哪些药品中使用的物质无需注册？

哪些药品中使用的物质无需注册？

Which substances used in medicinal products are exempted from registration?

当某种物质用于以下任一范围的药品中：《关于授权和监督人用和兽用药品以及建立欧洲药品管理局的共同体程序的法规》（(EC) No 726/2004）；或《关于兽药产品的共同体法规指令》（2001/82/EC）；或《关于人用药品的共同体法规指令》（2001/83/EC）；则该物质无需根据 REACH 注册。该豁免不区分活性成分或非活性成分，因为它适用于任何“用于药品的”物质。因此，药品中使用的辅料也免于注册。用于药物以外其他用途的相同物质的数量不予豁免。只有药品中使用的物质的数量才免于注册义务。更多信息，请参阅注册指南第 2.2.3.2 章：http://echa.europa.eu/documents/10162/13632/registration_en.pdf

When a substance is used in a medicinal product within the scope of either: The Regulation on Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency ((EC) No 726/2004); or The Directive on the Community code relating to veterinary medicinal Products (2001/82/EC); or The Directive on the Community code for medicinal products for human use (2001/83/EC); the substance does not have to be registered under REACH for that use. The exemption does not distinguish between active or non-active ingredients as it applies to any substance ‘used in medicinal products'. Excipients used in medicinal products are therefore also exempted from registration. Amounts of the same substance used for other uses than pharmaceuticals are not exempted. Only the amounts of the substance used in medicinal products are exempted from the registration obligation. For further information, see chapter 2.2.3.2 of the Guidance on registration: http://echa.europa.eu/documents/10162/13632/registration_en.pdf