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

Consolidated Text As Enacted Cited authorities 42 Cited in Amendments 7 Related
Vincent
JurisdictionUK Non-devolved
CitationSI 2019/482
Year2019
  • These Regulations may be cited as the Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2019 and come into force on exit day.
    • (1) The Human Fertilisation and Embryology Act 1990 (2) In section 1A (reference to Directives) , for the definition of “the third Directive” substitute—
      • “the third Directive” means—
        • (a) 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) , and
        • (b) in the application of this Act in relation to Northern Ireland, the 2006 Directive as amended by Commission Directive 2015/565/EU,
    ,    in the definition of “competent authority” omit “other than the United Kingdom or in relation to Gibraltar”;at the appropriate place, insert—
      “tissue establishment” means a tissue bank or a unit of a hospital or another body which procures, tests, processes, preserves, stores or distributes human F14gametes or embryos,
    ;    for subsection (2B) substitute—
    • (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.
    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, andin 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.(4) In section 2A F4 (third party agreements) after subsection (1) insert—
    • “(1A) For the purposes of subsection (1) , F16as 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.
    .    For the purposes of subsection (1) , F16as 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.in subsection (2) (b) omit “into the United Kingdom”;for subsections (4) , (5) and (6) substitute—
    • (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.
    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,in relation to the import of qualifying gametes or embryos into Northern Ireland, a country other than Northern Ireland or an EEA state, andin relation to the export of qualifying gametes or embryos from Northern Ireland, a country other than the United Kingdom or an EEA state.they are in a country other than the United Kingdom, andthey 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, andthey are in a country other than Northern Ireland or an EEA state, andthey 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.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, andin 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.for the heading substitute “Duties of the Authority in relation to the Single European Code: Northern Ireland”;in subsection (1) , after “The Authority” insert “ in relation to Northern Ireland,”;for subsection (3) substitute—
    • (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.
    ;    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.omit subsection (4) ;for subsection (5) substitute—
    • (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.
    ;    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.in subsection (7) , for the words before paragraph (a) substitute “The Authority must take steps to enable the information to be corrected or updated”;in subsection (11) , for the definition of “relevant state” substitute—
      • “relevant state” means an EEA State,
    .    for the heading substitute “Duty of Authority to communicate with competent authorities of EEA states: Northern Ireland”;for the words from “The Authority” to “Gibraltar” substitute “The Authority must, in relation to Northern Ireland, communicate to the competent authorities of EEA states”.(8) In section 14A (conditions of licences: human application) , in subsection (3) , for the words from “the United Kingdom” to “Gibraltar” substitute “Northern Ireland from an EEA State”.(9) In section 15A (duties of the Authority in relation to serious adverse events and serious adverse reactions) , in subsection (3) , for the words from “If the Authority” to “Gibraltar” substitute “If the Authority, in relation to Northern Ireland, receives a request from a competent authority in an EEA state”.for the heading substitute “Inspection of third country premises etc.: Northern Ireland”;in paragraph (a) , for “the United Kingdom” substitute “Northern Ireland”;in paragraph (b) , omit “other than the United Kingdom or in Gibraltar”;in paragraph (c) , omit “or in Gibraltar”;in subsection (4) , after “imported” insert “into Northern Ireland”.for the heading substitute “Third country premises and third country suppliers: report of inspections etc: Northern Ireland”;in subsection (1) , for the words from “This section” to “Gibraltar” substitute “This section applies in relation to Northern Ireland where the European Commission or a competent authority in an EEA state”.for paragraph (c) (but not including the “or” that follows it) substitute—
    • (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,
    ;    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,in paragraph (d) for “country which is not an EEA state” substitute “ third country ”;for subsection (4) substitute—
    • (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.
    from outside the United Kingdom, andin respect of Northern Ireland, from Great Britain, orsend gametes, embryos or human admixed embryos outside the United Kingdom,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.for subsection (4AD) substitute—
    • (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...
    in relation to Great Britain, provide that person with a certificate of authority in such form as the Authority considers appropriate; andin relation to Northern

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