Ref. Ares(2012)836360 - 10/07/2012
参考文件号(2012)836360 - 10/07/2012
EUROPEAN COMMISSION
欧洲委员会
HEALTH AND CONSUMERS DIRECTORATE-GENERAL
大连星海广场健康与消费者保护总司
Health systems and products
健康体系与产品
Medicinal products – quality, safety and efficacy卖火柴的小女孩课文
药品–质量、安全性、有效性
Brusls, 10/07/2012
布鲁塞尔，2012年7月10日
蒸番薯SANCO/SF/sl/ddg1.d.6(2012)997444
Template for the 'written confirmation' for active substances exported to the European Union for medicinal products for human u, in accordance with Article
46b(2)(b) of Directive 2001/83/EC
根据第2001/83/EC号法令的第46b(2)(b)条，出口欧盟人用药品使用原料药“书面确认”
模板
1. Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human u, as regards the prevention of the entry into the legal supply chain of falsified medicinal products (OJ L 174, 1.7.2011, p. 74) introduces EU-wide rules for the importation of active substances: According to Article 46b(2) of Directive 2001/83/EC, active substances shall only be imported if, inter alia, the active substances are accompanied by a written confirmation from the competent authority of the exporting third country which, as regards the plant manufacturing the exported active substance, con
firms that the standards of good manufacturing practice and control of the plant are equivalent to tho in the Union.
欧洲议会以及欧洲理事会于2011年6月8日对第2001/83/EC号有关人用药品共同法规进行了修订，为防止伪造药品进入合法供应链(《欧盟官方公告》L174，1.7.2011，第74页)，在欧盟范围对进口原料药采取如下规定：除非另有规定，根据第
2001/83/EC号法令的第46b(2)条，仅可进口附有出口第三国药监机构出具的出口原料药生产厂符合等同于欧盟所使用的药品生产质量管理规范标准及对工厂控制的书面确认的原料药。
2. The template for this written confirmation is t out in annex. 书面确认的模板见附件。
Annex:
附件：
Letterhead of the issuing regulatory authority
带有颁发药监机构名头的函
Written confirmation for active substances exported to the European Union (EU) for medicinal products for human u, in accordance with Article 46b(2)(b) of
Directive 2001/83/EC
根据第2001/83/EC 号法令的第46b(2)(b)条，出口到欧盟人用药使用原料药的书面确认
书
Confirmation no. (given by the issuing regulatory authority):
子畏于匡
确认书编号(由颁发的药监机构编排):
1. Name and address of site (including building number, where applicable): 生产现场名称与地址(如果有，包括建筑物编号):
2.
Manufacturer's licence number(s):[1] 生产许可证编号:[2] REGARDING THE MANUFACTURING PLANT UNDER (1) OF THE FOLLOWING ACTIVE SUBSTANCE(S) EXPORTED TO THE EU FOR MEDICINAL PRODUCTS FOR HUMAN USE
在(1)项下的生产厂出口人用药使用的原料药到欧盟
Active substance(s):[3]
原料药名称:[4]
Activity(ies):[5] 活动:[6]
THE ISSUING REGULATORY AUTHORITY HEREBY CONFIRMS THAT:
颁发的药监机构确认如下：
The standards of good manufacturing practice applicable to this manufacturing plant are at least equivalent to tho laid down in the EU;
该工厂所实施的药品生产质量管理规范标准至少与欧盟的等同；
The manufacturing plant is subject to regular, strict and transparent controls and to the effective enforcement of good manufacturing practice, including repeated and unannounced inspections, so as to ensure a protection of public health at least equivalent to that in the EU; and
该生产厂接受定期、严格，透明的控制，以及有效实施药品生产质量管理规范，包括反复及飞行检查，以确保对公众健康的保障与欧盟等同；并且
In the event of findings relating to non-compliance, information on such findings
is supplied by the exporting third country without delay to the EU.[7]
如一经发现相关不符合情况，出口的第三国将及时告知欧盟上述结果[8]。
Date of inspection of the plant under (1)
对(1)项下工厂实施检查日期
This written confirmation remains valid until
本书面确认有效期
The authenticity of this written confirmation may be verified with the issuing regulatory authority.
关于本书面确认的可靠性可向本颁发药监机构查询确证。
Address of the issuing regulatory authority:
颁发药监机构地址：
Name and function of responsible person:
负责人姓名及职务：
E-mail, Telephone no., and Fax no.:
电子邮箱、电话、传真：
Signature 签字Stamp of the authority and date 颁发机构盖章与日期
[1] Where the regulatory authority issues a licence for the site. Record 'not applicable' in ca where there is no legal framework for issuing of a licence.
[2]适用于药监部门对该现场办法生产许可证情况。在没有颁发原料药生产许可法律框架的情况下，则记录为“不适用”。
[3] Identification of the specific active substances through an
internationally-agreed terminology (preferably international nonproprietary name).
[4]用国际通用术语命名(最好用国际通用名)来识别特定原料药。
[5] For example, 'Chemical synthesis', 'Extraction from natural sources',
'Biological process', 'Finishing steps'.
[6]例如:“化学合成”、“从自然资源提取”、“生物工艺”、“最终步骤”。
[7]******************.eu.西岩
[8]******************.eu.
Ref. Ares(2012)836450 - 10/07/2012
参考文件号(2012)836450 - 10/07/2012
EUROPEAN COMMISSION
欧洲委员会
HEALTH AND CONSUMERS DIRECTORATE-GENERAL
面字的笔顺
健康与消费者保护总司
Health systems and products
健康体系与产品
Medicinal products – quality, safety and efficacy
药品–质量、安全性、有效性
Brusls, 10/07/2012
布鲁塞尔，2012年7月10日
SANCO/SF/sl/ddg1.d.6(2012)997513
IMPORTATION OF ACTIVE SUBSTANCES FOR MEDICINAL PRODUCTS FOR HUMAN USE
进口人用药品用原料药
老实人的特点
QUESTIONS AND ANSWERS
问答
家庭蛋糕的制作方法VERSION 1.0
第1.0版
This documents ts out frequently-asked 'questions and answers' regarding the new rules for the importation of active substances for medicinal products for human
u.
此文件列出了关于进口人用药使用原料药的有关新规定经常询问的“问答”。
The rules are contained in Articles 46b and 111b of Directive 2001/83/EC.
这些规定收载于欧盟第2001/83/EC法令的第46b与111b 条中。
The 'written confirmation' is addresd in Article 46b(2)(b) of Directive 2001/83/EC.
“书面确认”见欧盟第2001/83/EC法令第46b(2)(b)条。
Important notice: The views expresd in this questions and answers document are not legally binding. Ultimately, only the European Court of Justice can give an authoritative interpretation of Union law.
重要通告：此问答文件中所表达的观点不具有法律约束力，只有欧洲法院可以给出欧盟法律的权威性的最终解释。
1. QUESTION: WHEN DO THE NEW RULES FOR THE WRITTEN CONFIRMATION APPLY?
问：书面确认的新规定何时开始实施?
Answer: They apply as of 2 July 2013. Any active substance imported into the EU from that date is subject to the rules on the written confirmation. 答: 该规定将于2013年7月2日开始实施。从该日期开始，任何进口到欧盟的原料药受书面确认规定的管辖。
2. QUESTION: DO THE RULES ON THE WRITTEN CONFIRMATION ALSO APPLY TO ACTIVE SUBSTANCES FOR VETERINARY MEDICINAL PRODUCTS?
问：是否书面确认规定也适用于兽药用的原料药?
Answer: No. The rules apply only to active substances for medicinal products for human u.
答：不适用。该规定仅适用于人用药的原料药。
3. QUESTION: DO THE RULES ON THE WRITTEN CONFIRMATION APPLY TO ACTIVE SUBSTANCES FOR MEDICINAL PRODUCTS INTENDED FOR RESEARCH AND DEVELOPMENT TRIALS?
问：是否书面确认规定也适用于临床研究与开发试验用的原料药?
Answer: No. Active substances ud for investigational medicinal products or for medicinal products intended for rearch and development trials are excluded from the rules.
答：不适用。临床实验或药品研究与开发试验为目的原料药不在本规定管辖之内。
4. QUESTION: DO THE RULES ON THE WRITTEN CONFIRMATION APPLY TO ACTIVE SUBSTANCES WHICH ARE BROUGHT INTO THE EU WITHOUT BEING IMPORTED ('INTRODUCED' ACTIVE SUBSTANCES)? AN EXAMPLE IS THE INTRODUCTION OF AN ACTIVE SUBSTANCE WHICH IS SUBSEQUENTLY EXPORTED.
问：是否书面确认规定适用于不进口而进入欧盟的原料药(“进入”原料药)?例如，进一种原料药，随后出口。
Answer: No. The rules on the written confirmation only apply to the import
