Importing drugs is regulated by the Pharmaceutical Affairs Law which covers “manufacture and sale,” “production,” “marketing,” and “advertising” of pharmaceuticals, quasi-drugs, medical devices, and cosmetics.
Pharmaceuticals and Quasi-drugs
1 Importation as a Business
In the case of importing pharmaceuticals and quasi-drugs as a business and selling them in Japan:
- The business operator conducting the importation is required to obtain a manufacturing and sales license.
- Those who intend to manufacture pharmaceuticals and quasi-drugs imported into Japan from foreign countries need to be certified as foreign manufacturers for each manufacturing site.
- If there is a business operator who manufactures label replacement for Japanese text labeling in Japan, a manufacturing license is required for the business operator who replaces the label.
- It is necessary to obtain approval for the drug or quasi-drug itself. However, drugs and quasi-drugs that are designated by the Minister of Health, Labor and Welfare based on established standards do not require approval, but instead require notification of manufacture and sale.
- Manufacturers and sellers are required to submit notifications and publicize the information contained in the attached documents.
2 Imports other than for Business Purposes
In cases such as (1) importation for personal use, (2) personal importation by a physician or dentist for treatment, and (3) importation for use in clinical trials conducted primarily by a physician or dentist, importation of drugs is possible without approval. In such cases, import verification is required.
However, importation for personal use of: ①(i) topical medicines in quantities of 24 or less; (ii) poisonous, deleterious, or prescription medicines in quantities of 1 month; and (iii) other medicines in quantities of 2 months and ②(i) quasi-drugs in topical form not exceeding 24 units, and (ii) quasi-drugs not exceeding 2 months’ supply, does not require Import verification as well.
3 Prohibition of Importation
The importation of defective drugs and quasi-drugs is prohibited, whether as a business or personal import.
4 Prohibition of Advertising
It is illegal for foreign distributors to advertise unapproved/unauthenticated drugs on drug sales websites, even to those in Japan. In many cases, advertising by import agents is also illegal.
Please contact us if you have any questions.