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The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019

Consolidated Text As Enacted Cited authorities 16 Cited in Amendments 3 Related
Vincent
JurisdictionUK Non-devolved
CitationSI 2019/744
Year2019
  • These Regulations may be cited as the Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019 and come into force on exit day.
  • The Medicines for Human Use (Clinical Trials) Regulations 2004
    • (1) Regulation 2(1) (2) For the definition of “Commission Directive 2003/94/EC” substitute—
      F13“Commission Directive 2003/94/EC”, other than in Parts 2 and 3 of Schedule 7, means—
    • (a) in the case of an investigational medicinal product manufactured or assembled in, or imported into, Great Britain— (i) Commission Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice for medicinal products for human use and for investigational medicinal products for human use, as modified by Schedule 2A to the 2012 Regulations, or(ii) if Regulations have been made under the powers in regulation B17(1) of the 2012 Regulations, and have come into force, those Regulations;
    • (b) in the case of an investigational medicinal product manufactured or assembled in, or imported into, Northern Ireland, Commission Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice for medicinal products for human use and for investigational medicinal products for human use;
    .    Commission Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice for medicinal products for human use and for investigational medicinal products for human use, as modified by Schedule 2A to the 2012 Regulations, orif Regulations have been made under the powers in regulation B17(1) of the 2012 Regulations, and have come into force, those Regulations; in the case of an investigational medicinal product manufactured or assembled in, or imported into, Northern Ireland, Commission Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice for medicinal products for human use and for investigational medicinal products for human use; (3) After the definition of “container” insert—
      “country” means a country or territory;
    .    (4) In the definition of “export”, for “a third country from an EEA State” substitute “ another country from the United Kingdom ”.(5) Omit the definition of “the GCP Directive”.(6) For the definition of “import” substitute—
      F14“import”, except in regulation 13 and Schedule 13, means import, or attempt to import—
      • (a) into Great Britain other than from Northern Ireland, or
      • (b) into Northern Ireland from a country other than an EEA State,
      whether by land, sea or air and “imported” is to be construed accordingly;;
    .    (7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .(8) For the definition of “marketing authorization”, substitute—
      F16“marketing authorization” means—
    • (a) a UK marketing authorization,
    • (b) an EU marketing authorisation (as defined in the 2012 Regulations) , or
    • (c) an authorization granted by a regulatory body responsible for licensing medicinal products in a country that is included in the list referred to in regulation 2A(1) ;
    .     a UK marketing authorization, an EU marketing authorisation (as defined in the 2012 Regulations) , or an authorization granted by a regulatory body responsible for licensing medicinal products in a country that is included in the list referred to in regulation 2A(1) ;(9) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .(10) Omit the definition of “third country”.(11) After the definition of “trial site” insert—
      F18“UK marketing authorization”—
    • (a) has the same meaning as “UK marketing authorisation” in the 2012 Regulations (and references to “UKMA(UK) ”, “UKMA(GB) ” and “UKMA(NI) ” in these Regulations should be construed in accordance with that definition) ; and
    • (b) includes a product licence granted by the licensing authority for the purposes of section 7 of the Medicines Act 1968;
    .    has the same meaning as “UK marketing authorisation” in the 2012 Regulations (and references to “UKMA(UK) ”, “UKMA(GB) ” and “UKMA(NI) ” in these Regulations should be construed in accordance with that definition) ; andincludes a product licence granted by the licensing authority for the purposes of section 7 of the Medicines Act 1968;(12) In the definition of “unexpected adverse reaction”, in paragraph (a) , after “summary of product characteristics” insert “ , or equivalent document, ”.
  • After regulation 2, insert—
      (2A) List of countries for the purpose of the definition of “marketing authorization”
    • (1) The licensing authority must publish a list of countries for the purpose of the definition of “marketing authorization”.
    • (2) In order to determine whether a country should be included in the list referred to in paragraph (1) , the licensing authority may, in particular, take into account the regulatory equivalence of that country to the United Kingdom in assessing the safety, quality and efficacy of medicinal products.
    • (3) The licensing authority must—
    • (a) review the countries it has included in the list referred to in paragraph (1) to determine if it is still satisfied that the country should remain on that list, and if it is not so satisfied, remove that country from the list; and
    • (b) undertake such a review at least every three years beginning with the date on which that country is included in that list.
    • The licensing authority must publish a list of countries for the purpose of the definition of “marketing authorization”.In order to determine whether a country should be included in the list referred to in paragraph (1) , the licensing authority may, in particular, take into account the regulatory equivalence of that country to the United Kingdom in assessing the safety, quality and efficacy of medicinal products.review the countries it has included in the list referred to in paragraph (1) to determine if it is still satisfied that the country should remain on that list, and if it is not so satisfied, remove that country from the list; andundertake such a review at least every three years beginning with the date on which that country is included in that list.(1) Regulation 3 (2) In paragraph (11) (a) , for “an EEA State”, substitute “ the United Kingdom or a country that is included in the list referred to in paragraph (11A) ”.(3) After paragraph (11) , insert—
    • (11A) The licensing authority must publish a list of countries where a sponsor of a clinical trial, or their legal representative, may be established for the purpose of paragraph (11) .
    • (11B) In order to determine whether a country should be included in the list referred to in paragraph (11A) , the licensing authority may, in particular, take into account—
    • (a) the mechanisms that the country has in place to assist the licensing authority in contacting, or obtaining information in respect of, a sponsor or legal representative that is established there; and
    • (b) the country's ability to assist the licensing authority in any action it may need to take in respect of a sponsor or legal representative that is established there.
    The licensing authority must publish a list of countries where a sponsor of a clinical trial, or their legal representative, may be established for the purpose of paragraph (11) .the mechanisms that the country has in place to assist the licensing authority in contacting, or obtaining information in respect of, a sponsor or legal representative that is established there; andthe country's ability to assist the licensing authority in any action it may need to take in respect of a sponsor or legal representative that is established there.review the countries it has included in the list referred to in paragraph (11A) to determine if it is still satisfied that the country should remain on that list, and if it is not so satisfied, remove that country from the list; andundertake such a review at least every three years beginning on the date on which that country is included in that list.
  • Omit regulation 4
    • (1) Regulation 13 is amended as follows.(2) For paragraph (2) (b) F6, substitute—
    • (b) in the case of—(i) an investigational medicinal product manufactured or assembled in the United Kingdom, the product has been manufactured or assembled—(aa) in accordance with the terms of a manufacturing authorisation, or(bb) in the case of assembly only, under the exemption in regulation 37;(ii) an investigational medicinal product imported into Northern Ireland from an EEA State—(aa) the product has been manufactured, assembled or imported into an EEA State in accordance with the terms of an authorisation referred to in Article 13 of the Directive granted by a competent authority of an EEA State, and(bb) the production batch of investigational medicinal products of which the product is a part has been checked and certified by a qualified person pursuant to Article 13(3) and (4) of the Directive;(iii) an investigational medicinal product imported into Northern Ireland from a country other than an EEA State, the product has been imported into Northern Ireland in accordance with the terms of a manufacturing authorisation;(iv) an investigational medicinal product imported into Great Britain other than from Northern Ireland, the product has been imported in accordance with the terms of a manufacturing authorisation.
    .    in accordance with the terms of a manufacturing authorisation, orin the case of assembly only, under the exemption in regulation 37;the product has been manufactured, assembled or imported into an EEA State in accordance with the terms of an authorisation referred to in Article 13 of the Directive granted by a competent authority of an EEA State, andthe production batch of investigational medicinal products of which the product is a part has been checked and certified by a qualified person pursuant to Article 13(3) and (4) of the Directive;an investigational medicinal product imported into Northern Ireland from a country other than an EEA State, the product has been imported into Northern Ireland in accordance with the terms of a manufacturing authorisation;an investigational medicinal product imported into Great Britain other than from Northern Ireland, the product has been imported in accordance with the terms of a manufacturing authorisation.(3) After paragraph (2) , insert—
    • (2A) The condition specified in paragraph (2) (b) does not apply to an investigational medicinal product that has been manufactured or assembled in accordance...
    The condition specified in paragraph (2) (b) does not apply to an investigational medicinal product that has been manufactured or assembled in accordance

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