Conditions for wholesale dealer's licenceU.K.
42.—(1) Regulations 43 to 45 [F1(not including regulation 43ZA)] [F2(in the case of a wholesale dealer’s licence held in Northern Ireland) or regulations 43 to 45AA [F3(including regulation 43ZA)] (in the case of a wholesale dealer’s licence held in Great Britain)] apply to the holder of a wholesale dealer's licence (referred to in those regulations as “the licence holder”) and have effect as if they were provisions of the licence (but the provisions specified in paragraph (2) do not apply to the holder of a wholesale dealer's licence insofar as the licence relates to exempt advanced therapy medicinal products).
[F4(2) Those provisions are regulations 43(2) and (8) and 44.]
(3) The requirements in Part 2 of Schedule 6 apply to the holder of a wholesale dealer's licence insofar as the licence relates to exempt advanced therapy medicinal products, and have effect as if they were provisions of the licence.
[F5(4) [F6Where a wholesale dealer’s licence relates to wholesale dealings in Northern Ireland, the requirements] and obligations contained in a provision of Commission Regulation 2016/161 listed in paragraph (5) have effect as if they were [F7provisions of that] licence under this Part.
(5) The provisions mentioned in paragraph (4) are—
(a)Article 10 (verification of the safety features) insofar as it relates to wholesalers;
(b)Article 11 (verification of the authenticity of the unique identifier) insofar as it relates to wholesalers;
(c)Article 12 (unique identifiers which have been decommissioned);
(d)Article 13 (reversing the status of a decommissioned unique identifier) insofar as it relates to wholesalers;
(e)Article 20 (verification of the authenticity of the unique identifier), subject to the exemption contained in Article 21 (derogations from Article 20(b));
(f)Article 22 (decommissioning of unique identifiers); and
(g)Article 24 (actions to be taken in case of tampering or suspected falsification).]
[F8(6) Paragraph (4) does not apply in relation to listed NIMAR products in Northern Ireland.]
Textual Amendments
F1Words in reg. 42(1) inserted (1.1.2022) by The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 10(a)(i)
F2Words in reg. 42(1) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 31(2) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 21(a)); 2020 c. 1, Sch. 5 para. 1(1)
F3Words in reg. 42(1) inserted (1.1.2022) by The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 10(a)(ii)
F4Reg. 42(2) substituted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 13
F5Reg. 42(4)(5) inserted (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.I. 2019/62), regs. 1, 6 and reg. 42(4)(5) inserted (N.I.) (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.R. 2019/10), regs. 1, 6
F6Words in reg. 42(4) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 31(3)(a) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 21(b)); 2020 c. 1, Sch. 5 para. 1(1)
F7Words in reg. 42(4) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 31(3)(b) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 21(b)); 2020 c. 1, Sch. 5 para. 1(1)