Provisional Translation
| OTO No. | 83 | Classification | MHW-68 |
|---|---|---|---|
| Date of Acceptance | November 25, 1982 | Ministry/Agency Receiving Complaint | Ministry of Foreign Affairs |
| Responsible Ministries | Ministry of Health and Welfare | Related Laws | The Pharmaceutical Affairs Law Health Insurance Law |
| Complainant | Yugoslav firm | Exporting Countries | Yugoslavia |
| Subject | Expeditious issuance of import approval of metoo drugs (later-developed medicines which is identical to the already approved medicines), prompt adoption of these drugs in the medical insurance system, and acceptance of the foreign test data. | ||
| Details of Measures | Reply was made as follow: 1. Although annual applications for the approval of medicines have increased in number, efforts are made to dispose them promptly. No distinctions between home and foreign made medicines are made in disposing them. 2. The metoo drugs, whether it is home or foreign made, are not adopted in the medical insurance system immediately after its individual approval, as their necessity is relatively small from medical point of view. 3. The foreign test data are acceptable if they comply with the GLP standards. |
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| Classification of Processing | 1. Cc 2. Cc 3. Ca |
Directions | 1. II-a 2. II-b 3. II-a |
| Remarks | |||