{
  "url": "https://openlegislation.uk/human-fertilisation-and-embryology-act-1990/schedule-3A/paragraph-11C",
  "json_url": "https://openlegislation.uk/human-fertilisation-and-embryology-act-1990/schedule-3A/paragraph-11C.json",
  "legislation": "ukpga/1990/37",
  "legislation_title": "Human Fertilisation and Embryology Act 1990",
  "legislation_url": "https://openlegislation.uk/human-fertilisation-and-embryology-act-1990",
  "path": "schedule/3A/paragraph/11C",
  "kind": "paragraph",
  "number": "11C",
  "heading": null,
  "text": "(1) The modifications to the third Directive are as follows.\n(2) Annex 1 is to be read as if—\n(a) in paragraph A.1—\n(i) for “responsible person” there were substituted “ person responsible ”;\n(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 ”;\n(b) in paragraph A.4, for “laid down in this Directive” there were substituted “ required by the Human Fertilisation and Embryology Act 1990 ”;\n(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 ”;\n(d) in paragraph D.1, for “laid down in this Directive” there were substituted “ required by the Human Fertilisation and Embryology Act 1990 ”;\n(e) in paragraph E.1, for “laid down in this Directive” there were substituted “ required by the Human Fertilisation and Embryology Act 1990 ”;\n(f) in paragraph E.8, the reference to the competent authority were a reference to the Authority.\n(3) Annex 2 is to be read as if—\n(a) in the first paragraph, the reference to the competent authority were a reference to the Authority;\n(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 ”;\n(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 ”;\n(d) in paragraph B.8, the second sentence were omitted;\n(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 ”;\n(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;\n(g) in paragraph D.5, the reference to the competent authority were a reference to the Authority;\n(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 ”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Sch. 3A inserted (25.5.2007 for certain purposes, otherwise 5.7.2007) by The Human Fertilisation and Embryology (Quality and Safety) Regulations 2007 (S.I. 2007/1522), regs 1, 30"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Sch. 3A paras. 11A-11C and cross-heading inserted (31.12.2020) by The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/482), regs. 1, 2(17)(c) (with reg. 4) (as amended by The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1307), regs. 1, 16(c)); 2020 c. 1, Sch. 5 para. 1(1)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/ukpga/1990/37/schedule/3A/paragraph/11C",
    "retrieved_at": "2026-10-29T09:42:58.103804+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}