Enforcement record
Administrative Guidance disclosure naming ノバルティス株式会社
This page records one action from a Japanese government disclosure, including the published name, governing law, authority, action details, and official source.
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
16 April 2014
RegBase evidence report
Japanese public-record enforcement check
Saveable record of the published action, regulator source, source status, and review notes for internal compliance files.
- Report ID
- RB-EN-ENFORCEMENT-YAKKIHO-NOBARUTEI-202607270753
- Generated at
- 27 July 2026 at 16:53
- Record URL
- https://regbase.jp/en/enforcement/yakkiho-nobaruteisu-20140416
1. Review Summary
| Disclosure name | ノバルティス株式会社 | Corporate Number | Not stated in the disclosure |
|---|---|---|---|
| Enforcement record | 1 record | Other confirmed records for this company | Outside this report's scope |
| Action date | 16 April 2014 | Authority | Ministry of Health, Labour and Welfare |
| Law | Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices | Action type | Administrative Guidance |
| Source status | Preserved public-source archive recorded | ||
This report summarizes public Japanese government disclosure data held by RegBase. It is not a credit score, sanctions conclusion, legal opinion, or adverse-media determination. Confirm important decisions against the linked official Japanese source.
2. Published Information
| Published name | ノバルティス株式会社 |
|---|
3. Enforcement Record
| Target name in disclosure | ノバルティス株式会社 |
|---|---|
| Authority | Ministry of Health, Labour and Welfare (厚生労働省) |
| Law / action type | Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices / Administrative Guidance |
| Action / announcement date | Action: 16 April 2014 / Announcement: 6 May 2026 |
| English summary | The Ministry of Health, Labour and Welfare in Japan conducted an awareness campaign on April 16, 2014, through prefectural authorities and related organizations, to remind medical institutions and pharmacies to thoroughly observe the condition of pharmaceuticals and confirm the absence of abnormalities before dispensing. This guidance pertains to compliance with the Pharmaceutical and Medical Device Act (薬機法). |
| 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。 |
| Official source | https://www.mhlw.go.jp/stf/houdou/0000043739.html |
| Source archive | https://kiroku.today/a/7e2914fa44talzl8 |
| Extraction / evidence timestamps | Extracted: 6 May 2026 at 09:02 / Evidence checked: 6 May 2026 at 09:02 / Archive captured: 6 May 2026 at 09:02 |
4. Business Location and Permit Details
No additional structured business-location or permit fields are recorded for this disclosure.
5. Other Confirmed Records for This Company
This report covers the single government disclosure shown on this page.
Reviewer Notes
| Reviewer | Team / company | ||
|---|---|---|---|
| Review purpose | |||
| Additional notes | |||
- □ Official source URL or archived source was checked.
- □ Corporate Number, address, or other identifiers were reviewed to avoid confusing similarly named entities.
- □ This document is understood as a public-record evidence file, not a credit decision or legal opinion.
Current page: Enforcement record
This screen focuses on one disclosed action: the published name, governing law, authority, facts, source status, and review evidence.
Free report
Save the disclosure record naming ノバルティス株式会社
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Preserved evidence by Kiroku
Review the preserved source for ノバルティス株式会社
Open the preserved public source with its capture time, original artifact, available verification data, and downloadable evidence pack.
For developers: JSON integration details
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Action summary
- Company
- ノバルティス株式会社Japanese onlyOriginal: 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
- 16 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
The Ministry of Health, Labour and Welfare in Japan conducted an awareness campaign on April 16, 2014, through prefectural authorities and related organizations, to remind medical institutions and pharmacies to thoroughly observe the condition of pharmaceuticals and confirm the absence of abnormalities before dispensing. This guidance pertains to compliance with the Pharmaceutical and Medical Device Act (薬機法).
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-mediumAdministrative 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
- Extracted at
- 2026-05-06T00:02:06.771+00:00
- Evidence checked
- 2026-05-06T00:02:06.771+00:00
- Archive captured
- 2026-05-06T00:02:14.888188+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": 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-20140416",
"officialSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000043739.html",
"officialDocumentUrl": null,
"archiveUrl": "https://kiroku.today/a/7e2914fa44talzl8",
"archivedSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000043739.html",
"archiveCapturedAt": "2026-05-06T00:02:14.888188+00:00",
"extractedAt": "2026-05-06T00:02:06.771+00:00",
"translatedAt": "2026-07-06T07:41:52.084+00:00",
"evidenceCheckedAt": "2026-05-06T00:02:06.771+00:00",
"generatedAt": "2026-07-27T07:53:36.888Z"
},
"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.