Paragraph 9A F1

F2Except in the case of an active substance that contains human cells or tissues, or that is part of a medicinal product which is (or is in a form which means a dose or part of it is) to be administered immediately after manufacture, a written confirmation that the manufacturer of the medicinal product has verified compliance of the manufacturer of the active substance with the principles and guidelines of good manufacturing practice by conducting audits, in accordance with regulation 37(5)(a) and containing—