The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020

These Regulations are made in exercise of the powers conferred by section 8(1) and 8C of the European Union (Withdrawal) Act 2018 (c. 16) in order to address failures of retained EU law to operate effectively and other deficiencies (in particular under section 8(2)(a), (b), (c), (d), (f) and (g) and (6)) arising from the withdrawal of the United Kingdom from the European Union and to make provision in connection with the Protocol on Ireland/Northern Ireland in the withdrawal agreement. They are also made under paragraphs 1(1) and 7(2) of Schedule 4 to the European Union (Withdrawal) Act 2018, insofar as they make provision in relation to fees, and paragraph 21 of Schedule 7 in relation to consequential and transitional arrangements.