{
  "url": "https://openlegislation.uk/eu-decision-2013-1/schedule-ANNEX/division-ON MUTUAL ACCEPTANCE OF INDUSTRIAL PRODUCTS/division-SECTION IV/division-10.",
  "json_url": "https://openlegislation.uk/eu-decision-2013-1/schedule-ANNEX/division-ON MUTUAL ACCEPTANCE OF INDUSTRIAL PRODUCTS/division-SECTION IV/division-10..json",
  "legislation": "eudn/2013/1",
  "legislation_title": "Council Decision 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) (2013/1/EU)",
  "legislation_url": "https://openlegislation.uk/eu-decision-2013-1",
  "path": "schedule/ANNEX/division/ON MUTUAL ACCEPTANCE OF INDUSTRIAL PRODUCTS/division/SECTION IV/division/10.",
  "kind": "division",
  "number": "10",
  "heading": "Information and Cooperation",
  "text": "The Parties to the Protocol shall regularly exchange information on the implementation and operation of this Annex.\nThey shall keep each other informed on training sessions for inspectors and scientists from Official Medicines Control Laboratories. Such sessions, organised by one Party, shall where practicable be made accessible to the other Party.\nRepresentatives of Israel are encouraged to participate regularly in the discussions on GMP and quality related topics of working groups coordinated by the European Medicines Agency and the network of OMCLs coordinated by the European Directorate for the Quality of Medicines and Healthcare (EDQM) under the auspices of the Council of Europe. In addition, Israel is encouraged to participate in coordinated inspection activities in third countries.\nAs part of its implementation of relevant EU law, Israel shall participate in the operation of the Community database on GMP managed by the European Medicines Agency.\nFor the purposes of demonstration of capability and compliance of GMP inspection systems and OMCLs with European standards and requirements in the evolving regulatory systems, the parties shall participate in the Joint Audit Programme of the Member States of the EU, as published by the EMEA, and the Mutual Joint Audit Programme, as established by the EDQM and any future comparable audit programme.\nAdditional specific information shall on request be supplied by a Party in relation to its official inspection service and Official Medicines Control Laboratories. Such specific information may include training, observed audits, general information and document exchange, transparency of agency audits, exchanges of external assessments and review reports relating to official inspection services.\nParties agree to facilitate information exchange and interdisciplinary cooperation in cases when actors in the manufacturing and distribution chain are suspected of contravening the legislation.\nWith respect to medicinal products covered by the scope of this Annex, but not covered under Section II.3, the Parties may cooperate in planning and performing inspections and in exchanging information on such inspections.\nThe Parties will agree to meet upon reasonable request of either party to discuss issues of preparation, implementation of and compliance with relevant EU and Israeli national law.\nRequests for cooperation under this clause should be made through the contact points referred to in clause 11.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudn/2013/1/schedule/ANNEX/division/ON MUTUAL ACCEPTANCE OF INDUSTRIAL PRODUCTS/division/SECTION IV/division/10.",
    "retrieved_at": "2026-11-01T15:15:12.970392+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."
}