Labelling
46.—(1) An investigational medicinal product shall be labelled in accordance with Article 15 of Commission Directive 2003/94/EC(1).
(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 an authorised 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(2) that apply in relation to dispensed relevant medicinal products.
OJ No. L262, 14.10.2003, p.22.
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.