http://www.legislation.gov.uk/id/uksi/2019/775

http://www.legislation.gov.uk/uksi/2019/775/regulation/154

The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019

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EXITING THE EUROPEAN UNION

MEDICINES

Statute Law Database

2024-05-16

Expert Participation

2021-08-03

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.

The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019

reg. 17(4)

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Sch. 1

para. 3

reg. 1

The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019

PART 11Amendment of Part 11 (Pharmacovigilance)

F1Amendment of regulation 194 (responding to a single assessment of PSUR under Article 107e of the 2001 Directive)I1F2154

In regulation 194(1) after “medicinal product” insert “authorised under a UKMA(NI), UKMA(UK), THR(NI), THR(UK) or Article 126a authorisation”.

Annotations:

Commencement Information

Reg. 154 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Amendments (Textual)

Words in reg. 154 substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 121(b)

Word in reg. 154 heading substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 121(a)