Regulation 38 Imports from states other than EEA States / countries other than approved countries for importF4

in the case of an import into Great Britain, a country other than an approved country for import, or

in the case of an import into Northern Ireland, a country other than an EEA State.

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

ensure that active substances have been used as starting materials in the manufacture of medicinal products, other than special medicinal products, imported from F2, in the case of an import into Great Britain, a country other than an approved country for import and in the case of an import into Northern Ireland, a country other than an EEA State only if those substances have been manufactured or assembled in accordance with F3good manufacturing practice for active substances.