SCHEDULES
SCHEDULE 4Standard provisions of licences under Part 3
PART 1Manufacturer’s licence relating to manufacture and assembly
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The licence holder must keep readily available for examination by a person authorised by the licensing authority durable records of the details of the manufacture of intermediate products held by the licence holder for use in the manufacture of biological medicinal products, and the records must—
a
be in such form as to ensure that the licence holder has a comprehensive record of all matters that are relevant to an evaluation of the safety, quality and efficacy of a finished biological medicinal product manufactured using those intermediate products; and
b
not be destroyed without the consent of the licensing authority until the records of the details of manufacture of finished medicinal products which were or may be manufactured using those intermediate products may be destroyed in accordance with the requirements of these Regulations.