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

PART 18 U.K. Amendment of Part 17 (miscellaneous and general)

[F1 Amendment of regulation 335 (contravention due to fault of another person) U.K.

224ZA.   In regulation 335(6)(b) for “268 and 269” substitute “268, 268A, 269 and 269A”.

Textual Amendments

F1 Regs. 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

I1 Reg. 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

Amendment of regulation 336 (warranty as defence) U.K.

224ZB.   In regulation 336(3)(b) for “268 and 269” substitute “268, 268A, 269 and 269A”.

Textual Amendments

F1 Regs. 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

I2 Reg. 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

Amendment of regulation 340 (presumptions) U.K.

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

F1 Regs. 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

I3 Reg. 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

Amendment of Schedule 32 (transitional provisions and savings) U.K.

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

F1 Regs. 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

I4 Reg. 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

Amendment of regulation 341 (decisions under the Human Medicines Regulations 2012) U.K.

[F2 224.   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

F2 Reg. 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

I5 Reg. 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

Insertion of regulation 344A (modifications to deal with serious shortages) and 344B (regulation making powers) U.K.

225.  After regulation 344 insert—

“Modifications to deal with serious shortages

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 [F3 IP completion day].

Regulation making powers

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

F3 Words 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

I6 Reg. 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

Amendment of regulation 345 (immunity from civil liability) U.K.

[F4 226.   In regulation 345(5), for “marketing authorisation” substitute “UK marketing authorisation, EU marketing authorisation”.]

Textual Amendments

F4 Reg. 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

I7 Reg. 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

Amendment of regulation 346 (Secretary of State to carry out a review of certain provisions) U.K.

227.  In regulation 346 M1 —

(a) in sub-paragraph (c), omit [F5 paragraph (xixa)]; and

(b) in sub-paragraph (d), omit [F6 paragraph (ia)].

Textual Amendments

F5 Words 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)

F6 Words 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

I8 Reg. 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

M1 Regulation 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.