Provisional Translation
| OTO No. | 177 | Classification | MHW-116 |
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| Date of Acceptance | March 15, 1985 | Ministry/Agency Receiving Complaint | Economic Planning Agency |
| Responsible Ministries | Ministry of Health and Welfare | Related Laws | The Pharmaceutical Affairs Law |
| Complainant | Domestic firm | Exporting Countries | |
| Subject | Concerning drugs, etc., 1. Expansion of the scope of delegation of the authority to approve of them to the prefectural governors. 2. Simplification and expediting of the cosmetics licensing procedures. 3. Concerning the examination of the new drugs, etc., clarification of the instructions and expediting of the examination at the Central Pharmaceutical Affairs Council. |
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| Details of Measures | 1. Reply was made that the scope of delegation of the authority to approve of the manufacture or import of drugs, etc. to the prefectural governors would be expanded to expedite the examination procedure. 2. Reply was made that, concerning the licensing procedures for permission of the cosmetics, the flexibility of the compounding ratio of ingredients such as pigments would be allowed and the application documents would be simplified when the same importer applies for the license for importing the cosmetics with the same prescription from plural business offices. 3. Reply was made that concerning the examination at the Subcommittee on New Drugs, etc. of the Central Pharmaceutical Affairs Council, such measures for improvement that the instructions common to the manufactures and importer were published as a guide book had been taken, and in addition, such measures for improvement that applicant companies could hear the instructions directly from the committeemen and make comments to them after the Committee was closed would be taken. |
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| Classification of Processing | 1. A 2. A 3. A, A |
Directions | 1. III 2. II-a 3. I-b, II-a |
| Remarks | 1.2. Improvement measures were taken on April 1, 1985. 3. Improvement measures were taken on July 1, 1985. |
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