material (active substance, excipient or packaging) or any batch of the product does not fully meet the requirements of the authorisation or animal test certificate, the holder may apply to the Secretary of State to place one or more batches on the market notwithstanding this.

(2) The Secretary of State may authorise the placing on the market on being satisfied that the safety, quality and efficacy of the product are not compromised, and that in all the circumstances of the case the product should be placed on the market.

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