Provisional Translation
OTO No. | 299 | Classification | MHW-154 |
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Date of Acceptance | August 7, 1987 | Ministry/Agency Receiving Complaint | Economic Planning Agency |
Responsible Ministries | Ministry of Health and Welfare | Related Laws | The Pharmaceutical Affairs Law |
Complainant | Keidanren (proxy complaint) | Exporting Countries | |
Subject | Automatic import approval for pharmaceutical products that are not listed in the Japanese pharmacopoeia when their ingredients meet the foreign pharmacopoeia standards and the finished product meets the Japanese approval standards. | ||
Details of Measures | It was explained that important ingredients in common use are listed in the Japan Pharmacopoeia with a view to ensuring final product quality, and that it is necessary in approving products containing ingredients listed in the Japan Pharmacopoeia to confirm that said ingredients conform to the Japan Pharmacopoeia. | ||
Classification of Processing | D | Directions | II-a |
Remarks |