Regulations related to Importing Drugs

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:

  1. The business operator conducting the importation is required to obtain a manufacturing and sales license.
  2. 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.
  3. 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.
  4. 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.
  5. 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.