PART 6MANUFACTURE AND IMPORTATION OF INVESTIGATIONAL MEDICINAL PRODUCTS

Obligations of manufacturing authorisation holderF142

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.