PART 6 U.K.MANUFACTURE AND IMPORTATION OF INVESTIGATIONAL MEDICINAL PRODUCTS

Obligations of manufacturing authorisation holder U.K.

[F1 42.  The holder of a manufacturing authorisation shall—

(a) comply with the principles and guidelines of good manufacturing practice;

(b) comply with the provisions referred to in regulation 40(3);

(c) allow the licensing authority access to his premises at any reasonable time; and

(d) put and keep in place arrangements which enable the qualified person to carry out his duties, including placing at his disposal all the necessary facilities.]

Textual Amendments

F1 Reg. 42 substituted (29.8.2006) by The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 (S.I. 2006/1928), regs. 1(1), 22