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Memorandwm Esboniadol
15.—(1) The qualified person is responsible for ensuring, in relation to a medicinal product, that documentary evidence is produced that each batch of the product satisfies the requirements of paragraph 12.U.K.
(2) The documentary evidence referred to in sub-paragraph (1) must be kept up to date and must be available for inspection by the licensing authority for a period of at least five years.