Annex 3附录.docVIP

Annex 3 附录三 Procedure for prequalification of pharmaceutical Products 药品预认证程序 1. Introduction 介绍 2. Glossary 术语 3. Purpose and principles 目的及原则 4. Steps of the procedure 预认证步骤 5. Invitation for expressions of interest 意向书邀请 6. Data and information to be submitted 提交日期和信息 7. Screening of dossiers submitted 所申报品种技术资料的筛选 8. Dossier assessment 所申报品种技术资料评估 9. Site inspection 现场检查 10. Reporting and communication of results of the evaluation 评估结果报告及讨论 11. Outcome of the prequalification procedure 预认证结果 12. Maintenance of prequa