Possible Administrative Guidance against ノバルティス株式会社

ノバルティス株式会社 (Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices)
Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical DevicesMinistry of Health, Labour and WelfarePossible entity match16 April 2014
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/api/v1/enforcements?company=%E3%83%8E%E3%83%90%E3%83%AB%E3%83%86%E3%82%A3%E3%82%B9%E6%A0%AA%E5%BC%8F%E4%BC%9A%E7%A4%BE&limit=10

Action summary

Company
Original: ノバルティス株式会社
Entity match
Possible entity match60/100Machine extracted
Company name extracted from the Japanese public disclosure
Governing law
Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices
薬機法
Action type
Administrative Guidance
行政指導
Action date
16 April 2014
Issuing authority
Ministry of Health, Labour and Welfare
厚生労働省

Violation

Show original Japanese text

医薬品の交付に当たっては、医薬品の状態を十分に観察し、異常が無いことの確認をする必要があります。

Compliance context

Low-medium

Administrative guidance or supervision was publicly disclosed by the authority.

Health product law covering pharmaceuticals, medical devices, cosmetics, quasi-drugs, labeling, and advertising.

Use as a monitoring signal. Confirm details before treating it as a formal sanction.

This context is an operational aid for review workflows, not a credit opinion or legal conclusion.

Evidence pack

Original Ministry of Health, Labour and Welfare announcement (Japanese)Archived source snapshot
Extracted at
2026-05-06T00:02:06.771+00:00
Evidence checked
2026-05-06T00:02:06.771+00:00
Archive captured
2026-05-06T00:02:07.55+00:00
Show audit JSON
{
  "record": {
    "id": "1817161e-c6ed-46a8-a323-d3fc0e2e18de",
    "url": "https://regbase.jp/en/enforcement/yakkiho-nobaruteisu-20140416",
    "company_name_original": "ノバルティス株式会社",
    "company_name_registry": "ノバルティス株式会社",
    "corporate_number": null,
    "law": {
      "ja": "薬機法",
      "en": "Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices"
    },
    "action_type": {
      "ja": "行政指導",
      "en": "Administrative Guidance"
    },
    "authority": {
      "ja": "厚生労働省",
      "en": "Ministry of Health, Labour and Welfare"
    }
  },
  "entity_match": {
    "status": "possible",
    "confidence": 60,
    "method": "extracted_japanese_name",
    "method_label": "Company name extracted from the Japanese public disclosure",
    "notes": null
  },
  "review": {
    "status": "unreviewed",
    "label": "Machine extracted"
  },
  "compliance_context": {
    "severity": "Low-medium",
    "actionMeaning": "Administrative guidance or supervision was publicly disclosed by the authority.",
    "practicalNote": "Use as a monitoring signal. Confirm details before treating it as a formal sanction.",
    "lawContext": "Health product law covering pharmaceuticals, medical devices, cosmetics, quasi-drugs, labeling, and advertising."
  },
  "evidence": {
    "recordUrl": "https://regbase.jp/en/enforcement/yakkiho-nobaruteisu-20140416",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000043739.html",
    "archiveUrl": "https://kiroku.today/view/7e2914fa44talzl8",
    "archiveCapturedAt": "2026-05-06T00:02:07.55+00:00",
    "extractedAt": "2026-05-06T00:02:06.771+00:00",
    "translatedAt": null,
    "evidenceCheckedAt": "2026-05-06T00:02:06.771+00:00",
    "generatedAt": "2026-05-20T22:31:49.731Z"
  },
  "limitations": [
    "RegBase aggregates public Japanese government disclosures and does not provide a credit opinion.",
    "English summaries are provided for reference. The original Japanese source is authoritative.",
    "Possible or unresolved entity matches should be manually verified before use in a decision."
  ]
}

The original Japanese disclosure is the authoritative record. Use possible or unresolved matches only as leads for manual review.

Company info

English name
ノバルティス株式会社 Japanese original
Japanese name
ノバルティス株式会社
See company profile →

About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.