Provisional Translation

OTO No. 148 Classification MHW-97
Date of Acceptance May 24, 1984 Ministry/Agency Receiving Complaint Ministry of Foreign Affairs
Responsible Ministries Ministry of Health and Welfare Related Laws The Pharmaceutical Affairs Law
Complainant German firm Exporting Countries Germany
Subject Concerning the import of cosmetics, propriety of foreign manufacture obtaining directly the manufacturers license under the Pharmaceutical Affairs Law, instead of the importers making application for the license.
Details of Measures 1. It was explained to the complainant that, through revision of the Pharmaceutical Affairs Law, it had been permitted for foreign manufacturers to obtain directly the approval to manufacture drugs etc. including the cosmetics containing hormones to be imported to Japan, but concerning the other cosmetics, the approval was unnecessary, and that they could be imported through simpler procedures than drugs.
2. It was further explained to the complainant that it was not permitted, as in the case of drugs, for foreign manufacturers to obtain directly the manufacturing license of cosmetics, because performance of their obligations under the Pharmaceutical Affairs Law can not be made sure as it is difficult to supervise their foreign factories at all times like the domestic factories, and it is impossible to apply to them any administrative measures or penalty against any violation of the Pharmaceutical Affairs Law, and that therefore the importer's application for the license is necessary for the import of any cosmetics.
Classification of Processing 1. Cc
2. Cc
Directions 1. I-b
2. I-b
Remarks

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