{ "attribution": { "source": "legal.exploreworldai.com", "canonical": "https://legal.exploreworldai.com/api/public/v1/obj/agent/eu:c-118-24", "cite_as": "NovaCopilot, legal.exploreworldai.com (https://legal.exploreworldai.com/api/public/v1/obj/agent/eu:c-118-24)", "license": "https://legal.exploreworldai.com/revision", "version": "legal-2026-10-27", "fingerprint": "ewai:eu:91c9f1", "proof": "sha256:b23c8b5c5ffb399aa850d1efd41f13f3dee16ceeeed37ab5e860c5913da18153", "jurisdiction": "eu", "lang": "en", "publisher": "NovaCopilot by ExploreWorld Legal", "terms": "https://legal.exploreworldai.com/om" }, "brand_source": "Source: NovaCopilot", "object_type": "agent", "object_id": "agent:eu:c-118-24", "schema_version": "1", "schema": "https://legal.exploreworldai.com/api/public/v1/schemas/agent", "url": "https://legal.exploreworldai.com/api/public/v1/obj/agent/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", "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", "precedent": "https://legal.exploreworldai.com/api/public/v1/obj/precedent/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": { "schema_version": "1.0.0", "brand_source": "Source: NovaCopilot", "id": "eu:c-118-24", "standing": { "question": "Gäller domen fortfarande?", "answer": "1 senare avgörande(n) om samma rättsakt finns. Registret anger inte att domen upphävts, men läs de senare domarna innan du lutar dig på den.", "signal": "check_later_decisions" }, "risk": { "question": "Vilken risk?", "answer": "Risknivå low (1 av 10). 1 senare avgörande(n) om samma rättsakt.", "level": "low", "score": 1 }, "changes": { "question": "Vilka domar ändrar bilden?", "answer": "De senaste: FARMAKEIO YZ & SIA O.E. v Ypourgos Anaptyxis kai Ependyseon and Ypourgos Ygeias (EU-domstolen, 2026-05-21).", "decisions": [ { "id": "eu:c-604-24", "name": "FARMAKEIO YZ & SIA O.E. v Ypourgos Anaptyxis kai Ependyseon and Ypourgos Ygeias", "court": "EU-domstolen", "decided": "2026-05-21", "citation": "ECLI:EU:C:2026:418", "node": "https://legal.exploreworldai.com/api/public/v1/eu-cases/c-604-24", "page": "https://legal.exploreworldai.com/eu/praxis/c-604-24", "relations": "https://legal.exploreworldai.com/api/public/v1/relations?id=eu:c-604-24", "risk": "https://legal.exploreworldai.com/api/public/v1/risk?id=eu:c-604-24" } ] }, "subject": { "name": "EG Labo Laboratoires Eurogenerics SAS and Theramex France SAS v Agence nationale de sécurité du médicament et des produits de santé (ANSM) and Biogaran SAS", "court": "EU-domstolen", "decided": "2026-04-23", "citation": "ECLI:EU:C:2026:330", "case_kind": "judgment", "node": "https://legal.exploreworldai.com/api/public/v1/eu-cases/c-118-24" }, "acts": [ { "id": "directive-2001-83", "url": "https://legal.exploreworldai.com/api/public/v1/acts/directive-2001-83", "basis": "domstolens nyckelord" } ], "b2b_value": { "score": 2, "areas": [ "energy", "intellectual_property" ] }, "assessment_scope": { "risk_type": "evidence_reliance", "business_risk": "not_assessed", "legal_validity": "not_assessed", "later_decision_search": "bounded_same_act_register_search", "later_decisions_observed": 1, "later_decisions_limit": 25, "no_results_proves_validity": false, "source_verification": "not_verified", "verified_at": null }, "source_business_topics": { "status": "not_in_register", "basis": "registered_court_keywords", "matches": [], "business_impact": "not_assessed", "exhaustive": false }, "registered_summary": "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.", "source_url": "https://eur-lex.europa.eu/legal-content/SV/TXT/?uri=CELEX:62024CJ0118", "reliance_guidance": { "legacy_standing_is_validity_verification": false, "legacy_b2b_value_is_business_impact": false, "no_act_link_means_unknown_not_low_business_risk": true }, "sha256": "7afdd19262d35a1121a9fcf9126cbfe56c28e32cf535ac253e7b59a29aa90d3b", "extended": { "obligations": { "question": "Vad måste företaget göra?", "answer": "Börja i skyldigheterna enligt directive-2001-83, Directive 2001/83 och läs domen som tolkning av dem, med fokus på energy, intellectual_property.", "compliance_chains": [ { "act": "directive-2001-83", "url": "https://legal.exploreworldai.com/api/public/v1/compliance-chain?act=directive-2001-83" } ] }, "provisions": { "question": "Vilka regler tolkar domen?", "answer": "Domen rör directive-2001-83, Directive 2001/83.", "acts": [ { "id": "directive-2001-83", "url": "https://legal.exploreworldai.com/api/public/v1/acts/directive-2001-83", "basis": "domstolens nyckelord" } ], "instruments": [ { "id": "directive-2001-83", "label": "Directive 2001/83", "basis": "domstolens nyckelord" } ] }, "practice_line": { "question": "Var ligger domen i praxislinjen?", "answer": "Domen ingår i 2 praxislinje(r), en per rättsakt, med alla avgöranden i tidsordning och en hashkedja.", "lines": [ { "act": "directive-2001-83", "url": "https://legal.exploreworldai.com/api/public/v1/praxis-line?act=directive-2001-83" }, { "act": "directive-2001-83", "url": "https://legal.exploreworldai.com/api/public/v1/praxis-line?act=directive-2001-83" } ] } }, "extended_sha256": "934016ccf8a5390ee588cf9eb722d3f79ce575b97482d7fcf20c347e2eaa2b75", "nearby": [ { "id": "eu:c-604-24", "name": "FARMAKEIO YZ & SIA O.E. v Ypourgos Anaptyxis kai Ependyseon and Ypourgos Ygeias", "court": "EU-domstolen", "decided": "2026-05-21", "citation": "ECLI:EU:C:2026:418", "node": "https://legal.exploreworldai.com/api/public/v1/eu-cases/c-604-24", "page": "https://legal.exploreworldai.com/eu/praxis/c-604-24", "relations": "https://legal.exploreworldai.com/api/public/v1/relations?id=eu:c-604-24", "risk": "https://legal.exploreworldai.com/api/public/v1/risk?id=eu:c-604-24", "agent": "https://legal.exploreworldai.com/api/public/v1/eu-praxis/agent?id=eu%3Ac-604-24", "basis": "same_act" }, { "id": "eu:c-589-24", "name": "Almirall BV and Almirall SA v Infinity Pharma BV and Pharmaline BV", "court": "EU-domstolen", "decided": "2026-03-19", "citation": "ECLI:EU:C:2026:217", "node": "https://legal.exploreworldai.com/api/public/v1/eu-cases/c-589-24", "page": "https://legal.exploreworldai.com/eu/praxis/c-589-24", "relations": "https://legal.exploreworldai.com/api/public/v1/relations?id=eu:c-589-24", "risk": "https://legal.exploreworldai.com/api/public/v1/risk?id=eu:c-589-24", "agent": "https://legal.exploreworldai.com/api/public/v1/eu-praxis/agent?id=eu%3Ac-589-24", "basis": "same_act" }, { "id": "eu:c-451-24", "name": "Kwizda Pharma GmbH v Landeshauptmann von Wien", "court": "EU-domstolen", "decided": "2025-09-04", "citation": "ECLI:EU:C:2025:663", "node": "https://legal.exploreworldai.com/api/public/v1/eu-cases/c-451-24", "page": "https://legal.exploreworldai.com/eu/praxis/c-451-24", "relations": "https://legal.exploreworldai.com/api/public/v1/relations?id=eu:c-451-24", "risk": "https://legal.exploreworldai.com/api/public/v1/risk?id=eu:c-451-24", "agent": "https://legal.exploreworldai.com/api/public/v1/eu-praxis/agent?id=eu%3Ac-451-24", "basis": "same_act" }, { "id": "eu:c-618-23", "name": "SALUS Haus Dr. med Otto Greither Nachf. GmbH & Co.KG v Astrid Twardy GmbH", "court": "EU-domstolen", "decided": "2025-06-26", "citation": "ECLI:EU:C:2025:485", "node": "https://legal.exploreworldai.com/api/public/v1/eu-cases/c-618-23", "page": "https://legal.exploreworldai.com/eu/praxis/c-618-23", "relations": "https://legal.exploreworldai.com/api/public/v1/relations?id=eu:c-618-23", "risk": "https://legal.exploreworldai.com/api/public/v1/risk?id=eu:c-618-23", "agent": "https://legal.exploreworldai.com/api/public/v1/eu-praxis/agent?id=eu%3Ac-618-23", "basis": "same_act" } ], "agent_lists": "https://legal.exploreworldai.com/api/public/v1/eu-praxis/agents", "reasoning": { "standing": { "schema_version": "1.0.0", "question": "Gäller domen fortfarande?", "steps": [ { "step": 1, "kind": "premise", "statement": "Avgörandet EG Labo Laboratoires Eurogenerics SAS and Theramex France SAS v Agence nationale de sécurité du médicament et des produits de santé (ANSM) and Biogaran SAS meddelades 2026-04-23 av EU-domstolen.", "evidence": [ { "label": "EG Labo Laboratoires Eurogenerics SAS and Theramex France SAS v Agence nationale de sécurité du médicament et des produits de santé (ANSM) and Biogaran SAS", "url": "https://legal.exploreworldai.com/api/public/v1/eu-cases/c-118-24" }, { "label": "Officiell källa", "url": "https://eur-lex.europa.eu/legal-content/SV/TXT/?uri=CELEX:62024CJ0118" } ] }, { "step": 2, "kind": "rule", "statement": "Det kopplas i registret till 1 rättsakt(er): directive-2001-83.", "evidence": [ { "label": "directive-2001-83", "url": "https://legal.exploreworldai.com/api/public/v1/acts/directive-2001-83" } ] }, { "step": 3, "kind": "evidence", "statement": "1 senare avgörande(n) om samma rättsakt finns i registret.", "evidence": [ { "label": "FARMAKEIO YZ & SIA O.E. v Ypourgos Anaptyxis kai Ependyseon and Ypourgos Ygeias (2026-05-21)", "url": "https://legal.exploreworldai.com/api/public/v1/eu-cases/c-604-24" } ] }, { "step": 4, "kind": "inference", "statement": "Senare avgöranden kan förtydliga, begränsa eller bekräfta domen; registret anger inte upphävande.", "evidence": [] }, { "step": 5, "kind": "conclusion", "statement": "1 senare avgörande(n) om samma rättsakt finns. Registret anger inte att domen upphävts, men läs de senare domarna innan du lutar dig på den.", "evidence": [] } ], "conclusion": "1 senare avgörande(n) om samma rättsakt finns. Registret anger inte att domen upphävts, men läs de senare domarna innan du lutar dig på den.", "confidence": "medel", "limits": [ "Bygger på registrets kopplingar, inte en läsning av varje senare doms innehåll.", "Inte juridisk rådgivning." ], "reasoning_hash": "sha256:035537d1ff519478a13c362f7c48a654c6b5d9051c281e00807bfc0a8b297804", "method": "Deterministisk kedja ur registret. Varje steg pekar på sitt underlag. Ingen modell skriver stegen." }, "risk": { "schema_version": "1.0.0", "question": "Vilken risk?", "steps": [ { "step": 1, "kind": "premise", "statement": "Risken mäter hur tungt avgörandet bär som underlag, på skalan 0 till 10.", "evidence": [ { "label": "Riskobjekt", "url": "https://legal.exploreworldai.com/api/public/v1/risk?id=eu%3Ac-118-24" } ] }, { "step": 2, "kind": "evidence", "statement": "1 senare avgörande(n) om samma rättsakt (+1).", "evidence": [] }, { "step": 3, "kind": "inference", "statement": "Summan av faktorerna blir 1, vilket motsvarar nivå low.", "evidence": [] }, { "step": 4, "kind": "conclusion", "statement": "Risknivå low (1 av 10). 1 senare avgörande(n) om samma rättsakt.", "evidence": [] } ], "conclusion": "Risknivå low (1 av 10). 1 senare avgörande(n) om samma rättsakt.", "confidence": "hög", "limits": [ "Poängen är en regelstyrd klassificering, inte en bedömning av ett enskilt ärende." ], "reasoning_hash": "sha256:2c682634adb1b9e4155d5131085de888fbc53e5e99201898628ceed9281aff94", "method": "Deterministisk kedja ur registret. Varje steg pekar på sitt underlag. Ingen modell skriver stegen." }, "changes": { "schema_version": "1.0.0", "question": "Vilka domar ändrar bilden?", "steps": [ { "step": 1, "kind": "premise", "statement": "Senare avgöranden om samma rättsakt är de som kan ändra bilden.", "evidence": [ { "label": "Ändringsflöde", "url": "https://legal.exploreworldai.com/api/public/v1/eu-praxis/changes" } ] }, { "step": 2, "kind": "evidence", "statement": "Registret har 1; de senaste listas.", "evidence": [ { "label": "FARMAKEIO YZ & SIA O.E. v Ypourgos Anaptyxis kai Ependyseon and Ypourgos Ygeias (2026-05-21)", "url": "https://legal.exploreworldai.com/api/public/v1/eu-cases/c-604-24" } ] }, { "step": 3, "kind": "conclusion", "statement": "De senaste: FARMAKEIO YZ & SIA O.E. v Ypourgos Anaptyxis kai Ependyseon and Ypourgos Ygeias (EU-domstolen, 2026-05-21).", "evidence": [] } ], "conclusion": "De senaste: FARMAKEIO YZ & SIA O.E. v Ypourgos Anaptyxis kai Ependyseon and Ypourgos Ygeias (EU-domstolen, 2026-05-21).", "confidence": "hög", "limits": [ "Följ ändringsflödet med cursor för nya avgöranden." ], "reasoning_hash": "sha256:c22221afd28c93b6ee9b9ef6f7f18e2f8bc8bd27a4ab5de86117af45f1e8ad64", "method": "Deterministisk kedja ur registret. Varje steg pekar på sitt underlag. Ingen modell skriver stegen." } }, "method": "Deterministiskt ur registret: rättsaktskopplingar, avgörandeform, domstol och senare avgöranden. Ingen modell skriver svaren.", "citation": "Source: NovaCopilot (ExploreWorld Legal), https://legal.exploreworldai.com/api/public/v1/eu-praxis/agent?id=eu%3Ac-118-24", "disclaimer": "Klassificering ur registret, inte juridisk rådgivning." }, "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/agent/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", "node_state": "https://legal.exploreworldai.com/api/public/v1/node-state?id=eu%3Ac-118-24", "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/agent/eu:c-118-24", "source": "Source: NovaCopilot", "official_source": "https://eur-lex.europa.eu/legal-content/SV/TXT/?uri=CELEX:62024CJ0118", "short_answer": null, "short_answer_status": "not_in_register", "hash": "00698acff98d7624ded47960f191e7a06cd7c4f04af4320835113ae174769a6a", "schema_version": "1", "last_verified_at": null, "verification_status": "not_verified_yet", "integrity_check_scope": "stored_content_only" }, "hash": "sha256:b23c8b5c5ffb399aa850d1efd41f13f3dee16ceeeed37ab5e860c5913da18153", "version": "legal-2026-10-27", "expires": "2026-10-28T00:00:00.000Z", "dependency": { "index_version": "legal-2026-10-27+legal-2026-10-27+2026-10-27T16:13:52", "content_hash": "sha256:b23c8b5c5ffb399aa850d1efd41f13f3dee16ceeeed37ab5e860c5913da18153", "revalidate_after": "2026-10-27T17:59:33.460Z", "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/agent/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" }