{
  "url": "https://openlegislation.uk/eu-decision-2015-1057/introduction",
  "json_url": "https://openlegislation.uk/eu-decision-2015-1057/introduction.json",
  "legislation": "eudn/2015/1057",
  "legislation_title": "Commission Implementing Decision (EU) 2015/1057 of 1 July 2015 amending Implementing Decision 2012/715/EU establishing a list of third countries with a regulatory framework applicable to active substances for medicinal products for human use and the respective control and enforcement activities ensuring a level of protection of public health equivalent to that in the Union (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-decision-2015-1057",
  "path": "introduction",
  "kind": "introduction",
  "number": null,
  "heading": "Introductory text",
  "text": "Commission Implementing Decision (EU) 2015/1057\nof 1 July 2015\namending Implementing Decision 2012/715/EU establishing a list of third countries with a regulatory framework applicable to active substances for medicinal products for human use and the respective control and enforcement activities ensuring a level of protection of public health equivalent to that in the Union\n(Text with EEA relevance)\nTHE EUROPEAN COMMISSION,\nHaving regard to the Treaty on the Functioning of the European Union,\nHaving regard to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code relating to medicinal products for human use, and in particular Article 111b(1) thereof,\nWhereas:\n(1)\nIn accordance with Article 111b(1) of Directive 2001/83/EC a third country may request the Commission to assess whether its regulatory framework applicable to active substances exported to the Union and the respective control and enforcement activities ensure a level of protection of public health equivalent to that of the Union in order to be included in a list of third countries ensuring an equivalent level of protection of public health.\n(2)\nIsrael requested, by letter dated 9 May 2012, to be listed in accordance with Article 111b(1) of Directive 2001/83/EC. The equivalence assessment by the Commission concluded that the requirements of that Article were fulfilled. In exercising this equivalence assessment, account was taken of the agreement on conformity assessment and acceptance of industrial products, as referred to in Article 51(2) of that Directive, between Israel and the Union.\n(3)\nBrazil requested, by letter dated 4 October 2012, to be listed in accordance with Article 111b(1) of Directive 2001/83/EC. On the basis of a review of relevant documentation and two on-site reviews, and taking due account of the action plan proposed by Brazil on 12 March 2015, the equivalence assessment by the Commission concluded that the requirements of that Article were fulfilled.\n(4)\nCommission Implementing Decision 2012/715/EU should therefore be amended accordingly,\nHAS ADOPTED THIS DECISION:",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "OJ L 311, 28.11.2001, p. 67."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "Council Decision 2013/1/EU of 20 November 2012 on the conclusion of a Protocol to the Euro-Mediterranean Agreement establishing an association between the European Communities and their Member States, of the one part, and the State of Israel, of the other part, on Conformity Assessment and Acceptance of Industrial Products (CAA) (OJ L 1, 4.1.2013, p. 1)."
    },
    {
      "type": "footnote",
      "label": "f3",
      "text": "Commission Implementing Decision 2012/715/EU of 22 November 2012 establishing a list of third countries with a regulatory framework applicable to active substances for medicinal products for human use and the respective control and enforcement activities ensuring a level of protection of public health equivalent to that in the Union, in accordance with Directive 2001/83/EC of the European Parliament and of the Council (OJ L 325, 23.11.2012, p. 15)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudn/2015/1057/introduction",
    "retrieved_at": "2026-11-01T15:14:19.406960+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."
}