- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Pwynt Penodol mewn Amser (06/11/2020)
- Gwreiddiol (a wnaed Fel)
Version Superseded: 31/12/2020
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The Human Medicines Regulations 2012, Section 42 is up to date with all changes known to be in force on or before 22 September 2024. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations.
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42.—(1) Regulations 43 to 45 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).
[F1(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.
[F2(4) The requirements and obligations contained in a provision of Commission Regulation 2016/161 listed in paragraph (5) have effect as if they were provisions of a wholesale dealer’s 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).]
Textual Amendments
F1Reg. 42(2) substituted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 13
F2Reg. 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
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