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The Medicines for Human Use (Clinical Trials) Regulations 2004
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LabellingU.K.
46.—(1) An investigational medicinal product shall be labelled in accordance with Article 15 of Commission Directive 2003/94/EC F1.
(2) Paragraph (1) shall not apply where the investigational medicinal product is—
(a)for use in a clinical trial with the characteristics specified in the second paragraph of Article 14 of the Directive;
(b)dispensed to a subject in accordance with a prescription given by [F2a] health care professional; and
(c)labelled in accordance with the requirements of [F3Part 13 of the 2012 Regulations that apply in relation to medicinal products sold or supplied in accordance with a prescription given by a person who is an appropriate practitioner within the meaning of regulation 214(3) to (6) of those Regulations].
Textual Amendments
F1OJ No. L262, 14.10.2003, p.22.
F2Word in reg. 46(2)(b) substituted (29.8.2006) by The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 (S.I. 2006/1928), regs. 1(1), 24
F3Words in reg. 46(2)(c) substituted (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 56 (with Sch. 32)
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