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The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2019

Type Statutory-Instrument
Publication 2019-03-05
Last updated 2020-12-31
State In force
Department King's Printer of Acts of Parliament
Source legislation.gov.uk
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Made: 5th March 2019

Coming into force in accordance with regulation 1

The Secretary of State makes these Regulations in exercise of the powers conferred by section 8(1) of, and paragraph 21(b) of Schedule 7 to, the European Union (Withdrawal) Act 2018 .

A draft of these Regulations was laid before Parliament in accordance with paragraph 1(1) of Schedule 7 to that Act and approved by a resolution of each House of Parliament.

PART 1 — Introduction

Citation and commencement

1

These Regulations may be cited as the Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2019 and come into force on exit day.

PART 2 — Amendment of primary legislation

Amendment of the Human Fertilisation and Embryology Act 1990

2

  • “the third Directive” means—in the application of this Act in relation to Great Britain, Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells (“the 2006 Directive”), as it had effect immediately before 29 April 2015 (which is the date on which the amendments made by Commission Directive 2015/565/EU came into force), andin the application of this Act in relation to Northern Ireland, the 2006 Directive as amended by Commission Directive 2015/565/EU,

“tissue establishment” means a tissue bank or a unit of a hospital or another body which procures, tests, processes, preserves, stores or distributes human gametes or embryos,

(2B) Any reference in this Act to a requirement of a provision of the first, second, third or fourth Directive— (a) in the application of this Act in relation to Great Britain, is to be read as a reference to a requirement which that provision would require to be imposed if the provision formed part of the law of England and Wales or Scotland, and (b) in the application of this Act in relation to Northern Ireland, is to be read as a reference to a requirement which that provision requires to be imposed.

(1A) For the purposes of subsection (1), as it applies in relation to Great Britain, Article 24 of the first Directive is to be read subject to the modifications set out in paragraph 11A(8) of Schedule 3A.

(4) “Third country” means— (a) in relation to the import of qualifying gametes or embryos into, or the export of qualifying gametes or embryos from, Great Britain, a country other than the United Kingdom, (b) in relation to the import of qualifying gametes or embryos into Northern Ireland, a country other than Northern Ireland or an EEA state, and (c) in relation to the export of qualifying gametes or embryos from Northern Ireland, a country other than the United Kingdom or an EEA state. (5) Premises are “third country premises” if— (a) in relation to Great Britain— (i) they are in a country other than the United Kingdom, and (ii) they are premises in or from which a third country supplier, or a person providing services to a third country supplier, procures, tests, processes, stores, distributes or exports qualifying gametes or embryos intended for import into Great Britain, and (b) in relation to Northern Ireland— (i) they are in a country other than Northern Ireland or an EEA state, and (ii) they are premises in or from which a third country supplier, or a person providing services to a third country supplier, procures, tests, processes, stores, distributes or exports qualifying gametes or embryos intended for import into Northern Ireland. (6) “Third country supplier” means— (a) in relation to qualifying gametes or embryos intended for import into Great Britain, a person in a country other than the United Kingdom who has an agreement with an importing licensee for exporting such gametes or embryos into Great Britain, and (b) in relation to qualifying gametes or embryos intended for import into Northern Ireland, a person in a country other than Northern Ireland or an EEA state who has an agreement with an importing licensee for exporting such gametes or embryos into Northern Ireland.

(3) In relation to Northern Ireland, the Authority must take steps to enable the information specified in Annex VIII to be recorded in the EU Tissue Establishment Compendium in relation to each holder of a relevant licence.

(5) The Authority must take the steps mentioned in subsection (3) to enable the information mentioned in that subsection to be recorded before the end of the period of 10 working days beginning with the day on which the person becomes the holder of a relevant licence.

  • “relevant state” means an EEA State,

(c) in relation to Northern Ireland, between premises referred to in paragraphs (a) and (b) and tissue establishments accredited, designated, authorised or licensed under the laws, or other measures, of an EEA state which implement the first, second and third Directives,

(4) Directions may authorise any person to whom a licence applies to— (a) receive gametes, embryos or human admixed embryos— (i) from outside the United Kingdom, and (ii) in respect of Northern Ireland, from Great Britain, or (b) send gametes, embryos or human admixed embryos outside the United Kingdom, in such circumstances and subject to such conditions as may be specified in the directions. (4ZA) Directions made by virtue of subsection (4) may provide for sections 12 to 14 of this Act to have effect with such modifications as may be specified in the directions.

(4AD) Where the Authority gives any directions under subsection (4) authorising any person to whom a licence applies to make any qualifying imports, it must— (a) in relation to Great Britain, provide that person with a certificate of authority in such form as the Authority considers appropriate; and (b) in relation to Northern Ireland, provide that person with a certificate in the form set out in Annex II to the fourth Directive.

(11A) In relation to Great Britain, directions must specify the systems to be adopted for the identification of gametes and embryos intended for human application which the Authority considers appropriate to facilitate traceability.

(42A) (1) The Secretary of State may by regulations make provision specifying requirements to be met for the purposes of ensuring traceability. (2) The Secretary of State may by regulations make provision in relation to the notification of serious adverse events and serious adverse reactions (whether to the Authority or such other person as may be specified in the regulations). (3) The Secretary of State may by regulations make provision specifying requirements to be met for the purposes of verifying that standards of quality and safety equivalent to those required pursuant to this Act apply in relation to imports by tissue establishments of gametes and embryos from third countries. (4) The Secretary of State may by regulations make provision specifying technical requirements in relation to the following— (a) the licensing or authorisation of tissue establishments; (b) the procurement of gametes or embryos; (c) selection criteria for donors of gametes and embryos; (d) laboratory tests required for donors; (e) procedures for the reception of gametes and embryos at the tissue establishment; (f) the gamete and embryo preparation process; (g) gamete and embryo processing, storage and distribution. (5) The provision that may be made in regulations under this section includes provision amending this Act and may modify, or further modify, the provisions of the second, third and fourth Directives as they apply by virtue of this Act. (6) The Secretary of State may only make regulations under this section in relation to Great Britain.

Tissue establishment Section 2(1)

(A1) For the purposes of this Act, as it applies in relation to Great Britain, the first, second and third Directives are to be read subject to the modifications set out in paragraphs 11A to 11C.

(3A) In relation to Northern Ireland, licence conditions shall require such— (a) systems to report, investigate, register and transmit information about serious adverse events and serious adverse reactions, and (b) accurate, rapid and verifiable procedures for recalling from distribution any product which may be related to a serious adverse event or serious adverse reaction, to be in place as are necessary to secure compliance with the requirements of Article 11 (notification of serious adverse events and reactions) of the first Directive and Article 5 (notification of serious adverse reactions) and Article 6 (notification of serious adverse events) of the third Directive.

(11A) (1) The modifications to the first Directive are as follows. (2) Article 8 is to be read as if— (a) in paragraph 1— (i) the reference to Member States were a reference to the Authority; (ii) for “on their territory” there were substituted “in Great Britain”; (b) paragraphs 2, 3 5 and 6 were omitted. (3) Article 14 is to be read as if— (a) in paragraph 1— (i) the reference to Member States were a reference to the Authority; (ii) for “within the scope of this Directive” there were substituted “ in accordance with the Human Fertilisation and Embryology Act 1990 ”; (b) in paragraph 2, the reference to Member States were a reference to the Authority; (c) in paragraph 3— (i) the first reference to Member States were a reference to the Authority; (ii) “in Member States” were omitted. (4) Article 15 is to be read as if paragraphs 1, 2 and 4 were omitted. (5) Article 19(5) is to be read as if the words “in accordance with Article 8” were omitted. (6) Article 20 is to be read as if in paragraph 1, the reference to Article 28(h) were a reference to the requirements of Annex 2 to the third Directive listed in paragraph 11 of this Schedule. (7) Article 21 is to be read as if— (a) in paragraph 4, for “laid down in this Directive” there were substituted “ of the Human Fertilisation and Embryology Act 1990 ”; (b) in paragraph 5— (i) the first reference to Member States were a reference to the Authority; (ii) the reference to a tissue establishment accredited, designated, authorised or licensed in accordance with Article 6 were a reference to a tissue establishment authorised or licensed in accordance with the provisions of this Act; (iii) for the words “Member States' legislation” there were substituted “ legislation ”. (8) Article 24 is to be read as if— (a) in paragraph 2, for “laid down in this Directive” there were substituted “ required by the Human Fertilisation and Embryology Act 1990 ”; (b) in paragraph 5, the reference to the competent authority or authorities were a reference to the Authority. (9) The Annex is to be read as if— (a) in paragraph B.1, for “legislation in force in Member States” there were substituted “ requirements of Schedule 3 to the Human Fertilisation and Embryology Act 1990 ”; (b) paragraph B.2 were omitted. (11B) (1) The modifications to the second Directive are as follows. (2) Article 2 is to be read as if, in paragraph 1, the reference to Member States were a reference to the Authority. (3) Articles 3, 4 and 5 are to be read as if any reference to the competent authority or authorities were a reference to the Authority. (4) Annex 1 is to be read as if, in the first paragraph, for “responsible person as defined in Article 17 of Directive 2004/23/EC” there were substituted “ person responsible in accordance with section 17 of the Human Fertilisation and Embryology Act 1990 ”. (5) Annex 2 is to be read as if, in paragraph 2.1, the reference to the competent authority in the Member State were a reference to the Authority. (6) Annex 3 is to be read as if, in paragraph 3.6, for “in force in Member States” there were substituted “ of the Human Fertilisation and Embryology Act 1990 ”. (7) Annex 4 is to be read as if— (a) in paragraphs 1.1.1 and 1.2.1, the reference to an authorised person were to— (i) the person responsible in accordance with section 17 of this Act, or (ii) a person authorised by the person responsible or the Authority to carry out the specified tasks; (b) in paragraph 1.1.1(a), for “Article 13 of Directive 2004/23/EC” there were substituted “ the Human Fertilisation and Embryology Act 1990 ”; (c) in paragraph 1.4.4, the reference to the competent authority were a reference to the Authority. (11C) (1) The modifications to the third Directive are as follows. (2) Annex 1 is to be read as if— (a) in paragraph A.1— (i) for “responsible person” there were substituted “ person responsible ”; (ii) for “as provided in Article 17 of Directive 2004/23/EC” there were substituted “ in accordance with the requirements of sections 16 and 17 of the Human Fertilisation and Embryology Act 1990 ”; (b) in paragraph A.4, for “laid down in this Directive” there were substituted “ required by the Human Fertilisation and Embryology Act 1990 ”; (c) in paragraph C.6, for the words from “requirements of Council” to the end there were substituted “ requirements of the Medical Devices Regulations 2002 ” ; (d) in paragraph D.1, for “laid down in this Directive” there were substituted “ required by the Human Fertilisation and Embryology Act 1990 ”; (e) in paragraph E.1, for “laid down in this Directive” there were substituted “ required by the Human Fertilisation and Embryology Act 1990 ”; (f) in paragraph E.8, the reference to the competent authority were a reference to the Authority. (3) Annex 2 is to be read as if— (a) in the first paragraph, the reference to the competent authority were a reference to the Authority; (b) in paragraph A, for the words from “the tissues and cells must” to the end there were substituted “ tissue establishment procedures must ensure that the licence conditions in paragraph 9 of Schedule 3A to the Human Fertilisation and Embryology Act 1990 are met ”; (c) in paragraph B.3, for the words from “the standards” to the end there were substituted “ the requirements of paragraph 10 of Schedule 3A to the Human Fertilisation and Embryology Act 1990 ”; (d) in paragraph B.8, the second sentence were omitted; (e) in paragraph C.2, for “laid down in this Directive” there were substituted “ of Schedule 3A to the Human Fertilisation and Embryology Act 1990 ”; (f) in paragraphs C.4 and C.5, any reference to the responsible person as defined or specified in Article 17 of Directive 2004/23/EC were a reference to the person responsible in accordance with section 17 of this Act; (g) in paragraph D.5, the reference to the competent authority were a reference to the Authority; (h) in paragraph E.2(h), for “as set out in Articles 5 to 6” there were substituted “ in accordance with paragraph 3 of Schedule 3A to the Human Fertilisation and Embryology Act 1990 ”.

(A1) For the purposes of this Act, as it applies in relation to Great Britain, the fourth Directive is to be read subject to the modifications set out in paragraph 3A. Directions

(c) provide the Authority— (i) in relation to Great Britain, with any information or documents specified in the direction for the purposes of demonstrating traceability, and that the import is a one-off import within the meaning given by section 24(4AE), (ii) in relation to Northern Ireland, with any information or documents specified in the direction for the purposes of securing compliance with the requirements of Articles 5(2) and 7(1) of the fourth Directive (requirements in relation to one-off imports).

(3A) (1) The modifications to the fourth Directive are as follows. (2) The Directive is to be read as if references to a third country were references to any country other than the United Kingdom. (3) Article 2 is to be read as if for “the Union”, in each place where it occurs, there were substituted “Great Britain”. (4) Article 5(1) is to be read as if— (a) for “laid down in Directive 2004/23/EC” there were substituted “ required by the Human Fertilisation and Embryology Act 1990 ”; (b) the references to the competent authority or authorities were references to the Authority. (5) Article 6 is to be read as if— (a) in paragraph 2— (i) the reference to the competent authority or authorities were a reference to the Authority; (ii) the words from “The information laid out” to the end were omitted; (b) in paragraph 3— (i) the first reference to the competent authority or authorities were a reference to the Authority; (ii) the reference to the competent authority or authorities in sub-paragraph (b) were a reference to the authority or authorities in the third country concerned responsible for regulating tissue establishments in that country. (6) Article 7 is to be read as if— (a) in paragraph 2, for “laid down in Directive 2004/23/EC” there were substituted “ required by the Human Fertilisation and Embryology Act 1990 ”; (b) in paragraph 3, the reference to the competent authority or authorities were a reference to the Authority. (7) Annex 1 is to be read as if— (a) in paragraph A.4, for “TE compendium code” there were substituted “ reference number previously allocated to the tissue establishment by the Authority ”; (b) in paragraph B.4, the reference to the Responsible Person were a reference to the person responsible in accordance with section 17 of this Act; (c) in paragraph C.2, the words “(where applicable, in accordance with the EU generic list”) were omitted; (d) in paragraph F.3, the references to a third country competent authority or authorities were references to the authority or authorities in the third country responsible for regulating tissue establishments in that country. (8) Annex 3 is to be read as if— (a) in the first paragraph, the reference to the competent authority or authorities were a reference to the Authority; (b) in paragraph A.1, for “as laid down in Directive 2004/23EC” there were substituted “ in accordance with sections 16 and 17 of the Human Fertilisation and Embryology Act 1990 ”; (c) in paragraph A.3, the words “applying the Single European Code,” were omitted; (d) in paragraph B.7, the reference to a third country competent authority or authorities were a reference to the authority or authorities in the third country responsible for regulating tissue establishments in that country. (9) Annex 4 is to be read as if— (a) in paragraph 1, for “laid down in Directive 2004/23/EC” there were substituted “ required by the Human Fertilisation and Embryology Act 1990 ”; (b) in paragraph 4, the reference to a third country competent authority or authorities were a reference to the authority or authorities in the third country responsible for regulating tissue establishments in that country; (c) in paragraph 5, the reference to the competent authority or authorities were to the Authority; (d) in paragraph 7, for “EU data protection rules” there were substituted “ data protection legislation within the meaning of section 3(9) of the Data Protection Act 2018 ” ; (e) in paragraph 8, for the words from “requirements” to the end there were substituted “ quality and safety standards required by the Human Fertilisation and Embryology Act 1990 ”. Interpretation of this Schedule

PART 3 — Amendment of subordinate legislation

Amendment of the Human Fertilisation and Embryology (Quality and Safety) Regulations 2007

3

In regulation 2 of the Human Fertilisation and Embryology (Quality and Safety) Regulations 2007—

PART 4 — Transitional provision

Transitional provision

4

provided that the Authority is satisfied that the import or, as the case may be, export, meets requirements of traceability and standards of quality and safety equivalent to those laid down in the Act.

Signed

Signed by authority of the Secretary of State for Health and Social Care.

Jackie Doyle-Price — Parliamentary Under-Secretary of State, — 2019-03-05

Explanatory note

(This note is not part of the Regulations)

Footnotes

[^f00001]: 2018 c. 16.

[^f00002]: 1990 c. 37. Relevant amendments have been made by sections 2, 22, 25, 28, 30 and 65 of, and Schedules 5 and 7 to, the Human Fertilisation and Embryology Act 2008 (c. 22) and by S.I. 2007/1522, 2014/2884 and 2018/334.

[^f00003]: Section 1A was inserted by S.I. 2007/1522 and amended by S.I. 2014/2884 and 2018/334.

[^f00004]: Section 2 was amended by sections 2 and 65 of, and paragraph 2 of Schedule 7 to, the Human Fertilisation and Embryology Act 2008 and by S.I. 2007/1522 and 2018/334.

[^f00005]: Section 2A was inserted by S.I. 2007/1522.

[^f00006]: Section 2B was inserted by S.I. 2018/334.

[^f00007]: Section 8ZB was inserted by S.I. 2018/334.

[^f00008]: Section 8A was inserted by S.I. 2007/1522.

[^f00009]: Section 14A was inserted by S.I. 2007/1522 and amended by section 65 of, and paragraph 6 of Schedule 7 to, the Human Fertilisation and Embryology Act 2008.

[^f00010]: Section 15A was inserted by S.I. 2007/1522.

[^f00011]: Section 15B was inserted by S.I. 2018/334.

[^f00012]: Section 15C was inserted by S.I. 2018/334.

[^f00013]: Section 24 was amended by section 22 of the Human Fertilisation and Embryology Act 2008 and by S.I. 2007/1522 and 2018/334.

[^f00014]: Section 33A was inserted by section 25 of the Human Fertilisation and Embryology Act 2008.

[^f00015]: Section 45 was amended by section 30 of the Human Fertilisation and Embryology Act 2008.

[^f00016]: Section 47 was amended by sections 65 of, and paragraph 13 of Schedule 7 to, the Human Fertilisation and Embryology Act 2008 and by S.I. 2007/1522 and 2018/334.

[^f00017]: Schedule 3A was inserted by S.I. 2007/1522 and amended by S.I. 2018/334.

[^f00018]: S.I. 2002/618.

[^f00019]: Schedule 3AA was inserted by S.I. 2018/334.

[^f00020]: 2018 c. 12; section 3(9) was amended by S.I. 2019/419.

[^f00021]: Schedule 3B was inserted by section 28(2) of, and Schedule 5 to, the Human Fertilisation and Embryology Act 2008, and amended by S.I. 2018/334.

[^f00022]: S.I. 2007/1522.

Editorial notes

[^c23624961]: 2018 c. 16.

[^c23624971]: 1990 c. 37. Relevant amendments have been made by sections 2, 22, 25, 28, 30 and 65 of, and Schedules 5 and 7 to, the Human Fertilisation and Embryology Act 2008 (c. 22) and by S.I. 2007/1522, 2014/2884 and 2018/334.

[^c23624991]: Section 2 was amended by sections 2 and 65 of, and paragraph 2 of Schedule 7 to, the Human Fertilisation and Embryology Act 2008 and by S.I. 2007/1522 and 2018/334.

[^c23625001]: Section 2A was inserted by S.I. 2007/1522.

[^c23625081]: Section 24 was amended by section 22 of the Human Fertilisation and Embryology Act 2008 and by S.I. 2007/1522 and 2018/334.

[^c23625101]: Section 45 was amended by section 30 of the Human Fertilisation and Embryology Act 2008.

[^c23625111]: Section 47 was amended by sections 65 of, and paragraph 13 of Schedule 7 to, the Human Fertilisation and Embryology Act 2008 and by S.I. 2007/1522 and 2018/334.

[^c23625121]: Schedule 3A was inserted by S.I. 2007/1522 and amended by S.I. 2018/334.

[^c23625131]: S.I. 2002/618.

[^c23625141]: Schedule 3AA was inserted by S.I. 2018/334.

[^c23625151]: 2018 c. 12; section 3(9) was amended by S.I. 2019/419.

[^key-057386348e2d559208dfbf2c8d3c7fde]: Reg. 1 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

[^key-ed8d997bff394edc745b2382c84d08f3]: Reg. 2 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

[^key-7079fb0d5bce07bf79feb930faa719e1]: Reg. 4 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

[^key-01f473d5f0447f86360d6e80562562ed]: Reg. 3 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

[^key-adb43a4cf9c13d0232377a5395af9dda]: Reg. 2(2) substituted (31.12.2020 immediately before IP completion day) by The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1307), regs. 1, 3

[^key-fa7bec06354c34879767914450e004af]: Reg. 2(3)(a)(i) substituted (31.12.2020 immediately before IP completion day) by The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1307), regs. 1, 4(a)

[^key-56357e351ae2224ccaa029b00a6b1158]: Words in reg. 2(3)(a)(ii) substituted (31.12.2020 immediately before IP completion day) by The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1307), regs. 1, 4(b)

[^key-7a4f4a8bd33ed494f321a82d19b43829]: Reg. 2(3)(b) substituted (31.12.2020 immediately before IP completion day) by The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1307), regs. 1, 4(c)

[^key-b956192b2b25c361488a13335d7dc088]: Words in reg. 2(4) inserted (31.12.2020 immediately before IP completion day) by The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1307), regs. 1, 5

[^key-f8093722a566a29f4d1c883c41f58790]: Reg. 2(5) substituted (31.12.2020 immediately before IP completion day) by The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1307), regs. 1, 6

[^key-56c13d71d3440c8c0f6c7c767f72a0ad]: Reg. 2(6) substituted (31.12.2020 immediately before IP completion day) by The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1307), regs. 1, 7

[^key-8f0865c0e65532dfa12f03e5532b30a6]: Reg. 2(7) substituted (31.12.2020 immediately before IP completion day) by The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1307), regs. 1, 8

[^key-f1b6b14ccc92adc38d739cca0a31298c]: Reg. 2(8) substituted (31.12.2020 immediately before IP completion day) by The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1307), regs. 1, 9

[^key-3a97edd7dd3cf8ff59aca12656d637f5]: Reg. 2(9) substituted (31.12.2020 immediately before IP completion day) by The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1307), regs. 1, 10

[^key-d5c13bef2da524803254d8df879a5f67]: Reg. 2(10) substituted (31.12.2020 immediately before IP completion day) by The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1307), regs. 1, 11

[^key-b4ffeaadec29a3894de83432fcb0c6cd]: Reg. 2(11) substituted (31.12.2020 immediately before IP completion day) by The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1307), regs. 1, 12

[^key-b5349d80fe1ce0d70b6be0480ff5ac6c]: Reg. 2(12)(a)(i) substituted (31.12.2020 immediately before IP completion day) by The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1307), regs. 1, 13(a)

[^key-8d76c219759654c4286168d85585aeb5]: Reg. 2(12)(aa) inserted (31.12.2020 immediately before IP completion day) by The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1307), regs. 1, 13(b)

[^key-84b7bcc5fe401889d4b909a0aebe67c0]: Reg. 2(12)(b)(ba) substituted for reg. 2(12)(b) (31.12.2020 immediately before IP completion day) by The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1307), regs. 1, 13(c)

[^key-887709ea6adcc9acc6bcc3061d58c142]: Reg. 2(12)(c)(ca) substituted for reg. 2(12)(c) (31.12.2020 immediately before IP completion day) by The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1307), regs. 1, 13(d)

[^key-06ca53c111aa253b91404683369b7d7d]: Reg. 2(12)(d)(e) substituted for reg. 2(12)(d) (31.12.2020 immediately before IP completion day) by The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1307), regs. 1, 13(e)

[^key-a474bd99a977b1da1819a89737ff9553]: Reg. 2(13) substituted (31.12.2020 immediately before IP completion day) by The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1307), regs. 1, 14

[^key-ec0a79145b710a0f19ace71fff46dec9]: Words in reg. 2(14) inserted (31.12.2020 immediately before IP completion day) by The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1307), regs. 1, 15

[^key-3bf8fa02a43277fd9891c65340103bed]: Words in reg. 2(17)(a) inserted (31.12.2020 immediately before IP completion day) by The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1307), regs. 1, 16(a)

[^key-e6a29c11ceb64a3e27557d09c2ab5f32]: Reg. 2(17)(b)(ba) substituted for reg. 2(17)(b) (31.12.2020 immediately before IP completion day) by The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1307), regs. 1, 16(b)

[^key-7c2da04aaf000d5712c5af4a63c7b4f7]: Words in reg. 2(17)(c) substituted (31.12.2020 immediately before IP completion day) by The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1307), regs. 1, 16(c)

[^key-de97f4a2797a5698f827e432eaaa719f]: Words in reg. 2(18)(a) inserted (31.12.2020 immediately before IP completion day) by The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1307), regs. 1, 17(a)

[^key-bd912b8ab69efd2b86207f231a581712]: Words in reg. 2(18)(b) substituted (31.12.2020 immediately before IP completion day) by The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1307), regs. 1, 17(b)

[^key-81b80b32c428e7bf7b19e7a90d9c49fd]: Words in reg. 2(18)(c) substituted (31.12.2020 immediately before IP completion day) by The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1307), regs. 1, 17(c)

[^key-d22fcbf1c9fc6dd4fc71984fddb267c7]: Reg. 2(19) substituted (31.12.2020 immediately before IP completion day) by The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1307), regs. 1, 18

[^key-2f9757330641e44716892580172266db]: Reg. 3 substituted (31.12.2020 immediately before IP completion day) by The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1307), regs. 1, 19

[^key-de91b9ab0d7c0b77f09fe737a43154b1]: Words in reg. 4(1) substituted (31.12.2020 immediately before IP completion day) by The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1307), regs. 1, 20(a)

[^key-9395b49e9f5cc89891a8418eaf6e24a8]: Words in reg. 4(1)(a) substituted (31.12.2020 immediately before IP completion day) by The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1307), regs. 1, 20(b)

[^key-0dd074480a9b9452d5b0bf442a88732c]: Words in reg. 4(1)(b) substituted (31.12.2020 immediately before IP completion day) by The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1307), regs. 1, 20(b)

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