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.
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.
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(1).
(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.
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.
32. The Secretary of State shall appoint inspectors for the purposes of the enforcement of these Regulations.
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.
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.
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.
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.
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.
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(2) 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.
39. On an appeal against an improvement notice, the court may either cancel the notice or confirm it, with or without modification.
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.
41. The Secretary of State shall publicise improvement notices and seizure notices as he sees fit.
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.
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(3));
(b)Regulation (EC) No. 1831/2003 (of the European Parliament and the Council on additives for use in animal nutrition(4));
(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(5)); and
(d)Regulation (EC) No. 183/2005 (of the European Parliament and of the Council laying down requirements for feed hygiene(6)).
(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(7) applies.
44.—(1) The Veterinary Medicines Regulations 2005(8) 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(9) 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.
Published by the World Health Organization at: www.who.int/medicines/en
1980 c. 43; sections 51 and 52 have been substituted by the Courts Act 2003 (c. 39), section 47.
OJ No. L 31, 1.2.2002, p. 1.
OJ No. L268, 18.10.2003, p. 29.
Corrected version at OJ No. L191, 28.5.2004, p. 1.
OJ No. L35, 8.2.2005, p. 1.
S.I. 1981/1675 (N.I. 26).
S.I. 2005/2745.