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The Human Medicines Regulations 2012
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Changes to legislation:
The Human Medicines Regulations 2012, Section 78B is up to date with all changes known to be in force on or before 23 February 2025. 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.
Changes to Legislation
Revised legislation carried on this site may not be fully up to date. Changes and effects are recorded by our editorial team in lists which can be found in the ‘Changes to Legislation’ area. Where those effects have yet to be applied to the text of the legislation by the editorial team they are also listed alongside the legislation in the affected provisions. Use the ‘more’ link to open the changes and effects relevant to the provision you are viewing.
Changes and effects yet to be applied to Regulation 78B:
- Sch. 3 para. 1(2)(ca)(cb) inserted by S.I. 2025/87 reg. 34(2)(b)
- Sch. 3 para. 1(3)(ba) inserted by S.I. 2025/87 reg. 34(3)
- Sch. 3 para. 1A 1B inserted by S.I. 2025/87 reg. 34(4)
- Sch. 4 Pt. 1A 1B inserted by S.I. 2025/87 reg. 35
- Sch. 7 para. 12B inserted by S.I. 2025/87 reg. 36
- Sch. 24 Pt. 6 inserted by S.I. 2025/87 reg. 38
- reg. 17(1A) inserted by S.I. 2025/87 reg. 5(3)
- reg. 17(10)(11) inserted by S.I. 2025/87 reg. 5(4)
- reg. 17A 17B inserted by S.I. 2025/87 reg. 6
- reg. 22(1A)(1B) inserted by S.I. 2025/87 reg. 8
- reg. 26(2)(d)(e) inserted by S.I. 2025/87 reg. 9(b)
- reg. 27A inserted by S.I. 2025/87 reg. 10
- reg. 29(2A)-(2F) inserted by S.I. 2025/87 reg. 11
- reg. 29A 29B inserted by S.I. 2025/87 reg. 12
- reg. 37(6)(ab)(ac) inserted by S.I. 2025/87 reg. 13(2)(b)
- reg. 37A 37B inserted by S.I. 2025/87 reg. 14
- reg. 39(5A)-(5E) inserted by S.I. 2025/87 reg. 15(3)
- reg. 50(5AA)(5AB) inserted by S.I. 2025/87 reg. 16(3)
- reg. 50K inserted by S.I. 2025/87 reg. 17
- reg. 74A 74B inserted by S.I. 2025/87 reg. 18
- reg. 167(6A)(6B) inserted by S.I. 2025/87 reg. 19(3)
- reg. 167G(1A)(1B) inserted by S.I. 2025/87 reg. 20(3)
- reg.169(A1) inserted by S.I. 2025/87 reg. 21
- reg. 170(A1) inserted by S.I. 2025/87 reg. 22
- reg. 170A 170B inserted by S.I. 2025/87 reg. 23
- reg. 171(A1) inserted by S.I. 2025/87 reg. 24
- reg. 188(1)(ca) inserted by S.I. 2025/87 reg. 27(2)(b)
- reg. 188(1A)(ba) inserted by S.I. 2025/87 reg. 27(3)(b)
- reg. 188(1B)(1C) inserted by S.I. 2025/87 reg. 27(4)
- reg. 202A(2)(d)(e) inserted by S.I. 2025/87 reg. 28
- reg. 257(10) inserted by S.I. 2025/87 reg. 29
- reg. 257CA inserted by S.I. 2025/87 reg. 31
- reg. 258(9) inserted by S.I. 2025/87 reg. 32
- reg. 346(2)(c)(ai)(bi) inserted by S.I. 2025/87 reg. 33(2)(a)
- reg. 346(2)(c)(iiza)-(iizc) inserted by S.I. 2025/87 reg. 33(2)(b)
- reg. 346(2)(c)(iiiza)(iiizb) inserted by S.I. 2025/87 reg. 33(2)(c)
- reg. 346(2)(c)(va) inserted by S.I. 2025/87 reg. 33(2)(d)
- reg. 346(2)(c)(xivb)(xivc) inserted by S.I. 2025/87 reg. 33(2)(e)
- reg. 346(2)(c)(xxviiiazb)(xxviiiazc) inserted by S.I. 2025/87 reg. 33(2)(f)
- reg. 346(2)(c)(xxviiik) inserted by S.I. 2025/87 reg. 33(2)(g)
Changes and effects yet to be applied to the whole Instrument associated Parts and Chapters:
Whole provisions yet to be inserted into this Instrument (including any effects on those provisions):
- Sch. 3 para. 1(2)(ca)(cb) inserted by S.I. 2025/87 reg. 34(2)(b)
- Sch. 3 para. 1(3)(ba) inserted by S.I. 2025/87 reg. 34(3)
- Sch. 3 para. 1A 1B inserted by S.I. 2025/87 reg. 34(4)
- Sch. 4 Pt. 1A 1B inserted by S.I. 2025/87 reg. 35
- Sch. 7 para. 12B inserted by S.I. 2025/87 reg. 36
- Sch. 24 Pt. 6 inserted by S.I. 2025/87 reg. 38
- reg. 17(1A) inserted by S.I. 2025/87 reg. 5(3)
- reg. 17(10)(11) inserted by S.I. 2025/87 reg. 5(4)
- reg. 17A 17B inserted by S.I. 2025/87 reg. 6
- reg. 22(1A)(1B) inserted by S.I. 2025/87 reg. 8
- reg. 26(2)(d)(e) inserted by S.I. 2025/87 reg. 9(b)
- reg. 27A inserted by S.I. 2025/87 reg. 10
- reg. 29(2A)-(2F) inserted by S.I. 2025/87 reg. 11
- reg. 29A 29B inserted by S.I. 2025/87 reg. 12
- reg. 37(6)(ab)(ac) inserted by S.I. 2025/87 reg. 13(2)(b)
- reg. 37A 37B inserted by S.I. 2025/87 reg. 14
- reg. 39(5A)-(5E) inserted by S.I. 2025/87 reg. 15(3)
- reg. 50(5AA)(5AB) inserted by S.I. 2025/87 reg. 16(3)
- reg. 50K inserted by S.I. 2025/87 reg. 17
- reg. 74A 74B inserted by S.I. 2025/87 reg. 18
- reg. 167(6A)(6B) inserted by S.I. 2025/87 reg. 19(3)
- reg. 167G(1A)(1B) inserted by S.I. 2025/87 reg. 20(3)
- reg.169(A1) inserted by S.I. 2025/87 reg. 21
- reg. 170(A1) inserted by S.I. 2025/87 reg. 22
- reg. 170A 170B inserted by S.I. 2025/87 reg. 23
- reg. 171(A1) inserted by S.I. 2025/87 reg. 24
- reg. 188(1)(ca) inserted by S.I. 2025/87 reg. 27(2)(b)
- reg. 188(1A)(ba) inserted by S.I. 2025/87 reg. 27(3)(b)
- reg. 188(1B)(1C) inserted by S.I. 2025/87 reg. 27(4)
- reg. 202A(2)(d)(e) inserted by S.I. 2025/87 reg. 28
- reg. 257(10) inserted by S.I. 2025/87 reg. 29
- reg. 257CA inserted by S.I. 2025/87 reg. 31
- reg. 258(9) inserted by S.I. 2025/87 reg. 32
- reg. 346(2)(c)(ai)(bi) inserted by S.I. 2025/87 reg. 33(2)(a)
- reg. 346(2)(c)(iiza)-(iizc) inserted by S.I. 2025/87 reg. 33(2)(b)
- reg. 346(2)(c)(iiiza)(iiizb) inserted by S.I. 2025/87 reg. 33(2)(c)
- reg. 346(2)(c)(va) inserted by S.I. 2025/87 reg. 33(2)(d)
- reg. 346(2)(c)(xivb)(xivc) inserted by S.I. 2025/87 reg. 33(2)(e)
- reg. 346(2)(c)(xxviiiazb)(xxviiiazc) inserted by S.I. 2025/87 reg. 33(2)(f)
- reg. 346(2)(c)(xxviiik) inserted by S.I. 2025/87 reg. 33(2)(g)
[F1Post authorisation requirements in relation to [F2UKMA(UK)(Category 1)] for advanced therapy medicinal productsU.K.
This section has no associated Explanatory Memorandum
78B.—(1) The holder of a [F3UKMA(UK)(Category 1)] 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 [F4UKMA(UK)(Category 1)]; and
(d)in the event of the [F5UKMA(UK)(Category 1)] 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 [F6UKMA(UK)(Category 1)] who is subject to the obligations in paragraph (1) remains subject to them even if the [F6UKMA(UK)(Category 1)] 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)
F2Words in reg. 78B heading substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 61(a)
F3Words in reg. 78B(1) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 61(b)(i)
F4Words in reg. 78B(1)(c) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 61(b)(ii)
F5Words in reg. 78B(1)(d) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 61(b)(iii)
F6Words in reg. 78B(2) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 61(c)
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