人用药品中使用原料药流通质量管理规范基本原则指南.docVIP

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(2013)148102 - 05/02/2013参考编号(2013)148102-2013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药品-质量、安全性与有效性Brussels,布鲁塞尔，SANCO/D/6/SF/mg/ddg1.d.6(2013)179367GUIDELINES 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 2013 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.诚邀各利益相关方于2013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 us (i.e. not just in the covering letter or e-mail). In this case,only an indication of the contributor will be disclosed.征集期结束后，所有意见与回复将在“Europa网站”的制药部分公布。如果您不希望将意见公开，请在您发送的文件上特别注明(即，而不仅是在首页函或电子邮件中注明)。此种情况下，只公开投稿人。Professi