人用药品中使用的原料药流通质量管理规范基本原则指南
（徐禾丰翻译）
Ref. Ares(2019)148102 - 05/02/2019
参考编号(2019)148102-2019年02月05日
EUROPEAN COMMISSION
欧盟委员会
HEALTH AND CONSUMERS DIRECTORATE-GENERAL
健康与消费者总司
Health Systems and Products
健康体系与产品
Medicinal Products - Quality, safety and efficacy
第 1 页
药品-质量、安全性与有效性
Brussels,
布鲁塞尔，
SANCO/D/6/SF/mg/ddg1.d.6(2019)179367
GUIDELINES ON THE PRINCIPLES OF GOOD DISTRIBUTION PRACTICES FOR ACTIVE SUBSTANCES FOR MEDICINAL PRODUCTS FOR HUMAN USE
人用药品中使用的原料药流通质量管理规范基本原则指南
DRAFT SUBMITTED FOR PUBLIC CONSULTATION
用于公共征求意见的草案
Stakeholders are invited to comment on this draft by 30 April 2019 at the latest.Responses should be sent preferably by e-mail to sanco-pharmaceuticalsd6@ec.europa.eu, or by post to Unit SANCO/D/6, DM24 02/050, BE-1049 Brussels.
第 2 页
诚邀各利益相关方于2019年4月30日前将对本草案的意见发送至邮箱sanco-pharmaceuticalsd6@ec.europa.eu，或用信函邮寄至Unit SANCO/D/6, DM24 02/050, BE-1049 Brussels。
When sending your comments and responses, you should state whether you are a stakeholder association or a private individual. If you represent an association, pleaseindicate clearly what type of association this is (active substance manufacturer, medicinal products manufacturer, importer etc.). If you represent a company, please state whether itfalls within the EU definition of a small and medium-sized enterprise (i.e. less than�50million annual turnover and fewer than 250 employees).
当回复意见时，请注明您是利益相关的社会团体或是个人。如果您代表社会团体，请明确注明类型(原料药制造商、药品制造商、进口商等)。如果您代表公司，请注明其是否属于欧盟定义的中小企业(即，年营业额小于5千万欧圆且雇员少于250人)。
All comments and responses will be made publicly available on the ‘Europa website’ on pharmaceuticals once the consultation period is over. If you do not wish yourcontribution to be made public please indicate this clearly and specifically in thedocumentation you send
第 3 页
人用药品中使用的原料药流通质量管理规范基本原则指南word精品文档32页
