The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019
1Citation and commencement
2Amendment of the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019
3Amendment of the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019
SCHEDULE 1Amendment of the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019
1Interpretation
2Amendment of regulation 15 (amendment of regulation 18 of the 2012 Regulations – wholesale dealing in medicinal products)
3Amendment of regulation 17 (amendment of regulation 19 of the 2012 Regulations – exemptions from requirement for wholesale dealer's licence)
4Amendment of regulation 47 (amendment of regulation 48 of the 2012 Regulations – application of Part 5)
5Amendment of regulation 56 (substitution of regulation 51 of the 2012 Regulations - applications relating to generic medicinal products)
6Amendment of regulation 58 (amendment of regulation 53 of the 2012 Regulations - applications relating to similar biological medicinal products)
7Amendment of regulation 63 (amendment of Schedule 11 to the 2012 Regulations – advice and representations)
8Amendment of regulation 139 (amendment of regulation 177 of the 2012 Regulations – application of Part 11 (pharmacovigilance) and interpretation)
9Amendment of Schedule 6 (insertion of Schedule 12A into the 2012 Regulations)
10Amendment of Schedule 7 (insertion of Schedule 33A into the 2012 Regulations)
SCHEDULE 2Amendment of the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019
1Interpretation
2Amendment of regulation 3 (amendment of Part I of the 2002 Regulations)
3Amendment of regulation 4 (amendment of Part II of the 2002 Regulations)
4Amendment of regulation 5 (amendment of Part III of the 2002 Regulations)
5Amendment of regulation 6 (amendment of Part IV of the 2002 Regulations)
6Amendment of regulation 7 (amendment of Part V of the 2002 Regulations)
7Amendment of regulation 8 (amendment of Part VI of the 2002 Regulations)
8Amendment of regulation 9 (amendment of Part VII of the 2002 Regulations)
9Amendment of regulation 10 (insertion of Part VIII into the 2002 Regulations)
10Amendment of regulation 11 (insertion of new Part IX into the 2002 Regulations)
11Amendment of regulation 12 (new Schedules to the 2002 Regulations)

2019 No. 1385

Exiting The European Union
Consumer Protection
Medicines

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

Made

Coming into force in accordance with regulation 1

The Secretary of State makes the following Regulations in exercise of the powers conferred by section 8(1) of, and paragraph 21 of Schedule 7 to, the European Union (Withdrawal) Act 2018 M1.

In accordance with paragraph 1(3) of Schedule 7 to the European Union (Withdrawal) Act 2018, a draft of these Regulations has been laid before and approved by a resolution of each House of Parliament.

Annotations:
Marginal Citations