# The Human Medicines Regulations 2012, Regulation 38: Imports from states other than EEA States / countries other than approved countries for import

Extent: E+W+S+N.I.

(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) in the case of an import into Great Britain, a country other than an approved country for import, or
(b) in the case of an import into Northern Ireland, a country 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 , 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 good manufacturing practice for active substances.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/regulation/38 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/regulation-38
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.