Provisional Translation
| OTO No. | 391 | Classification | MHW-190 |
|---|---|---|---|
| Date of Acceptance | January 17, 1990 | 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 | India |
| Subject | Concerning the import procedures for a hair dye, 1. Clarification of the procedures for quasi-drugs. 2. Reduction of the inspection time period and expense for quasi-drugs. |
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| Details of Measures | 1. The sale of products professing to have a hair-dying effect such as this one is subject to the Pharmaceutical Affairs Law. Those that produce their effect with a chemical reaction are treated as quasi-drugs and those that produce their effect with a physical process such as painting are treated cosmetics. In importing quasi-drugs, it was replied, each product requires the approval of the Ministry of Health and Welfare under the stipulations of Article 14 of the Pharmaceutical Affairs Law and each importing office requires import licensing from the Ministry of Health and Welfare under the stipulations of Article 12 of the Pharmaceutical Affairs Law. It was further suggested that the complainant consult the textbook for applying for manufacturing or importing permission for quasi-drugs published in Japanese. 2. It was replied that, in applying for approval for a quasi-drug, documentation will be required testifying to the product's safety and effectiveness. The costs of application, it was explained, are as set by the regulations. |
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| Classification of Processing | 1. D 2. D |
Directions | 1. I-b 2. II-a |
| Remarks | |||