The Human Medicines (Amendment) Regulations 2023
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.