WHO TRS 1025 附录8 医用产品送达时剩余货架期
设定医用产品送达时剩余货架期的考量要点
1. Introduction 概述
2. Scope 范围龙魔
3. Glossary 术语
压耳式耳机4. The need for recommendations 建议需求
5. Remaining shelf-life 剩余货架期
References 参考文献
Further reading 扩展阅读
Appendix1 Example of minimum remaining shelf-life of medical products
附录1 医用产品最短剩余货架期举例
1. Introduction 概述
Following discussions relating to establishing a document for the remaining shelf- life of medical products upon delivery, and considering the discussion between the Interagency Pharmaceutical Coordination group (IPC) reprentatives, it was decided to initiate a project to establish a document on remaining shelf-life for procurement and supply of medical products.
在讨论了为药品送达时剩余货架期制订一份文件，并考虑了机构间药品合作组（IPC）代表之间的讨论后，我们决定启动一个项目，制订一份关于医用产品采购和供应中剩余货架期的文件。
The concept and project to establish such a document was also discusd during the meeting of the Fifty-third Expert Committee on Specifications for Pharmaceutical Products (ECSPP) in October 2018. It was noted that some guidance documents were available from different procurement agencies. It was agreed that the World Health Organ
ization (WHO) would initiate the discussion and preparation of a document, while following the WHO process for the establishment of such a paper.
在2018年10月药品专家委员会（ECSPP）第53次会议中，也讨论了制订这样一份文件的概念和项目。我们注意到不同采购机构有一些指南文件。在执行了WHO起草此类报告的程序之后，我们一致同意WHO应开始讨论并起草一份文件。
Information and policy on remaining shelf-life was collected from different agencies and interested parties and a first draft document was prepared after an informal discussion meeting in Geneva, Switzerland, in January 2019.
喜旱莲子草
我们从不同机构和有关当事方采集了关于剩余货架期的信息和政策，并在2019年1月瑞士日内瓦的正式讨论会议之后起始了第一份草案。
It was then agreed that the document should not cover only finished pharmaceutical products but should be extended to also cover other products, including, but not limited to, medical devices, vaccines and in vitro diagnostics (IVD) products. (The products are collectively referred to as “medical products” hereafter.)
然后我们认为该文件应不仅仅包括制剂药品，还应扩展至其它产品，包括但不仅限于医疗器械、疫苗和体外诊断试剂（IVD）产品。（下文中这些产品统一称为“医用产品”）
沙发家具A draft document was prepared and circulated to IPC members, as well as other interested parties, inviting comments. The comments received were reviewed during an informal discussion meeting in June 2019 and the draft document was updated.
草案起草之后交IPC成员和其它有关当事方传阅以征求意见。在2019年6月的正式讨论会议中，我们对所收到的建议进行审核，更新了草案。自然风险
The aims of this document are: 本文件目的在于：
■ to facilitate the national authorization of importation of medical products where applicable;
■ 便于国家批准医用产品进口（适用时）；
■ to promote and support the efficient processing of medical products in the supply chain at all levels and thus prevent wastage becau of delays;
小班教学计划
■ 促进和支持供应链中医用产品在各层次的高效处理，从而防止因延误引起的浪费；
■ to assist in ensuring that there is sufficient stock of medical products, with acceptable remaining shelf life,in-country;
■ 有助于确保在国家内具备足够数据在可接受剩余货架期的医用产品库存；
赤豆小元宵■ to prevent dumping of medical products;
■ 防止医用产品倾销；
■ to ensure that barriers to access and supply of medical products are addresd;
■ 确保解决医用产品获取和供应障碍；
■ to prevent out-of-stock situations;
配料大全■ 预防库存不足；
■ to prevent receipt of donations of medical products that are not in accordance with thi
s guideline; and
