# The Human Medicines (Amendment) Regulations 2023, Note: Explanatory note


(This note is not part of the Regulations)
These Regulations make amendments to legislation in the field of the regulation of medicinal products for human use. These amendments ensure that the Human Medicines Regulations 2012 (S.I. 2012/1916, “the 2012 Regulations”) continue to be effective in Northern Ireland and Great Britain, taking into account the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community. They transpose provisions from Directive (EU) 2022/642 of the European Parliament and of the Council of 12 April 2022 amending Directives 2001/20/EC and 2001/83/EC as regards derogations from certain obligations concerning certain medicinal products for human use made available in the United Kingdom in respect of Northern Ireland and in Cyprus, Ireland and Malta (OJ No. L 118, 20.4.2022, p.4). The transposition note is published alongside the instrument at legislation.gov.uk .
Regulation 3 amends regulation 17 of the 2012 Regulations to provide an exemption from the requirement to hold a manufacturer’s licence when the holder of a wholesale dealer’s licence imports medicinal products into Northern Ireland from Great Britain in specified circumstances.
Regulation 4 amends regulation 49 of the 2012 Regulations to permit the holder of a marketing authorisation for a medicinal product that applies in the whole of the UK, or Northern Ireland only, to be established in the United Kingdom or an EEA State. It also makes the rules on establishment consistent in the case of holders of GB-only marketing authorisations and parallel import licences.
Regulation 5 inserts a new regulation into the 2012 Regulations, which requires the licensing authority for human medicines in the UK to maintain and keep up to date a list of medicinal products that have benefited from certain derogations in Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use.
A full impact assessment has not been produced for this instrument as no, or no significant, impact on the private, voluntary or public sector is foreseen.

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Source: https://www.legislation.gov.uk/uksi/2023/437/note (the official version)
Page: https://openlegislation.uk/human-medicines-amendment-regulations-2023/note
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.