Compliance and authorized imports
Imported the right way,
straight to your clinic.
We handle import procedures on behalf of doctors in line with Japan’s Pharmaceuticals and Medical Devices Act and the Ministry of Health, Labour and Welfare’s notice. This page explains how our service works, and describes a violation that’s common among import agents.
Our import service
We handle the paperwork.
Products ship from abroad.
When a clinic places an order, we order from the overseas supplier, pay on the doctor’s behalf and apply for import confirmation. Products ship directly from the supplier to the clinic.
- ① RequestThe clinic chooses products in the ordering system and names the doctor who will use them as the importer.
- ② Order & payWe place the order with the overseas supplier and pay for it on the doctor’s behalf.
- ③ Import checkFor products that require import confirmation, we apply with every order, under the authority the clinic gives us in the agreement.
- ④ Shipped directThe supplier ships straight to the clinic. Products that require import confirmation clear customs with the certificate. We never receive the products.
The Ministry’s notice
What an import agent should be.
In its notice of August 28, 2002, “Guidance and enforcement regarding personal import agency businesses” (PFSB Notice No. 0828014), the Ministry of Health, Labour and Welfare pointed out businesses that call themselves import agents but in fact import drugs without a license or advertise unapproved drugs. The notice sets out which forms of business count as violations, and describes the scope of an import agent’s work as follows.
“The scope of an import agent’s work is, in general, to undertake services (procedures) for the import of individual products at the request of the importer. Where the effects of the import, such as receiving the products, belong to the agent, a license for the import and sale business is required.”
Guidance and enforcement regarding personal import agency businesses (PFSB Notice No. 0828014, August 28, 2002), Part 2-1. Our translation. “Import and sale business” is a term from the Pharmaceutical Affairs Act in force at the time.
- Import
- Taking goods shipped from a foreign country into the territory of Japan.
- Importer
- The person who, in substance, holds the right to dispose of the goods brought into Japan. In other words, the person to whom the effects of the import belong.
- An import agent’s work
- Undertaking the procedures for importing individual products at the importer’s request.
A plain-language summary of Part 1 (definitions) and Part 2-1 of the notice. In our service, the importer is the doctor who uses the product.
Three forms in the notice
Not every “import agent”
is within the law.
The notice sorts businesses that call themselves import agents into three forms. Two are considered violations. One is not.
Appendix 1
Importing by the agent
The agent hands over products it imported in advance in anticipation of orders, or imports products with its own money on request and hands them over.
A violation without a licenseAppendix 2
Active agency
The agent shows a list of unapproved drugs to the general public and solicits import requests. The overseas seller ships directly to the consumer.
A violation if the list is advertisingAppendix 3
Passive agency
At the consumer’s request, the agent collects the payment and delivery details and sends them to the overseas seller, who ships directly to the consumer. The consumer is the importer.
Not a violationIn our service too, the doctor is the importer, and products ship directly from the overseas supplier to the clinic. We never receive the products. Only medical institutions that log in to the ordering system can see product names and prices, after their membership is approved and they’ve agreed to the contract.
A common violation
Parallel importing:
what’s the problem?
Parallel importing means buying products sold abroad outside the manufacturer’s official channels, importing them and selling them in Japan. Only businesses holding a marketing authorization holder license, or a similar license, may import drugs as a business. Importing drugs to sell them also requires approval for each product.
- 1
A dealer bulk-imports
For a dealer to import drugs as the importer in order to sell them to clinics, it needs a marketing authorization holder license and approval for each product.
PMD Act, Articles 12 and 14 - 2
Selling from a warehouse in Japan (“in stock in Japan”, “same-day shipping”)
As a rule, only pharmacies and businesses with a drug sales license may sell drugs as a business or store them for sale. The notice says handing over products imported in anticipation of orders is a violation without a license.
PMD Act, Article 24; the notice, Appendix 1 - 3
Publishing product names and prices where anyone can see them
No one may advertise the name or efficacy of an unapproved drug. The notice says partly hidden names or photos alone still count as advertising if the product can be identified, for example from the price.
PMD Act, Article 68; the notice, Part 4
Passing products imported under one doctor’s name to other clinics
When a doctor imports for treatment, the import confirmation application includes a pledge that the products will be used for the stated purpose and will not be sold, lent or given to others. Import confirmation is refused when the products may be imported for sale or transfer. Passing products imported under one doctor’s name to other clinics breaks this pledge.
PMD Act, Article 56-2(2); Enforcement Regulations, Form 97-3 (pledge in the import confirmation application)Parallel importing compared with our service
| Item | Parallel importing without a license or approval | Our import service |
|---|---|---|
| Importer | The dealer | The doctor who uses the product |
| Seller | The dealer | The overseas supplier (the sale is between the doctor and the supplier) |
| Receipt | The dealer receives the goods in Japan | Shipped directly from the supplier to the clinic |
| Stock in Japan | Kept in the dealer’s warehouse | None |
| Required | Marketing authorization holder license, approval for each product, drug sales license | Import confirmation (with every order, for products that require it) |
Penalties
- Marketing without a license (Art. 12) or without approval (Art. 14); selling without a license (Art. 24); importing without import confirmation (Art. 56-2)
- Imprisonment of up to 3 years, a fine of up to 3 million yen, or both (Art. 84)
- Advertising an unapproved drug (Art. 68)
- Imprisonment of up to 2 years, a fine of up to 2 million yen, or both (Art. 85)
What we follow
By the law,
one step at a time.
Our agreement with each medical institution (the import agency agreement) sets out the following.
- 01
We verify the doctor’s license
We check each doctor’s license with the license itself and the Ministry of Health, Labour and Welfare’s online license search.
- 02
An importer for every order
For every order, the clinic names the doctor who will use the products as the importer. The products are for diagnosing or treating that doctor’s own patients. Orders on behalf of other medical institutions aren’t allowed.
- 03
The sale is between the doctor and the supplier
We place orders and make payments on the doctor’s behalf. We are neither the seller nor the importer, and we never take ownership of the products.
- 04
Import confirmation for every order
For products that require import confirmation, we apply with every order under the authority given in the agreement. We prepare the application documents from the order details and the doctor’s registered information.
- 05
Shipped from abroad, straight to the clinic
Products ship directly from the supplier to the clinic. We never receive or store them.
- 06
We pass on safety information
If we learn of a recall, a suspension of use or other safety information about a product we imported on your behalf, we notify the clinics that ordered it right away. The notice sets this out as guidance for import agents (Part 3).
Laws and notices
Read the
original texts.
- Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act)Articles 12, 14, 24, 56-2, 68, 84 and 85 (e-Gov, Japanese)
- Guidance and enforcement regarding personal import agency businessesPFSB Notice No. 0828014, August 28, 2002 (Ministry of Health, Labour and Welfare, Japanese)
- Guidelines for Import Confirmation of PharmaceuticalsRevised by notice of June 30, 2025 (Ministry of Health, Labour and Welfare, Japanese)
- Customs checks for import rules under the PMD ActCustoms Answer 1805 (Japan Customs, Japanese)
- Medical license searchMinistry of Health, Labour and Welfare (Japanese)
This page explains the laws and notices in plain language and summarizes parts of them. The translations are ours. For the exact wording, please refer to the original Japanese texts.
New customers
Start using
our import service
Once we approve your membership application, we’ll guide you through the agreement and doctor registration.
Existing customers can log in to the ordering system.