药品是否需要进行分类并通知分类和标签清单？

药品是否需要进行分类并通知分类和标签清单？

Will medicinal products need to be classified and notified to the Classification and Labelling Inventory?

处于成品状态并打算供最终用户使用的物质和混合物，以及属于关于人用药品共同体法规的 2001/83/EC 指令范围内的药品或属于关于兽药共同体法规的 2001/82/EC 指令范围内的兽药，总体上不受 CLP 法规条款的约束，即它们不必进行分类、包装、贴标签和向 C&L 清单进行通报。但是，如果制造商或进口商供应尚未处于成品状态的物质和混合物，例如活性药物成分 (API) 或辅料，则该制造商或进口商必须根据 CLP 对这些物质和混合物进行分类、包装和贴标签。此外，如果这些物质投放市场，还必须向 C&L 清单进行通报。 CLP 法规条款的豁免并不区分活性和非活性药物成分：它适用于药品中使用的任何物质或混合物，例如赋形剂，这些物质或混合物处于成品状态并用于药用。

Substances and mixtures which are in the finished state and intended for the final user and which are medicinal products within the scope of Directive 2001/83/EC on the Community code for medicinal products for human use, or veterinary medicinal products within the scope of Directive 2001/82/EC on the Community code relating to veterinary medicinal products are on the whole exempted from the provisions of the CLP Regulation, i.e. they do not have to be classified, packaged, labelled and notified to the C&L Inventory.   However, in cases where a manufacturer or importer supplies substances and mixtures, e.g. active pharmaceutical ingredients (APIs) or excipients, that are not yet in the finished state, this manufacturer or importer will have to classify, package and label these substances and mixtures in accordance with CLP. In addition, if these substances are placed on the market, they will also have to be notified to the C&L Inventory.   The exemption from the provisions of the CLP Regulation does not distinguish between active and non-active pharmaceutical ingredients: it applies to any substance or mixture used in medicinal products, e.g. excipients, which is in the finished state and intended for pharmaceutical use.