新的《医药产品退货处理要求》，交付超30天的退货不允许重新销售！

近日，瑞士药监局发布了“医药产品退货要求”（I-SMI.TI.28e）的技术指南。该文件自2025年6月30日起生效。该文件规定了处理医药产品退货的最低要求，特别是关于产品交付和退货之间必须遵守的时间限制。

关键点归纳如下：

在交货后10天内的退货可以通过常规程序接受。

超过10天但在30天内的退货必须证明是合理的退货，而不是零售商转售给批发商的退货（例如，由于库存清仓）。不允许出于库存清仓原因退回已售出的产品。超过30天的退货通常不再符合GDP要求，这通常是不允许的。只有在特殊情况下才能重新进入可销售库存，并应作为偏差管理的一部分。

FDA 关于退货的GMP问答：

What should a firm do if its drug products or components have been subjected to improper storage conditions such as those caused by a natural disaster?

如果公司的药品或组分受到不当储存条件的影响，例如由于自然灾害，公司应该怎么做？

Drug products that have been subjected to improper storage conditions (including extremes in temperature, humidity, smoke, fumes, pressure, age, or radiation) due, for example, to natural disasters, fires, accidents, or equipment failures shall not be salvaged and returned to the marketplace. Such exposure can pose a serious risk to a drug’s identity, strength, quality, purity or safety (see 21 CFR 211.208). This fundamental CGMP principle applies to any component, in-process material, or finished drug product subjected to such conditions. In some cases, there may be substantial and reasonable uncertainty whether a drug was subjected to these conditions. In such a circumstance, it is essential that a firm nonetheless err on the side of caution in its risk assessment to ensure an appropriate lot disposition decision and conduct a rigorous evaluation in accordance with the standards described under § 211.208. When there is reasonable uncertainty whether a drug was subjected to such conditions, salvaging operations may be conducted only if there is evidence from laboratory testing that the drugs meet all applicable standards of identity, strength, quality, and purity, and from inspection that the drugs and their associated packaging were not subject to improper storage conditions as a result of the disaster or accident. When determining whether drugs have been subjected to such improper conditions, a firm’s actions should include but not be limited to:

例如，由于自然灾害、火灾、事故或设备故障而遭受不当储存条件（包括极端温度、湿度、烟雾、压力、老化或辐射）的药品不得挽救（返工或重新加工）并返回市场。这种接触可能对药物的特性、强度、质量、纯度或安全性构成严重风险（参见21 CFR 211.208）。这一基本的CGMP原则适用于受此类条件影响的任何组分、中间产品和成品。在某些情况下，药物是否受到这些条件的影响可能存在实质性和合理的不确定性。在这种情况下，公司必须在风险评估中谨慎行事，以确保做出适当的批处置决定，并根据 §211.208中描述的标准进行严格的评估。当有理由不确定某种药物是否受到此类条件的影响时，只有在实验室检测证据表明该药物符合所有适用的特性、剂量、质量和纯度标准，并且检查表明该药物及其相关包装没有因灾害或事故而受到不当储存条件的影响时，才能进行（返工或重新加工）。在确定药物是否受到此类不当条件的影响时，公司的行动应包括但不限于：

Obtaining supply chain information, including knowing the names and addresses of all suppliers and distributors of a drug (including components and packaging) to determine if there is a reasonable possibility that such materials were stored under improper conditions.

获取供应链信息，包括了解药品（包括组件和包装）的所有供应商和分销商的名称和地址，以确定此类物料是否有可能在不当条件下储存。Determining details such as the time frame, duration, nature, scope, and location of exposure as well as identity of all lots potentially subjected to the improper conditions (e.g., ramifications of a natural disaster such as power disruptions should be considered to ensure a complete risk assessment).

确定细节，如时间范围、持续时间、性质、范围和暴露的地点，以及可能受到不当条件影响的所有批次（例如，应考虑电力中断等自然灾害的后果，以确保进行完整的风险评估）Obtaining certification (either on the certificate of analysis or as a separate statement) declaring that drug lots, including components and packaging, were not subjected to improper storage conditions.

获得认证（在分析证书上或作为单独的声明），声明药品批次（包括组件和包装）没有受到不当储存条件的影响。

WHO GOOD STORAGE AND DISTRIBUTION PRACTICES FOR MEDICAL PRODUCTS

WHO医药产品的良好储存和分销指南

Returned medical products should be handled in accordance with authorized procedures.

退回的医药产品应按照批准的程序处理。

All returned medical products should be placed in quarantine upon receiving. The status of the goods should be clear. Precautions should be taken to prevent access and distribution until a decision has been taken with regard to their disposition. The particular storage conditions applicable to the medical products should be maintained.

所有退回的医药产品在收到后都应进行隔离。货物的状态应清晰。应采取预防措施防止进入和分发，直到对其处置做出决定。应保持适当的储存条件。

Medical products returned should be destroyed unless it is certain that their quality is satisfactory after they have been critically assessed in accordance with a written and authorized procedure.

退回的医药产品应予以销毁，除非在按照批准的书面程序进行严格评估后确定其质量令人满意。

The nature of the medical product, any special storage conditions it requires, its condition and history and the time lapse since it was issued, should all be taken into account in this assessment. Where any doubt arises over the quality of the medical product, it should not be considered suitable for reissue or reuse. Any action taken should be appropriately recorded.

评估应考虑医药产品的性质、所需的任何特殊储存条件、状况和历史以及自签发以来的时间间隔。如果对医药产品的质量产生任何疑问，则不应认为它适合重新销售或重复使用。所采取的任何行动都应被适当记录下来。

When handling returned goods, the following considerations at least should be taken:

在处理退货时，至少应考虑以下因素：

A risk-based process should be followed when deciding on the fate of the returned goods. This should include, but not be limited to, the nature of the product, storage conditions, condition of the product history, time-lapse since distribution and the manner and condition of transport while being returned.