| TOP |
| 5th Report of Market Access Ombudsman Council (March 17, 1998) |
1. Complainant: U.S. Chamber of Commerce in Japan
2. Ministry concerned: Ministry of Health and Welfare
3. Complaint:
For the antiseptic solution used in piercing, import approval as a pharmaceutical used in treating wounds must be obtained. However, without obtaining the import approval, some enterprises in Japan are importing and selling this antiseptic solution within Japan as a quasi-drug, in violation of Articles 13, 23, and 59 of the Pharmaceutical Affairs Law.
Or, they obtain approval for its use solely on the ears and market self-piercing as body piercing.
Sanctions should be brought against this type of illegal marketing of pharmaceuticals, etc., and the law enforced fairly.
4. Corresponding Policy of the Ministries concerned:
The Pharmaceutical Affairs Law regulates the manufacture and distribution of pharmaceuticals, quasi-drugs, cosmetics, and medical devices.
For example, under Article 22 of the Pharmaceutical Affairs Law, a party attempting to engage in the import of pharmaceuticals, quasi-drugs, cosmetics, and medical devices as a business would need the license of the Minister of Health and Welfare (or the prefectural governor). Moreover, this license would be required for each sales office, and if it were not renewed within the period stipulated in the government ordinance, it would become invalid once said period has elapsed.
Based on this ordinance, the Minister of Health and Welfare (or the prefectural governor) strictly handles any acts in the manufacture and distribution of pharmaceuticals, quasi-drugs, cosmetics, and medical devices that are in violation of the Pharmaceutical Affairs Law.
This time we will conduct an investigation to determine if the brokers indicated are actually in violation of the law and will handle the matter accordingly.
5. Remarks
The complainant's opinion is as follows:
"I understand that this is the policy as it now stands."