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There are currently no known outstanding effects for the The Veterinary Medicines Regulations 2006, PART 4.
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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)(1).
Commencement Information
I1Sch. 1 para. 33 in force at 1.10.2006, see reg. 1
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.
Commencement Information
I2Sch. 1 para. 34 in force at 1.10.2006, see reg. 1
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.
Commencement Information
I3Sch. 1 para. 35 in force at 1.10.2006, see reg. 1
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.
Commencement Information
I4Sch. 1 para. 36 in force at 1.10.2006, see reg. 1
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.
Commencement Information
I5Sch. 1 para. 37 in force at 1.10.2006, see reg. 1
OJ No. L 159, 27.6.2003, p. 1.
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