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Medicines Act 1968, Section 105 is up to date with all changes known to be in force on or before 13 January 2025. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations.
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(1)The Ministers may by order specify any substance appearing to the Ministers to be a substance which is not itself a medicinal product but—
(a)is used as an ingredient in the manufacture of medicinal products, or
(b)if used without proper safeguards, is capable of causing danger to the health of the community, or of causing danger to the health of animals generally or of one or more species of animals,
and direct that, subject to such exceptions and modifications as may be specified in the order, such provisions of this Act[F1, or the Clinical Trials Regulations,] as may be so specified (including any provisions so specified which relate to offences or penalties) shall have effect in relation to that substance as those provisions have effect in relation to medicinal products.
(2)The power conferred by the preceding subsection may be exercised in relation to a class of substances if it appears to the Ministers that the conditions specified in paragraph (a) or paragraph (b) of that subsection are fulfilled in relation to all substances falling within that class.
(3)No order shall be made under this section—
(a)in relation to a substance as being a substance in respect of which the condition specified in subsection (1)(b) of this section is fulfilled, or
(b)in relation to a class of substances as being substances in respect of which that condition is fulfilled,
unless a draft of the order has been laid before Parliament and approved by a resolution of each House of Parliament.
Textual Amendments
F1Words in s. 105(1) inserted (1.5.2004) by Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg. 1, Sch. 10 para. 18
Modifications etc. (not altering text)
C1Pt. VIII (ss. 104–136) extended by S.I.s 1982/425, art. 3, 1984/187 art. 2; and extended with modifications by S.I. 1985/403, art. 3(1)
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