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[F1211. For regulation 279 substitute—
“279.—(1) A person may not publish an advertisement in Great Britain for a medicinal product unless one of the following is in force for the product—
(a)a UKMA(GB) or UKMA(UK);
(b)a COR(GB) or COR(UK); or
(c)a THR(GB) or THR(UK).
(2) A person may not publish an advertisement in Northern Ireland for a medicinal product unless one of the following is in force for the product—
(a)a UKMA(NI) or UKMA(UK);
(b)a COR(NI) or COR(UK);
(c)a THR(NI) or THR(UK);
(d)an EU marketing authorisation; or
(e)an Article 126a authorisation.
(3) A person may not publish an advertisement in the whole United Kingdom for a medicinal product unless, in relation to that product—
(a)one of the authorisations or registrations specified in paragraph (1) is in force in Great Britain; and
(b)one of the authorisations or registrations specified in paragraph (2) is in force in Northern Ireland.”.]
Textual Amendments
F1Reg. 211 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. 167
Commencement Information
I1Reg. 211 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
212. In regulation [F2280] —
(a)[F3in paragraph (1)] for “marketing authorisation,” substitute “ [F4UK marketing authorisation, EU marketing authorisation,] ”; and
[F5(b)after paragraph (1) insert—
“(1A) Where an advertisement mentioned in paragraph (1) relates to a product in relation to which there is a separate authorisation or registration in force in Great Britain and in Northern Ireland, it may not be published in the whole United Kingdom unless it complies with the particulars listed in the summary of the product characteristics in each of those authorisations or registrations (as the case may be).”.]
Textual Amendments
F2Word in reg. 212 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. 168(a)
F3Words in reg. 212(a) 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. 168(b)(i)
F4Words in reg. 212(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. 168(b)(ii)
F5Reg. 212(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. 168(c)
Commencement Information
I2Reg. 212 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
213. In regulation 281(1)—
(a)in sub-paragraph (a), insert “ UK ” before “marketing authorisation”;
[F6(b)omit “or” at the end of sub-paragraph (c); and
(c)in sub-paragraph (d), after “for a medicinal product” insert—
“; or
(e)an EU marketing authorisation for a medicinal product.”.]
Textual Amendments
F6Reg. 213(b)(c) 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. 169
Commencement Information
I3Reg. 213 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
213A. After regulation 284, insert—
284A. In the case of a medicinal product for sale or supply in Great Britain where the product concerned is not a prescription only medicine in Great Britain but is either—
(a)a prescription only medicine in Northern Ireland; or
(b)not authorised for sale or supply in Northern Ireland,
any advertisement to the public must include a statement that the medicinal product is not available without a prescription, or is not available for sale or supply, in Northern Ireland (as the case may be).”.]
Textual Amendments
F7Reg. 213A 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. 170
Commencement Information
I4Reg. 213A in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
[F8214. For regulation 293(1) substitute—
“(1) The holder of—
(a)in the case of a medicinal product for sale or supply in Great Britain, a UKMA(GB), UKMA(UK), COR(GB), COR(UK), THR(GB) or THR(UK); or
(b)in the case of a medicinal product for sale or supply in Northern Ireland, a UKMA(NI), UKMA(UK), COR(NI), COR(UK), THR(NI), THR(UK), EU marketing authorisation or Article 126a authorisation,
may not sell or supply a medicinal product for a promotional purpose to a person who is not qualified to prescribe medicinal products.”.]
Textual Amendments
F8Reg. 214 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. 171
Commencement Information
I5Reg. 214 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
214A. In regulation 294, after paragraph (4) insert—
“(5) In the case of an advertisement which relates to a medicinal product for sale or supply—
(a)in Northern Ireland only, the requirements of this regulation must be met in relation to the product for sale or supply in Northern Ireland,
(b)in Great Britain only, the requirements of this regulation must be met in relation to the product for sale or supply in Great Britain, and
(c)in the whole of the United Kingdom, the requirements of this regulation must be met in relation to both—
(i)the product for sale or supply in Great Britain, and
(ii)the product for sale or supply in Northern Ireland.”.]
Textual Amendments
F9Reg. 214A 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. 172
Commencement Information
I6Reg. 214A in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
[F10215. In regulation 295—
(a)for paragraph (2)(d) substitute—
“(d)the name and address of the holder—
(i)in the case of a medicinal product for sale or supply in Great Britain, of the UKMA(GB), UKMA(UK), COR(GB), COR(UK), THR(GB) or THR(UK) for the medicinal product, or
(ii)in the case of a medicinal product for sale or supply in Northern Ireland, the name and address of the holder of the UKMA(NI), UKMA(UK), COR(NI), COR(UK), THR(NI), THR(UK), EU marketing authorisation, or Article 126a authorisation for the medicinal product,
or the business name and address of the part of the holder’s business that is responsible for the sale or supply of the medicinal product.”;
(b)after paragraph (4) insert—
“(4A) In the application of this regulation to a medicinal product for sale or supply—
(a)in Northern Ireland only, the requirements of this regulation must be met in relation to the product for sale or supply in Northern Ireland,
(b)in Great Britain only, the requirements of this regulation must be met in relation to the product for sale or supply in Great Britain, and
(c)in the whole of the United Kingdom, the requirements of this regulation must be met in relation to both—
(i)the product for sale or supply in Great Britain, and
(ii)the product for sale or supply in Northern Ireland.”.]
Textual Amendments
F10Reg. 215 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. 173
Commencement Information
I7Reg. 215 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
215A. In regulation 298, for paragraph (5)(a) substitute—
“(a)is no larger than the smallest presentation of the product that is available for sale—
(i)in the case of a medicinal product for sale or supply in Great Britain, in Great Britain, or
(ii)in the case of a medicinal product for sale or supply in Northern Ireland, in Northern Ireland;”.]
Textual Amendments
F11Reg. 215A 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. 174
Commencement Information
I8Reg. 215A in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
[F12216. In Schedule 30—
(a)in paragraphs 1, 2 and 6, for “marketing authorisation,” substitute “UK marketing authorisation, EU marketing authorisation”;
(b)after paragraph 2 insert—
“2A. In relation to an advertisement in Great Britain (other than an advertisement falling within the exception in regulation 296) where the medicinal product concerned is authorised under a UKMA(GB), a statement that the product concerned is authorised under a UKMA(GB).”.]
Textual Amendments
F12Reg. 216 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. 175
Commencement Information
I9Reg. 216 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
217. In regulation 299(3), [F13for “marketing authorisation,” substitute “UK marketing authorisation, EU marketing authorisation”.]
Textual Amendments
F13Words in reg. 217 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. 176
Commencement Information
I10Reg. 217 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
217A. In regulation 305—
(a)for paragraph (3)(a) substitute—
“(a)state that the Ministers are minded to make a determination under regulation 306 that the advertisement is incompatible with the prohibitions imposed by Chapter 2 and specify whether the incompatibility is insofar as the advertisement is for publication—
(i)in Great Britain;
(ii)in Northern Ireland; or
(iii)in both Great Britain and Northern Ireland;”;
(b)in paragraph (4), after “the advertisement” insert—
“—
(a)in Great Britain;
(b)in Northern Ireland; or
(c)in both Great Britain and Northern Ireland”.
Textual Amendments
F14Regs. 217A-217D 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. 177
Commencement Information
I11Reg. 217A in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
217B. In regulation 306—
(a)in paragraph (2), after “Chapter 2” insert—
“and specify whether the incompatibility is insofar as the advertisement is for publication—
(a)in Great Britain;
(b)in Northern Ireland; or
(c)in both Great Britain and Northern Ireland”;
(b)in paragraph (4)—
(i)in sub-paragraph (a), after “Chapter 2” insert—
“insofar as the advertisement is for publication—
(i)in Great Britain;
(ii)in Northern Ireland; or
(iii)in both Great Britain and Northern Ireland”;
(ii)after “no longer applies” insert “in Great Britain, Northern Ireland, or both Great Britain and Northern Ireland (as appropriate)”;
(c)in paragraph (5), after “Chapter 2” insert—
“insofar as the advertisement is for publication—
(a)in Great Britain;
(b)in Northern Ireland; or
(c)in both Great Britain and Northern Ireland”;
(d)in paragraph (7)(b), after “no longer applies” insert—
“,
and where that original notice related to both Great Britain and Northern Ireland, the new notice may be expressed to apply in relation to either of or both Great Britain and Northern Ireland”;
(e)in paragraph (8), after “the advertisement” insert—
“—
(a)in Great Britain;
(b)in Northern Ireland; or
(c)in both Great Britain and Northern Ireland”.
Textual Amendments
F14Regs. 217A-217D 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. 177
Commencement Information
I12Reg. 217B in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
217C. In regulation 307—
(a)in paragraph (1)(a), after “subject of the notice” insert—
“in—
(i)Great Britain;
(ii)Northern Ireland; or
(iii)both Great Britain and Northern Ireland”;
(b)in paragraph (1)(b), after “that advertisement” insert—
“in—
(i)Great Britain;
(ii)Northern Ireland; or
(iii)both Great Britain and Northern Ireland”;
(c)in paragraph (2)(a), for “, either in full or in part; and” substitute—
“in respect of—
(i)Great Britain;
(ii)Northern Ireland; or
(iii)both Great Britain and Northern Ireland,
either in full or in part; and”.
Textual Amendments
F14Regs. 217A-217D 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. 177
Commencement Information
I13Reg. 217C in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
217D. In regulation 311—
(a)in paragraph (1)(a), for “Chapter 2; and” substitute—
“Chapter 2 in respect of—
(i)Great Britain;
(ii)Northern Ireland; or
(iii)both Great Britain and Northern Ireland; and”;
(b)in paragraph (3), after “ the advertisement” insert—
“in—
(i)Great Britain;
(ii)Northern Ireland; or
(iii)both Great Britain and Northern Ireland,
as the case may be.”.]
Textual Amendments
F14Regs. 217A-217D 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. 177
Commencement Information
I14Reg. 217D in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1