{
  "attribution": {
    "source": "legal.exploreworldai.com",
    "canonical": "https://legal.exploreworldai.com/api/public/v1/obj/precedent/eu:c-118-24",
    "cite_as": "NovaCopilot, legal.exploreworldai.com (https://legal.exploreworldai.com/api/public/v1/obj/precedent/eu:c-118-24)",
    "license": "https://legal.exploreworldai.com/revision",
    "version": "legal-2026-10-25",
    "fingerprint": "ewai:se:30d53b",
    "proof": "sha256:081799707bc26e5e4a224ff1334d13657fcb9d7188f4290468bbb2161439d32f",
    "jurisdiction": "se",
    "lang": "en"
  },
  "brand_source": "Source: NovaCopilot",
  "object_type": "precedent",
  "object_id": "precedent:eu:c-118-24",
  "schema_version": "1",
  "schema": "https://legal.exploreworldai.com/api/public/v1/schemas/precedent",
  "url": "https://legal.exploreworldai.com/api/public/v1/obj/precedent/eu:c-118-24",
  "judgment": {
    "id": "eu:c-118-24",
    "text": "https://legal.exploreworldai.com/api/public/v1/judgment-text?id=eu:c-118-24"
  },
  "siblings": {
    "risk": "https://legal.exploreworldai.com/api/public/v1/obj/risk/eu:c-118-24",
    "relation": "https://legal.exploreworldai.com/api/public/v1/obj/relation/eu:c-118-24",
    "change": "https://legal.exploreworldai.com/api/public/v1/obj/change/eu:c-118-24",
    "agent": "https://legal.exploreworldai.com/api/public/v1/obj/agent/eu:c-118-24",
    "provenance": "https://legal.exploreworldai.com/api/public/v1/obj/provenance/eu:c-118-24",
    "status": "https://legal.exploreworldai.com/api/public/v1/obj/status/eu:c-118-24",
    "edge": "https://legal.exploreworldai.com/api/public/v1/obj/edge/eu:c-118-24",
    "element": "https://legal.exploreworldai.com/api/public/v1/obj/element/eu:c-118-24",
    "decision": "https://legal.exploreworldai.com/api/public/v1/obj/decision/eu:c-118-24",
    "weight": "https://legal.exploreworldai.com/api/public/v1/obj/weight/eu:c-118-24",
    "conflict": "https://legal.exploreworldai.com/api/public/v1/obj/conflict/eu:c-118-24",
    "citation_graph": "https://legal.exploreworldai.com/api/public/v1/obj/citation_graph/eu:c-118-24"
  },
  "source": "NovaCopilot",
  "precedent_graph": "https://legal.exploreworldai.com/api/public/v1/precedent-graph/eu:c-118-24",
  "item": {
    "judgment": "eu:c-118-24",
    "issue": "Reference for a preliminary ruling – Directive 2001/83/EC – Medicinal products for human use – Articles 28 and 29 – Decentralised procedure for marketing authorisation for a medicinal product – Article 10 – Generic medicinal product – Abridged procedure for granting a marketing authorisation – Biological medicinal product serving as reference medicinal product for a chemical medicinal product – Jurisdiction of the courts of the Member States concerned to determine whether there is a potential serious risk for public health – Jurisdiction of those courts to review the conditions for granting a marketing authorisation for a generic medicinal product.",
    "court": "CJ",
    "decided": "2026-04-23",
    "binding": "binding",
    "status": "final",
    "holdings": [
      {
        "n": 1,
        "paragraph_id": "para_282",
        "text": "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, as amended by Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007,",
        "kind": "operative_part",
        "precedent_id": "precedent:eu:c-118-24#1"
      },
      {
        "n": 2,
        "paragraph_id": "para_283",
        "text": "must be interpreted as meaning that the Member States are free to provide that, in an action brought by the holder of a marketing authorisation for a biosimilar of a biological medicinal product against a decision to grant a marketing authorisation for a generic medicinal product of that biological medicinal product, adopted following a decentralised marketing authorisation procedure, a court of a Member State concerned has jurisdiction to review whether the medicinal product the marketing of which has been authorised by that decision may be classified as a ‘generic medicinal product’, within the meaning of Article 10(2)(b) of that directive, as amended.",
        "kind": "operative_part",
        "precedent_id": "precedent:eu:c-118-24#2"
      },
      {
        "n": 3,
        "paragraph_id": "para_285",
        "text": "Article 10 of Directive 2001/83, as amended by Regulation No 1394/2007,",
        "kind": "operative_part",
        "precedent_id": "precedent:eu:c-118-24#3"
      },
      {
        "n": 4,
        "paragraph_id": "para_286",
        "text": "must be interpreted as meaning that it does not preclude a marketing authorisation from being granted, following an abridged procedure provided for in Article 10(1) for a medicinal product deriving from a chemical synthesis, where the reference medicinal product is a biological medicinal product, provided that the conditions set out in Article 10(2)(b) are met.",
        "kind": "operative_part",
        "precedent_id": "precedent:eu:c-118-24#4"
      }
    ],
    "text_sha256": "670e940717d7c98cb43741ac23b2c10f8d5d16280dd6276123979ea2644cb336",
    "method": "Domslutet efter 'On those grounds' i domens egen text.",
    "limits": [],
    "hash": "acfa7c1773274be0e63fb3a97f46d7fcefdf77156f9e1b1a8243179de9bb7430"
  },
  "links": {
    "provisions": null,
    "case_law": {
      "precedent": "https://legal.exploreworldai.com/api/public/v1/obj/precedent/eu:c-118-24",
      "conflict": "https://legal.exploreworldai.com/api/public/v1/obj/conflict/eu:c-118-24",
      "citation_graph": "https://legal.exploreworldai.com/api/public/v1/obj/citation_graph/eu:c-118-24",
      "weight": "https://legal.exploreworldai.com/api/public/v1/obj/weight/eu:c-118-24"
    },
    "evidence": {
      "provenance": "https://legal.exploreworldai.com/api/public/v1/obj/provenance/eu:c-118-24",
      "chain_verify": "https://legal.exploreworldai.com/api/public/v1/changes/verify",
      "object_changes": "https://legal.exploreworldai.com/api/public/v1/objects/changes"
    },
    "compact": "https://legal.exploreworldai.com/api/public/v1/obj/precedent/eu:c-118-24?view=compact",
    "representations": {
      "sv": "https://legal.exploreworldai.com/eu/praxis/c-118-24",
      "en": "https://legal.exploreworldai.com/en/eu/praxis/c-118-24"
    },
    "machine_languages": [
      "en",
      "sv"
    ],
    "ref": "eu:c-118-24"
  },
  "watch": {
    "risk": "https://legal.exploreworldai.com/api/public/v1/risk?id=eu%3Ac-118-24",
    "relations": "https://legal.exploreworldai.com/api/public/v1/relations?id=eu%3Ac-118-24",
    "risk_changes": "https://legal.exploreworldai.com/api/public/v1/risk-changes",
    "provenance": "https://legal.exploreworldai.com/api/public/v1/obj/provenance/eu:c-118-24"
  },
  "metadata": {
    "schema": "novacopilot_object_metadata/1",
    "canonical_url": "https://legal.exploreworldai.com/api/public/v1/obj/precedent/eu:c-118-24",
    "source": "Source: NovaCopilot",
    "official_source": null,
    "short_answer": null,
    "short_answer_status": "not_in_register",
    "hash": "acfa7c1773274be0e63fb3a97f46d7fcefdf77156f9e1b1a8243179de9bb7430",
    "schema_version": "1",
    "last_verified_at": null,
    "verification_status": "not_verified_yet",
    "integrity_check_scope": "stored_content_only"
  },
  "hash": "sha256:081799707bc26e5e4a224ff1334d13657fcb9d7188f4290468bbb2161439d32f",
  "version": "legal-2026-10-25",
  "expires": "2026-10-27T00:00:00.000Z",
  "dependency": {
    "index_version": "legal-2026-10-25+legal-2026-10-25+2026-10-25T13:37:31",
    "content_hash": "sha256:081799707bc26e5e4a224ff1334d13657fcb9d7188f4290468bbb2161439d32f",
    "revalidate_after": "2026-10-26T05:13:58.437Z",
    "max_copy_age_seconds": 3600,
    "policy": "revalidate-required; attribution-preferred",
    "changelog": "https://legal.exploreworldai.com/api/public/v1/dependency",
    "verify": "https://legal.exploreworldai.com/api/public/v1/verify",
    "stale_copy_invalid": true
  },
  "canonical": "https://legal.exploreworldai.com/api/public/v1/obj/precedent/eu:c-118-24",
  "disclaimer": "Source reference with official identifier. Not legal advice and not a compliance decision.",
  "content_notice": {
    "legal_advice": false,
    "nature": "Source register. Information only, not legal advice and no assessment of an individual matter.",
    "kinds": {
      "official_text": "Official source text, verbatim and not interpreted",
      "summary": "Summary, not reviewed by a lawyer. Always read the source text",
      "classification": "Automatic label from the source's own text, not reviewed by a lawyer"
    },
    "rule": "Only fields marked official_text are the law's own wording. Everything else points to it.",
    "report_error": "https://legal.exploreworldai.com/api/public/v1/corrections",
    "ai_act_declaration": "https://legal.exploreworldai.com/api/public/v1/ai-act-declaration"
  },
  "usageInfo": "https://legal.exploreworldai.com/citering"
}