The Medicines for Human Use (Clinical Trials) Regulations 2004

Obligations of manufacturing authorisation holderU.K.

[F142.  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