送往欧盟进行包装的桶装药片是否被视为“处于成品状态并供最终用户使用”，因此可免于遵守 CLP 法规第 1(5)a 条？

送往欧盟进行包装的桶装药片是否被视为“处于成品状态并供最终用户使用”，因此可免于遵守 CLP 法规第 1(5)a 条？

Are medicine tablets in a drum being sent to the EU for packaging considered to be "in the finished state and intended for the final user" and therefore exempted from Article 1(5)a of the CLP Regulation?

是的。根据关于人用药品共同体法规的指令 2001/83/EC，药片如果处于成品状态，则属于药品，不受 CLP 法规条款的约束。药品的成品状态与物质或混合物有关，而与其包装无关，因为重新包装药片不会改变物质/混合物。因此，生产后不会改变的散装药片将被视为供最终用户使用的成品状态。因此，既不需要根据 CLP 对这些散装药片进行分类、贴标签和包装，也不需要将其通知 C&L 库存。但是，有必要考虑工人的健康和安全，以确保在转移和包装阶段安全处理这些散装药片，直到它们以适当的包装和适当的安全使用说明到达最终用户。

Yes they are. According to Directive 2001/83/EC on the Community code for medicinal products for human use, medicine tablets are medicinal products and exempted from the provisions of the CLP Regulation if they are in the finished state. The finished state of the medicinal product relates to the substance or mixture and not to its package since re-packing the tablets does not alter the substance/mixture.Bulk tablets that will not be altered after having been produced are therefore considered in the finished state intended for the final user. Therefore, it is neither necessary to classify, label and package these bulk tablets according to CLP nor to notify them to the C&L inventory.   However, it will be necessary to take worker health and safety considerations into account to ensure the safe handling of these bulk tablets during the transfer and packaging stages, until they reach the final user in the appropriate package with appropriate safe use instructions.