{
  "url": "https://openlegislation.uk/medicines-standard-provisions-for-licences-and-certificates-regulations-1971",
  "json_url": "https://openlegislation.uk/medicines-standard-provisions-for-licences-and-certificates-regulations-1971.json",
  "id": "uksi/1971/972",
  "title": "The Medicines (Standard Provisions for Licences and Certificates) Regulations 1971",
  "short_title": "Medicines (Standard Provisions for Licences and Certificates) 1971",
  "long_title": null,
  "citation": "S.I. 1971/972",
  "type": "uksi",
  "year": "1971",
  "number": "972",
  "version": "current",
  "date": "1971-06-09",
  "revised": false,
  "valid_from": null,
  "extent": null,
  "unapplied_effects": 88,
  "provisions": [],
  "has_text": false,
  "pdfs": [
    {
      "title": "Printed copy",
      "main": true,
      "language": null,
      "date": "2023-11-22",
      "size": 601593,
      "url": "https://openlegislation.uk/medicines-standard-provisions-for-licences-and-certificates-regulations-1971/pdf/uksi_19710972_en.pdf",
      "source_url": "https://www.legislation.gov.uk/uksi/1971/972/pdfs/uksi_19710972_en.pdf"
    }
  ],
  "outstanding_effects": [
    {
      "type": "amended",
      "affected_provisions": "Sch.2, para 8",
      "affecting": "uksi/1992/2846",
      "affecting_title": "The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1992",
      "affecting_provisions": "reg.5(6)"
    },
    {
      "type": "amended",
      "affected_provisions": "Sch.2, para 9",
      "affecting": "uksi/1992/2846",
      "affecting_title": "The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1992",
      "affecting_provisions": "reg.5(8)"
    },
    {
      "type": "added",
      "affected_provisions": "Sch.2, para 9A",
      "affecting": "uksi/1992/2846",
      "affecting_title": "The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1992",
      "affecting_provisions": "reg.5(9)"
    },
    {
      "type": "added",
      "affected_provisions": "Sch.1A",
      "affecting": "uksi/1992/2846",
      "affecting_title": "The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1992",
      "affecting_provisions": "reg.4"
    },
    {
      "type": "amended",
      "affected_provisions": "Sch.2. para 3",
      "affecting": "uksi/1992/2846",
      "affecting_title": "The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1992",
      "affecting_provisions": "reg.5(2)"
    },
    {
      "type": "added",
      "affected_provisions": "Sch.2, para 3A",
      "affecting": "uksi/1992/2846",
      "affecting_title": "The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1992",
      "affecting_provisions": "reg.5(3)"
    },
    {
      "type": "amended",
      "affected_provisions": "Sch.2, para 5",
      "affecting": "uksi/1992/2846",
      "affecting_title": "The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1992",
      "affecting_provisions": "reg.5(4)"
    },
    {
      "type": "added",
      "affected_provisions": "Sch.2, paras 5A, 5B",
      "affecting": "uksi/1992/2846",
      "affecting_title": "The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1992",
      "affecting_provisions": "reg.5(5)"
    },
    {
      "type": "added",
      "affected_provisions": "Sch.2, paras 8A, 8B",
      "affecting": "uksi/1992/2846",
      "affecting_title": "The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1992",
      "affecting_provisions": "reg.5(7)"
    },
    {
      "type": "revoked",
      "affected_provisions": "Sch.4, Pt V, para 1",
      "affecting": "uksi/1992/2846",
      "affecting_title": "The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1992",
      "affecting_provisions": "reg.7"
    },
    {
      "type": "revoked",
      "affected_provisions": "Sch.5, Pt I, para 1",
      "affecting": "uksi/1992/2846",
      "affecting_title": "The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1992",
      "affecting_provisions": "reg.8"
    },
    {
      "type": "revoked",
      "affected_provisions": "Sch.4, Pt IV. para 1",
      "affecting": "uksi/1992/2846",
      "affecting_title": "The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1992",
      "affecting_provisions": "reg.7"
    },
    {
      "type": "revoked",
      "affected_provisions": "Sch.4, Pt I, para 1",
      "affecting": "uksi/1992/2846",
      "affecting_title": "The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1992",
      "affecting_provisions": "reg.7"
    },
    {
      "type": "added",
      "affected_provisions": "Sch.3, para 8A",
      "affecting": "uksi/1992/2846",
      "affecting_title": "The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1992",
      "affecting_provisions": "reg.6(2)"
    },
    {
      "type": "rev in pt",
      "affected_provisions": "Sch.2. para 16(5)",
      "affecting": "uksi/1992/2846",
      "affecting_title": "The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1992",
      "affecting_provisions": "reg.5(10)"
    },
    {
      "type": "added",
      "affected_provisions": "reg.2(1) (defn of allergen product)",
      "affecting": "uksi/1992/2846",
      "affecting_title": "The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1992",
      "affecting_provisions": "reg.2(2)"
    },
    {
      "type": "added",
      "affected_provisions": "reg.2(1) (defn of blood product*)",
      "affecting": "uksi/1992/2846",
      "affecting_title": "The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1992",
      "affecting_provisions": "reg.2(3)"
    },
    {
      "type": "added",
      "affected_provisions": "reg.2(1) (defns of expiry date and good manufacturing practice)",
      "affecting": "uksi/1992/2846",
      "affecting_title": "The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1992",
      "affecting_provisions": "reg.2(4)"
    },
    {
      "type": "added",
      "affected_provisions": "reg.2(1) (defn of relevant period)",
      "affecting": "uksi/1992/2846",
      "affecting_title": "The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1992",
      "affecting_provisions": "reg.2(5)"
    },
    {
      "type": "added",
      "affected_provisions": "reg.3A",
      "affecting": "uksi/1992/2846",
      "affecting_title": "The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1992",
      "affecting_provisions": "reg.3"
    },
    {
      "type": "added",
      "affected_provisions": "Sch.5, Pt I, para 3A",
      "affecting": "uksi/1992/3272",
      "affecting_title": "The Medicines (Standard Provisions for Licences and Certificates) Amendment (No. 2) Regulations 1992",
      "affecting_provisions": "reg.2(3)"
    },
    {
      "type": "amended",
      "affected_provisions": "Sch.5. Pt I. para 3",
      "affecting": "uksi/1992/3272",
      "affecting_title": "The Medicines (Standard Provisions for Licences and Certificates) Amendment (No. 2) Regulations 1992",
      "affecting_provisions": "reg.2(2)"
    },
    {
      "type": "amended",
      "affected_provisions": "Sch.5, Pt I, para 4",
      "affecting": "uksi/1992/3272",
      "affecting_title": "The Medicines (Standard Provisions for Licences and Certificates) Amendment (No. 2) Regulations 1992",
      "affecting_provisions": "reg.2(4)"
    },
    {
      "type": "amended",
      "affected_provisions": "Sch.1, Pt I, paras 2(1)(2), 3",
      "affecting": "uksi/1993/2539",
      "affecting_title": "The Medicines (Standard Provisions for Licences and Certificates) Amendment (No. 2) Regulations 1993",
      "affecting_provisions": "reg.2(3)"
    },
    {
      "type": "added",
      "affected_provisions": "Sch.1, Pt I, paras 1A-1C",
      "affecting": "uksi/1993/2539",
      "affecting_title": "The Medicines (Standard Provisions for Licences and Certificates) Amendment (No. 2) Regulations 1993",
      "affecting_provisions": "reg.2(2)"
    },
    {
      "type": "added",
      "affected_provisions": "Sch.1, Pt I, paras 15, 16",
      "affecting": "uksi/1993/2539",
      "affecting_title": "The Medicines (Standard Provisions for Licences and Certificates) Amendment (No. 2) Regulations 1993",
      "affecting_provisions": "reg.2(4)"
    },
    {
      "type": "added",
      "affected_provisions": "Sch.3. paras 7A-7C",
      "affecting": "uksi/1993/833",
      "affecting_title": "The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1993",
      "affecting_provisions": "reg.3(3)"
    },
    {
      "type": "added",
      "affected_provisions": "Sch.3, paras 4A, 4B",
      "affecting": "uksi/1993/833",
      "affecting_title": "The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1993",
      "affecting_provisions": "reg.3(2)"
    },
    {
      "type": "added",
      "affected_provisions": "reg.2(1) (defn of product to which Chapters 1I-V of the 1965 Directive apply)",
      "affecting": "uksi/1993/833",
      "affecting_title": "The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1993",
      "affecting_provisions": "reg.2"
    },
    {
      "type": "amended",
      "affected_provisions": "Sch.3, para 6(1)",
      "affecting": "uksi/1994/103",
      "affecting_title": "The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1994",
      "affecting_provisions": "reg.4(2)"
    },
    {
      "type": "added",
      "affected_provisions": "Sch.2, para 16(3)(aa)",
      "affecting": "uksi/1994/103",
      "affecting_title": "The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1994",
      "affecting_provisions": "reg.3(2)(a)"
    },
    {
      "type": "amended",
      "affected_provisions": "Sch.2, para 16(3)(b)",
      "affecting": "uksi/1994/103",
      "affecting_title": "The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1994",
      "affecting_provisions": "reg.3(2)(b)"
    },
    {
      "type": "rev. in Pt.",
      "affected_provisions": "Sch.2, para 16(5)",
      "affecting": "uksi/1994/103",
      "affecting_title": "The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1994",
      "affecting_provisions": "reg.3(2)(c)"
    },
    {
      "type": "amended",
      "affected_provisions": "Sch.3, para 8(3)(b)",
      "affecting": "uksi/1994/103",
      "affecting_title": "The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1994",
      "affecting_provisions": "reg.4(3)(c)"
    },
    {
      "type": "added",
      "affected_provisions": "Sch.3, para 8(3)(aa)",
      "affecting": "uksi/1994/103",
      "affecting_title": "The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1994",
      "affecting_provisions": "reg.4(3)(b)"
    },
    {
      "type": "added",
      "affected_provisions": "reg.2(1) (defn of certificate of registration)",
      "affecting": "uksi/1994/103",
      "affecting_title": "The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1994",
      "affecting_provisions": "reg.2(a)"
    },
    {
      "type": "amended",
      "affected_provisions": "reg.2(1) (defn of product to which Chapters II to V of the 1965 Directive appl)",
      "affecting": "uksi/1994/103",
      "affecting_title": "The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1994",
      "affecting_provisions": "reg.2(b)"
    },
    {
      "type": "superseded",
      "affected_provisions": "reg.3(4), Sch.2",
      "affecting": "uksi/1994/2852",
      "affecting_title": "The Medicines (Standard Provisions for Manufacturer’s Licences for Veterinary Medicinal Products) Regulations 1994",
      "affecting_provisions": "reg.9"
    },
    {
      "type": "am. (defns added)",
      "affected_provisions": "reg.2",
      "affecting": "uksi/1999/4",
      "affecting_title": "The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1999",
      "affecting_provisions": "reg.2"
    },
    {
      "type": "amended",
      "affected_provisions": "Sch.3. para 8",
      "affecting": "uksi/1999/4",
      "affecting_title": "The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1999",
      "affecting_provisions": "reg.3(1)-(3)"
    },
    {
      "type": "added",
      "affected_provisions": "Sch.3, para.SB",
      "affecting": "uksi/1999/4",
      "affecting_title": "The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1999",
      "affecting_provisions": "reg.3(1)(4)"
    },
    {
      "type": "words substituted",
      "affected_provisions": "Sch. 3 para. 8(1)",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002",
      "affecting_provisions": "reg. 3(d)(iii)"
    },
    {
      "type": "words substituted",
      "affected_provisions": "Sch. 5 Pt. 1 para. 3A",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002",
      "affecting_provisions": "reg. 3(e)"
    },
    {
      "type": "words inserted",
      "affected_provisions": "reg. 2(1)",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002",
      "affecting_provisions": "reg. 3(a)(i)"
    },
    {
      "type": "words substituted",
      "affected_provisions": "reg. 2(1)",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002",
      "affecting_provisions": "reg. 3(a)(ii)"
    },
    {
      "type": "words substituted",
      "affected_provisions": "reg. 2(1)",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002",
      "affecting_provisions": "reg. 3(a)(iii)"
    },
    {
      "type": "words omitted",
      "affected_provisions": "reg. 2(1)",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002",
      "affecting_provisions": "reg. 3(a)(iv)"
    },
    {
      "type": "words substituted",
      "affected_provisions": "Sch. 1 para. 16",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002",
      "affecting_provisions": "reg. 3(b)"
    },
    {
      "type": "words substituted",
      "affected_provisions": "Sch. 2 para. 16(1)",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002",
      "affecting_provisions": "reg. 3(c)"
    },
    {
      "type": "words substituted",
      "affected_provisions": "Sch. 2 para. 16(4)",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002",
      "affecting_provisions": "reg. 3(c)"
    },
    {
      "type": "words substituted",
      "affected_provisions": "Sch. 3 para. 4A",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002",
      "affecting_provisions": "reg. 3(d)(i)"
    },
    {
      "type": "words substituted",
      "affected_provisions": "Sch. 3 para. 4B(1)",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002",
      "affecting_provisions": "reg. 3(d)(i)"
    },
    {
      "type": "words substituted",
      "affected_provisions": "Sch. 3 para. 7A(1)",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002",
      "affecting_provisions": "reg. 3(d)(i)"
    },
    {
      "type": "words substituted",
      "affected_provisions": "Sch. 3 para. 7B",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002",
      "affecting_provisions": "reg. 3(d)(i)"
    },
    {
      "type": "words substituted",
      "affected_provisions": "Sch. 3 para. 7C(1)",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002",
      "affecting_provisions": "reg. 3(d)(i)"
    },
    {
      "type": "words substituted",
      "affected_provisions": "Sch. 3 para. 7(3)(a)",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002",
      "affecting_provisions": "reg. 3(d)(ii)"
    },
    {
      "type": "words substituted",
      "affected_provisions": "Sch. 3 para. 8(1)",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002",
      "affecting_provisions": "reg. 3(d)(ii)"
    },
    {
      "type": "words substituted",
      "affected_provisions": "Sch. 3 para. 8(6)",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002",
      "affecting_provisions": "reg. 3(d)(ii)"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 1, Pt I, para 16",
      "affecting": "uksi/2003/2321",
      "affecting_title": "The Medicines for Human Use (Fees and Miscellaneous Amendments) Regulations 2003",
      "affecting_provisions": "reg 3(b)"
    },
    {
      "type": "am",
      "affected_provisions": "reg 2 defn(s)",
      "affecting": "uksi/2003/2321",
      "affecting_title": "The Medicines for Human Use (Fees and Miscellaneous Amendments) Regulations 2003",
      "affecting_provisions": "reg 3(a)"
    },
    {
      "type": "rev in pt (12.1.2004)",
      "affected_provisions": "reg 3",
      "affecting": "uksi/2003/3309",
      "affecting_title": "The Animal Test Certificates (Revocation) Regulations 2003",
      "affecting_provisions": "reg 3"
    },
    {
      "type": "rev in pt (12.1.2004)",
      "affected_provisions": "Sch 1, Pt III",
      "affecting": "uksi/2003/3309",
      "affecting_title": "The Animal Test Certificates (Revocation) Regulations 2003",
      "affecting_provisions": "reg 3"
    },
    {
      "type": "revoked in part",
      "affected_provisions": "Regulations",
      "affecting": "uksi/2004/1031",
      "affecting_title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
      "affecting_provisions": "Sch. 11"
    },
    {
      "type": "omitted",
      "affected_provisions": "reg. 3(2)",
      "affecting": "uksi/2004/1031",
      "affecting_title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
      "affecting_provisions": "Sch. 10 Pt. 2 para. 1(b)"
    },
    {
      "type": "words omitted",
      "affected_provisions": "reg. 2",
      "affecting": "uksi/2004/1031",
      "affecting_title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
      "affecting_provisions": "Sch. 10 Pt. 2 para. 1(a)"
    },
    {
      "type": "omitted",
      "affected_provisions": "Sch. 1 Pt. 2",
      "affecting": "uksi/2004/1031",
      "affecting_title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
      "affecting_provisions": "Sch. 10 Pt. 2 para. 1(c)"
    },
    {
      "type": "subst",
      "affected_provisions": "reg 2 defn(s)",
      "affecting": "uksi/2004/1678",
      "affecting_title": "The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 2004",
      "affecting_provisions": "reg 2"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 2, para 8B",
      "affecting": "uksi/2005/1710",
      "affecting_title": "The Medicines (Provision of False or Misleading Information and Miscellaneous Amendments) Regulations 2005",
      "affecting_provisions": "reg 2(1), (4)(b)"
    },
    {
      "type": "rev in pt",
      "affected_provisions": "Sch 1, Pt I, para 16",
      "affecting": "uksi/2005/1710",
      "affecting_title": "The Medicines (Provision of False or Misleading Information and Miscellaneous Amendments) Regulations 2005",
      "affecting_provisions": "reg 2(1), (3)"
    },
    {
      "type": "added",
      "affected_provisions": "reg 2 defn(s)",
      "affecting": "uksi/2005/1710",
      "affecting_title": "The Medicines (Provision of False or Misleading Information and Miscellaneous Amendments) Regulations 2005",
      "affecting_provisions": "reg 2(1), (2)"
    },
    {
      "type": "added",
      "affected_provisions": "Sch 3, para 10",
      "affecting": "uksi/2005/1710",
      "affecting_title": "The Medicines (Provision of False or Misleading Information and Miscellaneous Amendments) Regulations 2005",
      "affecting_provisions": "reg 2(1), (5)(b)"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 3, para 7A",
      "affecting": "uksi/2005/1710",
      "affecting_title": "The Medicines (Provision of False or Misleading Information and Miscellaneous Amendments) Regulations 2005",
      "affecting_provisions": "reg 2(1), (5)(a)"
    },
    {
      "type": "added",
      "affected_provisions": "Sch 2, para 18",
      "affecting": "uksi/2005/1710",
      "affecting_title": "The Medicines (Provision of False or Misleading Information and Miscellaneous Amendments) Regulations 2005",
      "affecting_provisions": "reg 2(1), (4)(c)"
    },
    {
      "type": "added",
      "affected_provisions": "Sch 2, para 8AA",
      "affecting": "uksi/2005/1710",
      "affecting_title": "The Medicines (Provision of False or Misleading Information and Miscellaneous Amendments) Regulations 2005",
      "affecting_provisions": "reg 2(1), (4)(a)"
    },
    {
      "type": "inserted",
      "affected_provisions": "reg. 1A",
      "affecting": "uksi/2005/2745",
      "affecting_title": "The Veterinary Medicines Regulations 2005",
      "affecting_provisions": "Sch. 8 Pt. 3 para 1"
    },
    {
      "type": "am",
      "affected_provisions": "reg 3",
      "affecting": "uksi/2005/2789",
      "affecting_title": "The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005",
      "affecting_provisions": "regs 13, 15, Sch 5, Pt 2, para 1(1), (3), Sch 6"
    },
    {
      "type": "rev",
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      "affecting_provisions": "regs 13, 15, Sch 5, Pt 2, para 1(1), (4), Sch 6"
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      "affected_provisions": null,
      "affecting": "uksi/2005/2789",
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      "affecting_provisions": "regs 14(1), 15, Sch 6"
    },
    {
      "type": "am",
      "affected_provisions": "reg 2 defn(s)",
      "affecting": "uksi/2005/2789",
      "affecting_title": "The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005",
      "affecting_provisions": "regs 13, 15, Sch 5, Pt 2, para 1(1), (2)(a), (c), Sch 6"
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    {
      "type": "rev",
      "affected_provisions": "Sch 3, paras 7A, 7B, 8, 8A, 8B, 9",
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      "affecting_title": "The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005",
      "affecting_provisions": "regs 13, 15, Sch 5, Pt 2, para 1(1), (6), Sch 6"
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    {
      "type": "rev",
      "affected_provisions": "Sch 3, paras 4A, 4B",
      "affecting": "uksi/2005/2789",
      "affecting_title": "The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005",
      "affecting_provisions": "regs 13, 15, Sch 5, Pt 2, para 1(1), (6), Sch 6"
    },
    {
      "type": "added",
      "affected_provisions": "Sch 2A",
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      "affecting_title": "The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005",
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    },
    {
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      "affecting_title": "The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005",
      "affecting_provisions": "regs 13, 15, Sch 5, Pt 2, para 1(1), (2)(b), Sch 6"
    },
    {
      "type": "added",
      "affected_provisions": "Sch 2, para 5C",
      "affecting": "uksi/2005/50",
      "affecting_title": "The Blood Safety and Quality Regulations 2005",
      "affecting_provisions": "reg 25(2)(b)"
    },
    {
      "type": "added",
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      "affecting": "uksi/2005/50",
      "affecting_title": "The Blood Safety and Quality Regulations 2005",
      "affecting_provisions": "reg 25(2)(a)"
    },
    {
      "type": "inserted",
      "affected_provisions": "reg. 1B",
      "affecting": "uksi/2010/1882",
      "affecting_title": "The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010",
      "affecting_provisions": "reg. 6(a)"
    },
    {
      "type": "words substituted",
      "affected_provisions": "reg. 2",
      "affecting": "uksi/2010/1882",
      "affecting_title": "The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010",
      "affecting_provisions": "reg. 6(b)"
    }
  ],
  "made_under": [],
  "changes_made_to": 88,
  "changes_made_to_url": "https://openlegislation.uk/medicines-standard-provisions-for-licences-and-certificates-regulations-1971/changes.json",
  "changes_made_by": 0,
  "changes_made_by_url": "https://openlegislation.uk/medicines-standard-provisions-for-licences-and-certificates-regulations-1971/changes/by-it.json",
  "instruments_made_under": 0,
  "instruments_made_under_url": "https://openlegislation.uk/medicines-standard-provisions-for-licences-and-certificates-regulations-1971/instruments.json",
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1971/972",
    "retrieved_at": "2026-10-29T22:44:21.333874+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}