Provisional Translation

OTO No. 194 Classification MHW-123
Date of Acceptance March 27, 1985 Ministry/Agency Receiving Complaint Economic Planning Agency
Responsible Ministries Ministry of Health and Welfare Related Laws The Pharmaceutical Affairs Law
Complainant Israeli firm Exporting Countries Israel
Subject Concerning the import of the pregnancy test kits, simplification of the import procedure and propriety of its sale for household use.
Details of Measures 1. Procedure for approval and examination of the in vitro diagnostic reagents, in which this product is categorized, was expedited and simplified (July 31, 1985).
2. Regarding their sale, our principles of dealing with these reagents were explained to the complainant.
Classification of Processing 1. A
2. Cc
Directions II-a
III
Remarks 1. Improvement measures were taken on July 31, 1985.

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