Provisional Translation

OTO No. 299 Classification MHW-154
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

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