Enforcement record

Administrative Guidance disclosure naming 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)

This page records one action from a Japanese government disclosure, including the published name, governing law, authority, action details, and official source.

Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical DevicesMinistry of Health, Labour and WelfareGovernment disclosure17 April 2014

Action type

Administrative Guidance

Law

Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices

Authority

Ministry of Health, Labour and Welfare

Action date

17 April 2014

Current page: Enforcement record

This screen focuses on one disclosed action: the published name, governing law, authority, facts, source status, and review evidence.

Source verification

Public-source and preservation status

Publishing authority: Ministry of Health, Labour and Welfare
Official source URL: Recorded by RegBase
Entity match: Not confirmed; shown under the published name
Kiroku preservation: Completed archive verified; Captured: Apr 28, 2026, 09:04 PM JST

“Confirmed” means that RegBase matched this record to the cited public disclosure or entity under the stated checks. It does not verify the truth of the disclosure or guarantee the entity’s current status, creditworthiness, or any legal conclusion.

Open the official source links in the section below to review the original disclosure.

Action summary

Company: ノバルティス株式会社Japanese only
Original: ノバルティス株式会社
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: 17 April 2014
Issuing authority: Ministry of Health, Labour and Welfare
厚生労働省
Industry context: 医薬品製造・販売

Violation

Machine-translated summary — verify against original

When dispensing pharmaceuticals, it is necessary to carefully observe the condition of the medication and confirm that there are no abnormalities. In pharmacies within Saitama Prefecture and medical institutions within Chiba Prefecture, vials contaminated with needle-shaped foreign matter were found, but there are no descriptions of specific violations or methods.

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。埼玉県内の薬局及び千葉県内の医療機関で、針状の異物が混入したボルタレンサポが発見されたが、具体的な違反手口や態様についての記述はない。

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.

Open original sources and verification detailsOfficial URL, direct PDF, and Kiroku archive

Original Ministry of Health, Labour and Welfare source (Japanese)Open preserved source and evidence pack

Extracted at: 2026-04-28T12:00:36.063+00:00
Evidence checked: 2026-04-28T12:00:36.063+00:00
Archive captured: 2026-04-28T12:04:33.626049+00:00

Show audit JSON

{
  "record": {
    "id": "ad6fb46c-83f8-4a74-a9ba-bd579f6b372d",
    "url": "https://regbase.jp/en/enforcement/yakkiho-nobaruteisu-20140417",
    "company_name_original": "ノバルティス株式会社",
    "company_name_registry": null,
    "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": "unresolved",
    "confidence": 60,
    "method": "extracted_japanese_name",
    "method_label": "Company name extracted from the Japanese public disclosure",
    "notes": "The linked company profile has not been verified under the current identity policy."
  },
  "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-20140417",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000043739.html",
    "officialDocumentUrl": null,
    "archiveUrl": "https://kiroku.today/a/7e2914fa44ikr5t5",
    "archivedSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000043739.html",
    "archiveCapturedAt": "2026-04-28T12:04:33.626049+00:00",
    "extractedAt": "2026-04-28T12:00:36.063+00:00",
    "translatedAt": "2026-05-01T09:44:18.475+00:00",
    "evidenceCheckedAt": "2026-04-28T12:00:36.063+00:00",
    "generatedAt": "2026-09-19T12:51:18.889Z"
  },
  "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.

Language

日本語版を見る (Japanese)

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