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

UK Statutory Instrument 2020 No. 1488 — creates 6 criminal offences.

6offences created

0recorded in force

0revoked

Made: 8 December 2020
In force from: Not determined
Extent: Not stated
Subject: Drugs and medicines
Made under: Schedule 4 to the European Union (Withdrawal) Act 2018, Schedule 7 to, the European Union (Withdrawal) Act 2018, Schedule 7 to, the European Union (Withdrawal) Act 2018

Explanatory note

(This note is not part of the Regulations) — published with the instrument by the department that made it. © Crown copyright, reused under the Open Government Licence v3.0.

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. These Regulations make amendments to legislation in the field of the regulation of medicinal products for human use. The majority of the instrument (regulation 4 and Schedule 2) amends the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775) which itself amends the Human Medicines Regulations 2012 (S.I. 2012/1916) and the Medicines (Products for Human Use) (Fees) Regulations 2016 (S.I. 2016/190). Regulation 3 and Schedule 1 amend the Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/744) which itself amends the Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031). Regulation 2 amends the Good Laboratory Practice Regulations 1999 (S.I. 1999/3106), and regulation 5 and Schedule 3 amend the Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/1385) to remove superseded provisions. 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.

Offences created by this instrument

1 The holder of a THR(NI) or a THR(UK) is guilty of an offence if the holder— a fails to inform the licensing… paragraph 131 of SCHEDULE 2 · Status not determined · Strict liability
The holder of a THR(GB) is guilty of an offence if the holder— a fails to inform the licensing authority in accordance… paragraph 131 of SCHEDULE 2 · Status not determined · Strict liability
A person to whom this regulation applies is guilty of an offence if— a a package or package leaflet relating to the… paragraph 268A(2) of SCHEDULE 2 · Status not determined · Strict liability
A person to whom this regulation applies is guilty of an offence if the person sells or supplies, or offers to sell or… paragraph 269A(2) of SCHEDULE 2 · Status not determined · Objective fault
A person who is— a the holder of a UKMA(NI), UKMA(UK) or parallel import licence, or b a parallel distributor, is… paragraph 91 of SCHEDULE 2 · Status not determined · Strict liability
A person who is— a the holder of a UKMA(NI), UKMA(UK) or parallel import licence, or b a parallel distributor, is… paragraph 91(a) of SCHEDULE 2 · Status not determined · Strict liability

What Parliament said about it

Contributions, debates and written statements mentioning this instrument by name. Parliamentary material is reused under the Open Parliament Licence v3.0.

Draft Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 Draft Medical Devices (Amendment Etc.) (EU Exit) Regulations 2020 Commons · General Committees · 26 November 2020
Draft Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 Draft Medical Devices (Amendment Etc.) (EU Exit) Regulations 2020 Commons · General Committees · 26 November 2020 · The Minister for Health (Edward Argar)
I beg to move, That the Committee has considered the draft Human Medicines (Amendment etc.) (EU Exit) Regulations 2020.
Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 Lords · Lords Chamber · 2 December 2020

How Parliament handled it

Parliament's Statutory Instruments service has no record of this instrument, although it covers the period. Nothing is inferred from that.

Check the source

This instrument on legislation.gov.uk The authoritative text, including amendments made since
Other instruments from 2020