{
  "url": "https://openlegislation.uk/eu-directive-1989-105/article-6",
  "json_url": "https://openlegislation.uk/eu-directive-1989-105/article-6.json",
  "legislation": "eudr/1989/105",
  "legislation_title": "Council Directive of 21 December 1988 relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion in the scope of national health insurance systems (89/105/EEC)",
  "legislation_url": "https://openlegislation.uk/eu-directive-1989-105",
  "path": "article/6",
  "kind": "article",
  "number": "6",
  "heading": null,
  "text": "The following provisions shall apply if a medicinal product is covered by the national health insurance system only after the competent authorities have decided to include the medicinal product concerned in a positive list of medicinal products covered by the national health insurance system.\n1.. Member States shall ensure that a decision on an application submitted, in accordance with the requirements laid down in the Member State concerned, by the holder of a marketing authorization to include a medicinal product in the list of medicinal products covered by the health insurance systems is adopted and communicated to the applicant within 90 days of its receipt. Where an application under this Article may be made before the competent authorities have agreed the price to be charged for the product pursuant to Article 2, or where a decision on the price of a medicinal product and a decision on its inclusion within the list of products covered by the health insurance system are taken after a single administrative procedure, the time limit shall be extended for a further 90 days. The applicant shall furnish the competent authorities with adequate information. If the information supporting the application is inadequate, the time limit shall be suspended and the competent authorities shall forthwith notify the applicant of what detailed additional information is required.\nWhere a Member State does not permit an application to be made under this Article before the competent authorities have agreed the price to be charged for the product pursuant to Article 2, the Member State concerned shall ensure that the overall period of time taken by the two procedures does not exceed 180 days. This time limit may be extended in accordance with Article 2 or suspended in accordance with the provisions of the preceding subparagraph.\n2.. Any decision not to include a medicinal product in the list of products covered by the health insurance system shall contain a statement of reasons based upon objective and verifiable criteria, including, if appropriate, any expert opinions or recommendations on which the decision is based. In addition, the applicant shall be informed of the remedies available to him under the laws in force and of the time limits allowed for applying for such remedies.\n3.. Before the date referred to in Article 11 (1), Member States shall publish in an appropriate publication and communicate to the Commission the criteria which are to be taken into account by the competent authorities in deciding whether or not to include medicinal products on the lists.\n4.. Within one year of the date referred to in in Article 11(1), Member States shall publish in an appropriate publication and communicate to the Commission a complete list of the products covered by their health insurance system, together with their prices fixed by the national competent authorities. This information shall be updated at least once every year.\n5.. Any decision to exclude a product from the list of products covered by the health insurance system shall contain a statement of reasons based on objective and verifiable criteria. Such decisions, including, if appropriate, any expert opinions or recommendations on which the decisions are based, shall be communicated to the person responsible, who shall be informed of the remedies available to him under the laws in force and the time limits allowed for applying for such remedies.\n6.. Any decision to exclude a category of medicinal products from the list of products covered by the health insurance system shall contain a statement of reasons based on objective and verifiable criteria and be published in an appropriate publication.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudr/1989/105/article/6",
    "retrieved_at": "2026-11-01T15:23:30.828549+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."
}