Explanatory Note
(This note is not part of the Regulations)
These Regulations are made in exercise of the powers conferred by section 8(1) 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. 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.
These Regulations make amendments to legislation in the field of the regulation of medicinal products for human use. The main body of the Regulations amends the Human Medicines Regulations 2012 (S.I. 2012/1916) and Schedule 1 amends the Medicines (Products for Human Use) (Fees) Regulations 2016 (S.I. 2016/190). Transitional provision is made in new Schedule 33A to the Human Medicines Regulations 2012. Consequential amendments are made in Schedule 8 and revocations of retained EU law are made in Schedule 9.
An impact assessment of the effect that this instrument will have on the costs of business, the voluntary sector and the public sector is available from the Medicines and Healthcare products Regulatory Agency, 10 South Colonnade, Canary Wharf, London, E14 4PU and is published alongside this instrument at .