This Statutory Instrument has been printed to correct an error in S.I. 2020/1488 (which amended S.I. 2019/775 , which amended S.I. 2012/1916 ) and is being issued free of charge to all known recipients of that Statutory Instrument.
Statutory Instruments
2021 No. 834
Exiting The European Union
Medicines
The Human Medicines (Amendment) (EU Exit) Regulations 2021
Made
12th July 2021
Laid before Parliament
13th July 2021
Coming into force
3rd August 2021
The Secretary of State for Health and Social Care makes these Regulations in exercise of the powers conferred by section 8C(1) of the European Union (Withdrawal) Act 2018( 1 ).
Citation, commencement and extent
1. —(1) These Regulations may be cited as the Human Medicines (Amendment) (EU Exit) Regulations 2021.
(2) These Regulations come into force on the twenty-first day after the day on which they are laid before Parliament.
(3) These Regulations extend to the whole of the United Kingdom.
Amendment of regulation 3 of the Human Medicines Regulations 2012
2. In regulation 3 of the Human Medicines Regulations 2012 (scope of these Regulations: special provisions), in paragraph (15), after sub-paragraph (a) insert—
“ (aa) an EU marketing authorisation; ” .
Amendment of the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019
3. In regulation 5 of the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019( 2 ) (amendment of regulation 3 (scope of Regulations: special provisions)), in paragraph (3), omit sub-paragraph (b).
Amendment of the Human Medicines (Amendment etc.) (EU Exit) Regulations 2020
4. In Schedule 2 to the Human Medicines (Amendment etc.) (EU Exit) Regulations 2020( 3 ) (amendment of the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019), in paragraph 2, omit sub-paragraph (b).
Signed by authority of the Secretary of State for Health and Social Care
Edward Argar
Minister of State,
Department of Health and Social Care
12th July 2021
2018 c. 16 ; section 8C was inserted by the European Union (Withdrawal Agreement) Act 2020 (c. 1) , section 21.
S.I. 2019/775 ; the relevant amending instrument is S.I. 2020/1488 .