Unapproved drug / off label use / genuine

Unapproved drugs are drugs that are approved and sold overseas but not approved or sold in Japan. Unapproved drugs include drugs that have not been approved both overseas or in Japan. Off-label drugs are drugs that are approved and sold both in Japan and overseas, but have different indications and cannot be used for some indications in Japan.

There are some problems with medical drugs that are not unapproved drugs or off-label drugs with high medical need, but are personally imported (including import agency) or personally imported by a drug supervision certificate obtained by a doctor.

1 Risk of counterfeit products
2 Risk of infringement of copyright and sales rights
3 Contents that may cause health damage
4 There is another risk if illegal drugs are mixed in the contents
5 When there is side effect damage Drug side effect damage relief system is not covered
6 Transportation costs are high if you think about it
7 Risk of secondary use damage such as credit cards

There is no regular expression called genuine. Since it is used to mean that it was obtained through the regular route, Japanese residents will be required to prescribe it from Japanese medical institutions and prescription pharmacies. Purchases made through overseas online pharmacies or import agents are non-regular routes. Even if there are reimported products, 100% of them will be obtained through non-regular routes because they will be expensive. Regarding the expression of approved drug, it means overseas approved drug or approved drug (domestic). The purpose is to explain in an easy-to-understand manner when used by medical institutions and pharmacies. It may be used by mail-order companies (import agents), but the intention is that the content content is the same. This is because even if the name, content, and content are the same, it cannot be described as an approved drug unless the manufacturer and distributor approved in Japan are the same. Even if they seem to be the same drug, the phytotoxicity relief system cannot be used.

Confirmation of approved / unapproved drugs

Medical drug information search  
If the search results cannot be confirmed, it is an unapproved drug.

Related information

Difference between free medical care and insurance medical care
What is drug price standard unlisted?
Prescription drug personal import is dangerous

Precautions regarding personal imports – Ministry of Health, Labor and Welfare

for guidance and enforcement of personal import agency business
the Ministry of Health, Labor and Welfare pharmaceutical Director pharmaceutical onset No. 0828014
for Internet sales of OTC drugs
Ministry of Health, Labor and welfare pharmaceutical and food Safety Bureau, Department