Yakkan Shoumei (薬監証明) was replaced in 2020 — Japan's import confirmation certificate explained
Yakkan Shoumei (薬監証明) was Japan's certificate for importing unapproved medicines, and MHLW replaced it on 1 September 2020: items once imported with Yakkan Shoumei now need an import confirmation certificate (輸入確認証, Yunyu Kakunin-sho) (MHLW). This article explains when the certificate is needed, what the application includes, what it does not do, and how it applies to research peptides, using MHLW's import-confirmation guideline and Japan Customs guidance. For BPC-157 specifically, see Is BPC-157 legal in Japan?.
What changed: MHLW states that items previously imported with Yakkan Shoumei have needed an import confirmation certificate (輸入確認証) since 1 September 2020. The legal basis is Article 56-2 of the PMD Act: importing a medicine without the Article 14 approval requires the Minister's confirmation, which is withheld where the quantity goes beyond what is deemed to be for personal use and not for sale (PMD Act on e-Gov). Importing without a confirmation the Article requires is punishable under Article 84 by up to three years' imprisonment, a fine of up to ¥3 million, or both. Since 1 February 2023, applications can also be filed through MHLW's online system.
When you need it: within set quantities, an individual can import medicines for their own use after a customs check, without a certificate. The limits are one month's supply at the labelled dosage for prescription drugs and poisonous or powerful drugs, 24 standard-size units per item for external-use products, and two months' supply for other medicines (Japan Customs). Above those quantities a certificate is required. MHLW's English page for travellers also lists injectable drugs at up to one month's supply, limited to pre-filled syringes or self-injection kits. Medicines on MHLW's list of products that could cause serious harm if self-used cannot be imported by individuals in any quantity unless a doctor's prescription can be confirmed.
What the application includes: under MHLW's import-confirmation guideline (revised 30 June 2025), a personal-use application above the limits is filed with a product description, a copy of a doctor's prescription or instructions, the invoice and the air waybill or bill of lading. Applications go to a Regional Bureau of Health and Welfare, and the certificate must be shown to customs at the import declaration. The listed documents do not include proof that the product is approved in another country.
What it does not do: the certificate confirms that an import is not for sale. It is not a product approval. MHLW notes that the quality, efficacy and safety of personally imported medicines have not been confirmed under the PMD Act, and that health damage caused by them is not eligible for relief (MHLW). Imported medicines may not be sold or given to anyone else, even free of charge.
Research peptides: PeptideGuide found no MHLW statement on which quantity category applies to a research-labelled peptide vial. Because an application above the limits needs a doctor's prescription or instructions, such imports depend on a doctor prescribing or instructing use of the product. Laboratories follow a different line of the same guideline: importing unapproved medicines for quality, pharmacology or formulation testing needs import confirmation with a research plan (試験研究計画書). Clinical trials (治験) are notified to the Minister in advance under Article 80-2(2) of the PMD Act.
Checks on purpose: the guideline tells reviewers to confirm the import purpose in detail, including whether anything will be passed to others. PeptideGuide does not endorse misdescribing any product on an import application or customs declaration.
✓Pros
- MHLW publishes the import-confirmation guideline, the quantity limits and an English page for travellers
- Applications can be filed online since February 2023
- Imports within the quantity limits need no certificate
×Cons
- Above the limits, the application needs a doctor's prescription or instructions
- No MHLW guidance says which quantity category applies to research-labelled peptides
- The certificate is not a product approval; MHLW has not confirmed the quality or safety of personally imported medicines
- Imported medicines may not be shared or resold, even free of charge
What is Yakkan Shoumei in plain English?
It was the certificate used to import unapproved medicines into Japan, and it is no longer issued. MHLW states that from 1 September 2020 an import confirmation certificate (輸入確認証) is obtained in its place (MHLW). Japan Customs describes the new certificate as confirmation that the import is not for sale.
Can I use Yakkan Shoumei to import BPC-157 or TB-500?
Yakkan Shoumei was replaced by the import confirmation certificate in 2020. Within MHLW's quantity limits, no certificate is needed. Above them, the application needs a copy of a doctor's prescription or instructions (MHLW guideline). PeptideGuide found no MHLW statement on which category applies to research-labelled BPC-157 or TB-500. See Is BPC-157 legal in Japan?.
What about Tirzepatide or Semaglutide — those are FDA-approved?
The same rules apply as for any medicine: MHLW's quantity limits, and above them an import confirmation certificate filed with a copy of a doctor's prescription or instructions. MHLW's listed application documents do not depend on whether a product is approved abroad.
Can I apply online?
Yes. MHLW's online system for the import confirmation certificate started operating on 1 February 2023.
Who handles the application?
A Regional Bureau of Health and Welfare (地方厚生局) (Japan Customs). The certificate must be obtained before the import declaration and shown to customs.
What is the realistic path for Japanese researchers buying research peptides?
For laboratories, MHLW's guideline sets the route: import confirmation with a research plan (試験研究計画書) for testing and research, and a trial-plan notification under PMD Act Article 80-2(2) for clinical trials. For individuals, the personal-use rules apply: own use only, within the quantity limits, and a certificate with a doctor's prescription or instructions above them. PeptideGuide does not endorse non-compliant import.
Can I misdescribe a product to get an import confirmation certificate?
No. MHLW's guideline tells reviewers to confirm the import purpose in detail, including whether anything will be passed to others, and Article 56-2(2) of the PMD Act lets the Minister withhold confirmation where the applicant may be importing for sale or supply. PeptideGuide does not endorse misdescribing any product.
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- 2026-10-07Earlier versions presented Yakkan Shoumei as the current certificate, with a "Form 37" application, a requirement that the product be approved abroad, a general two-month limit, bureau routing by port of entry and 1–2 week processing, and said approved-manufacturer tirzepatide or semaglutide qualifies while research-grade versions do not. MHLW replaced Yakkan Shoumei with the import confirmation certificate (輸入確認証) on 1 September 2020. PeptideGuide could not find Form 37, the approval-abroad requirement, the routing, the processing time or the approved-versus-research-grade distinction in MHLW's guidance; the limits are one month's supply for prescription drugs and two months' for most other medicines. The article was rewritten from MHLW and Japan Customs sources.