{
  "url": "https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-201",
  "json_url": "https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-201.json",
  "legislation": "uksi/2019/775",
  "legislation_title": "The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019",
  "legislation_url": "https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019",
  "path": "regulation/201",
  "kind": "regulation",
  "number": "201",
  "heading": "Amendment of Schedule 24 (packaging information requirements)",
  "text": "(1) Schedule 24 is amended as follows.\n(2) In paragraph 7(b), for “published pursuant to Article 65 of the 2001 Directive” substitute “ published under regulation 257D in the case of products for sale or supply in Great Britain, or in the case of products for sale or supply in Northern Ireland, any guidance published pursuant to Article 65 of the 2001 Directive or under regulation 257D that is applicable to such products.”.\n(3) In paragraphs 15, 16 and 23, for “marketing authorisation,” substitute “UK marketing authorisation, EU marketing authorisation”..\n(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .\n(5) After Part 3 insert—\n“PART 4\nOuter and immediate packaging: advanced therapy medicinal products for sale or supply in Great Britain only\n34 The name of the advanced therapy medicinal product which is the international non-proprietary name, or if none, the common name.\n35 Where appropriate, whether the product is intended for babies, children or adults.\n36 The expiry date in clear terms including the year and month and, if applicable, day.\n37 A description of the active substance, expressed qualitatively and quantitatively.\n38 Where the product contains tissues and cells of human or animal origin—\n(a) a statement that the product contains such cells or tissues; and\n(b) a short description of the cells or tissues and of their specific origin, including the species of animal in cases on non-human origin.\n39 The pharmaceutical form and the contents by weight, volume or number of doses of the product.\n40 A list of excipients, including preservative systems.\n41 The method of use, application, administration or implantation and, if appropriate, the route of administration, with space provided for the prescribed dose to be indicated.\n42 A special warning that the product is to be stored out of the sight and reach and children.\n43 Any special warning necessary for the particular product.\n44 Any special storage precautions.\n45 Specific precautions relating to the disposal of the unused product or of waste derived from the product and, where appropriate, reference to any appropriate collection system.\n46 The name and address of the holder of the UK marketing authorisation and, where applicable, the name of the representative appointed by the holder to represent him.\n47 The UK marketing authorisation number.\n48 The manufacturer's batch number.\n49 The unique donation code assigned by a tissue establishment pursuant to—\n(a) paragraph 1 of Schedule 3A to the Human Fertilisation and Embryology Act 1990 , as regards human gametes and embryos; and\n(b) paragraph 1 of Schedule 2 to the Human Tissue (Quality and Safety for Human Application) Regulations 2007 , as regards other human tissues and cells.\n50 Where the exempt advanced therapy medicinal product is for autologous use, the unique patient identifier and the words “for autologous use only”.\nPART 5\nImmediate packaging: blister packs and small packaging (advanced therapy medicinal products for sale or supply in Great Britain only)\n51 The information specified in Part 2.\n52 The unique donation code assigned by a tissue establishment pursuant to—\n(a) paragraph 1 of Schedule 3A to the Human Fertilisation and Embryology Act 1990, as regards human gametes and embryos; and\n(b) paragraph 1 of Schedule 2 to the Human Tissue (Quality and Safety for Human Application) Regulations 2007, as regards other human tissues and cells.\n53 Where the exempt advanced therapy medicinal product is for autologous use, the unique patient identifier and the words “for autologous use only”.”",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in reg. 201(2) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 155(a)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in reg. 201(3) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 155(b)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Reg. 201(4) omitted (31.12.2020 immediately before IP completion day) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 155(c)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Words in reg. 201(5) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 155(d)(i)"
    },
    {
      "type": "F",
      "label": "F5",
      "text": "Words in reg. 201(5) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 155(d)(ii)"
    },
    {
      "type": "M",
      "label": "M1",
      "text": "1990 c. 37. Schedule 3A was inserted by the Human Fertilisation and Embryology (Quality and Safety) Regulations 2007/1522, regulation 30."
    },
    {
      "type": "M",
      "label": "M2",
      "text": "S.I. 2007/1523."
    },
    {
      "type": "I",
      "label": "I1",
      "text": "Reg. 201 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2019/775/regulation/201",
    "retrieved_at": "2026-10-28T22:42:14.621781+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."
}