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Regulation 42 Obligations of manufacturing authorisation holderF1

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.

Annotations

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