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

(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;

“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—

(a)    the Horse Passports (England) Regulations 2004;

(b)    the Horse Passports Regulations (Northern Ireland) 2004;

(c)    the Horse Passports (Scotland) Regulations 2005; or

(d)    the Horse Passports (Wales) Regulations 2005,

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—

(a)    any risk to human or animal health relating to the quality, safety or efficacy of the veterinary medicinal product; or

(b)    any risk of undesirable effects on the environment;

“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.

(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, 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.

(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.

(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.

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.

(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.

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).

(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.

(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.

(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.

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.

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.

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

(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.

Schedule 7 (fees) has effect.

(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.

(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.

(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.

(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.

(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.

(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.

(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.

(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.

(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.

(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.

(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.

(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.

(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.

(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.

(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.

(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.

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

(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.

(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.

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.

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.

(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.

(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 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.

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

(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.

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.

(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.

(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);

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

(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); and

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

(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 applies.

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

Jeff Rooker

Minister of State

Department for Environment, Food and Rural Affairs

24th July 2007

Dave Watts

Steve McCabe

Two of the Lords Commissioners of Her Majesty's Treasury

30th August 2007

•  

  1    Administration under the cascade

•  

  2    Withdrawal periods

•  

  3    Administration to food-producing horses

•  

  4    Immunological products for serious epizootic disease

•  

  5    Immunological products for an imported or exported animal

•  

  6    Administration by veterinary surgeons from other member States

•  

  7    Treatment in exceptional circumstances

•  

  8    Administration of a homeopathic remedy

•  

  9    Administration under an animal test certificate

Administration under the cascade

1

(1)    A veterinary surgeon acting under this paragraph may either administer a veterinary medicinal product prescribed by him personally or may direct another person to do so under his responsibility.

(2)    If there is no authorised veterinary medicinal product in the United Kingdom for a condition the veterinary surgeon responsible for the animal may, in particular to avoid unacceptable suffering, treat the animal concerned with the following (“the cascade”), cascaded in the following order—

(a)    a veterinary medicinal product authorised in the United Kingdom for use with another animal species, or for another condition in the same species; or

(b)    if and only if there is no such product that is suitable, either—

(i)    a human medicinal product authorised in the United Kingdom; or

(ii)    a veterinary medicinal product not authorised in the United Kingdom but authorised in another member State for use with any animal species (in the case of a food-producing animal, it must be a food-producing species); or

(c)    if and only if there is no such product that is suitable, a veterinary medicinal product prepared extemporaneously by a pharmacist, a veterinary surgeon or a person holding a manufacturing authorisation authorising the manufacture of that type of product.

(3)    In the case of a veterinary medicinal product imported from another member State, if the veterinary surgeon has not obtained a certificate from the Secretary of State under regulation 25(5) permitting him to import it, he must obtain a certificate from the Secretary of State before he administers it.

(4)    Any pharmacologically active substances included in a medicinal product administered to a food-producing animal under the cascade must be listed in Annex I, II or III to Council Regulation (EEC) No 2377/90.

Withdrawal periods

2

(1)    A veterinary surgeon prescribing or administering a veterinary medicinal product to a food-producing animal under the cascade must specify an appropriate withdrawal period.

(2)    The withdrawal period must ensure that, if there is a maximum residue limit specified for the active substance in Council Regulation (EEC) No 2377/90, the level of residue of the active substance does not exceed that limit.

(3)    In any event, unless the Secretary of State has specified in writing a different withdrawal period for a particular veterinary medicinal product, the withdrawal period (irrespective of whether or not a maximum residue limit is specified in Council Regulation (EEC) No 2377/90) must not be less than—

(a)    7 days for eggs;

(b)    7 days for milk;

(c)    28 days for meat from poultry and mammals including fat and offal;

(d)    500 degree days for fish meat.

(4)    In the case of a homeopathic remedy in which active principles figure in Annex II to Council Regulation (EEC) No 2377/90, the withdrawal period is zero.

Administration to food-producing horses

3

(1)    If there is no authorised veterinary medicinal product for a food-producing horse (as shown on its horse passport) and treatment under the cascade is unsuitable, substances may be administered in accordance with Commission Regulation (EC) No 1950/2006 (establishing, in accordance with Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products, a list of substances essential for the treatment of equidae).

(2)    The person administering the substance must comply with Article 3(2) of Commission Regulation (EC) No 1950/2006 (recording the details of the treatment in the animal's passport) and failure to do so is an offence.

Immunological products for serious epizootic disease

4

(1)    In the event of serious epizootic diseases, the Secretary of State may permit in writing the administration of immunological veterinary medicinal products without a marketing authorisation, in the absence of a suitable medicinal product and after informing the Commission of the detailed conditions of use.

(2)    He may publicise any permit as he sees fit.

Immunological products for an imported or exported animal

5

If an animal is imported from, or exported to, a third country, the Secretary of State may permit the administration to that animal of an immunological veterinary medicinal product that is not covered by a marketing authorisation in the United Kingdom but is authorised under the legislation of the third country.

Administration by veterinary surgeons from other member States

6

(1)    Veterinary surgeons practising in another member State may bring into the United Kingdom and administer to animals small quantities of veterinary medicinal products that are not authorised for use in the United Kingdom if—

(a)    the quantity does not exceed the requirements for the treatment of specific animals;

(b)    the product is authorised in the member State in which the veterinary surgeon is established;

(c)    the product is transported by the veterinary surgeon in the original manufacturer's packaging;

(d)    in the case of administration to food-producing animals, there is a veterinary medicinal product authorised in the United Kingdom that has the same qualitative and quantitative composition in terms of active substances;

(e)    the veterinary surgeon has acquainted himself with the Guide to Professional Conduct issued by the Royal College of Veterinary Surgeons.

(2)    The veterinary surgeon must only supply to the owner or keeper enough veterinary medicinal product to complete the treatment of animals concerned.

(3)    He must—

(a)    ensure that the withdrawal period specified on the label of the product is complied with, or the United Kingdom withdrawal period for the equivalent product authorised in the United Kingdom if this is longer than the one on the label; and

(b)    keep detailed records of the animals treated, the diagnosis or clinical assessment, the products administered, the dosage administered, the duration of treatment and the withdrawal period applied, and must keep them in the United Kingdom for at least three years,

and failure to comply with this sub-paragraph is an offence.

(4)    The overall range and quantity of veterinary medicinal products carried by the veterinary surgeon must not exceed that generally required for the daily needs of good veterinary practice.

(5)    This paragraph does not apply in relation to immunological veterinary medicinal products.

Treatment in exceptional circumstances

7

(1)    Where the health situation so requires, and where there is no suitable veterinary medicinal product available either as an authorised product or under the cascade, a veterinary surgeon may treat an animal with a medicinal product authorised in a third country; but if the veterinary surgeon has not obtained a certificate from the Secretary of State under regulation 25(5) permitting him to import it, he must obtain a certificate from the Secretary of State before he treats the animal.

(2)    The certificate may be granted subject to any condition the Secretary of State thinks fit.

Administration of a homeopathic remedy

8

(1)    A registered homeopathic remedy or a homeopathic remedy prepared and supplied by a pharmacist under paragraph 10 of Schedule 3 may be administered to an animal by anyone, subject to any restrictions specified in its registration.

(2)    A homeopathic remedy that was on the market before 1st January 1994 may be administered by anyone.

(3)    A veterinary surgeon may administer, either himself or under his responsibility—

(a)    a homeopathic remedy authorised for human use, or

(b)    a homeopathic remedy prepared extemporaneously by a veterinary surgeon, a pharmacist or a person holding a manufacturing authorisation authorising the manufacture of that type of product.

Administration under an animal test certificate

9

(1)    A medicinal product may be administered in accordance with an animal test certificate granted for research purposes by the Secretary of State.

(2)    An application for an animal test certificate may be refused if this is necessary for the protection of animal or public health or the environment, and the animal test certificate may be varied, suspended or revoked in the same way as a marketing authorisation.

(3)    The holder of an animal test certificate is guilty of an offence if he supplies a product for administration that is not within the terms of the animal test certificate.

•  

  1    Scope and interpretation

•  

  2    Enforcement of Regulation (EC) No 178/2002

•  

  3    Enforcement of Regulation (EC) No 1831/2003

•  

  4    Enforcement of Regulation (EC) No 882/2004

•  

  5    Enforcement of Regulation (EC) No 183/2005

•  

  6    Approval of manufacturers and distributors of feedingstuffs containing veterinary medicinal products

•  

  7    Incorporation of a veterinary medicinal product into a premixture

•  

  8    Incorporation of a veterinary medicinal product into feedingstuffs

•  

  9    Additional record keeping requirements relating to veterinary medicinal products

•  

  10    Labelling a premixture containing a veterinary medicinal product

•  

  11    Labelling of feedingstuffs containing a specified feed additive

•  

  12    Labelling of feedingstuffs containing a veterinary medicinal product

•  

  13    Supply of specified feed additives

•  

  14    Supply of premixture

•  

  15    Supply of feedingstuffs containing a veterinary medicinal product

•  

  16    Prescriptions for feedingstuffs containing a veterinary medicinal product

•  

  17    Writing the prescription

•  

  18    Possession

•  

  19    Sampling and analysis

•  

  20    Storage

•  

  21    Packages and other containers

•  

  22    Transport

•  

  23    Possession, placing on the market and use of feedingstuffs

•  

  24    Imports from third countries

•  

  25    Trade between member States

Scope and interpretation

1

(1)    This Schedule applies in relation to the following (referred to in this Schedule as “specified feed additives”) when used as feed additives—

(a)    coccidiostats;

(b)    histomonostats; and

(c)    all other zootechnical additives except—

(i)    digestibility enhancers;

(ii)    gut flora stabilisers; and

(iii)    substances incorporated with the intention of favourably affecting the environment.

(2)    It also applies in relation to the manufacture and placing on the market of feedingstuffs containing a veterinary medicinal product.

(3)    In this Schedule—

“premixture” means a mixture of a veterinary medicinal product or a specified feed additive with feedingstuffs materials, intended for further mixing with feedingstuffs before being fed to animals;

“zootechnical additive” means any additive used to maintain animals in good health or favourably affect their performance.

Enforcement of Regulation (EC) No 178/2002

2

(1)    For the purposes of 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) the competent authority is the Secretary of State.

(2)    Any person who contravenes any of the following provisions of that Regulation is guilty of an offence—

(a)    Article 11 (requirements relating to imports);

(b)    Article 12 (requirements relating to exports);

(c)    Article 15 (1) (prohibition on the placing on the market or feeding unsafe feedingstuffs);

(d)    Article 16 so far as it prohibits misleading labelling, advertising or presentation of feedingstuffs;

(e)    Article 18 (2) and (3) (requirements of traceability) in so far as it relates to feed business operators; and

(f)    Article 20 (responsibilities of feed business operators).

Enforcement of Regulation (EC) No 1831/2003

3

(1)    For the purposes of Regulation (EC) No 1831/2003 (of the European Parliament and the Council on additives for use in animal nutrition) the competent authority is the Secretary of State.

(2)    When he grants an authorisation under Article 3(2) of that Regulation, the authorisation must be in writing.

(3)    It is an offence to be in possession of a specified feed additive, or a premixture or feedingstuffs containing a specified feed additive, unless the specified feed additive has been authorised under Regulation (EC) No 1831/2003 or is for export to a third country.

(4)    Any person who contravenes any of the following provisions of that Regulation is guilty of an offence—

(a)    Article 3(1) or Article 3(3) (the authorisation, conditions of use and labelling of specified feed additives);

(b)    Article 12(1) or (2) (conditions relating to specified feed additives);

(c)    Article 16(1) (labelling);

(d)    Article 16(3) (additional labelling requirement);

(e)    Article 16(4) (premixtures containing specified feed additives);

(f)    Article 16(5) (packaging).

Enforcement of Regulation (EC) No 882/2004

4

For the purposes of 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) the competent authority is the Secretary of State.

Enforcement of Regulation (EC) No 183/2005

5

(1)    For the purposes of Regulation (EC) No 183/2005 (of the European Parliament and of the Council laying down requirements for feed hygiene) the competent authority is the Secretary of State.

(2)    Any person who contravenes any of the following provisions of that Regulation is guilty of an offence—

(a)    Article 5(2), (5) or (6) (specific obligations);

(b)    Article 6(1) as read with (2) and (3) (HACCP system);

(c)    Article 7(1) (documents concerning the HACCP system);

(d)    Article 9(2) (official controls, notification and registration);

(e)    Article 11 (prohibition on operating without approval or registration);

(f)    Article 17(2) (exemption from on-site visits);

(g)    Article 18(3) (declaration of compliance);

(h)    Article 23(1) (conditions relating to imports from third countries);

(i)    Article 25 (feedingstuffs produced for export to third countries).

(3)    A manufacturer must ensure that, so far as is reasonably practicable, the active ingredient is evenly incorporated throughout the feedingstuffs and failure to do so is an offence.

(4)    In the case of the refusal, suspension or revocation of an approval under the Regulation the appeals procedure relating to a manufacturing authorisation in paragraph 6 of Schedule 2 applies.

Approval of manufacturers and distributors of feedingstuffs containing veterinary medicinal products

6

(1)    It is an offence to incorporate a veterinary medicinal product into a premixture or feedingstuffs, or to act as a distributor of premixtures or feedingstuffs containing a veterinary medicinal product, without being approved to do so by the Secretary of State.

(2)    The requirements of this paragraph do not apply in relation to a person who incorporates a veterinary medicinal product into feedingstuffs in domestic premises for feeding, on those premises—

(a)    non-food-producing animals, or

(b)    food-producing animals kept purely for domestic consumption.

(3)    The provisions of Regulation (EC) No 183/2005 apply to those producers and distributors in the same way as to persons approved under Article 9 of that Regulation.

(4)    A manufacturer must ensure that, so far as is reasonably practicable, the veterinary medicinal product is evenly incorporated throughout the feedingstuffs and failure to do so is an offence.

(5)    In the case of the refusal, suspension or revocation of an approval under this paragraph the appeals procedure relating to a manufacturing authorisation in paragraph 6 of Schedule 2 applies.

Incorporation of a veterinary medicinal product into a premixture

7

(1)    Any person who incorporates a veterinary medicinal product into a premixture—

(a)    must do so in accordance with the summary of product characteristics, and must take account of any interactions listed there; and

(b)    must ensure that the veterinary medicinal product does not contain the same active substance as any other additive.

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

Incorporation of a veterinary medicinal product into feedingstuffs

8

(1)    Any person who incorporates a veterinary medicinal product (or a premixture containing a veterinary medicinal product) into feedingstuffs—

(a)    must do so in accordance with the summary of product characteristics, and must take account of any interactions listed there;

(b)    must ensure that the veterinary medicinal product does not contain the same active substance as any other additive;

(c)    must ensure that the veterinary medicinal product is incorporated in accordance with its marketing authorisation (unless it has been prescribed under the cascade) and the prescription;

(d)    must ensure that the daily dose of the veterinary medicinal product is contained in a quantity of medicated feedingstuffs corresponding to at least half the daily feedingstuffs ration of the animals treated or, in the case of ruminants, corresponding to at least half the daily requirements of non-mineral supplementary feedingstuffs.

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

Additional record keeping requirements relating to veterinary medicinal products

9

(1)    Any person who—

(a)    incorporates a veterinary medicinal product into a premixture;

(b)    incorporates a premixture containing a veterinary medicinal product into feedingstuffs; or

(c)    incorporates a veterinary medicinal product into feedingstuffs,

must make a daily record of—

(i)    the types and quantities of all veterinary medicinal products (and specified feed additives, if any) and premixture used in the manufacturing process; and

(ii)    the quantity of feedingstuffs and premixture containing veterinary medicinal product manufactured that day.

(2)    An approved distributor must make a daily record of—

(a)    the types and quantities of all premixtures and feedingstuffs containing veterinary medicinal products bought and sold that day;

(b)    the quantity held.

(3)    A manufacturer and distributor must also record, as soon as reasonably practicable, for each consignment supplied—

(a)    the date of delivery;

(b)    the name and address of each consignee (or, in the case of a manufacturer supplying to a distributor, the name and address of the distributor);

(c)    the type of feedingstuffs or premixture supplied;

(d)    the quantity;

(e)    the type of veterinary medicinal product incorporated into the feedingstuffs; and

(f)    the expiry date.

(4)    Records must be kept for five years.

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

Labelling a premixture containing a veterinary medicinal product

10

(1)    A premixture containing a veterinary medicinal product must be clearly and legibly labelled with the following—

(a)    the words “MEDICATED PREMIXTURE” in upper case letters;

(b)    the proprietary name of the veterinary medicinal product and the authorisation number;

(c)    the name and amount of the active substance (mg/kg) in the premixture;

(d)    the range of acceptable inclusion rates of the premixture into the final feedingstuffs, the range of acceptable levels of the active ingredients in the final feedingstuffs and the words “refer to the prescription for the exact inclusion rate” or equivalent wording;

(e)    warnings and contra-indications;

(f)    the withdrawal period;

(g)    the expiry date;

(h)    any special storage instructions;

(i)    where a prescription is required, a statement to this effect.

(2)    The withdrawal period must be that specified in the marketing authorisation for the veterinary medicinal product, and if there is more than one veterinary medicinal product used it must be the longest.

(3)    If the premixture also contains a specified feed additive to which this Schedule applies it must also contain the information required under Article 16 of Regulation (EC) No 1831/2003.

(4)    It is an offence to supply such a premixture not labelled in accordance with this paragraph.

Labelling of feedingstuffs containing a specified feed additive

11

(1)    Feedingstuffs containing a specified feed additive must be clearly and legibly labelled with the following—

(a)    the name of the specified feed additive;

(b)    the name and amount of the active substance (mg/kg) in the feedingstuffs;

(c)    the withdrawal period if one is specified in the authorisation;

(d)    the expiry date;

(e)    the name and approval number of the manufacturer or the distributor;

(f)    any particulars concerning the proper use of the feedingstuffs specified in the authorisation of the specified feed additive.

(2)    It is an offence to supply such feedingstuffs not labelled in accordance with this paragraph.

Labelling of feedingstuffs containing a veterinary medicinal product

12

(1)    Feedingstuffs containing a veterinary medicinal product must be clearly and legibly labelled with the following—

(a)    the words “MEDICATED FEEDINGSTUFFS” in upper case letters;

(b)    the proprietary name, authorisation number and inclusion rate (kg/tonne or mg/kg) of the veterinary medicinal product incorporated into the feedingstuffs;

(c)    the name and amount of the active substance (mg/kg) in the feedingstuffs;

(d)    the species of animal for which the feedingstuffs are intended;

(e)    warnings and contra-indications;

(f)    the withdrawal period;

(g)    the expiry date;

(h)    any special storage instructions required by the marketing authorisation;

(i)    a statement to the effect that the feedingstuffs must only be fed in accordance with the prescription;

(j)    the name and approval number of the manufacturer or the distributor.

(2)    The withdrawal period must be that specified in the marketing authorisation for the veterinary medicinal product.

(3)    If there is more than one veterinary medicinal product used—

(a)    if there is a prescription at the time of labelling, it must be the period specified in the prescription or, if none is specified, the longest withdrawal period;

(b)    if there is no prescription at the time of labelling it must be the longest withdrawal period but the label must also state “If the prescription specifies a longer withdrawal period this must be applied”.

(4)    It is an offence to supply feedingstuffs not labelled in accordance with this paragraph.

Supply of specified feed additives

13

(1)    It is an offence for any person other than the person who manufactured a specified feed additive or an approved distributor to supply a specified feed additive.

(2)    The person who manufactured the specified feed additive may only supply it to—

(a)    an approved distributor;

(b)    an approved premixture manufacturer; or

(c)    a feedingstuff manufacturer approved to mix a specified feed additive directly into feedingstuff.

(3)    An approved distributor may only supply it to—

(a)    another approved distributor;

(b)    an approved premixture manufacturer; or

(c)    a feedingstuff manufacturer approved to mix a specified feed additive directly into feedingstuff.

(4)    It is an offence for a manufacturer or distributor to supply a specified feed additive to anyone not specified in this paragraph.

Supply of premixture

14

(1)    It is an offence for any person other than the person who manufactured a premixture or an approved distributor to supply a premixture.

(2)    The person who manufactured the premixture may only supply it to—

(a)    an approved distributor; or

(b)    a feedingstuff manufacturer approved to incorporate that premixture.

(3)    An approved distributor may only supply it to—

(a)    another approved distributor, or

(b)    a feedingstuff manufacturer approved to incorporate that premixture.

(4)    It is an offence for a manufacturer or distributor to supply a premixture to anyone not specified in this paragraph.

Supply of feedingstuffs containing a veterinary medicinal product

15

(1)    It is an offence for any person other than the person who manufactured the feedingstuffs or an approved distributor to supply feedingstuffs containing a veterinary medicinal product.

(2)    The person who manufactured the feedingstuff may only supply it to—

(a)    an approved distributor, or

(b)    a person who keeps animals for feeding to those animals.

(3)    A distributor may only supply it to—

(a)    another approved distributor, or

(b)    a person who keeps animals for feeding to those animals.

(4)    Supply to a person who keeps animals must be in accordance with a written prescription as specified in the following paragraph.

(5)    If a prescription is for a period of longer than one month, the supplier may not provide more than one month's supply at any one time.

(6)    It is an offence for a manufacturer or distributor to supply a feedingstuff to anyone not specified in this paragraph, or otherwise than in accordance with this paragraph.

(7)    The person supplying the feedingstuff must keep the prescription for five years, and failure to do so is an offence.

Prescriptions for feedingstuffs containing a veterinary medicinal product

16

(1)    A prescription for feedingstuffs containing a veterinary medicinal product must contain the following—

(a)    the name and address of the person prescribing the product;

(b)    the qualifications enabling the person to prescribe the product;

(c)    the name and address of the keeper of the animals to be treated;

(d)    the species of animal, identification and number of the animals;

(e)    the premises at which the animals are kept if this is different from the address of the keeper;

(f)    the date of the prescription;

(g)    the signature or other authentication of the person prescribing the product;

(h)    the name and amount of the product prescribed;

(i)    the dosage and administration instructions;

(j)    any necessary warnings;

(k)    the withdrawal period;

(l)    the manufacturer or the distributor of the feedingstuffs (who must be approved for the purpose);

(m)    if the validity exceeds one month, a statement that not more than 31 days supply may be provided at any time;

(n)    the name, type and quantity of feedingstuffs to be used;

(o)    the inclusion rate of the veterinary medicinal product and the resulting inclusion rate of the active substance;

(p)    any special instructions; and

(q)    the percentage of the prescribed feedingstuffs to be added to the daily ration.

(2)    It is valid for three months or such shorter period as may be specified in the prescription.

(3)    It must be sufficient for only one course of treatment.

Writing the prescription

17

(1)    The person who writes the prescription must—

(a)    give a copy to the person incorporating the veterinary medicinal product into the feedingstuffs or to the distributor of the feedingstuffs;

(b)    give one copy to the keeper of the animals to be treated;

(c)    keep a copy himself.

(2)    He must be satisfied that—

(a)    there is no undesirable interaction between the veterinary medicinal product and any feed additive used in the feedingstuffs; and

(b)    the active substance of the veterinary medicinal product is not the same as an active substance in any feed additive used in the feedingstuffs.

(3)    For the avoidance of doubt, a veterinary surgeon may prescribe either a veterinary medicinal product authorised for that species and condition, or under the cascade.

(4)    The requirement for a written prescription does not apply in relation to a veterinary medicinal product supplied to a person specified in paragraph 6(2) for incorporation into feedingstuffs in their premises, but in this case paragraph 5 of Schedule 3 applies in relation to the supply of the veterinary medicinal product.

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

Possession

18

(1)    It is an offence for any person other than a person holding the appropriate approval under this Schedule to be in possession of any—

(a)    specified feed additive or veterinary medicinal product to which this Schedule applies;

(b)    premixtures containing such an additive or a veterinary medicinal product; or

(c)    feedingstuffs containing such an additive or a veterinary medicinal product unless supplied under these Regulations.

(2)    It is an offence for any person other than a manufacturer or distributor to be in possession of feedingstuffs incorporating a veterinary medicinal product unless it has been supplied under a prescription.

Sampling and analysis

19

(1)    If any enforcement action is taken under this Schedule based on a sample, that sample must have been taken and analysed in accordance with Council Directive 76/371/EEC (establishing Community methods of sampling for the official control of feedingstuffs).

(2)    Unless otherwise specified in the marketing authorisation, it is a defence if the active ingredient in the sample is within the following tolerances—

Storage

20

It is an offence to store a veterinary medicinal product intended for incorporation into feedingstuffs, or a premixture or feedingstuffs containing a veterinary medicinal product, except in—

(a)    a suitable storage area that is locked when not in use, or

(b)    a hermetic container designed to store those products.

Packages and other containers

21

It is an offence to place on the market feedingstuffs containing a veterinary medicinal product except in packages or containers that are sealed in such a way that, when the package or container is opened, the seal is damaged.

Transport

22

(1)    In the case of feedingstuffs distributed by road tankers or in bulk the labelling requirements must be given in a document accompanying the feedingstuffs, and the transporter must hand over details when he delivers the feedingstuffs unless these have already been provided to the purchaser.

(2)    Any person transporting feedingstuffs containing veterinary medicinal products or specified feed additives in road tankers or similar containers must ensure that the vehicle or container is cleaned before any re-use if this is necessary to prevent undesirable interaction or contamination.

(3)    In the case of feedingstuffs containing a veterinary medicinal product he must ensure that the vehicle is accompanied by documentation stating this.

(4)    Any person operating an undertaking transporting feedingstuffs containing veterinary medicinal products or specified feed additives must give written instructions to drivers on how to load and unload vehicles so as to avoid cross-contamination, and take reasonable steps to ensure that the driver complies with those instructions.

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

Possession, placing on the market and use of feedingstuffs

23

(1)    It is an offence for any person to possess, place on the market or feed to animals any feedingstuffs incorporating veterinary medicinal products or specified feed additives unless they have been incorporated in accordance with this Schedule.

(2)    It is an offence to feed to any animal, or buy or possess for the purpose of feeding to any animal, any feedingstuff containing a veterinary medicinal product or specified feed additive unless that veterinary medicinal product or specified feed additive is authorised for that species of animal and for the purpose for which it is used (unless prescribed under the cascade).

(3)    This paragraph does not apply in relation to feedingstuffs if the veterinary medicinal product has been incorporated in accordance with an animal test certificate or the feedingstuff has been imported in accordance with this Schedule.

Imports from third countries

24

Any person who imports a feedingstuff containing a veterinary medicinal product from a third country is guilty of an offence.

Trade between member States

25

Any person who brings in from another member State a feedingstuff containing a veterinary medicinal product is guilty of an offence unless—

(a)    the feedingstuff has been manufactured in accordance with the provisions of Council Directive 90/167/EEC (laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the Community and Regulation (EC) No 183/2005; and

(b)    it only contains a veterinary medicinal product that has the same quantitative and qualitative composition as a veterinary medicinal product authorised in the United Kingdom.

•  

  1    Animals to which this Schedule applies

•  

  2    Placing on the market, importing and administering the product

•  

  3    Manufacture

•  

  4    Approval of the active substance

•  

  5    The product

•  

  6    Labelling

•  

  7    Administration

•  

  8    Pack size

•  

  9    Adverse reactions

Animals to which this Schedule applies

1

This Schedule applies in relation to veterinary medicinal products intended solely for the following animals kept exclusively as a pet—

(a)    aquarium fish;

(b)    cage birds;

(c)    ferrets;

(d)    homing pigeons;

(e)    rabbits;

(f)    small rodents; and

(g)    terrarium animals.

Placing on the market, importing and administering the product

2

A veterinary medicinal product intended solely for an animal to which this Schedule applies may be placed on the market, imported or administered without a marketing authorisation if it complies with this Schedule.

Manufacture

3

(1)    The product must have been manufactured by—

(a)    the holder of a manufacturing authorisation if manufactured in the United Kingdom;

(b)    the holder of a manufacturing authorisation issued under Directive 2001/82/EC if manufactured in another member State;

(c)    in the case of Australia, Canada, New Zealand, or Switzerland, the holder of an authorisation from the competent authority permitting him to manufacture medicinal products;

(d)    in the case of any other country, a manufacturer whose premises have been inspected and approved by an officer of the Secretary of State.

(2)    This paragraph does not apply until 1st November 2007.

Approval of the active substance

4

(1)    The Secretary of State may approve an active substance for use in a veterinary medicinal product manufactured under this Schedule.

(2)    The Secretary of State may not grant an approval if the active substance requires veterinary control.

(3)    The approval must specify the animals for which it is approved, and may specify how the active substance or a product containing it is to be administered.

(4)    The Secretary of State may suspend or revoke the approval (or limit it to a smaller number of species) if—

(a)    it is demonstrated that the substance requires veterinary control;

(b)    serious adverse reactions are reported making suspension or revocation necessary; or

(c)    it is demonstrated that the substance—

(i)    is carcinogenic;

(ii)    is genotoxic; or

(iii)    shows developmental toxicity (including teratogenicity).

(5)    The procedure for the refusal, suspension or revocation of an approval under this paragraph is the same as the procedure for a marketing authorisation.

The product

5

(1)    The active substance in the veterinary medicinal product must be approved under paragraph 4.

(2)    The veterinary medicinal product must not be an antibiotic.

(3)    It must not contain any narcotic or psychotropic substance.

(4)    It must not be intended for treatments or pathological processes that require a precise prior diagnosis or the use of which may cause effects that impede or interfere with subsequent diagnostic or therapeutic measures.

(5)    The requirement that a veterinary medicinal product may only contain an active substance under paragraph 4 does not apply until 1st November 2007 in relation to a veterinary medicinal product on the market on 30th October 2005.

Labelling

6

(1)    The product must be clearly labelled as being exempt from the requirements of these Regulations in relation to a marketing authorisation.

(2)    The labelling must show the following—

(a)    the name of the veterinary product, including, if it is part of the name, its strength and pharmaceutical form;

(b)    the authorisation number of the manufacturer;

(c)    the name and strength of each active substance;

(d)    the route of administration;

(e)    the batch number;

(f)    the expiry date;

(g)    the words “For animal treatment only”;

(h)    the contents by weight, volume or number of dose units;

(i)    the name and address of the manufacturer;

(j)    the target species;

(k)    the words “Keep out of reach of children”;

(l)    storage instructions;

(m)    the shelf-life after the immediate packaging has been opened for the first time;

(n)    disposal advice;

(o)    full indications, including—

(i)    therapeutic indications;

(ii)    contra-indications;

(iii)    interaction with other medicines and other forms of interaction; and

(p)    dosage instructions.

(3)    If there is insufficient room on the label, the information may instead be in a package leaflet, but the leaflet must contain all the information in the preceding sub-paragraph other than the batch number and the expiry date, but the label on the product must contain at least the following—

(a)    the name of the veterinary medicinal product;

(b)    its active substance and its strength;

(c)    the route of administration;

(d)    the batch number;

(e)    the expiry date; and

(f)    the words “For animal treatment only”.

(4)    This paragraph does not apply until 1st November 2007 in relation to a veterinary medicinal product on the market on 30th October 2005.

Administration

7

The method of administration must be oral or topical or (in the case of a product for fish) by addition to the water.

Pack size

8

The pack size must only be sufficient for a single course of treatment or, in the case of a veterinary medicinal product for aquarium fish, sufficient for a single course of treatment of no more than 7 administrations to an aquarium of 25,000 litres.

Adverse reactions

9

(1)    The manufacturer, importer or retailer of a veterinary medicinal product must notify the Secretary of State of any serious adverse reactions (as defined in paragraph 57 of Schedule 1) of which he becomes aware within 15 days of learning of the reaction.

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

These Regulations revoke and remake with amendments the Veterinary Medicines Regulations 2006.

Principal changes to the 2006 Regulations

The new Regulations introduce a requirement for the registration of veterinary premises for the supply of veterinary medicinal products.

They implement Commission Directive 2006/130/EC and enforce Commission Regulation (EC) No 1950/2006.

They permit the advertising of POM-V medicines to veterinary nurses.

They extend the provision that the holder of a Marketing Authorisation for an immunological product must submit to the Secretary of State the results of all tests carried out on each batch of the product before he places the product on the market, to require that the holder must wait for confirmation from the Secretary of State before the product is placed on the market.

They control exports to other member States.

They update fees.

The Regulations

The Regulations make provision for the authorisation, manufacture, classification, distribution and administration of veterinary medicinal products.

They implement Directive 2001/82/EC

They enforce Regulations (EC) No 178/2002, No 1831/2003, No 882/2004, No 183/2005, in so far as they apply to veterinary medicinal products used in feedingstuffs, and to some specified feed additives used in feedingstuffs.

They implement Council Directive 90/167 so far it is not superseded by Regulation (EC) No 183/2005.

They provide that a veterinary medicinal product must have a marketing authorisation granted by the Secretary of State before being placed on the market, and make provision for the grant of a marketing authorisation (regulation 4 and Schedule 1).

They specify that a veterinary medicinal product must be manufactured by a person holding a manufacturing authorisation, and make provision for granting an authorisation (regulation 5 and Schedule 2).

They regulate supply and possession of veterinary medicinal products, and introduce new classifications of those products (regulation 7 and Schedule 3).

They provide that a veterinary medicinal product may only be administered as specified in its marketing authorisation or, in the case of administration by a veterinary surgeon, administration under the “cascade”” (regulation 8 and Schedule 4).

They control bringing a veterinary medicinal product into the United Kingdom (regulation 9) and advertising (regulation 10 to 12).

They control wholesale dealing (regulation 13).

They control medicated feedingstuffs and feedingstuffs containing additives specified in the Regulations (regulation 14 and Schedule 5).

They provide for exemptions (regulation 15 and Schedule 6).

They provide for fees (regulation 16 and Schedule 7).

They require records to be kept (regulations 17 to 24).

They create offences of importation, possession and supply of unauthorised veterinary medicinal products (regulations 25 to 27).

They make provision for the existence of the Veterinary Products Committee (regulation 28).

They make provision for an appeals procedure in the case of a refusal, etc, of a marketing authorisation (regulation 29).

They create administrative arrangements for the enforcement of the Regulations (regulations 32 to 41).

Under regulation 42 breach of the Regulations is an offence punishable—

(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.

A Regulatory Impact Assessment has been prepared and placed in the libraries of both Houses of Parliament. It is available, together with a transposition note and a table showing fee changes, on www.vmd.gov.uk at “Publications, Veterinary Medicines Regulations and Guidance”.