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.