The Human Medicines (Amendment etc.) (EU Exit) (No. 2) Regulations 2021

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations are made in exercise of the powers conferred by section 8C of the European Union (Withdrawal) Act 2018 (c. 16) in order to deal with matters arising out of, or related to, the Protocol on Ireland/Northern Ireland in the EU withdrawal agreement. They are also made under paragraphs 1(1)(ab) 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 transitional arrangements).

These Regulations make amendments to legislation in the field of the regulation of medicinal products for human use. These are minor and technical amendments to ensure that the instruments governing medicines, clinical trials and fees associated with the regulation of medicines continue to be effective in Northern Ireland and Great Britain, taking into account the Northern Ireland Protocol.

Part 2 amends the Human Medicines Regulations 2012 (S.I. 2012/1916). Part 3 amends the Medicines (Products for Human Use) (Fees) Regulations 2016 (S.I. 2016/190). Part 4 amends the Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031). The amendments made by these Regulations relate to the manufacture and distribution of medicinal products and active substances, marketing authorisations, pharmacovigilance, fees and functions in relation to good clinical practice.

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 www.legislation.gov.uk.