PART 7LABELLING OF INVESTIGATIONAL MEDICINAL PRODUCTS

Labelling46

1

An investigational medicinal product shall be labelled in accordance with Article 15 of Commission Directive 2003/94/ECF1.

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 F2 that apply in relation to dispensed relevant medicinal products.