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

PART 17 U.K. Amendment of Part 16 (enforcement)

Prospective

Amendment of regulation 322 (validity of proceedings) U.K.

F1 219.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F1 Reg. 219 omitted (31.12.2020 immediately before IP completion day) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 179

Amendment of regulation 323 (enforcement in England, Wales and Scotland) U.K.

220.—(1) Regulation 323 M1 is amended as follows.

(2) In paragraph (1) omit “and the relevant EU provisions”.

(3) In paragraph (3)—

(a) at the end of sub-paragraph (b) insert “ and ”; and

(b) omit sub-paragraph (d).

(4) Omit paragraph (4A).

Commencement Information

I1 Reg. 220 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 323 was amended S.I. 2019/62.

Amendment of regulation 327 (powers of inspection, sampling and seizure) U.K.

221.—(1) Regulation 327 M2 is amended as follows.

(2) In paragraph (1)(c)—

(a) in paragraph (v), insert “ UK ” before “marketing authorisation”;

[F2 (b) after paragraph (v), insert—

“(va) an EU marketing authorisation;”.]

[F3 (3) In paragraph (2)(g), after paragraph (iv) insert—

“(iva) the requirements of Schedule 12A (further provision as to the performance of pharmacovigilance activities);”.]

F4 (4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F5 (5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F2 Reg. 221(2)(b) substituted for reg. 221(2)(b)(c) (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. 180(a)

F3 Reg. 221(3) 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. 180(b)

F4 Reg. 221(4) omitted (31.12.2020 immediately before IP completion day) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 180(c)

F5 Reg. 221(5) omitted (31.12.2020 immediately before IP completion day) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 180(c)

Commencement Information

I2 Reg. 221 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

M2 Regulation 327 was amended by S.I. 2013/1855 and 2019/62.

Amendment of regulation 331 (findings and reports of inspections) U.K.

222.—(1) Regulation 331 is amended as follows.

[F6 (2) In paragraph (1)—

(a) for “marketing authorisation” substitute “UK marketing authorisation, EU marketing authorisation”;

(b) in sub-paragraph (c), at the beginning, insert “in the case of a product authorised under a UKMA(NI) or UKMA(UK),”.]

[F7 (3) In paragraph (4)—

(a) for sub-paragraph (b) substitute—

“(b) the guidelines on good distribution practice—

(i) in the case of Great Britain, published under, or that apply by virtue of, regulation C17;

(ii) in the case of Northern Ireland, published by the European Commission in accordance with Article 84 of the 2001 Directive;”;

(b) after sub-paragraph (c) insert—

“(d) Schedule 12A; and

(e) the Implementing Regulation (as defined in regulation 177(5)).”.]

Textual Amendments

F6 Reg. 222(2) 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. 181(a)

F7 Reg. 222(3) 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. 181(b)

Commencement Information

I3 Reg. 222 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 331A (guidelines on inspections) U.K.

223.  After regulation 331 (finding and reports of inspections) insert—

“Guidelines on inspections

331A.— (1) The licensing authority may publish guidelines specifying the principles applicable to inspections referred to in this Part.

(2) Guidelines under paragraph (1) may include the form and content of reports under regulation 331 and of certificates of good manufacturing practice or good distribution practice.

(3) Until the licensing authority exercises its power under paragraph (1), the guidelines adopted by the European Commission under Article 111a of the 2001 Directive, as they had effect immediately before [F8 IP completion day] M3 , are to continue to apply.”.

Textual Amendments

F8 Words in reg. 223 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. 182

Commencement Information

I4 Reg. 223 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

M3 The guidelines are available at: https://www.gov.uk/guidance/eu-guidance-documents-referred-to-in-the-human-medicines-regulations-2012 and a hard copy may be obtained from the Medicines and Healthcare products Regulatory Agency at the address given in the Explanatory Note.