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Prospective
F1219. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F1Reg. 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
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
I1Reg. 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
M1Regulation 323 was amended S.I. 2019/62.
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
F2Reg. 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)
F3Reg. 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)
F4Reg. 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)
F5Reg. 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
I2Reg. 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
M2Regulation 327 was amended by S.I. 2013/1855 and 2019/62.
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
F6Reg. 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)
F7Reg. 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
I3Reg. 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
223. After regulation 331 (finding and reports of inspections) insert—
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 [F8IP completion day] M3, are to continue to apply.”.
Textual Amendments
F8Words 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
I4Reg. 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
M3The 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.