Regulation 2 Medicinal productsC1

United Kingdom

(1)

In these Regulations “medicinal product” means—

(a)

any substance or combination of substances presented as having properties of preventing or treating disease in human beings; or

(b)

any substance or combination of substances that may be used by or administered to human beings with a view to—

(i)

restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action, or

(ii)

making a medical diagnosis.

(2)

These Regulations do not apply to—

(a)

whole human blood; or

(b)

any human blood component, other than plasma prepared by a method involving an industrial process.

Annotations

C1: Reg. 2 applied (with modifications) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg 47(1), Sch. 9 (as substituted (14.8.2012) by S.I. 2012/1916, reg. 1(2), Sch. 34 paras. 57(b), 64 (with Sch. 32))