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16. Where the holder of a marketing authorization is charged with an offence under these Regulations in respect of anything which has been manufactured or assembled to his order by another person and had been so manufactured or assembled as not to comply with the provisions of that authorization, it shall be a defence for him to prove—
(a)that he had communicated the provisions relating to the authorization to that other person; and
(b)that he did not know, and could not by the exercise of reasonable care have known, that those provisions has not been complied with.