{
  "url": "https://openlegislation.uk/unlicensed-medicinal-products-for-human-use-transmissible-spongiform-encephalopathies-safety-regulations-2003/regulation-3",
  "json_url": "https://openlegislation.uk/unlicensed-medicinal-products-for-human-use-transmissible-spongiform-encephalopathies-safety-regulations-2003/regulation-3.json",
  "legislation": "uksi/2003/1680",
  "legislation_title": "The Unlicensed Medicinal Products for Human Use (Transmissible Spongiform Encephalopathies) (Safety) Regulations 2003",
  "legislation_url": "https://openlegislation.uk/unlicensed-medicinal-products-for-human-use-transmissible-spongiform-encephalopathies-safety-regulations-2003",
  "path": "regulation/3",
  "kind": "regulation",
  "number": "3",
  "heading": "Procedure for determinations of compliance with the TSE Guideline",
  "text": "(1) The appropriate Minister may serve on any person who has imported or marketed, or who in his opinion may import or market, an unlicensed product a notice in writing requiring him, within a period of 21 days from the date on which the notice was served on him, to furnish the appropriate Minister with material demonstrating to the appropriate Minister that the product has been manufactured in accordance with the TSE Guideline.\n(2) Where the appropriate Minister considers that, because of exceptional circumstances or the nature and complexity of the issues, additional time is needed to furnish material under paragraph (1), he may alter the period of 21 days referred to in that paragraph to a different period, and then that different period shall be the period within which the person on whom the notice is served is required to furnish the material.\n(3) After the period allowed for furnishing material under paragraph (1), the appropriate Minister shall (whether or not he has been furnished with any material by the person on whom the notice was served), after further consideration of the matter—\n(a) determine that, in his opinion, the product has been manufactured in accordance with the TSE Guideline, and shall notify the person on whom the notice was served under paragraph (1) of his determination; or\n(b) provisionally determine that, in his opinion, the product has not been manufactured in accordance with the TSE Guideline, and shall, by a notice in writing (referred to in these Regulations as a “provisional determination notice”)—\n(i) inform the person on whom the notice was served under paragraph (1) of this provisional determination and his reasons for it, and\n(ii) advise that person that if he disagrees with the provisional determination, he may request that the appropriate Minister review the provisional determination, provided that within 14 days of the date on which the provisional determination notice was served on him he makes such a request, and if that person wishes the review to include an oral hearing before the appropriate committee (at which the appropriate Minister may also make representations to the appropriate committee), he must also within those 14 days inform the appropriate Minister of his wish for such a hearing.\n(4) Where the appropriate Minister has been informed pursuant to paragraph (3)(b)(ii) that a person wishes to make oral representations to the appropriate committee, he shall, after consultation with that person (“the appellant”), set a date for the oral hearing and, subject to paragraph (5), that date shall be the date fixed for the oral hearing.\n(5) Where the Chairman of the appropriate committee considers that, because of exceptional circumstances or the nature and complexity of the issues, additional time is needed for preparation for the oral hearing, he may alter the date set for the hearing to a different date, and—\n(a) that different date shall be the date fixed for the oral hearing; and\n(b) the appropriate committee shall inform the appellant and the appropriate Minister of the alteration and of the reasons for it.\n(6) Where a person on whom a provisional determination notice is served fails within 14 days of the date on which the notice was served on him to request a review of the provisional determination, the appropriate Minister shall—\n(a) after further consideration of the matter, determine whether or not, in his opinion, the product has been manufactured in accordance with the TSE Guideline; and\n(b) by a notice in writing, inform that person of the determination and his reasons for it.\n(7) Where a person on whom a provisional determination notice is served requests, within 14 days of the date on which the notice was served on him, a review of the provisional determination, but that review is not to include an oral hearing before the appropriate committee, the appropriate Minister shall—\n(a) specify a period within which the person must furnish the appropriate Minister with any additional material which that person wishes the appropriate Minister to consider as part of the review;\n(b) once that period has expired (whether or not any further material has been submitted), after further consideration of the matter, determine whether or not, in his opinion, the product has been manufactured in accordance with the TSE Guideline;\n(c) by a notice in writing, inform that person of the determination and his reasons for it.\n(8) Where a person on whom a provisional determination notice is served requests, within 14 days of the date on which the notice was served on him, a review of the provisional determination and that review is to include an oral hearing before the appropriate committee, the appropriate Minister shall—\n(a) once that hearing has taken place (whether or not the appellant made any representations at the hearing), after further consideration of the matter, and in particular having considered the advice of the appropriate committee arising out of the hearing, determine whether or not, in his opinion, the product has been manufactured in accordance with the TSE Guideline;\n(b) by a notice in writing, inform that person of his determination and his reasons for it; and\n(c) if the appropriate Minister makes a determination which is contrary to the advice of the appropriate committee, give his reasons for disagreeing with the advice of the appropriate committee.\n(9) Where the appropriate Minister serves a notice under paragraph (1), he shall not issue a suspension notice under section 14 of the 1987 Act in respect of any unlicensed product to which the notice under paragraph (1) relates until he has determined in accordance with paragraph (6), (7) or (8) whether or not, in his opinion, the product has been manufactured in accordance with the TSE Guideline, unless he considers it necessary to issue such a suspension notice in the interests of safety.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in reg. 3(3)(b)(ii) substituted (30.10.2005) by The Medicines (Advisory Bodies) (No. 2) Regulations 2005 (S.I. 2005/2754), reg. 1(2)(b), Sch. 4 para. 7(3)(a)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in reg. 3(4) substituted (30.10.2005) by The Medicines (Advisory Bodies) (No. 2) Regulations 2005 (S.I. 2005/2754), reg. 1(2)(b), Sch. 4 para. 7(3)(b)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Words in reg. 3(5) substituted (30.10.2005) by The Medicines (Advisory Bodies) (No. 2) Regulations 2005 (S.I. 2005/2754), reg. 1(2)(b), Sch. 4 para. 7(3)(c)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Words in reg. 3(7) substituted (30.10.2005) by The Medicines (Advisory Bodies) (No. 2) Regulations 2005 (S.I. 2005/2754), reg. 1(2)(b), Sch. 4 para. 7(3)(d)"
    },
    {
      "type": "F",
      "label": "F5",
      "text": "Words in reg. 3(8) substituted (30.10.2005) by The Medicines (Advisory Bodies) (No. 2) Regulations 2005 (S.I. 2005/2754), reg. 1(2)(b), Sch. 4 para. 7(3)(e)"
    },
    {
      "type": "I",
      "label": "I1",
      "text": "Reg. 3 in force at 30.7.2003, see reg. 1(1)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2003/1680/regulation/3",
    "retrieved_at": "2026-10-29T06:18:33.650829+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."
}