OTO No.615

OTO No.	615	Classification	MHW-254
Date of Acceptance	October 30, 2000	Respective Office Receiving Complaint	Cabinet Office (Economic Planning Agency)
Responsible Ministries	Ministry of Health, Labour and Welfare (Ministry of Health and Welfare)	Related Laws	Pharmaceutical Affairs Law
Complainant	European Business Community	Exporting Countries	Germany and France
Subject	Relaxation of regulations on import approval and item change approval for medical instruments
Description of Complaint	The complainant imports medical instruments from abroad. When importing new products, the complainant submits medical instrument import approval applications to the minister of health, labour and welfare through prefectural governments and medical instrument import item addition permit applications to prefectural governors. The minister of health, labour and welfare first issues import approvals and sends written approval to prefectural governments. In response, prefectural governments launch examinations regarding import item addition permits. They then issue written medical instrument import approvals and written medical instrument import item addition permits to applicants simultaneously. Therefore, prefectural governors give the permits five to eight days after import approvals by the minister of health, labour and welfare. During the period of five to eight days, import item addition permits do not exist in spite of existing import approvals, barring importers from marketing activities including advertisement and participation in biddings to effectively hamper business chances. As from August 1999, importers of medical instruments are required under "the Rules on Controls on Import and Sale, and Quality of Medical Instruments" (an ordinance of the Ministry of Health, Labour and Welfare) to control import and sale, and quality of medical instruments (GMPI on medical instruments). This means that prefectural governments check quality control before issuing medical instrument import item addition permits. As a result, the period between approval and permit issuance is expanding from the range of five to eight days. Accordingly, the complainant requests the Ministry of Health, Labour and Welfare to: (1) Allow importers to conduct marketing activities including advertisement and participation in biddings after the import approvals, and (2) Conclude an agreement for mutual recognition of medical instrument standards including quality control between Japan and Europe in order to simplify import approval examinations.
Details of Measures	The ministry replied as follows: (1) Advertisement before import approval could be false or exaggerated depending on details of approval, because applications may not necessarily be approved as submitted. Therefore, Article 68 of the Pharmaceutical Affairs Law bans advertisement of medical instruments before approval to forestall false or exaggerated advertisement. On the other hand, advertisement of medical instruments after approval is not banned under the law. As soon as import approval is given, applicants are allowed to conduct marketing activities including advertisement and participation in biddings. (2) The mutual recognition agreement involves government-to-government negotiations between Japan and the European Commission. We here only take note of the request.
Status of Processing	Processed (November 24, 2000)	Classification of Action	Ca for (1) D for (2)
Remarks	A written reply was made on November 24, 2000.