The Medicines for Human Use (Clinical Trials) Regulations 2004

Labelling U.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 [F2 a] health care professional; and

(c) labelled in accordance with the requirements of Schedule 5 to the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 F3 that apply in relation to dispensed relevant medicinal products.

Textual Amendments

F1 OJ No. L262, 14.10.2003, p.22.

F2 Word 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

F3 S.I. 1994/3144; Schedule 5 was amended by S.I. 1998/3105, 2000/292 and 2002/542; “dispensed relevant medicinal product” is defined in paragraph 1 of Schedule 5.