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Medicines Act 1968, Section 86 is up to date with all changes known to be in force on or before 15 February 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 F1... Ministers may make regulations imposing such requirements as, for any of the purposes specified in section 85(2) of this Act, they consider necessary or expedient with respect to leaflets relating to medicinal products which are supplied, or are intended to be supplied, with the products, whether by being enclosed in containers or packages of the products or otherwise.
(2)No person shall, in the course of a business carried on by him, supply with any medicinal product, or have in his possession for the purpose of so supplying, a leaflet which contravenes any requirements imposed by regulations under this section which are applicable to that leaflet.
(3)Without prejudice to the preceding provisions of this section, no person shall, in the course of a business carried on by him, supply with a medicinal product of any description, or have in his possession for the purpose of so supplying, a leaflet which—
(a)falsely describes the product, or
(b)is likely to mislead as to the nature or quality of the product or as to the uses or effects of medicinal products of that description.
[F2(4)No person shall, in the course of a business carried on by him, supply a product to which [F3the 2001 Directive applies], unless—
(a)a leaflet enclosed in, or supplied with, the container or package of the product, or
(b)the container or package itself,
contains the particulars which a leaflet relating to the product is required by regulations under subsection (1) of this section to contain, and does so in the manner required by such regulations.]
Textual Amendments
F1Word in s. 86(1) omitted (1.10.2006) by virtue of The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 43 (with regs. 2(4), 3)
F2S. 86(4) inserted (13.2.1994) by S.I. 1994/276, reg. 7(1) (with reg. 7(2))( which S.I. revoked and replaced defective S.I. 1994/101 before the latter S.I. came into force)
F3Words in s. 86(4) substituted (28.2.2002) by S.I. 2002/236, reg. 2(a)(vi)
Modifications etc. (not altering text)
C1Pt. V (ss. 85–91) extended with modifications by S.I. 1985/1403, art. 3(1)
C2Ss. 85–88, 91 extended by S.I. 1984/187, art. 2
C3S. 86 applied (with modifications) (3.4.1992) by S.I. 1992/605, reg. 2(1)(2), Sch.
S. 86 applied (1.1.1995) by S.I. 1994/3142, reg. 18(2)
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