Provisional Translation
| OTO No. | 450 | Classification | MHW-212 |
|---|---|---|---|
| Date of Acceptance | June 28, 1991 | Ministry/Agency Receiving Complaint | Economic Planning Agency |
| Responsible Ministries | Ministry of Health and Welfare | Related Laws | The Pharmaceutical Affairs Law |
| Complainant | The American Chamber of Commerce in Japan (proxy complaint) | Exporting Countries | USA |
| Subject | Simplifying approval for quasi-pharmaceuticals | ||
| Details of Measures | Under the Pharmaceutical Affairs Law, the only process allowed to be carried out in manufacturing under contract of quasi-pharmaceuticals is the filling with aerosol propellant and so on. This complaint is about expanding the scope of manufacturing under contract for medicated cosmetics, which are a quasi-pharmaceutical. However, since manufacturing is carried out in more than two separate locations, the incomplete product could be contaminated during transport, and in such cases it tends to be unclear which party bears responsibility for the product. Accordingly, only the filling with aerosol propellant, which requires a specialized manufacturing process, is allowed. Limitations on manufacturing under contract for quasi-pharmaceuticals are in place for the above reasons, and the ministry replied that it would undertake a review of these limitations only after guidelines for manufacturing and quality control of quasi-pharmaceuticals had been drawn up and adhered to. |
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| Classification of Processing | Cc | Directions | II-a |
| Remarks | |||