我是否必须注册药品中使用的物质？

我是否必须注册药品中使用的物质？

Do I have to register substances used in medicinal products?

根据 REACH 法规第 2(5)(a) 条，在相关欧盟法规范围内用于人用或兽用药品的物质可免于 REACH 法规的注册标题（标题 II）。更多解释请参阅注册指南第 2.2.3.2 节“药品”：http://echa.europa.eu/guidance-documents/guidance-on-reach。符合 REACH 法规第 2(5)(a) 条条件的物质也可免于“下游用户、评估和授权”标题（法规标题 V、VI 和 VII）。重要的是，只有根据法规 726/2004、指令 2001/82 和指令 2001/83 用于药品的物质才可免于这些标题。用于其他用途的相同物质的数量不予豁免。豁免涵盖在欧盟境内生产出口药品中的物质；以及在欧盟出口药品法规范围内生产活性物质。豁免也适用于进口药品中的物质以及在欧盟药品法规范围内进口活性物质。药品中不存在的中间体（定义见第726/2004号法规、第2001/82号指令和第2001/83号指令）不予豁免注册。

According to Article 2(5)(a) of the REACH Regulation substances used in medicinal products for human or veterinary use within the scope of the relevant EU legislation are exempted from the Registration Title of the REACH Regulation (Title II). More explanation is provided for in Section 2.2.3.2- 'Medicinal products' of the Guidance on registration: http://echa.europa.eu/guidance-documents/guidance-on-reach. Substances fulfilling the conditions of Article 2(5)(a) of the REACH Regulation are also exempt from the Titles on Downstream Users, Evaluation and Authorisation (Titles V, VI and VII of the Regulation). Importantly, substances are exempted from these Titles only to the extent that they are used in medicinal products in accordance with Regulation 726/2004, Directive 2001/82 and Directive 2001/83. Quantities of the same substance used for other purposes are not exempted. The exemption covers the manufacture (in the EU) of substances in medicinal products that are exported; and the manufacture (in the EU) of active substances within the scope of EU legislation on medicinal products that are exported. The exemption also applies to imports of substances in medicinal products and imports of active substances within the scope of the EU rules on medicinal products. Intermediates that are not present in the medicinal product (as defined in Regulation 726/2004, Directive 2001/82 and Directive 2001/83) are not exempted from registration.