Statutory Instrument 2006 No. 2407
The Veterinary Medicines Regulations 2006
(The document as of February, 2008)
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STATUTORY INSTRUMENTS
2006 No. 2407
MEDICINES
The Veterinary Medicines Regulations 2006
| | Made | 5th September 2006 | |
| | Laid before Parliament | 8th September 2006 | |
| | Coming into force | 1st October 2006 | |
CONTENTSPART 1Introduction
| 2. | Definition of "veterinary medicinal product", interpretation and scope |
| 3. | Products to which these Regulations do not apply |
PART 2Authorised veterinary medicinal products
| 4. | Placing a veterinary medicinal product on the market |
| 5. | Manufacture of veterinary medicinal products |
| 7. | Classification, supply and possession of the product |
| 8. | Administration of the product |
| 9. | Importation of authorised veterinary medicinal products |
| 10. | Advertising the product |
| 11. | Advertising of prescription products and products containingpsychotropic drugs or narcotics |
| 12. | Defence of publication in the course of business |
PART 3Records
| 17. | Food-producing animals: proof of purchase of veterinary medicinal products |
| 18. | Food-producing animals: records of administration by a veterinary surgeon |
| 19. | Food-producing animals: records of acquisition and administration |
| 20. | Food-producing animals: retention of records |
| 21. | Records by a holder of a manufacturing authorisation |
| 22. | Records by a holder of a wholesale dealer's authorisation |
| 23. | Records of the receipt or supply of prescription products |
| 24. | Records of products administered to a food-producing animal under the cascade |
PART 4Unauthorised veterinary medicinal products
| 25. | Importation of an unauthorised veterinary medicinal product |
| 26. | Possession of an unauthorised veterinary medicinal product |
| 27. | Supply of an unauthorised veterinary medicinal product |
PART 5Miscellaneous provisions, enforcement and offences
| 28. | The Veterinary Products Committee |
| 29. | Procedure for suspending, etc. a marketing authorisation or animal test certificate |
| 30. | Duties on the Secretary of State relating to exports |
| 32. | Appointment of inspectors |
| 34. | Powers of an inspector |
| 35. | Inspection of pharmacies |
| 38. | Appeals against improvement notices |
| 39. | Powers of a court on appeal |
| 41. | Publication of notices |
| 44. | Revocations and amendments |
| | SCHEDULE 1— | Marketing authorisations |
| | PART 1— | Application for a marketing authorisation |
| | PART 2— | Derogations from some of the requirements in Part 1 |
| | PART 3— | Grant of a marketing authorisation |
| | PART 4— | Variations of marketing authorisations on the application of theholder |
| | PART 5— | Suspension, etc. of a marketing authorisation |
| | PART 6— | Mutual recognition and multiple applications |
| | PART 7— | Labelling and package leaflets |
| | PART 9— | Homeopathic remedies |
| | SCHEDULE 2— | The manufacture of veterinary medicinal products |
| | PART 1— | Manufacturing authorisation |
| | PART 2— | Authorisation of manufacturers of autogenous vaccines |
| | PART 3— | Authorisation of blood banks |
| | PART 4— | Authorisation of manufacturers of products for administration under the cascade |
| | SCHEDULE 3— | Classification and supply, wholesale dealers and sheep dip |
| | PART 1— | Classification and supply of authorised veterinary medicinal products |
| | PART 2— | Requirements for a wholesale dealer's authorisation |
| | SCHEDULE 4— | Administration of a veterinary medicinal product outside the terms of a marketing authorisation |
| | SCHEDULE 5— | Medicated feedingstuffs and specified feed additives |
| | SCHEDULE 6— | Exemptions for small pet animals |
| | PART 2— | Fees relating to marketing authorisations |
| | PART 3— | Fees payable by manufacturers |
| | PART 4— | Fees relating to a wholesale dealer's authorisation |
| | PART 5— | Fees relating to feedingstuffs |
| | SCHEDULE 8— | Amendments to the Medicines Acts etc. |
| | PART 1— | Consequential amendments to the Medicines Acts 1968 and 1971 |
| | PART 2— | Consequential amendments to secondary legislation |
| | SCHEDULE 9— | Other consequential amendments |
| | PART 1— | Consequential amendments to primary legislation |
| | PART 2— | Consequential revocations of and amendments to secondary legislation |
The Secretary of State is a Minister designated[1] for the purposes of making Regulations under section 2(2) of the European Communities Act 1972[2] in relation to measures in the veterinary and phytosanitary fields for the protection of public health.
He has carried out the consultation required by Article 9 of Regulation (EC) No. 178/2002 of the European Parliament and of the Council laying down the general principles of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety[3].
In accordance with section 56(1) of the Finance Act 1973[4], the Treasury consent to the making of these Regulations.
The Secretary of State makes these Regulations in exercise of the powers conferred on him by section 2(2) of the European Communities Act 1972 and by section 56(1) of the Finance Act 1973.
PART 1IntroductionTitle and commencement 1.These Regulations may be cited as the Veterinary Medicines Regulations 2006 and come into force on 1st October 2006.
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 given in paragraph 1 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 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 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 in relation to the administration of a product in the course of a procedure licensed under the Animals (Scientific Procedure) Act 1986[6], except that, if the animals used under that licence are to be put into the human food chain, the product must be administered in accordance with an animal test certificate granted under regulation 8(2).
PART 2Authorised veterinary medicinal productsPlacing a veterinary medicinal product on the market 4.—(1) It is an offence to place a veterinary medicinal product on the market unless that product has been granted a marketing authorisation by the Secretary of State or the Agency.
(2) Any person who certifies data in relation to an application for a marketing authorisation or in relation to an existing marketing authorisation and who knows that those data are false, or does not believe that they are accurate, is guilty of an offence.
(3) Schedule 1 (marketing authorisations) has effect.
Manufacture of veterinary medicinal products 5.—(1) The holder of a marketing authorisation must ensure that every stage in the manufacture of the veterinary medicinal product is carried out by the manufacturer specified in the marketing authorisation (who must, if the manufacture is carried out in the United Kingdom, hold a manufacturing authorisation for that type of product granted by the Secretary of State) and failure to do so is an offence.
(2) Schedule 2 (the manufacture of veterinary medicinal products) has effect.
(3) "Manufacture" includes any part of the manufacture of a veterinary medicinal product until the finished product is ready for sale in its final form as specified in the marketing authorisation but does not include the manufacture of an ingredient.
(4) However—
(a) a holder of a wholesale dealer's authorisation (in accordance with regulation 13) or a suitably qualified person (in accordance with paragraph 13 of Schedule 3) may break open packages (other than the immediate packaging of the veterinary medicinal product);
(b) a pharmacist may break open any package other than the immediate packaging of injectable products; and
(c) a veterinary surgeon may break open any package.
The finished product
6.The holder of a marketing authorisation for a veterinary medicinal product is guilty of an offence if he or the manufacturer supplies a product that is not completely in accordance with the marketing authorisation.
Classification, supply and possession of the product
7.—(1) Schedule 3 (classification and supply, wholesale dealers and sheep dip) has effect.
(2) Any person who supplies a veterinary medicinal product that has passed its expiry date is guilty of an offence.
(3) Any person who supplies a medicinal product authorised for human use for administration to an animal (other than in accordance with a prescription from a veterinary surgeon that specifically states that the medicinal product is for administration under the cascade, either by that veterinary surgeon or under his direction and responsibility) 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 of a marketing authorisation).
(2) 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.
(3) The Secretary of State may suspend or revoke an animal test certificate if this is necessary for reasons of animal or human health.
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 13 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 containing psychotropic drugs or narcotics
11.—(1) It is an offence to advertise a veterinary medicinal product that—
(a) is available on veterinary prescription only; or
(b) contains psychotropic drugs or narcotics.
(2) In the case of a product containing psychotropic drugs or narcotics, this does not apply to advertisements aimed at veterinary surgeons or pharmacists.
(3) In the case of POM-V medicines, this does not apply to price lists, or to advertisements aimed at veterinary surgeons, 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 13 of Schedule 3;
(d) other veterinary health care professionals;
(e) professional keepers of animals; or
(f) owners or keepers of horses.
Defence of publication in the course of business
12.In proceedings for an offence under these Regulations relating to advertising, it is a defence for the person charged to prove—
(a) that he is a person whose business it is to publish or arrange for the publication of advertisements, and
(b) that he received the advertisement in the ordinary course of business and did not know and had no reason to suspect that its publication would amount to an offence under these Regulations.
Wholesale dealing
13.It is an offence to buy a veterinary medicinal product, other than by retail or for the purposes of retail supply in accordance with Schedule 3, unless the buyer has a wholesale dealer's authorisation granted by the Secretary of State under this regulation and Schedule 3.
Feedingstuffs
14.Schedule 5 (medicated feedingstuffs and specified feed additives) has effect.
Exemptions
15.—(1) These Regulations do not apply to an inactivated autogenous vaccine that is manufactured, on the instructions of a veterinary surgeon, from pathogens or antigens obtained from an animal and used for the treatment of that animal.
(2) Schedule 1 and Part 1 of Schedule 2 do not apply in relation to an inactivated autogenous vaccine that is—
(a) manufactured by a person and in premises authorised in accordance with Part 2 of Schedule 2, on the instructions of a veterinary surgeon, from pathogens or antigens obtained from an animal; and
(b) used for the treatment of—
(i) other animals on the same site;
(ii) animals intended to be sent to those premises; or
(iii) animals on a site that receives animals from those premises.
(3) They do not apply to blood from a blood bank authorised in accordance with Part 3 of Schedule 2, nor to a product manufactured for administration under the cascade by a person and in premises authorised under Part 4 of Schedule 2.
(4) Schedule 6 (exemptions for small pet animals) has effect.
Fees
16.Schedule 7 (fees) has effect.
PART 3RecordsFood-producing animals: proof of purchase of veterinary medicinal products 17.—(1) The keeper of a food-producing animal must keep proof of purchase of all veterinary medicinal products (or, if he did not buy them, documentary evidence of how he acquired them) acquired for the animal.
(2) It is an offence to fail to comply with this regulation.
Food-producing animals: records of administration by a veterinary surgeon 18.—(1) If a veterinary surgeon administers a veterinary medicinal product to a food-producing animal he must either enter the following information himself in the keeper's records or give it to the keeper in writing (in which case the keeper must enter the following into his records)—
(a) the name of the veterinary surgeon;
(b) the name of the product and the batch number;
(c) the date of administration of the product;
(d) the amount of product administered;
(e) the identification of the animals treated; and
(f) the withdrawal period.
(2) It is an offence to fail to comply with this regulation.
Food-producing animals: records of acquisition and administration
19.—(1) When a veterinary medicinal product is bought or otherwise acquired for a food-producing animal the keeper must, at the time, record—
(a) the name of the product and the batch number;
(b) the date of acquisition;
(c) the quantity acquired; and
(d) the name and address of the supplier.
(2) At the time of administration (unless the administration is by a veterinary surgeon in which case the record must be in accordance with regulation 18) he must record—
(a) the name of the product;
(b) the date of administration;
(c) the quantity administered;
(d) the withdrawal period; and
(e) the identity of the animals treated.
(3) If he disposes of any or all of the veterinary medicinal product other than by treating an animal, he must record—
(a) the date of disposal;
(b) the quantity of product involved; and
(c) how and where he disposed of it.
(4) It is an offence to fail to comply with this regulation.
Food-producing animals: retention of records
20.—(1) The keeper of a food-producing animal must keep the documentation on the acquisition of a veterinary medicinal product and the records relating to the product for at least five years following the administration or other disposal of the product, irrespective of whether or not the animal concerned is no longer in his possession or has been slaughtered or has died during that period.
(2) It is an offence to fail to comply with this regulation.
Records by a holder of a manufacturing authorisation
21.—(1) A holder of a manufacturing authorisation must, as soon as is reasonably practicable, make a record of each batch of veterinary medicinal product manufactured, assembled or supplied by him, which must include—
(a) the name of the product;
(b) the quantity manufactured, assembled or supplied;
(c) the date of manufacture, assembly or supply;
(d) the batch number and expiry date; and
(e) in the case of supply, the name and address of the recipient.
(2) He must keep with the record all certification provided by the qualified person (manufacture) in relation to that batch.
(3) He must keep all records and certificates for at least five years from the date the veterinary medicinal product is placed on the market.
(4) It is an offence to fail to comply with this regulation.
Records by a holder of a wholesale dealer's authorisation
22.—(1) A holder of a wholesale dealer's authorisation must record the following as soon as is reasonably practicable after each incoming or outgoing transaction (including disposal) relating to a veterinary medicinal product—
(a) the date and nature of the transaction;
(b) the 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 the receipt or supply of prescription products
23.—(1) When any person permitted under these Regulations to supply a veterinary medicinal product classified as POM-V or POM-VPS receives or supplies any such veterinary medicinal product he must keep all documents relating to the transaction, which must include—
(a) the date;
(b) the identity of the veterinary medicinal product;
(c) the batch number (except that, in the case of a product for a non-food-producing animal, this need only be recorded either on the date he receives the batch or the date he starts to use it);
(d) the quantity;
(e) the name and address of the supplier or recipient; and
(f) if there is a written prescription, the name and address of the person who wrote the prescription and a copy of the prescription.
(2) If the documents do not include this information he must make a record of the missing information as soon as is reasonably practicable following the transaction.
(3) As an alternative to paragraphs (1) and (2) he may make a record of all the information required there provided that he does so as soon as is reasonably practicable following the transaction.
(4) He must keep the documentation and records for at least five years.
(5) It is an offence to fail to comply with this regulation.
Records of products administered to a food-producing animal under the cascade
24.—(1) A veterinary surgeon administering a veterinary medicinal product to 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.
PART 4Unauthorised veterinary medicinal productsImportation of an unauthorised veterinary medicinal product 25.—(1) It is an offence to import an unauthorised veterinary medicinal product except in accordance with this regulation.
(2) A marketing authorisation holder 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 supervision 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.
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) 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) 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.
(3) It is a defence for a person charged under paragraph (1) to prove that he supplied the veterinary medicinal product for the purposes of research or development of a veterinary medicinal product.
PART 5Miscellaneous provisions, enforcement and offencesThe Veterinary Products Committee 28.—(1) There shall continue to be a Veterinary Products Committee.
(2) The Secretary of State shall appoint members of the Committee from professional people who are eminent in their field, and any lay members as he shall see 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.
Procedure for suspending, etc. a marketing authorisation or animal test certificate 29.—(1) If the Secretary of State suspends a marketing authorisation or an animal test certificate, he must notify the holder immediately, and, unless he directs otherwise, the suspension has immediate effect, and continues in effect until any appeals process under this regulation is completed.
(2) If the suspension is on the grounds of safety, quality or efficacy, the holder may give notice within 28 days that he wishes to make representations to the Veterinary Products Committee.
(3) The Committee must 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 the suspension.
(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 his proposed determination and the reasons for it.
(8) A person may then 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 not available to the Secretary of State at the time of the suspension) 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 his final determination and the reasons for it.
(11) If the Secretary of State, on the grounds of safety, quality or efficacy, intends to—
(a) refuse to grant a marketing authorisation or animal test certificate;
(b) grant one that is different from that which was applied for;
(c) vary it other than on the application of the holder;
(d) refuse to grant a variation applied for by the holder; or
(e) revoke it,
he shall notify the applicant or holder of his intention.
(12) 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, and the procedure governing suspension shall then apply in the same way as it applies to suspension, except that a variation or revocation shall not take effect until the Secretary of State has made a 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 he 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 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, 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 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 of the premises of the marketing authorisation holder.
(8) He may carry out an inspection at the request of another member State, the European Commission or the Agency.
(9) In this regulation, a reference to a justice of the peace—
(a) in Scotland includes a reference to the sheriff and to a magistrate; and
(b) in Northern Ireland, is a reference to a lay magistrate.
Powers of an inspector
34.—(1) An inspector entering premises under the previous regulation may—
(a) inspect the premises, and any plant, machinery or equipment;
(b) search the premises;
(c) take samples;
(d) seize any computers and associated equipment for the purpose of copying documents provided they are returned as soon as practicable;
(e) seize any veterinary medicinal product, anything purporting to be a veterinary medicinal product, or any additive, premixture or feedingstuff specified in Schedule 5 and if he does so in circumstances where regulation 40 applies he shall act in accordance with that regulation;
(f) carry out any inquiries, examinations and tests;
(g) 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
(h) have access to, inspect and check the operation of any computer and any associated apparatus or material that is or has been in use in connection with the records; and for this purpose may require any person having charge of, or otherwise concerned with the operation of, the computer, apparatus or material to afford him such assistance as he may reasonably require and, where a record is kept by means of a computer, may require the records to be produced in a form in which they may be taken away.
(2) An officer of any local authority who has entered premises exercising any statutory power of entry for the purposes of enforcing any legislation relating to food hygiene, feed hygiene or animal health, may inspect any records made under these Regulations (in whatever form they are held) relating to food-producing animals, and may remove them to enable them to be copied.
Inspection of pharmacies
35.In relation to a pharmacy, all the powers of an inspector to enforce these Regulations may also be exercised by an officer of the Royal Pharmaceutical Society of Great Britain or the Pharmaceutical Society of Northern Ireland appointed for the purpose.
Obstruction
36.Any person who—
(a) intentionally obstructs any person acting in the execution of these Regulations;
(b) without reasonable cause, fails to give to any person acting in the execution of these Regulations any assistance or information that that person may reasonably require of him for the performance of his functions under these Regulations;
(c) furnishes to any person acting in the execution of these Regulations any information that he knows to be false or misleading; or
(d) fails to produce a record when required to do so to any person acting in the execution of these Regulations,
is guilty of an offence.
Improvement notices
37.—(1) If an inspector has reasonable grounds for believing that any person is failing to comply with these Regulations he may serve a notice on that person (in these Regulations referred to as an "improvement notice") that—
(a) states the inspector's grounds for believing this;
(b) specifies the matters that constitute the failure to comply;
(c) specifies the measures that, in the officer's opinion, the person must take in order to secure compliance; and
(d) requires the person to take those measures, or measures at least equivalent to them, within the period (being not less than 14 days) specified in the notice.
(2) It is an offence to fail to comply with an improvement notice.
Appeals against improvement notices
38.—(1) Any person who is aggrieved by an improvement notice may appeal to a magistrates' court or, in Scotland, to the sheriff.
(2) The procedure on an appeal to a magistrates' court under paragraph (1) is by way of complaint, and the Magistrates' Courts Act 1980[8] applies to the proceedings.
(3) An appeal to the sheriff under paragraph (1) is by summary application.
(4) The period within which an appeal may be brought is 28 days or the period specified in the improvement notice, whichever ends the earlier.
(5) An improvement notice must state—
(a) the right of appeal to a magistrates' court or to the sheriff; and
(b) the period within which such an appeal may be brought.
(6) A court may suspend an improvement notice pending an appeal.
Powers of a court on appeal
39.On an appeal against an improvement notice, the court may either cancel the notice or confirm it, with or without modification.
Seizure notices
40.—(1) An inspector must follow the procedures set out in this regulation if, acting under regulation 34, he seizes—
(a) any veterinary medicinal product that does not appear to him to be authorised in the United Kingdom;
(b) any authorised veterinary medicinal product not lawfully supplied in accordance with these Regulations; or
(c) any veterinary medicinal product that has been stored in any way that affects its safety, quality or efficacy.
(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 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) Any person claiming that the product was not liable to seizure may, within 28 days of the seizure, notify his claim 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 shall destroy the product.
(6) If a notification of a claim is received within 28 days, the Secretary of State shall either return the goods or take proceedings for an order for the confirmation of the 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 shall order its destruction.
(7) The person on whom the seizure 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 as he sees fit.
Penalties
42.—(1) A person guilty of an offence under these Regulations is liable—
(a) on summary conviction, to a fine not exceeding the statutory maximum or to imprisonment for a term not exceeding three months or both, or
(b) on conviction on indictment, to a fine or to imprisonment for a term not exceeding two years or both.
(2) Where a body corporate is guilty of an offence under these Regulations, and that offence is proved to have been committed with the consent or connivance of, or to have been attributable to any neglect on the part of—
(a) a qualified person appointed as such for the purposes of these Regulations;
(b) any director, manager, secretary or other similar person of the body corporate; or
(c) any person who was purporting to act in any such capacity,
he is guilty of the offence as well as the body corporate.
(3) For the purposes of paragraph (2) above, "director", in relation to a body corporate whose affairs are managed by its members, means a member of the body corporate.
(4) Where an offence that has been committed by a Scottish partnership is proved to have been committed with the consent or connivance of, or to be attributable to any neglect on the part of, a partner, he as well as the partnership is guilty of the offence.
Northern Ireland
43.—(1) This regulation has effect in relation to 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 13 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[9]);
(b) Regulation (EC) No. 1831/2003 (of the European Parliament and the Council on additives for use in animal nutrition[10]);
(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[11]); and
(d) Regulation (EC) No. 183/2005 (of the European Parliament and of the Council laying down requirements for feed hygiene[12]).
(4) 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[13] applies.
Revocations and amendments
44.—(1) The Veterinary Medicines Regulations 2005[14] are revoked.
(2) Schedule 8 (amendments to the Medicines Acts etc.) has effect.
(3) Schedule 9 (consequential amendments) has effect.
(4) The Medicines (Prohibition of Importation and Possession of Veterinary Drugs) Order (Northern Ireland) 1977[15] continues in force notwithstanding paragraph (2), and the Medicines Act 1968 continues to apply as if it had not been amended by these Regulations in so far as is necessary for the operation of that Order.
Ben Bradshaw
Parliamentary Under-Secretary of State, Department for Environment, Food and Rural Affairs
8th August 2006
Kevin Brennan
Claire Ward
Two of the Lords Commissioners of Her Majesty's Treasury
5th September 2006
SCHEDULE 1Regulation 4(3)
MARKETING AUTHORISATIONSCONTENTSPART 1Application for a marketing authorisation
| 1. | Application for a marketing authorisation |
| 2. | Information with the application |
| 3. | Summary of product characteristics |
| 4. | Supply of a copy of the summary of product characteristics |
| 5. | Time limits for applications for products for use in food-producing animals |
PART 2Derogations from some of the requirements in Part 1
| 7. | Bibliographic application |
| 8. | Application for a product using a new combination of active substances |
| 9. | Application using existing data |
| 10. | Application for a pharmacologically equivalent medicinal product |
| 11. | Time limits for marketing authorisations granted under the procedure for a pharmacologically equivalent product |
| 12. | Extension of time limits |
| 14. | Specific batch control scheme |
| 15. | Similar immunological products |
| 16. | Marketing in exceptional circumstances |
PART 3Grant of a marketing authorisation
| 18. | Place of establishment of applicant |
| 20. | Products authorised in another member State |
| 22. | Grant of a marketing authorisation |
| 23. | Marketing authorisations for food-producing species |
| 24. | Refusal of a marketing authorisation |
| 25. | Publication following the grant of a marketing authorisation |
| 26. | Provisional marketing authorisation |
| 27. | Provisions of samples and expertise |
| 29. | Duties on the holder of a marketing authorisation relating to an immunological product |
| 32. | Duration and validity of a marketing authorisation |
PART 4Variations of marketing authorisations on the application of the holder
| 33. | Variation of a marketing authorisation for a mutually recognised veterinary medicinal product |
| 34. | Variation of a marketing authorisation not authorised in another member State |
| 35. | Administrative variations |
| 36. | Changes after a marketing authorisation has been issued |
PART 5Suspension, etc. of a marketing authorisation
| 38. | Suspension, etc. of a marketing authorisation |
| 39. | Suspension, etc. of a marketing authorisation of a product authorised in more than one member State |
| 40. | Prohibiting the supply of veterinary medicinal products |
PART 6Mutual recognition and multiple applications
| 41. | Application for a marketing authorisation where one already exists in another member State |
| 42. | Application in another member State |
| 43. | Application for a marketing authorisation in multiple member States where a marketing authorisation does not exist in any member State |
PART 7Labelling and package leaflets
| 44. | Approval by the Secretary of State |
| 45. | Reference to being authorised |
| 47. | Labelling with all the information on the immediate packaging |
| 48. | Products with immediate and outer packaging |
| 51. | Small containers other than ampoules |
PART 8Pharmacovigilance
| 54. | Qualified persons responsible for pharmacovigilance |
| 55. | Duties relating to the qualified person |
| 56. | Adverse reactions to a veterinary medicinal product administered in the United Kingdom |
| 57. | Adverse reactions to a veterinary medicinal product administered in a third country |
| 58. | Periodic safety update reports |
| 59. | Release of information by the marketing authorisation holder |
| 60. | Action taken on account of pharmacovigilance |
PART 9Homeopathic remedies
| 61. | Meaning of "homeopathic remedy" |
| 62. | Placing a homeopathic remedy on the market in accordance with a registration |
| 63. | Application for registration |
| 64. | Procedure for registration |
| 65. | Products on the market before 1994 |
PART 1Application for a marketing authorisationApplication for a marketing authorisation 1.An application under these Regulations for a marketing authorisation for a veterinary medicinal product shall be made to the Secretary of State.
Information with the application 2.—(1) An application must include all necessary administrative information, and all scientific documentation necessary for demonstrating the safety, quality and efficacy of the product.
(2) In particular, the applicant must provide all the data required in Annex I to Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products[16], generated in accordance with that Annex.
(3) The application shall contain the following information—
(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 (INN) 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 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 or 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[17]) 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, 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.
PART 2Derogations from some of the requirements in Part 1Scope 6.This Part provides for applications for marketing authorisations in which not all the information required in Part 1 is required, but for the avoidance of doubt any applicant may apply for a marketing authorisation using Part 1 if he wishes to do so.
Bibliographic application 7.—(1) An applicant for a marketing authorisation need not provide the results of safety tests, residue tests, pre-clinical trials or clinical trials if the active substance of the veterinary medicinal product has been in an authorised veterinary medicinal product for that species in the Community for at least ten years, and the applicant provides appropriate scientific literature to demonstrate this.
(2) He may use any publicly available document.
(3) If an applicant makes use of scientific literature to obtain authorisation for a food-producing species, and submits, in respect of the same medicinal product and with a view to obtaining authorisation for another food-producing species, new residue studies, together with further clinical trials, a third party may not use those studies or trials in an application for a pharmacologically equivalent product for a period of three years from the grant of the authorisation for the additional species.
Application for a product using a new combination of active substances 8.If an application is for a veterinary medicinal product containing active substances already used in an authorised veterinary medicinal product but not previously used in that combination in a veterinary medicinal product, he need not provide the safety and efficacy data for the individual active substances.
Application using existing data 9.If the Secretary of State has granted a marketing authorisation, the holder may permit him to use data submitted in support of that marketing authorisation when assessing an application for another marketing authorisation.
Application for a pharmacologically equivalent medicinal product 10.—(1) An applicant need not provide the results of safety tests, residue tests, pre-clinical trials or clinical trials if he can demonstrate that the veterinary medicinal product is pharmacologically equivalent to a veterinary medicinal product already authorised in the Community.
(2) For the purposes of this paragraph a product is pharmacologically equivalent to an existing product if—
(a) it has the same qualitative and quantitative composition in active substances;
(b) it has the same pharmaceutical form; and
(c) bioequivalence has been demonstrated by means of appropriate bioavailability studies.
(3) For the purposes of this paragraph—
(a) the different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety or efficacy; and
(b) if they do differ significantly in properties with regard to efficacy or safety, additional information intended to provide proof of the safety or efficacy of the various salts, esters or derivatives of an authorised active substance must be supplied by the applicant.
(4) Different immediate-release oral pharmaceutical forms are regarded as the same pharmaceutical form.
(5) Bioavailability studies are not required if the bioequivalence guidelines produced by the 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, third paragraph of Directive 2001/82/EC by the member State in which the product is authorised are insufficient for him to be satisfied of this, he 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 paragraph 11 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 applies 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 from that member State 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 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 he 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.
PART 3Grant of a marketing authorisationTime limits 17.The Secretary of State shall ensure that the procedure for granting a marketing authorisation for a veterinary medicinal product is completed within a maximum of 210 days after the submission of the application.
Place of establishment of applicant 18.Only an applicant established in a member State may be granted a marketing authorisation.
Procedure 19.The Secretary of State may require the applicant to provide additional information or to generate additional data, including laboratory testing, or may require the applicant to provide samples of any medicinal product, its starting materials and intermediate products or other constituent materials so that he can test them in a laboratory.
Products authorised in another member State 20.Where the Secretary of State is informed or discovers that another member State has authorised a veterinary medicinal product that is the subject of an application for authorisation by the Secretary of State, he shall reject the application unless it was submitted in accordance with the mutual recognition procedure or the decentralised procedure in Part 6.
Assessment reports 21.The Secretary of State shall produce an assessment of the dossier, consisting of an evaluation of the results of the pharmaceutical, safety and residue tests and the pre-clinical and clinical trials of the veterinary medicinal product concerned, and any additional related information.
Grant of a marketing authorisation 22.When granting a marketing authorisation, the Secretary of State shall inform the applicant of the summary of product characteristics that he has approved, and the distribution category of the product.
Marketing authorisations for food-producing species 23.—(1) The Secretary of State shall not grant a marketing authorisation for a veterinary medicinal product for food-producing species unless all its pharmacologically active substances appear in Annex I, II or III to Council Regulation (EEC) No. 2377/90.
(2) This shall not apply in the case of a marketing authorisation for a veterinary medicinal product for administration to a horse that has been declared as not intended for slaughter for human consumption in accordance with—
(a) the Horse Passports (England) Regulations 2004[18];
(b) the Horse Passports Regulations (Northern Ireland) 2004[19];
(c) the Horse Passports (Scotland) Regulations 2005[20];
(d) the Horse Passports (Wales) Regulations 2005[21],
but the product must not include an active substance that appears in Annex IV to Council Regulation (EEC) No. 2377/90 and must not be intended for the treatment of a condition for which a veterinary medicinal product is already 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, he 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;
(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 he requests additional data and those data are not provided within such time limit as he may stipulate.
Publication following the grant of a marketing authorisation
25.—(1) When he 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 he has already prepared but with any commercially confidential or personal information deleted.
(2) He 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) He shall send a copy of the assessment report, and any update, to the holder of the marketing authorisation before he publishes it to enable the holder to make representations to him 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 fifteen 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 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 him 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, and not more than nine 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 not time-limited.
(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).
PART 4Variations of marketing authorisations on the application of the holderVariation of a marketing authorisation for a mutually recognised veterinary medicinal product 33.Where a veterinary medicinal product is authorised in more than one member State, the Secretary of State is the competent authority for the purposes of Commission Regulation (EC) No. 1084/2003 (concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products granted by a competent authority of a member State)[22].
Variation of a marketing authorisation not authorised in another member State 34.—(1) Where a veterinary medicinal product is not authorised in another member State, an application to vary it shall be made by the holder to the Secretary of State.
(2) Paragraph 24 of this Schedule (refusal of a marketing authorisation) applies to an application for a variation in the same way as it applies to an application for a marketing authorisation.
(3) In granting a variation of a veterinary medicinal product the Secretary of State shall (unless there are exceptional circumstances necessary to protect human or animal health or the environment) specify transitional measures to enable products produced in accordance with the previous authorisation to continue to be marketed for the transitional period.
Administrative variations 35.—(1) The holder of a marketing authorisation may apply for a minor change in a marketing authorisation to be made without the Secretary of State considering any scientific data (an "administrative variation").
(2) If the Secretary of State grants an administrative variation, and subsequently establishes that this should have been a variation requiring consideration of scientific data, he shall notify the marketing authorisation holder, require him to submit an application for a variation enabling data to be assessed and revoke the administrative variation.
Changes after a marketing authorisation has been issued 36.After a marketing authorisation has been issued, the holder must take account of scientific and technical progress in manufacturing and control methods, and apply to the Secretary of State for any variation in the marketing authorisation that may be required to enable that veterinary medicinal product to be manufactured and checked by means of generally accepted scientific methods.
Compulsory variation 37.—(1) If the Secretary of State decides, in order to protect human or animal heath or the environment, that a variation to a marketing authorisation is necessary, he shall notify the marketing authorisation holder in writing of the required variation, together with his reasons.
(2) In the notification he may specify a time limit within which the marketing authorisation holder must apply for the variation.
(3) If the marketing authorisation holder fails to apply within that time limit the Secretary of State may suspend or revoke the marketing authorisation.
PART 5Suspension, etc. of a marketing authorisationSuspension, etc. of a marketing authorisation 38.—(1) The Secretary of State may suspend, vary or revoke a marketing authorisation at any time if he is satisfied that—
(a) this is necessary for the protection of animal or public health or the environment;
(b) the terms of the marketing authorisation have not been complied with;
(c) the veterinary medicinal product has insufficient therapeutic effect.
(2) He must suspend, vary or revoke a marketing authorisation if he is satisfied that—
(a) the risk-benefit balance is unfavourable;
(b) the withdrawal period does not ensure that residues in foodstuffs obtained from the treated animal comply with Council Regulation (EEC) No. 2377/90;
(c) information given in the application documents is incorrect;
(d) any control tests required have not been carried out;
(e) changes have been made to the manufacturing process without the authority of the Secretary of State;
(f) any information required to be supplied to the Secretary of State has not been communicated to him.
(3) He may also suspend, vary or revoke a marketing authorisation if he 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 he 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) He shall publicise a revocation in such manner as he 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, suspension or revocation is necessary for the protection of human or animal health or the environment, he shall immediately refer the matter to the Agency, and shall comply with a decision of the Commission 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, he 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 he shall inform the Commission and the other member States no later than the following working day of the reasons for his action.
Prohibiting the supply of veterinary medicinal products
40.—(1) In addition to his powers to suspend a marketing authorisation, if he 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) He 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 him and the results demonstrate that the product is within the terms of the authorisation.
PART 6Mutual recognition and multiple applicationsApplication for a marketing authorisation where one already exists in another member State 41.—(1) If a veterinary medicinal product has already received a marketing authorisation in another member State at the time of application, and the holder of the marketing authorisation applies for a marketing authorisation in the United Kingdom, the following procedure ("the mutual recognition procedure") applies.
(2) The applicant must submit to the Secretary of State a dossier identical to the one submitted to the competent authority of the member State in which the veterinary medicinal product has been authorised ("the reference member State").
(3) If there is a marketing authorisation current in more than one member State the applicant must identify which member State is acting as the reference member State.
(4) If the applicant is applying in more than one member State he must supply the Secretary of State with a list of all the States in which he is applying.
(5) The Secretary of State shall obtain an assessment report from the reference member State and, if the application is made under paragraph 7 (bibliographic applications) or paragraph 10 (applications for pharmacologically equivalent products), ask for the report to include an explanation of any extension of the protection period generated under paragraph 11 or 12.
(6) Within 90 days after receipt of the assessment report, the Secretary of State must, subject to the following provisions, either—
(a) approve the assessment report, the summary of product characteristics, the labelling and the package leaflet, and inform the reference member State accordingly; or
(b) notify the reference member State that he will not approve them, and provide the reference member State with a detailed statement of the reasons.
(7) He may only refuse an application on the grounds of serious risk to human or animal health or the environment.
(8) If he approves the assessment report, the summary of product characteristics, the labelling and the package leaflet he shall ensure that he is in a position to decide whether or not to grant a marketing authorisation within 30 days of approving them.
(9) If the Secretary of State is notified by the reference member State that—
(a) not all member States concerned have within 90 days approved the assessment report, summary of product characteristics, labelling or package leaflet; and
(b) the reference member State has sent a detailed statement of the reasons to the other member States involved in the application, the applicant and the coordination group for action in accordance with Article 33(3) of Directive 2001/82/EC,
the Secretary of State shall within 30 days comply with the decision of the coordination group or, if the coordination group refers the matter to the Agency, the decision of the Commission.
(10) The Secretary of State may grant the marketing authorisation even though not all member States have agreed to grant it, but shall revoke or vary the authorisation if this is necessary to comply with the decision of the Commission when it is received.
Application in another member State
42.—(1) When the Secretary of State has granted a marketing authorisation for a veterinary medicinal product and he is notified by the marketing authorisation holder that he has applied to have that veterinary medicinal product authorised in another member State, he shall prepare an assessment report for the product within 90 days of the notification and send it to the member State or States concerned.
(2) If the other member State (or, if there is more than one, all of them) agrees with the assessment report, the summary of product characteristics, the labelling and the package leaflet he need take no further action.
(3) If not all the other member States concerned so agree within a further 90 days he shall send a detailed statement setting out why they have disagreed to the other member States, the applicant and the coordination group for action in accordance with Article 33(3) of Directive 2001/82/EC.
(4) The Secretary of State shal
