The Veterinary Medicines Regulations 2007

PART 1Introduction

Title and commencement

1.  These Regulations may be cited as the Veterinary Medicines Regulations 2007 and come into force on 1st October 2007.

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.

(2) In addition—

“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;

“horse passport” means a passport issued in accordance with the provisions of—

and “horse” includes all species of equidae;

“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;

“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 any reference to a member State is a reference to a member State of the European Union and Norway, Iceland and Liechtenstein.

(4) 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 the administration of a product in the course of a procedure licensed under the Animals (Scientific Procedure) Act 1986(6), 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 2Authorised veterinary medicinal products

Placing a veterinary medicinal product on the market

4.—(1) It is an offence to 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) Any person who certifies data in relation to an application for a marketing authorisation or in relation to an existing marketing authorisation and who knows that those data are false, or does not believe that they are accurate, is guilty of an offence.

(3) Schedule 1 (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 (who must, if the manufacture is carried out in the United Kingdom, hold a manufacturing authorisation for that type of product granted by the Secretary of State) and failure to do so is an offence.

(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(7).

The finished product

6.  The holder of a marketing authorisation for a veterinary medicinal product is guilty of an offence if he 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) Any person who supplies a veterinary medicinal product that has passed its expiry date is guilty of an offence.

(3) Any person who opens 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, is guilty of an offence.

(4) Any person who supplies 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) is guilty of an offence.

(5) Any person in possession of a veterinary medicinal product that was supplied to him other than in accordance with Schedule 3 is guilty of an offence.

Administration of the product

8.  It is an offence to 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).

Importation of authorised veterinary medicinal products

9.—(1) It is an offence to import a veterinary medicinal product authorised for use in the United Kingdom except in accordance with this regulation.

(2) A holder of a marketing authorisation may import a veterinary medicinal product for which he holds the marketing authorisation.

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

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

(a)his authorisation covers the product; and

(b)he has notified the holder of the marketing authorisation in writing before he imports it.

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

(6) A suitably qualified person (in accordance with paragraph 14 of Schedule 3) may import any authorised veterinary medicinal product that he 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) It is an offence to 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) It is an offence to 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;

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

(c)it only includes authorised human medicinal products that may be administered legally under the cascade.

Advertising of prescription products and products containing psychotropic drugs or narcotics

11.—(1) It is an offence to 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, this does not apply to advertisements aimed at veterinary surgeons or pharmacists.

(3) In the case of POM-V medicines, this does not apply to price lists, or to advertisements aimed at veterinary surgeons, veterinary nurses, pharmacists or professional keepers of animals.

(4) In the case of POM-VPS medicines, this 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;

(e)professional keepers of animals; or

(f)owners or keepers of horses.

Defence of publication in the course of business

12.  In proceedings for an offence under these Regulations relating to advertising, it is a defence for the person charged to prove—

(a)that he is a person whose business it is to publish or arrange for the publication of advertisements, and

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

Wholesale dealing

13.  It is an offence to 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 to blood from a blood bank authorised in accordance with Part 3 of Schedule 2, nor to a product manufactured for administration under the cascade by a person and in premises authorised under Part 4 of Schedule 2.

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

Fees

16.  Schedule 7 (fees) has effect.

PART 3Records

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

17.—(1) The keeper of a food-producing animal must keep proof of purchase of all veterinary medicinal products (or, if he did not buy them, documentary evidence of how he acquired them) acquired for the animal.

(2) It is an offence to fail to comply with this regulation.

Food-producing animals: records of administration by a veterinary surgeon

18.—(1) If a veterinary surgeon administers a veterinary medicinal product to a food-producing animal he must either enter the following information himself in the keeper’s records or give it to the keeper in writing (in which case the keeper must enter the following into his 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.

(2) It is an offence to fail to comply with this regulation.

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;

(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) he 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) If he disposes of any or all of the veterinary medicinal product other than by treating an animal, he must record—

(a)the date of disposal;

(b)the quantity of product involved; and

(c)how and where he disposed of it.

(4) It is an offence to fail to comply with this regulation.

Food-producing animals: retention of records

20.—(1) 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 his possession or has been slaughtered or has died during that period.

(2) It is an offence to fail to comply with this regulation.

Records by a holder of a manufacturing authorisation

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 by him, 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) He must keep with the record all certification provided by the qualified person (manufacture) in relation to that batch.

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

(4) It is an offence to fail to comply with this regulation.

Records by a holder of a wholesale dealer’s authorisation

22.—(1) 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.

(2) He must keep the records for at least three years.

(3) It is an offence to fail to comply with this regulation.

Records of the receipt or supply of prescription products

23.—(1) When any person permitted under these Regulations to supply a veterinary medicinal product classified as POM-V or POM-VPS receives or supplies any such veterinary medicinal product he 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 he receives the batch or the date he starts to use it);

(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 he 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) he may make a record of all the information required there provided that he does so as soon as is reasonably practicable following the transaction.

(4) He must keep the documentation and records for at least five years.

(5) It is an offence to fail to comply with this regulation.

Records of products administered to a food-producing animal under the cascade

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

(a)the date he examined 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.

(2) He must keep the record for at least five years.

(3) It is an offence to fail to comply with this regulation.

PART 4Unauthorised veterinary medicinal products

Importation of an unauthorised veterinary medicinal product

25.—(1) It is an offence to import 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 he 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 he 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 member State if it is for the purpose of administration by him or under his 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 himself or by using a wholesale dealer or pharmacist as his 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 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 the United Kingdom; and

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

Possession of an unauthorised veterinary medicinal product

26.—(1) It is an offence to be in possession of an unauthorised veterinary medicinal product.

(2) 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 wholesale dealer’s authorisation if the possession is for re-export; or

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

(3) A veterinary surgeon who practises in both the United Kingdom and another member State may hold veterinary medicinal products authorised in the other member State provided that the amount that he holds does not exceed the amount expected to be used in that member State.

(4) It is a defence for a person charged under paragraph (1) to prove that he was in possession of the veterinary medicinal product for the purposes of research or development of a veterinary medicinal product.

(5) A veterinary surgeon may have in his possession an authorised human medicinal product intended for administration to animals under the cascade, but he commits an offence if the amount in his possession exceeds the amount expected to be used under the cascade.

Supply of an unauthorised veterinary medicinal product

27.—(1) It is an offence to 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 under paragraph (1) to prove that he supplied the veterinary medicinal product for the purposes of research or development of a veterinary medicinal product.

PART 5Miscellaneous 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 he 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 he 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 there is an appeal to the Veterinary Products Committee.

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

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

(4) 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.

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

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

(7) He must then notify the provisional decision to the appellant, together with the reasons for it.

(8) The appellant may then appeal against the Secretary of State’s provisional decision to a person appointed for the purpose by the Secretary of State.

(9) The appointed person must consider the appeal (but may not consider any new data that were 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.

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

Exports

30.—(1) It is an offence to export a veterinary medicinal product for use in another member State unless the veterinary medicinal product may be lawfully supplied or administered in that member State.

(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 of export, provide a certificate to that effect.

(3) When he issues the certificate the Secretary of State must take account of the model certificates issued by the World Health Organization(8).

(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 limits

31.—(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 until the Secretary of State has checked that the application dossier is in accordance with these Regulations and has validated the application.

(2) The clock is stopped during any period that 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.

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

Appointment of inspectors

32.  The Secretary of State shall appoint inspectors for the purposes of the enforcement of these Regulations.

Powers of entry

33.—(1) An inspector may, on producing a duly authenticated document showing his authority 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) He may take with him—

(a)such other persons as he considers necessary; and

(b)any representative of the European Commission acting for the purpose of the enforcement of a Community obligation.

(3) Admission to any premises used only as a private dwellinghouse may not be demanded as of right unless 24 hours notice of the intended entry has been given to the occupier, or the entry is in accordance with a warrant granted under this regulation.

(4) 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 warrant signed by him authorise the inspector to enter the premises, if need be by reasonable force.

(5) A warrant under this section is valid for one month.

(6) If an inspector enters any unoccupied premises he must leave them as effectively secured against unauthorised entry as he found them.

(7) He 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.

(8) He may carry out an inspection at the request of another member State, the European Commission or the Agency.

(9) 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

34.—(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 for the purpose of copying documents provided they are returned as soon as practicable;

(e)seize any veterinary medicinal product, anything purporting to be a 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, anything purporting to be a veterinary medicinal product, any additive to which Schedule 5 applies, any premixture or any feedingstuff if—

(i)it has not been lawfully supplied in accordance with these Regulations;

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

(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 any documents or records (in whatever form they are held) relating to these Regulations, and remove them to enable them to be copied; 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 him such assistance as he may reasonably require 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) 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.

Inspection of pharmacies

35.  In relation to a pharmacy, all the powers of an inspector to enforce these Regulations may also be exercised by an officer of the Royal Pharmaceutical Society of Great Britain appointed for the purpose.

Obstruction

36.  Any person who—

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

(b)without reasonable cause, fails to give to any person acting in the execution of these Regulations any assistance or information that that person may reasonably require of him for the performance of his functions under these Regulations;

(c)furnishes to any person acting in the execution of these Regulations any information that he knows to be false or misleading; or

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

is guilty of an offence.

Improvement notices

37.—(1) If an inspector has reasonable grounds for believing that any person is failing to comply with these Regulations he 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.

(2) It is an offence to fail to comply with an improvement notice.

Appeals against improvement notices

38.—(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(9) 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) 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.

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

Powers of a court on appeal

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

Seizure notices

40.—(1) An inspector must follow the procedures set out in this regulation if he seizes anything under regulation 34.

(2) He must serve on the person appearing to him 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 him of his rights under this regulation to make a claim, and the address for the service of the claim.

(3) If an inspector is not able to remove products seized under this regulation immediately, he may mark the products in any way that he sees fit, 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 any person other than an inspector who removes products identified under this paragraph from the premises is guilty of an offence.

(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 (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 product seized unless a claim is made to a court and the court directs otherwise.

Publication

41.  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 he sees fit.

Penalties

42.—(1) 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 three 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,

he is guilty of the offence as well as the body corporate.

(3) 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.

(4) 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, he as well as the partnership is guilty of the offence.

Northern Ireland

43.—(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 32 (appointment of inspectors);

(b)regulation 40 (seizure notices);

(c)regulation 41 (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—

(a)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(10));

(b)Regulation (EC) No. 1831/2003 (of the European Parliament and the Council on additives for use in animal nutrition(11));

(c)Regulation (EC) No. 882/2004 (of the European Parliament and the Council on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules(12)); and

(d)Regulation (EC) No. 183/2005 (of the European Parliament and of the Council laying down requirements for feed hygiene(13)).

(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 40 the Magistrates' Courts (Northern Ireland) Order 1981(14) applies.

Revocation

44.  The Veterinary Medicines Regulations 2006(15) (other than paragraphs (2) to (4) of regulation 44 and Schedules 8 and 9) are revoked.