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The Human Medicines Regulations 2012
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Changes over time for: Section 78B
Version Superseded: 01/01/2025
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- 31/12/2020- Amendment
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[F1Post authorisation requirements in relation to UKMA(GB) for advanced therapy medicinal productsU.K.
This section has no associated Explanatory Memorandum
78B.—(1) The holder of a UKMA(GB) in respect of an advanced therapy medicinal product must—
(a)establish and maintain a system ensuring that the individual product and its starting raw materials, including all substances coming into contact with the cells or tissues it may contain, can be traced through the sourcing, manufacturing, packaging, storage, transport and delivery to the hospital, institution or private practice where the product is used;
(b)where the product contains human tissues or cells, ensure that the traceability system is complementary to and compatible with requirements imposed pursuant to—
(i)as regards gametes and embryos, sections 12(3), and 33A to 33D of, and paragraph 1 of Schedule 3A to, the Human Fertilisation and Embryology Act 1990,
(ii)as regards blood cells, regulations 8, 9(e) and 14 of the Blood Safety and Quality Regulations 2005, and
(iii)as regards other cells and tissues, regulations 13 and 16 of, and paragraph 1 of Schedule 2 to, the Human Tissue (Quality and Safety for Human Application) Regulations 2007;
(c)keep the data referred to in paragraph (a) for a minimum of 30 years after the expiry of the date of the product, or longer if required by the licensing authority as a term of the UKMA(GB); and
(d)in the event of the UKMA(GB) holder's bankruptcy or liquidation occurring within the period of time for which that holder is required to keep the data referred to in paragraph (a), transfer that data to another person or the licensing authority.
(2) The holder of a UKMA(GB) who is subject to the obligations in paragraph (1) remains subject to them even if the UKMA(GB) is suspended or revoked.]
Textual Amendments
F1Regs. 78A, 78B inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 87 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 64); 2020 c. 1, Sch. 5 para. 1(1)
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