Part VIII

Miscellaneous and Supplementary Provisions

Application of the 2012 Regulations to certain other substances which are not medicinal products.
105
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 ...,
and direct that, subject to such exceptions and modifications as may be specified in the order, such provisions of the 2012 Regulations, 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.
Pt. 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)
Pt. VIII (ss. 104–136) extended by S.I. 1982/425, art. 3; and S.I. 1984/187 art. 2; and extended (with modifications) by S.I. 1985/403, art. 3(1)
Words 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
Words in s. 105(1)(b) omitted (1.10.2006) by virtue of The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 55 (with regs. 2(4), 3)
Words in s. 105 substituted (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 16(a) (with Sch. 32)
Words in s. 105(1) substituted (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 16(b) (with Sch. 32)