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Home > Tokyo Customs > 16. The Law on Pharmaceuticals and Medical Devices

16. The Law on Pharmaceuticals and Medical Devices

Among the mail that has arrived, there is an item that appears to fall under the Law on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices.
Customs need to confirm the import license or import confirmation (hereinafter referred to as “Yunyu Kakunin-Sho”) issued by a pharmaceutical inspector of a Regional Bureau of Health and Welfare, Ministry of Health, Labour and Welfare (MHLW), each time such items are imported.

【Related Links】 Ministry of Health, Labour and Welfare website: Importing Pharmaceuticals, etc. (pharmaceuticals, quasi-drugs, cosmetics, medical devices)
　　　　https://kouseikyoku.mhlw.go.jp/kantoshinetsu/iji/000207496.pdf （Japanese）


  1. When pharmaceuticals and medical devices are imported by a company for sales purposes, please submit a copy of the following documents to Tokyo Overseas Mail Sub-branch Customs. （① or ②＋③）
  1. ① Manufacturing and Sales license （製造販売許可書）
  2. ② Manufacturing license （製造業許可書）
  3. ③ One of the following documents related to each import item:
  1. A) An Approval Statement of Manufacture and Sales （製造販売承認書）
  2. B) A Certification of Manufacturing and Sales （製造販売認証書）
  3. C) A Registration Statement of Manufacturing and Sales （製造販売届出書）

If you do not have any of the above documents, please obtain a Yunyu Kakunin-Sho from a pharmaceutical inspector of a Regional Bureau of Health and Welfare and submit it to Tokyo Overseas Mail Sub-branch Customs.
If you need Naiyo Tenken Kakunin-Sho prepared by Customs as an attached document for applying Yunyu Kakunin-Sho procedure, please contact Tokyo Overseas Mail Sub-branch Customs.

  1. When pharmaceuticals and medical devices are imported for personal use (including doctors, etc.)
Please ask the pharmaceutical inspector whether or not any procedures are required after ascertaining the product’s name, quantity, etc.

You will receive one of the following responses ① through ④ from the pharmaceutical inspector:
  1. ① Yunyu Kakunin-Sho procedure is required
    Please follow the necessary procedures as instructed by the pharmaceutical inspector.
    Once Yunyu Kakunin-Sho is issued, please submit it to Tokyo Overseas Mail Sub-branch Customs.
    Please contact the customs office if you need an Application for Contents Inspection of Pending International Mail (in advance) when applying for Yunyu Kakunin-Sho.
  2. ② If the quantity is within the scope of quantities that are allowed as self-medication by a physician, please submit a copy of the physician’s license to Tokyo Overseas Mail Sub-branch Customs.
  3. ③ No procedures are required
    Please contact Tokyo Overseas Mail Sub-branch Customs and inform the customs officer of the reason why the procedure is no longer required and the name of the pharmaceutical inspector at the Regional Bureau of Health and Welfare.
  4. ④ Unable to obtain a Yunyu Kakunin-Sho (full or partial importation is not possible)
    Please contact Tokyo Overseas Mail Sub-branch Customs for information on subsequent procedures.

【Contact Information】

Pharmaceutical Inspector,
Kanto Shin’etsu Regional Bureau of Health and Welfare,
Ministry of Health, Labour and Welfare
TEL 048-740-0800
Opening hours: 10:00~12:00 AM / 1:00~3:00 PM (Except Saturday, Sunday and Holidays)

【Related Links】 Ministry of Health, Labour and Welfare website: Bringing/Importing Medicines



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