{
  "legislation": {
    "id": "uksi/2004/1031",
    "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
    "short_title": "Medicines for Human Use (Clinical Trials) 2004",
    "citation": "S.I. 2004/1031",
    "type": "uksi",
    "date": "2004-03-31",
    "revised": true,
    "unapplied_effects": 4,
    "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004",
    "json_url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004.json"
  },
  "direction": "made_to",
  "with": "uksi/2025/538",
  "count": 222,
  "effects": [
    {
      "type": "word substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 29(a)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 18(2)(a)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Pt. 7",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 32",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words omitted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 2(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 3(2)(l)(i)(aa)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "word substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 4 para. 2(a)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 40(3)(a)(i)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "omitted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 8",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 8",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 2(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 3(2)(z4)(i)(aa)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "word omitted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 50(1)(b)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 35(a)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "omitted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 3 Pt. 4 para. 1",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 39(6)(a)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 31(2)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 21(3)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "word omitted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 49(1)(l)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 34(2)(c)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "word omitted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 2(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 3(2)(p)(iii)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "word substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 2(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 3(2)(b)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words inserted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 31(3)(b)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 21(4)(b)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 3(4)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 4(2)(b)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 31A(7)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 22(2)(c)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 2(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 3(2)(z4)(ii)(aa)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words inserted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 7 Pt. 2 para. 7(a)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 42(3)(c)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 35(2)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 26(5)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 6(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 7(3)(a)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words inserted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 7 Pt. 2 para. 4",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 42(3)(b)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words inserted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 2(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 3(2)(m)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 1 Pt. 5",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 37(6)(a)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "inserted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 49(1)(n)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 34(2)(e)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words omitted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 2(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 3(2)(n)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "inserted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Pt. 6A",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 31",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "word omitted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 2(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 3(2)(l)(ii)(bb)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 13(2)(b)(ii)(bb)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 13(3)(b)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 27B",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 16",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "word substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 49(6)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 34(3)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "word substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 28 heading",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 17(2)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 33(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 25(2)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 2(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 3(2)(u)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 2(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 3(2)(r)(i)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "word omitted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 4 para. 2(a)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 40(3)(a)(iii)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words omitted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 7 Pt. 1",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 42(2)(b)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 33(2)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 25(3)(a)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 29(c)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 18(3)(b)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words inserted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 2(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 3(2)(d)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 29(a)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 18(2)(b)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "word substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 5 para. 2(1)(a)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 41(3)(a)(ii)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "word substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 5 para. 2(1)(b)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 41(3)(a)(iii)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 5(3)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 6(2)(b)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 14-26",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 14",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words omitted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 4 para. 1(2)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 40(2)(b)(i)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words inserted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 7 Pt. 3 para. 5(a)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 42(4)(b)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "word inserted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 2(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 3(2)(l)(i)(bb)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 1 Pt. 3",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 37(5)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 2(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 3(2)(z4)(i)(bb)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 31(1)(b)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 21(2)(d)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "word inserted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 2(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 3(2)(p)(iv)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 2(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 3(2)(l)(ii)(aa)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 2(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 3(2)(t)(ii)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 2(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 3(2)(p)(ii)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 1 Pt. 5 para. 7",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 37(6)(c)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 3 Pt. 3 para. 6(b)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 39(5)(g)(ii)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 43(6)(a)(i)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 30(5)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 43(5)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 30(4)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "inserted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 37A",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 28",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "word substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 2(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 3(2)(j)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "word substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 2(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 3(2)(t)(i)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words inserted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 31A(7)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 22(2)(b)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words omitted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 3(10)(c)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 4(5)(b)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 3 Pt. 3 para. 2(b)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 39(5)(c)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "word substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 2(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 3(2)(z)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "word substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 28(5)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 17(6)(b)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 43(2A)(b)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 30(2)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words inserted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 27A",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 15",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "inserted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 4 para. 2(c)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 40(3)(c)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "omitted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 3 Pt. 2",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 39(4)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words inserted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 2(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 3(2)(h)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words omitted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 3(7)(a)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 4(4)(a)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 2(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 3(2)(q)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words omitted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 2(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 3(2)(o)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 1 Pt. 1",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 37(3)(c)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "omitted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 7",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 8",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 3(10)(a)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 4(5)(a)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words omitted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 1 Pt. 1 para. 1(7)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 37(3)(d)(ii)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "inserted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 31A(7A)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 22(3)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words omitted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 2(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 3(2)(y)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 3(6)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 4(3)(e)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words inserted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 7 Pt. 1",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 42(2)(a)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "inserted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 49(1)(fg)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 34(2)(b)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 13(2)(b)(ii)(aa)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 13(3)(a)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "omitted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 5(5)(b) and word",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 6(4)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "word substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 4 para. 1(3)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 40(2)(c)(ii)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 2(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 3(2)(z7)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "omitted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 3 Pt. 3 para. 1",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 39(5)(b)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words omitted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 1 Pt. 1 para. 2",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 37(3)(e)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "word substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 29A(2)(a)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 19(3)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 1 Pt. 1 para. 1(7)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 37(3)(d)(i)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 29A(1)(b)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 19(2)(b)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 11",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 10",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "word substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 1 heading",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 37(2)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 3(5)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 4(2)(b)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "word substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 3 Pt. 3 para. 5(b)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 39(5)(f)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "omitted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 12(4)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 12(4)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "word substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 31(3)(c)(ii)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 21(4)(c)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "inserted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 3B",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 5",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "word substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 32",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 24",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 56",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 44",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "word substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 31(6)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 21(6)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "inserted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. A32",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 23",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 4 para. 1(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 40(2)(a)(i)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "word substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 28(4)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 17(5)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "word substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 2(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 3(2)(g)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "omitted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 4 para. 1(1)(b) and word",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 40(2)(a)(iii)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "omitted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 4 para. 1(4)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 40(2)(d)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 2(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 3(2)(z4)(ii)(cc)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 58(c)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 36",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 31(1)(a)(ii)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 21(2)(b)(ii)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 2(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 3(2)(s)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "inserted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 50(1)(d)(e)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 35(b)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 5(3)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 6(2)(a)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "omitted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 3 Pt. 1",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 39(4)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "inserted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 33(4A)(4B)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 25(5)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 3 Pt. 3 para. 6(a)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 39(5)(g)(i)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words inserted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 7 Pt. 2 para. 8",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 42(3)(d)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "inserted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 6(1A)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 7(4)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 33(2)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 25(3)(b)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words inserted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 2(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 3(2)(z1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "omitted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 6(1)(a)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 7(3)(b)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "inserted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 49(8)(9)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 34(4)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "word substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 4 para. 2(a)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 40(3)(a)(ii)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 2(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 3(2)(r)(ii)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "word substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 2(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 3(2)(v)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "word substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 28(3)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 17(4)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 2(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 3(2)(z2)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "word substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 3 Pt. 4 para. 4(2)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 39(6)(c)(i)(bb)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "inserted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 35(1A)-(1D)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 26(4)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "word substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 31(5)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 21(5)(a)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words inserted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 31(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 21(2)(a)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 1 Pt. 1 para. 3(1)(b)(ii)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 37(3)(f)(i)(bb)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words omitted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 3(7)(b)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 4(4)(b)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words inserted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 7 Pt. 3 para. 2",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 42(4)(a)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "word substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 3(6)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 4(3)(d)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 1 Pt. 5 para. 1",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 37(6)(b)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 1 Pt. 1",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 37(3)(a)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 5 para. 2(2)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 41(3)(b)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words inserted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 2(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 3(2)(z3)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "word substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 3 Pt. 3 para. 3",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 39(5)(d)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "inserted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 14",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 45",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "word substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 31A(8)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 22(4)(a)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 1 Pt. 1",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 37(3)(b)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 3(6)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 4(3)(c)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 36(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 27",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "inserted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 49(1)(ba)-(bc)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 34(2)(a)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 3 Pt. 3 heading",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 39(5)(a)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words omitted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 35 heading",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 26(2)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "inserted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 28(1A)(1B)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 17(3)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words omitted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 5(4)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 6(3)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words omitted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 2(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 3(2)(c)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 3 Pt. 4 para. 2(b)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 39(6)(b)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words omitted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 2(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 3(2)(z6)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words omitted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 2(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 3(2)(w)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 31A(8)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 22(4)(b)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "word substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 31(3)(a)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 21(4)(a)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words inserted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 1 Pt. 1 para. 3(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 37(3)(f)(i)(aa)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 35(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 26(3)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 1 Pt. 2",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 37(4)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words omitted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 3(7)(c)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 4(4)(c)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words omitted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 4 para. 1(3)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 40(2)(c)(i)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 29(b)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 18(2)(b)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 12(3)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 12(3)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "word substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 13(1)(d)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 13(2)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 3(4)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 4(2)(a)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words omitted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 2(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 3(2)(i)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "word substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 29(b)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 18(2)(a)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "inserted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 3 Pt. A1",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 39(3)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 9",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 9",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 5(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 6(2)(a)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 30(2)(b)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 20(3)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 33(3)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 25(4)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words omitted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 4 para. 1(2)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 40(2)(b)(ii)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 4 para. 2(b)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 40(3)(b)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "word substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 12(2)(b)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 12(2)(b)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words inserted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 2(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 3(2)(p)(v)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words inserted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 7 Pt. 2 para. 3",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 42(3)(a)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words omitted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 31(1)(a)(ii)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 21(2)(b)(i)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 3(5)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 4(2)(a)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words omitted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 29(c)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 18(3)(a)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words inserted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 6 heading",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 7(2)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 5(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 6(2)(b)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 5(2)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 6(2)(a)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words inserted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 43(2C)(b)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 30(3)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 3 heading",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 39(2)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words inserted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 31A(7)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 22(2)(a)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words omitted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 2(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 3(2)(z5)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "word substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 29A(1)(b)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 19(2)(a)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "word substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 2(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 3(2)(a)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 2(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 3(2)(p)(i)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "word substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 3(6)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 4(3)(a)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words inserted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 31(5)(a)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 21(5)(b)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 2(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 3(2)(f)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "omitted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 4 para. 3-6",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 40(4)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 5 para. 2(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 41(3)(a)(i)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 3 Pt. 4 para. 4(3)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 39(6)(c)(ii)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 5(2)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 6(2)(b)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "word substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 3 Pt. 4 para. 4(2)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 39(6)(c)(i)(aa)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 3 Pt. 3 para. 4",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 39(5)(e)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "word substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 4 para. 1(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 40(2)(a)(ii)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 6(2)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 7(5)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words inserted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 2(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 3(2)(x)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words omitted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 2(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 3(2)(k)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "word substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 31(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 21(2)(c)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "omitted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 33(5)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 25(6)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words inserted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 40(1)(a)(ii)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 29",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "inserted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 11A 11B",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 11",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "word substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 49(7)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 34(3)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "word substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 12(2)(a)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 12(2)(a)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words omitted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 2(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 3(2)(l)(iii)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 49(1)(m)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 34(2)(d)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words omitted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 2(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 3(2)(z4)(ii)(bb)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "inserted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 1 Pt. 1 para. 3(3)-(5)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 37(3)(f)(ii)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 3(6)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 4(3)(b)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 2(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 3(2)(e)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "word substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 30(1)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 20(2)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "inserted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 6(3)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 7(6)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "word substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 28(5)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 17(6)(a)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 48(4)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 33",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "omitted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 2",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 38",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "inserted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "reg. 31(1)(c)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 21(2)(e)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    },
    {
      "type": "words substituted",
      "affected": {
        "id": "uksi/2004/1031",
        "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
        "provisions": "Sch. 5 para. 1",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004"
      },
      "affecting": {
        "id": "uksi/2025/538",
        "title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
        "provisions": "reg. 41(2)",
        "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025"
      },
      "applied": true,
      "requires_applied": true,
      "in_force_date": "2026-04-28"
    }
  ],
  "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."
}