SCHEDULE 1 continued PART 4
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).
34.—(1) Where a veterinary medicinal product is not authorised in another member State, an application to vary it must 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) If he grants a variation of a veterinary medicinal product the Secretary of State must (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.
(4) If he refuses to grant a variation he must give written reasons; and if those reasons are on the grounds of safety, quality or efficacy, the applicant may, within 28 days of the notification, appeal to the Veterinary Products Committee.
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 may notify the marketing authorisation holder, require him to submit an application for a variation enabling data to be assessed and revoke the administrative variation.
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.
37.—(1) If the Secretary of State decides, for any of the reasons for which he may or must suspend a marketing authorisation specified in paragraph 38, or because the classification of a veterinary medicinal product should be changed, that a variation to a marketing authorisation is necessary, he must 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 variation is on the grounds of safety, quality or efficacy, the applicant may, within 28 days of the notification, appeal to the Veterinary Products Committee.
(4) If the marketing authorisation holder fails to apply for the variation within that time limit the Secretary of State may suspend or revoke the marketing authorisation.
38.—(1) The Secretary of State may suspend 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; or
(c) the veterinary medicinal product has insufficient therapeutic effect.
(2) He may also suspend 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 the veterinary medicinal product to be manufactured and checked by means of generally accepted scientific methods.
(3) He must suspend 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; or
(f) any information required to be supplied to the Secretary of State has not been communicated to him.
39.—(1) If the Secretary of State suspends a marketing authorisation he must notify the holder immediately, and, unless he directs otherwise, the suspension has immediate effect, and continues in effect unless he reinstates the marketing authorisation.
(2) If the suspension is on the grounds of safety, quality or efficacy, the holder may, within 28 days of the notification, appeal to the Veterinary Products Committee.
(3) If the veterinary medicinal product is authorised in more than one member State—
(a) the Secretary of State must immediately refer the matter to the Agency, and must comply with a decision of the Commission within 30 days of the decision; and
(b) he may suspend the marketing and the use of the veterinary medicinal product in the United Kingdom pending a decision of the Agency, but must inform the Commission and the other member States no later than the following working day of the reasons for his action.
(4) When he suspends a marketing authorisation, the Secretary of State may in addition prohibit the supply of the 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.
40.—(1) The Secretary of State may revoke any marketing authorisation that has been suspended for more than 28 days unless there is a current appeal to the Veterinary Products Committee.
(2) He may publicise a revocation in such manner as he sees fit.
41.—(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.
OJ No. L 159, 27.6.2003, p. 1. Back [22]