Requesting a copy of the counterparty’s licence before starting business is standard practice when pharmaceuticals or medical devices are involved. What is less often shared is what to look at once it arrives. A licence certificate is a single sheet of paper, but every field on it bears directly on whether a given transaction is permitted.
1. Category — the same word “pharmaceutical”, different systems
Start with the heading. A wholesale distribution licence (医薬品卸売販売業許可証) and a store-based retail licence (医薬品店舗販売業許可証) are different licences. The former permits supply to pharmacies, hospitals and other businesses; the latter permits sale to general consumers.
If you intend your product to reach medical institutions, your counterparty needs the wholesale licence. Reading a store-based retail certificate and concluding “they hold a pharmaceutical licence” will not get your product to the channel you have in mind.
2. Scope of products — this determines what can be handled
Toward the foot of the certificate is the scope of products covered (取扱品目). In practice this is the field most often overlooked.
| Wording | Meaning |
|---|---|
| All prescription, guidance-required and OTC drugs | Full range, including prescription medicines |
| All guidance-required and OTC drugs | Excludes prescription medicines |
| Excluding Class 1 drugs | Restricted scope |
“We hold a pharmaceutical licence” does not tell you whether prescription medicines may be handled. Only the scope field answers that.
3. Validity — these licences are renewed
A pharmaceutical distribution licence is renewed every six years. The certificate states the period explicitly, from one date to another.
If you are planning a relationship spanning several years, the remaining term is worth checking. Renewal is routine, but an unrenewed licence number becomes an invalid number. Where a long-term contract would cross the expiry date, confirming the renewal plan avoids a later discrepancy.
4. Issuing authority — prefectural governor or city mayor
The issuing authority varies by licence type. Wholesale distribution is issued by the prefectural governor; store-based retail and highly-controlled medical device licences may be issued by the mayor of a city with its own public health centre.
A difference in issuing authority is not in itself a problem. What matters is whether the address on the certificate matches the premises you will actually transact with. Pharmaceutical distribution licences are granted per business premises. A head office holding a licence does not cover shipments dispatched from a different site.
Medical devices come on a separate certificate
Where medical devices are involved, a different certificate applies, because the required procedure changes with the device class.
- Highly-controlled medical devices (Classes III and IV) and specially-designated maintenance devices … a licence is required
- Controlled medical devices (Class II) … a notification is required
- General medical devices (Class I) … no distribution procedure is required
A track record of “handling medical devices” therefore does not establish eligibility to handle highly-controlled devices — the products may have been Class I. A licence and a notification are procedures of different weight.
Questions to settle
- Does the category of licence match the customers you intend to reach?
- Does the scope of products include your product’s classification?
- Does the validity period cover the intended term of business?
- Is the address shown the premises that will actually ship?
- If medical devices are involved, is there a licence or notification matching the class?
This is not an exercise in distrust. For both sides, the costliest outcome is discovering after the fact that the transaction was not permitted. It is a few minutes of checking before business begins.
INCAPE holds a wholesale distribution licence for pharmaceuticals (Osaka Prefecture, No. B14657), a licence for the sale and lease of highly-controlled medical devices (City of Osaka, No. 21N00270) and a store-based retail licence for pharmaceuticals (City of Osaka, No. 21V00061). Copies of the certificates are available on request.
