s 21 Special defences under section 20
21.—(1) Where the holder of a product licence is charged with an offence under section 20 in respect of any medicinal product which has been manufactured or assembled to the licence holder’s order by another person and has been so manufactured or assembled as not to comply with the provisions of that licence which are applicable to it, it is a defence for the licence holder to prove —(a) that the licence holder had communicated those provisions to that other person; and (b) that the licence holder did not know, and could not by the exercise of reasonable care have discovered, that those provisions had not been complied with. (2) Where the holder of a manufacturer’s licence is charged with an offence under section 20 in respect of any medicinal products which have been manufactured or assembled by the licence holder, in circumstances where the licence holder is not the holder of a product licence which is applicable to those products, but the products were manufactured or assembled to the order of another person, it is a defence for the licence holder to prove that the licence holder believed, and had reasonable grounds for believing —(a) that the other person in question was the holder of a product licence applicable to those products; and (b) that the products were manufactured or assembled in accordance with that product licence.