The Veterinary Medicines Regulations 2005

© Crown Copyright 2005

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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[5];

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

"the cascade" has the meaning assigned in paragraph 2 of Schedule 4;

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

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

(a) any risk relating to the quality, safety and efficacy of the veterinary medicinal product as regards animal or human health; 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 all 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 to a veterinary medicinal product that is the subject of a licence granted under the Animals (Scientific Procedure) Act 1986[6], except that, if the animals used under that licence are to be put into the human food chain, the veterinary medicinal product must be administered in accordance with an animal test certificate granted under regulation 8(3).

The finished product
     6. The holder of a marketing authorisation for a veterinary medicinal product is guilty of an offence if the finished product supplied by him or the manufacturer is not completely in accordance with the marketing authorisation.

Classification, supply and possession of the product
     7. —(1) Part I of Schedule 3 (Classification and supply of authorised veterinary medicinal products) 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 supplies a medicinal product authorised for human use for administration to an animal (other than in accordance with a prescription from a veterinary surgeon for administration under the cascade) is guilty of an offence.

    (4) 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. —(1) 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 a marketing authorisation).

    (2) It is an offence to administer a veterinary medicinal product to a food-producing animal unless it was prescribed in accordance with Schedule 3 or is administered in accordance with Schedule 4.

    (3) This regulation does not apply in the case of a product administered for research purposes in accordance with a certificate ("an animal test certificate") granted for the purpose by the Secretary of State.

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;

(b) the importation is in accordance with a certificate issued for the purpose by the Secretary of State; and

(c) 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 9 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 a human medicine for administration to animals (including sending a price list of or including human medicines 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 human medicines, 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 veterinary surgeon has specified the type of human medicinal product he wishes to use, and the list is confined to human medicines of that type;

(c) 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

(d) it only includes human medicines that may be administered legally under the cascade.

Advertising of prescription products and products with psychotropic drugs or narcotics
     11. —(1) It is an offence to advertise veterinary medicinal products that—

(a) are available on veterinary prescription only; or

(b) contain 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.

    (3) In the case of POM-V medicines, this does not apply to price lists, or to advertisements aimed at veterinary surgeons, 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 9 of Schedule 3;

(d) other veterinary health care professionals;

(e) professional keepers of animals;

(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) The requirements relating to marketing authorisations and manufacturing authorisations under Part 1 of Schedule 2 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 other animals on the same site if the product has been manufactured in accordance with Part 2 of Schedule 2.

    (3) They do not apply in relation to blood from blood banks operated in accordance with Part 3 of Schedule 2.

    (4) Schedule 6 (small animals exemption) has effect.

Fees
     16. Schedule 7 (fees) has effect.

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

Food-producing animals: records of purchase and administration
     19. —(1) When a veterinary medicinal product is bought for a food-producing animal the keeper must record, at the time of purchase—

(a) the name of the product;

(b) the date of purchase;

(c) the quantity purchased;

(d) the withdrawal period;

(e) 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 identity of the animals treated.

    (3) If he disposes of it other than by treating an animal, he must record the date and route of disposal.

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

Food-producing animals: retention of records
     20. —(1) The keeper must retain the proof of purchase and the record for at least five years following the administration or other disposal of the product, irrespective of whether or not the animals concerned are no longer in his possession or have been slaughtered or have died during that period.

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

Records by holders 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;

(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 (manufacturing) 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 wholesale dealers
     22. —(1) A wholesale dealer must record, as soon as is reasonably practicable after each incoming or outgoing transaction (including disposals), the following—

(a) the date and nature of the transaction;

(b) the identity 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 products supplied on prescription
     23. —(1) When any person permitted under these Regulations to supply veterinary medicinal products classified as POM-V or POM-VPS receives or supplies any such veterinary medicinal product he must keep all documents relating to the transaction, which must include—

(a) the date;

(b) the identity of the veterinary medicinal product;

(c) the quantity;

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

(e) 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.

    (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.

    (4) When he starts to use the veterinary medicinal product he must also record the batch number and the date.

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

    (6) 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 a food-producing animal 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 diagnosis;

(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;

(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.

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 veterinary medicinal product prescribed by a veterinary surgeon under the cascade;

(c) wholesale dealers if the possession is for re-export;

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

    (3) 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.

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.

she shall notify the applicant or holder of her intention.

    (2) The applicant or holder may within 28 days of the notification give notice that he wishes to make representations to the Veterinary Products Committee concerning the notice.

    (3) The Committee shall consider those representations.

    (4) The representations may be written or oral, but may not include any data not available to the Secretary of State at the time of her decision.

    (5) The Committee shall report in writing to the Secretary of State.

    (6) If the appellant so requests, the Secretary of State shall give him a copy of the report.

    (7) The Secretary of State shall give to the appellant written notification of her proposed determination and the reasons for it.

    (8) A person may make representations concerning the Secretary of State's proposed determination to a person appointed for the purpose by the Secretary of State.

    (9) The appointed person shall consider the representations (but shall not consider any data that was not available to the Secretary of State at the time of her decision) and report in writing, with a recommended course of action, to the Secretary of State.

    (10) The Secretary of State shall give written notification of her final determination and the reasons for it.

    (11) If the notification concerns suspension of a marketing authorisation, unless the Secretary of State directs otherwise, the suspension shall take effect when the notification is made and shall continue in force until she makes her final determination.

Duties on the Secretary of State relating to exports
     30. —(1) At the request of any person exporting a veterinary medicinal product to a third country, or the competent authorities of a third country to which a veterinary medicinal product is to be exported, the Secretary of State shall provide a certificate that the veterinary medicinal product was manufactured in accordance with the marketing authorisation, if there is one, and, if there is no marketing authorisation, that the manufacturer holds a manufacturing authorisation for that type of product.

    (2) When she issues the certificate the Secretary of State shall take account of the model certificates issued by the World Health Organization[7].

    (3) If the veterinary medicinal product is authorised in the United Kingdom the Secretary of State shall 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 shall, on producing, if so required, some duly authenticated document showing his authority, have a right at all reasonable hours, to enter any premises for the purpose of ensuring that the provisions of these Regulations are being complied with; and in this regulation "premises" includes any place, any vehicle or trailer, any container, any stall or moveable structure, and any 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 shall 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 shall continue in force for one month.

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

    (7) An inspector shall have the right to enter the premises of manufacturers of active substances used as starting materials for veterinary medicinal products, and of the premises of the marketing authorisation holder.

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

    (9) In the application of this regulation to Scotland a reference to a justice of the peace includes a reference to the sheriff and to a magistrate.

Powers of inspectors
     34. 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) examine or seize any documents or records (including financial records);

(e) seize any computers and associated equipment for the purpose of copying documents provided they are returned as soon as practicable;

(f) seize any veterinary medicinal product or anything purporting to be a veterinary medicinal product, and if he does so in circumstances where regulation 40 applies he shall act in accordance with that regulation;

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

(h) have access to, and inspect and copy any documents or records (in whatever form they are held) kept under these Regulations, or remove such records to enable them to be copied;

(i) have access to, inspect and check the operation of any computer and any associated apparatus or material which 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.

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. —(1) 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 which 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 which 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 which constitute the failure so to comply;

(c) specifies the measures which, in the officer's opinion, the person must take in order to secure compliance; and

(d) requires the person to take those measures, or measures which are at least equivalent to them, within such period (not being less than 14 days) as may be 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) shall be by way of complaint, and the Magistrates' Courts Act 1980[8] shall apply to the proceedings.

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

    (4) The period within which an appeal may be brought shall be one month or the period specified in the improvement notice, whichever ends the earlier.

    (5) An improvement notice shall 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 or affirm the notice and, if it affirms it, may do so either in its original form or with such modifications as the court may in the circumstances think fit.

Seizure notices
     40. —(1) If an inspector finds any veterinary medicinal product that does not appear to him to be authorised in the United Kingdom, or any authorised veterinary medicinal product not lawfully supplied in accordance with these Regulations, he may seize it.

    (2) He shall give to the person appearing to him to be in charge of the veterinary medicinal 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 movement of the products until they are collected, and any person who moves products identified under this paragraph is guilty of an offence.

    (4) Any person claiming that the product was not liable to seizure shall, within one month of the seizure notify his claim to the Secretary of State at the address specified in the original notice, setting out the grounds in full.

    (5) If a notification of a claim is not received within one month the Secretary of State shall destroy the product.

    (6) If a notification of a claim is received within one month, the Secretary of State shall either return the goods or take proceedings for an order for the destruction of the veterinary medicinal product in a magistrates' court (or, in Scotland, the sheriff court), and if the court finds that the veterinary medicinal product did not have a marketing authorisation in the United Kingdom, or had not been supplied in accordance with these Regulations, it shall order its destruction.

    (7) The person on whom the original notice was served is liable for the costs of destruction.

    (8) This regulation applies to additives, premixtures and feedingstuffs specified in Schedule 5 in the same way as it applies to veterinary medicinal products.

Publication of notices
     41. The Secretary of State shall publicise improvement notices and seizure notices in such manner as she shall see 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, as well as the body corporate, is guilty of the offence and is liable to be proceeded against and punished accordingly.

    (3) For the purposes of paragraph (2)(b) 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 which 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 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 shall exercise the powers of the Secretary of State in—

(a) regulation 32 (appointment of inspectors);

(b) regulation 40 (seizure notices);

(c) regulation 41 (publication of notices); and

(d) sub-paragraph (4) of paragraph 9 of Schedule 3 (approval of premises for suitably qualified persons).

    (3) In proceedings in a magistrate's court relating to an improvement notice under regulation 38, the Magistrates' Courts (Northern Ireland) Order 1981[9] shall apply.

Revocations and amendments
     44. —(1) The Medicines Act 1968[10] does not apply in relation to veterinary medicinal products.

    (2) The Medicines (Prohibition of Importation and Possession of Veterinary Drugs Order (Northern Ireland) 1977[11] continues in force notwithstanding paragraph (1), and the Medicines Act 1968 shall continue to apply in so far as is necessary for the operation of that Order.

    (3) The Consumer Protection Act 1987[12] does not apply in relation to veterinary medicinal products.

    (4) The instruments in Part 1 of Schedule 8 are revoked.

    (5) The instruments in Part 2 of that Schedule are revoked on 1st January 2006.

    (6) The instruments in Part 3 of that Schedule have effect subject to the amendments specified.

    (7) Part 4 of that Schedule (transitional provisions) has effect, and the provisions relating to feedingstuffs have effect on 1st January 2006.

    (8) For the avoidance of doubt, the fact that the Medicines Act 1968 does not apply in relation to veterinary medicinal products does not prevent the preparation of information on veterinary medicinal products in the British Pharmacopoeia.


Ben Bradshaw
Parliamentary Under-Secretary of State Department for Environment, Food and Rural Affairs

17th September 2005


Joan Ryan

Vernon Coaker
Two of the Lords Commissioners of Her Majesty's Treasury

6th October 2005

(a) the name of the person who will hold the marketing authorisation, that person's address and, if different, the name and address of all the manufacturers involved in each stage of the manufacture, and the sites where the manufacture will take place;

(b) the name of the veterinary medicinal product, which may be either—


(i) an invented name provided that this is not liable to be confused with the common name of the product or the international non-proprietary name recommended by the World Health Organization; or

(ii) a common or scientific name accompanied by a trademark or the name of the marketing authorisation holder;



(c) the qualitative and quantitative particulars of all the constituents of the veterinary medicinal product, including its international non-proprietary name (INN) recommended by the World Health Organization, where an INN exists, or its chemical name;

(d) a description of the method of manufacture;

(e) all therapeutic indications, contra-indications and adverse reactions;

(f) the dosage for each species of animal for which the veterinary medicinal product is intended, its pharmaceutical form, method and route of administration and proposed shelf life;

(g) any proposed precautionary and safety measures to be taken when storing the veterinary medicinal product, administering it to animals and disposing of waste, together with an indication of potential risks that the veterinary medicinal product might pose to the environment, to human or animal health or to plants, together with the reasons;

(h) in the case of medicinal products intended for food producing species, the proposed withdrawal period necessary to ensure that the maximum residue limits specified in Council Regulation (EEC) No. 2377/90 (laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin[14]) are not exceeded;

(i) a description of the testing methods to be used during manufacture;

(j) the results of—



(i) pharmaceutical (physico-chemical, biological or microbiological) tests;

(ii) safety tests and residue tests;

(iii) pre-clinical and clinical trials;

(iv) tests assessing the potential risks to the environment from the product;



(k) a detailed description of the pharmacovigilance system and, where appropriate, the risk management system that the applicant will put in place;

(l) a summary of the product characteristics, mock-ups of all proposed packaging and the proposed package leaflet, if any;

(m) a document showing that the manufacturer is authorised in his own country to produce veterinary medicinal products;

(n) copies (which must be updated if there are any changes while the application is being considered) of —



(i) any marketing authorisation obtained in another member State or in a third country for the relevant veterinary medicinal product, and a list of any other member States in which an application for authorisation of the product has been submitted;

(ii) if the product is already authorised outside the United Kingdom, a copy of the summary of product characteristics for each authorisation;

(iii) any decision to refuse authorisation, whether in the Community or a third country and the reasons for that decision;



(o) proof that the applicant has the services of a qualified person responsible for pharmacovigilance (referred to in these Regulations as a qualified person (pharmacovigilance)) and has the necessary means for the notification of any adverse reaction suspected of occurring either in the Community or in a third country;

(p) if the veterinary medicinal product is intended for food producing species and contains one or more pharmacologically active substances not yet included for the species in question in Annex I, II or III to Council Regulation (EEC) No. 2377/90, a document certifying that a valid application for the establishment of maximum residue limits has been submitted to the Agency in accordance with paragraph 5.

    (4) All documents relating to the results of tests or trials must be accompanied by a detailed and critical expert report that has been drafted and signed by a person with the requisite technical or professional qualifications and that has a brief curriculum vitae of the person signing the report attached to it.

    (5) In the case of immunological products, the applicant must submit a description of the methods used to establish that the manufacturing process will consistently produce a veterinary medicinal product that is in accordance with the marketing authorisation.

Summary of product characteristics
     3. The summary of product characteristics required under the preceding paragraph shall include the following information, set out in the same format—


Summary of product characteristics

1	Name of the veterinary medicinal product, including its strength and pharmaceutical form.
2	The name and proportion of each active substance, and of any excipient if knowledge of the excipient is needed for safety reasons.
3	Pharmaceutical form.
4	Clinical particulars—
4.1	target species;
4.2	indications for use, specifying the target species;
4.3	contra-indications;
4.4	special warnings for each target species;
4.5	special precautions for use, including special precautions to be taken by the person administering the medicinal product to the animals;
4.6	adverse reactions (frequency and seriousness);
4.7	use during pregnancy, lactation or lay;
4.8	interaction with other medicinal products and other forms of interaction;
4.9	amounts to be administered and administration route;
4.10	overdose (symptoms, emergency procedures, antidotes) if necessary;
4.11	withdrawal periods for the various foodstuffs, including those for which the withdrawal period is zero.
5	Pharmacological properties—
5.1	pharmacodynamic properties;
5.2	pharmacokinetic particulars.
6	Pharmaceutical particulars—
6.1	list of excipients;
6.2	major incompatibilities;
6.3	shelf life, when necessary after reconstitution of the medicinal product or when the immediate packaging is opened for the first time;
6.4	special precautions for storage;
6.5	nature and contents of immediate packaging;
6.6	special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products, if appropriate.
7	Marketing authorisation holder.
8	Marketing authorisation number.
9	Date of the first authorisation or date of renewal of the authorisation.
10	Date of any revision of the text.
11	Any other information required by the Secretary of State.

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

Time limits for applications for products for use in food-producing animals
     5. In the case of a veterinary medicinal product for food-producing animals (including food-producing horses), a marketing authorisation may not be applied for until at least six months after a valid application has been made for the establishment of a maximum residue limit in accordance with Council Regulation (EEC) No. 2377/90.

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

    (5) Bioavailability studies are not required if the bioequivalence guidelines produced by the Agency exempt the product.

    (6) In the case of a reference product authorised in another member State but not in the United Kingdom, the Secretary of State must be satisfied that the risk-benefit balance of the original product is appropriate for the product to be placed on the market in the United Kingdom, and if the data provided under Article 13(1), third paragraph of Directive 2001/82/EC by the member State in which the product is authorised are insufficient for her to be satisfied of this, she may notify the applicant and require the applicant to provide further data.

Time limits for marketing authorisations granted under the procedure for a pharmacologically equivalent product
     11. —(1) This paragraph establishes the time limits relating to granting a marketing authorisation under the procedure for a pharmacologically equivalent product.

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

    (3) The product shall not be placed on the market until ten years (or, in the case of medicinal products for fish or bees where the application for a marketing authorisation was submitted after 30th October 2005, thirteen years) have elapsed from the initial authorisation of the reference product.

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

Extension of time limits
     12. —(1) This paragraph applies in relation to veterinary medicinal products that —

(a) are intended for administration to food producing species, and

(b) contain a new active substance that was not authorised in the Community by 30th April 2004.

    (2) If a person submits an application for a marketing authorisation for a product on or after 30th October 2005, and within 5 years of the original marketing authorisation being granted, the marketing authorisation is extended to include additional food-producing species, the ten-year period provided for in the paragraph 11(3) shall be extended by one year for each additional food producing species added to the marketing authorisation.

    (3) The total period shall not exceed 13 years.

    (4) The extension shall be granted only if the marketing authorisation holder originally applied for determination of the maximum residue limits for the active substance.

Parallel imports
     13. —(1) The Secretary of State may grant a marketing authorisation in relation to a veterinary medicinal product authorised in another member State and imported into the United Kingdom in accordance with this paragraph without the data required in Part 1 if the applicant can demonstrate compliance with this paragraph.

    (2) If the product is for a food-producing species it must be identical to a product authorised in the United Kingdom.

    (3) Other products must be therapeutically the same as a product authorised in the United Kingdom unless the importer can justify any differences.

    (4) The member State from which it is imported must have authorised the product in accordance with Directive 2001/82/EC.

    (5) The applicant must be established within the European Community.

    (6) The applicant must hold (or have a contract with the holder of) a wholesale dealer's authorisation in the United Kingdom appropriate to the type of product to be imported.

    (7) If re-labelling is to take place in the United Kingdom the applicant must also be (or have a contract with) the holder of a suitable manufacturing authorisation in the United Kingdom.

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

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

    (3) This paragraph does not apply in relation to a product recognised in more than one member State.

    (4) In this paragraph a biological veterinary medicinal product is a veterinary medicinal product, the active substance of which is a biological substance; and a biological substance is a substance that is produced by or extracted from a biological source and for which a combination of physico chemical-biological testing and the production process and its control is needed for its characterisation and the determination of its quality.

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

Marketing in exceptional circumstances
     16. Where the health situation so requires, the Secretary of State may authorise the placing on the market of a veterinary medicinal product that has been authorised by another member State or, if there is no such authorised product, authorised in a third country.

(a) the Horse Passports (England) Regulations 2004[15];

(b) the Horse Passports Regulations (Northern Ireland) 2004[16];

(c) the Horse Passports (Scotland) Regulations 2005[17];

(d) the Horse Passports (Wales) Regulations 2005[18],

but the product shall neither include active substances that appear in Annex IV to Council Regulation (EEC) No. 2377/90 nor be intended for use in the treatment of conditions, as detailed in the authorised Summary of Product Characteristics, for which a veterinary medicinal product is authorised for horses.

    (3) In this paragraph "horse" includes any member of the equidae family.

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

    (2) In addition, she shall refuse to grant it if—

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

(b) the risk-benefit balance of the veterinary medicinal product is unfavourable so that the risks outweigh the benefits;

(c) the product has insufficient therapeutic effect;

(d) the withdrawal period proposed by the applicant is not long enough to ensure that Council Regulation (EEC) No. 2377/90 is complied with, or is insufficiently substantiated;

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

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

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

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

(b) if she requests additional data and those data are not provided within such time limit as she may stipulate.

Publication following the grant of a marketing authorisation
     25. —(1) When she grants a marketing authorisation the Secretary of State shall publish—

(a) the notice granting the marketing authorisation;

(b) the summary of the product characteristics;

(c) an assessment report which shall be the assessment report she has already prepared but with any commercially confidential or personal information deleted.

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

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

Provisional marketing authorisation
     26. —(1) In exceptional circumstances, the Secretary of State may grant a provisional marketing authorisation subject to a requirement for the applicant to provide further data.

    (2) The Secretary of State shall reassess the authorisation annually.

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

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

    (3) It is an offence to fail to comply with this paragraph or a requirement under it.

Supply of information
     28. —(1) A marketing authorisation holder must immediately inform the Secretary of State if he receives any new information that might adversely affect the risk-benefit balance of the veterinary medicinal product.

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

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

    (4) It is an offence to fail to comply with this paragraph or a requirement under it.

Duties on the holder of a marketing authorisation relating to an immunological product
     29. —(1) 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 at least ten days before he places the product on the market.

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

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

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

Placing on the market
     31. —(1) When a holder of a marketing authorisation first places the veterinary medicinal product on the market in the United Kingdom he must notify the Secretary of State that he has done so, and the date on which it was placed on the market.

    (2) If he removes the veterinary medicinal product from the market in the United Kingdom, he must notify the Secretary of State of the fact at least two months (or a shorter period in exceptional circumstances) before he does so.

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

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

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

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

Duration and validity of a marketing authorisation
     32. —(1) A marketing authorisation is initially valid for five years.

    (2) The authorisation may be renewed after five years on the basis of a re evaluation of the risk-benefit balance.

    (3) An application for renewal must be made at least six months before the marketing authorisation ceases to be valid.

    (4) When he applies for the renewal of the marketing authorisation the applicant must enclose a list of all documents concerning the product that he has submitted to the Secretary of State since the marketing authorisation was granted.

    (5) The Secretary of State may require the applicant to provide a copy of any of the listed documents at any time.

    (6) Once renewed, the marketing authorisation is valid indefinitely unless, within five years of the renewal, the Secretary of State notifies the holder, on justified grounds relating to pharmacovigilance, that the authorisation will cease to be valid five years from the first renewal unless the holder applies for a further renewal.

    (7) The further renewal is valid indefinitely.

    (8) Any marketing authorisation granted under these Regulations that is not followed within three years of its granting by the actual placing on the market of the authorised veterinary medicinal product in the United Kingdom ceases to be valid.

    (9) When a veterinary medicinal product authorised under these Regulations and previously placed on the market in the United Kingdom is not present on the market in the United Kingdom for a period of three consecutive years, its marketing authorisation ceases to be valid.

    (10) The Secretary of State may, on human or animal health grounds, grant exemptions from sub-paragraphs (8) and (9).

    (3) She may also suspend, vary or revoke a marketing authorisation if she is satisfied that a marketing authorisation holder has failed to make an application for a variation to take account of scientific and technical progress in manufacturing and control methods to enable a veterinary medicinal product to be manufactured and checked by means of generally accepted scientific methods.

    (4) When she suspends, varies or revokes a marketing authorisation, the Secretary of State may additionally prohibit the supply of a veterinary medicinal product, and if necessary require the marketing authorisation holder to recall the product; and failure to comply with a requirement or prohibition under this sub-paragraph is an offence.

    (5) She shall publicise a revocation in such manner as she sees fit.

Suspension, etc., of a marketing authorisation of a product authorised in more than one member State
     39. —(1) In the case of a veterinary medicinal product that is authorised in more than one member State, where the Secretary of State considers that a variation or its suspension or withdrawal is necessary for the protection of human or animal health or the environment, she shall immediately refer the matter to the Agency, and shall comply with a decision of the Agency within 30 days of the decision.

    (2) Where the Secretary of State considers that immediate suspension is necessary to protect human or animal health or the environment, she may suspend the marketing and the use of the veterinary medicinal product concerned in the United Kingdom pending a decision of the Agency, and in this case she shall inform the Commission and the other member States no later than the following working day of the reasons for her action.

Prohibiting the supply of veterinary medicinal products
     40. —(1) In addition to her powers to suspend a marketing authorisation, if she is satisfied that a product has not been manufactured in accordance with the marketing authorisation the Secretary of State may prohibit the supply of a veterinary medicinal product, and if necessary require the marketing authorisation holder to recall it, and failure to comply with a requirement or prohibition under this sub-paragraph is an offence.

    (2) She may confine the prohibition on supply and the requirement for recall to specific production batches.

    (3) In the case of an immunological veterinary medicinal product manufactured outside the United Kingdom, if a batch has had all the tests that were originally carried out by the manufacturer repeated by the competent authority of another member State, the Secretary of State may not prohibit the release of that batch if all the results have been submitted to her and the results demonstrate that the product is within the terms of the authorisation.