Regulation 17 Defence
Where the holder of a marketing authorisation 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 has been so manufactured or assembled as not to comply with the provisions of that authorisation, it shall be a defence for him to prove—
(a)
that he had communicated the provisions relating to the authorisation 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 had not been complied with.