Imports from states other than EEA StatesU.K.
38.—(1) This regulation applies in relation to a manufacturer's licence relating to the import of medicinal products.
(2) The licence holder must comply with the conditions set out in this regulation in relation to the import of medicinal products from a state other than an EEA State.
(3) The licence holder must—
(a)comply with the principles and guidelines on good manufacturing practice in the Good Manufacturing Practice Directive in so far as they are relevant to the import of medicinal products; and
(b)ensure that active substances have been used as starting materials in the manufacture of medicinal products, other than special medicinal products, imported from a state other than an EEA State only if those substances have been manufactured or assembled in accordance with the principles and guidelines mentioned in paragraph (a), in so far as those principles and guidelines relate to starting materials.