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There are currently no known outstanding effects for the The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019, PART 18.
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224ZA. In regulation 335(6)(b) for “268 and 269” substitute “268, 268A, 269 and 269A”.
Textual Amendments
F1Regs. 224ZA-224ZD inserted (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. 183
Commencement Information
I1Reg. 224ZA in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
224ZB. In regulation 336(3)(b) for “268 and 269” substitute “268, 268A, 269 and 269A”.
Textual Amendments
F1Regs. 224ZA-224ZD inserted (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. 183
Commencement Information
I2Reg. 224ZB in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
224ZC. In regulation 340(5) for “268 (offences relating to packaging and package leaflets: authorisation holders), 269 (offences relating to packaging and package leaflets: other persons)” substitute “268 (offences relating to packaging and package leaflets in Great Britain: authorisation holders), 268A (offences relating to packaging and package leaflets in Northern Ireland: authorisation holders), 269 (offences relating to packaging and package leaflets in Great Britain: other persons), 269A (offences relating to packaging and package leaflets in Northern Ireland: other persons)”.
Textual Amendments
F1Regs. 224ZA-224ZD inserted (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. 183
Commencement Information
I3Reg. 224ZC in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
224ZD. In paragraph 3(10) of Schedule 32 for “268 (offences relating to packaging and package leaflets: authorisation holders), 269 (offences relating to packaging and package leaflets: other persons)” substitute “268 (offences relating to packaging and package leaflets in Great Britain: authorisation holders), 268A (offences relating to packaging and package leaflets in Northern Ireland: authorisation holders), 269 (offences relating to packaging and package leaflets in Great Britain: other persons), 269A (offences relating to packaging and package leaflets in Northern Ireland: other persons)”.]
Textual Amendments
F1Regs. 224ZA-224ZD inserted (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. 183
Commencement Information
I4Reg. 224ZD in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
[F2224. In regulation 341(4)—
(a)in paragraph (a), insert “UK” before “marketing authorisation”;
(b)after paragraph (a), insert—
“(aa)a decision to grant or revoke an EU marketing authorisation;”.]
Textual Amendments
F2Reg. 224 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. 184
Commencement Information
I5Reg. 224 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
225. After regulation 344 insert—
344A.—(1) The Ministers may by regulations modify the application of any of the specified provisions in circumstances where the United Kingdom, or any part of the United Kingdom, is experiencing or may experience a serious shortage of medicinal products, or of medicinal products of a specified description, arising from the withdrawal of the United Kingdom from the European Union.
(2) Regulations may only be made under paragraph (1) for the purposes of preventing, remedying or mitigating the serious shortage that is being or may be experienced.
(3) For the purposes of paragraph (1), the “specified provisions” are the provisions of Parts 1, 3 to 5, 10 to 13 and 16, and of the associated Schedules.
(4) The reference in paragraph (1) to a serious shortage arising from the withdrawal of the United Kingdom from the European Union includes reference to a serious shortage where the withdrawal of the United Kingdom from the European Union is one but not the only significant factor contributing to the shortage.
(5) No regulations under paragraph (1) may be made, or have effect, after the end of the period of two years beginning with [F3IP completion day].
344B.—(1) Regulations made under a power in the regulations listed in paragraph (2)—
(a)are to be made by statutory instrument;
(b)may make different provision for different purposes and different areas; and
(c)may include incidental, supplemental, consequential, transitional, transitory or saving provisions, including consequential amendments to these Regulations.
(2) The regulations referred to in paragraph (1) are—
(a)regulation B17(1) and (4) (good manufacturing practice);
(b)regulation 50(5A) (Annex I to the 2001 Directive);
(c)regulation 50G(5) (orphan criteria etc);
(d)regulations 59(3A) and 61(7A) (post-authorisation efficacy studies);
(e)regulation 65C(7) (variations of UK marketing authorisations);
(f)regulation 102(7) (homoeopathic medicinal products);
(g)regulation 205A(2) (further obligations in respect of pharmacovigilance activities);
(h)regulation 257E (certain forms of labelling); and
(i)regulation 344A (modifications to deal with serious shortages).
(3) A statutory instrument containing regulations made under the powers listed in paragraph (2) is subject to annulment in pursuance of a resolution of either House of Parliament.”.
Textual Amendments
F3Words in reg. 225 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. 185
Commencement Information
I6Reg. 225 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
[F4226. In regulation 345(5), for “marketing authorisation” substitute “UK marketing authorisation, EU marketing authorisation”.]
Textual Amendments
F4Reg. 226 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. 186
Commencement Information
I7Reg. 226 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
227. In regulation 346 M1—
(a)in sub-paragraph (c), omit [F5paragraph (xixa)]; and
(b)in sub-paragraph (d), omit [F6paragraph (ia)].
Textual Amendments
F5Words in reg. 227(a) 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. 187(a)
F6Words in reg. 227(b) 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. 187(b)
Commencement Information
I8Reg. 227 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
Marginal Citations
M1Regulation 346 was substituted by S.I. 2013/1855 and then amended by S.I. 2013/2593, 2014/490 and 1878, 2015/323, 903 and 1503, 2016/186, 2017/715, 2018/199 and 2019/62.
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