Provisional Translation
| OTO No. | 303 | Classification | MHW-158 |
|---|---|---|---|
| Date of Acceptance | August 7, 1987 | Ministry/Agency Receiving Complaint | Economic Planning Agency |
| Responsible Ministries | Ministry of Health and Welfare | Related Laws | The Pharmaceutical Affairs Law |
| Complainant | Keidanren (proxy complaint) | Exporting Countries | |
| Subject | Permission to entrust tests except for organoleptic examination as required for the import/sale of pharmaceutical products to other testing institutions. | ||
| Details of Measures | It was explained that it is not felt appropriate to subcontract import pharmaceutical quality assurance testing, including routine testing, to outside testing agencies because this might allow a situation in which it was impossible to ensure pharmaceutical product quality. However, it was also explained that it has been confirmed that there is no health and hygiene impediment to allowing out-contracting of very unusual or specialized tests, that out-contracting to an affiliate or other testing organization would be allowed, and that import would be approved. |
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| Classification of Processing | D | Directions | II-a |
| Remarks | |||