Provisional Translation

OTO No. 307 Classification MHW-162
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 Concerning import inspections for pharmaceutical and other products, exemption from submission of test results for every lot when a comprehensive report is submitted on inspection procedures and results.
Details of Measures It was explained that although current regulations require the pharmaceutical product importer and seller to conduct tests on each lot of imported pharmaceutical products prior to their sale and to submit the results and other documentation to a pharmaceutical official promptly, this is being changed to henceforth require only a report on comprehensive tests that were conducted in place of individual-lot test results.
Classification of Processing A Directions II-a
Remarks Improvement measures were taken on September 17, 1987.

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