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 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.