Provisional Translation
| OTO No. | 302 | Classification | MHW-157 |
|---|---|---|---|
| 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 | Elimination of the import approval product-by-product requiring only import sales licenses, concerning the import of pharmaceutical ingredients (except for new drugs) | ||
| Details of Measures | It was explained that the specifications and testing methods for effective ingredients are stipulated and approval is required to ensure final product quality, but that approval is not required for ingredients that have long been in widespread use and that are listed in the Japanese Pharmacopoeia quality standards, and that the only legal requirement in this case is that they meet the Japan Pharmacopoeia quality standards. It was also explained that the common international practice is to require the exporting country to certify quality and that study is being given to this issue by the World Health Organization (WHO) in light of the desirability of enabling the exporting country to certify quality for pharmaceutical ingredients. |
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| Classification of Processing | D | Directions | II-a |
| Remarks | |||