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欧盟进口人用药API问答3.0版 IMPORTATION OF ACTIVE SUBSTANCES FOR MEDICINAL PRODUCTS FOR HUMAN USE QUESTIONS AND ANSWERS v3.0
Ref. Ares(2013)101574 - 28/01/2013
参考文件号(2013)101574 - 28/01/2013 EUROPEAN COMMISSION 欧洲委员会 HEALTH AND CONSUMERS DIRECTORATE-GENERAL 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 Brussels, 布鲁塞尔， SANCP/D/6/SF/mg/ddg1.d.6(2013)118674 IMPORTATION OF ACTIVE SUBSTANCES FOR MEDICINAL PRODUCTS FOR HUMAN USE QUESTIONS AND ANSWERS VERSION 3.0 进口人用药品用原料药问答3.0版 Document history:文件履历 Date of submission of draft to the Pharmaceutical Committee:[1]提交草案给制药委员会日期:[2] 16 January 2013 2013年1月16日 Date of publication: 发布日期:See above 参见上述 Date of entry into force:生效日期:N/A不适用 Supersedes:替代: Version 2.0 of October 2012 2012年10月第2.0版本 Changes compared to superseded version 2.0: 与已经替代的第2.0版本相比较的变更: Amended Q&A: 18a 更正问与答:18a New Q&As: 11a, 19a 新增问与答:11a、19a Important notice: The views expressed in this questions and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. 重要提示:在本问与答中所表达的意见并不具有法律约束力。最终，只有欧洲法院可以给欧盟法律的权威解释。 This documents sets out frequently-asked 'questions and answers' regarding the new rules for the importation of active substances for medicinal products for human use. 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“问与答”。 These 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 addressed 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 expressed 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 use. 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 used for investigational medicinal products or for medicinal products intended for research 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 of active substances for medicinal products for human use. 答:不适用。书面确认规定只适用于进口供人用药品使用的原料药。 5.QUESTION: WHAT IF, AT THE TIME OF EXPORT OF AN ACTIVE SUBSTANCE TO THE EU, IT IS NOT KNOWN WHETHER THE ACTIVE SUBSTANCE IS USED IN A MEDICINAL PRODUCT FOR HUMAN USE OR NOT? 问: 如果出口到欧盟的一种原料药时，尚不知道该原料药是否用于人用药品，如何处理? Answer: If the consignment is not accompanied by a written confirmation, the active substance cannot be used in a medicinal product for human use. 答:如果货物没带有书面确认，那么该原料药就不能用于人用药品。 6.QUESTION: IS THE WRITTEN CONFIRMATION EXPECTED TO CONFIRM COMPLIANCE WITH EU-RULES? 问:是否书面确认能确认与欧盟规定符合性? Answer: No. The written confirmation has to confirm compliance with GMP rules 'equivalent' to the rules applied in the EU. 答:不能。书面确认是仅仅用来确认与“等同”在欧盟实施的GMP 的符合性。 7.QUESTION: IN MY NON-EU COUNTRY, THE APPLICABLE STANDARDS FOR MANUFACTURING OF ACTIVE SUBSTANCES ARE THE GOOD MANUFACTURING PRACTICES FOR ACTIVE SUBSTANCES OF THE WORLD HEALTH ORGANISATION (WHO) – FORTY-FOURTH TECHNICAL REPORT, NO. 957, 2010, ANNEX 2. ARE THESE STANDARDS EQUIVALENT TO THOSE IN THE EU, AS REQUIRED ACCORDING TO EU LEGISLATION? 问:在我们非欧盟国家，原料药生产所应用的标准是世界卫生组织(WHO)的原料药药品生产质量管理规范-2010年的第957号文件，第44号技术报告的附件 2，是否这些标准等同于在欧盟标准，从而符合欧盟立法要求? Answer: Yes. 答:是的。 8.QUESTION: IN MY NON-EU COUNTRY, THE APPLICABLE STANDARDS ARE ICH Q7. ARE THESE STANDARDS EQUIVALENT TO THOSE IN THE EU, AS REQUIRED ACCORDING TO EU LEGISLATION? 问:在我们非欧盟国家，所应用的标准是ICH-Q7，是否这些标准等同于在欧盟标准，从而符合欧盟立法要求? Answer: Yes. 答:是的。 9.QUESTION: DOES THE WRITTEN CONFIRMATION HAVE TO BE ISSUED BY A CENTRAL, REGIONAL OR LOCAL AUTHORITY? 问:书面确认必须由中央、地区或地方机构颁发吗? Answer: Each non-EU country decides autonomously which body within that country issues the written confirmation. That non-EU country may decide to issue the written confirmation at central, regional or local level. 答:每个非欧盟国家自主决定在本国由哪个机构颁发书面确认。非欧盟国家可能会决定在中央、地区或地方一级颁发书面确认。 10.QUESTION: DO THE RULES APPLY ALSO TO ACTIVE SUBSTANCES CONTAINED IN AN IMPORTED FINISHED MEDICINAL PRODUCT? 问:是否该规定亦适用于进口药品中所用的原料药吗? Answer: No. Regarding finished medicinal products, the rules for importation of finished medicinal products (importation authorisation and batch release by a qualified person, see Articles 40(3) and 51 of Directive 2001/83/EC) apply. These rules remain unchanged. 答:不适用。对于药品，实施的是药品进口规定(进口许可与质量受权人批放行，请参阅第2001/83/EC号法令的40(3)条与51条)。这些规定保持不变。 11.QUESTION: IS THE WRITTEN CONFIRMATION ALSO REQUIRED FOR IMPORTED ACTIVE SUBSTANCES WHICH HAVE ALREADY BEEN MIXED WITH EXCIPIENTS, WITHOUT YET BEING THE FINISHED MEDICINAL PRODUCT? 问:是否进口已经与辅料混合而没有形成药品的原料药也需要书面确认? Answer: No. Such partial manufacturing of the finished product is not included in the rules on the written confirmation. 答:不需要。其是制剂生产的一个部分，不包括在书面确认规定内。 11A. QUESTION: IS THE WRITTEN CONFIRMATION ALSO REQUIRED WHERE THE FINISHED DOSAGE FORM MANUFACTURED IN THE EU IS DESTINED FOR EXPORTATION ONLY?问:当在欧洲生产仅仅预定供出口的制剂产品，是否也同样需要书面确认？ Answer: Yes.答:是。 12.QUESTION: WHO CHECKS THAT THE IMPORTED ACTIVE SUBSTANCE IS ACCOMPANIED BY THE WRITTEN CONFIRMATION? 问:谁来检查进口原料药是否附带有书面确认? Answer: This should be checked by the receiving manufacturer of the finished medicinal product. It may also be checked by the importer of the active substance upon its importation. 答:这应该由负责接收的制剂生产企业进行检查。它还可能在进口时由进口商来检查。 The verification whether such checks take place depends on the transposing law of the Member State where the active substance is imported. It may be verified 对是否进行了诸如此类的检查的确证取决于进口原料药成员国法律规定。可能需要对其进行确证如下: -by the relevant authority upon importation; and/or 一旦进口，由有监管机构进行;和/或 -in the context of an inspection of the importer of the active substance, and/or 由原料药进口商检查;和/或 -in the context of an inspection of the manufacturer of the medicinal product that uses the imported active substance. 由使用进口原料药的制剂生产企业检查。 13.QUESTION: HOW CAN I CHECK IF THE WRITTEN CONFIRMATION IS AUTHENTIC? 问:如何检查书面确认是否是真实的? Answer: You should contact the manufacturer of the active substance or the issuing authority in the non-EU country. 答:您应该联系原料药的生产企业或非欧盟国家的颁发机构。 14.QUESTION: IS THE WRITTEN CONFIRMATION SENT TO AN EU REGULATORY AGENCY? 问:书面确认是提交给欧盟药监机构吗? Answer: No. The written confirmation accompanies the imported active substance. 答:不需要。书面确认与进口的原料药相伴随。 15.QUESTION: DOES THE WRITTEN CONFIRMATION HAVE TO BE SUBMITTED WITH A REQUEST FOR AUTHORISATION OF A MARKETING AUTHORISATION OF A MEDICINAL PRODUCT? 问:书面确认是否要与药品上市许可申请一起递交呢? Answer: No. 答:不需要。 16.QUESTION: IS THE WRITTEN CONFIRMATION TO BE ISSUED FOR EACH BATCH/CONSIGNMENT'? 问:是否对每个批次/运输都颁发书面确认吗? Answer: No. The written confirmation is issued per manufacturing plant and the active substance(s) manufactured on this site. 答:不需要。书面确认是颁发给每个生产厂及在该现场所生产的原料药。 17.QUESTION: DOES EACH IMPORTED CONSIGNMENT HAVE TO BE ACCOMPANIED BY THE WRITTEN CONFIRMATION? 问:是否每次进口运输都要附有书面确认呢? Answer: Yes. 答:是的。 18.QUESTION: IS IT ACCEPTABLE THAT THE WRITTEN CONFIRMATION ACCOMPANYING THE IMPORTED CONSIGNMENT OF THE ACTIVE SUBSTANCE IS A COPY? 问: 书面确认副本伴随进口原料药口可以接受吗? Answer: Yes, provided that the original written confirmation is still valid.答: 如果原始的书面确认仍然有效就可以接受。 18A QUESTION: REGARDING THE WRITTEN CONFIRMATION OF 'EQUIVALENT' STANDARDS OF GOOD MANUFACTURING PRACTICE, CAN THE ISSUING AUTHORITY OF THE NON-EU COUNTRY BASE ITSELF ON INSPECTION RESULTS FROM EU AUTHORITIES OR OTHER AUTHORITIES APPLYING EQUIVALENT STANDARDS FOR GOOD MANUFACTURING PRACTICE, SUCH AS US FDA? 问:考虑到与GMP等同标准的书面确认，非欧盟国家发行机关可以用来自欧盟官方或其他GMP等同标准的官方（例如，美国FDA）检查结果为依据吗？ Answer: Yes. In this case, the written confirmation should indicate which authority has inspected the site.答:可以。在这种情况下，书面确认应当显示哪个官方已经检查了该现场。 18B QUESTION: REGARDING THE WRITTEN CONFIRMATION OF 'EQUIVALENT' STANDARDS OF GOOD MANUFACTURING PRACTICE, CAN THE ISSUING AUTHORITY OF THE NON-EU COUNTRY BASE ITSELF ON INSPECTIONS CONDUCTED IN THE PAST? 问:考虑到与GMP等同标准的书面确认，非欧盟国家发行机关可以用过去进行的检查为依据吗？ Answer: Yes. It is not necessary to conduct an inspection specifically for the purpose of issuing the 'written confirmation'. 答:可以。没有必要特别为颁发“书面确认”进行一次检查。 19.QUESTION: WHAT IS THE VALIDITY PERIOD OF THE WRITTEN CONFIRMATION? 问:书面确认的有效期多长? Answer: The validity of the written confirmation is established by the issuing authority of the non-EU country. 答:书面确认的有效期由非欧盟国家颁发机构所规定。 19A. QUESTION: THE WRITTEN CONFIRMATION REFERS TO 'UNANNOUNCED INSPECTIONS'. DOES THIS MEAN THAT AN UNANNOUNCED INSPECTION HAS TO HAVE BEEN CONDUCTED? 问:书面确认中所说的“飞行检查”，这是否意味必须进行飞行检查？ Answer: No. Rather, the system of supervision as a whole (including different types of inspections, such as unannounced inspections) has to ensure a protection of public health at least equivalent to that in the EU. 答:不是。而是作为监督体系作为一个整体（包括不同类型的检查，例如，未经通知检查），以确保至少相当于欧盟对公众健康保护水平。 20. QUESTION: IF ACTIVE SUBSTANCES ARE MANUFACTURED IN A NON-EU COUNTRY 'A', BUT IMPORTED IN THE EU VIA THE NON-EU COUNTRY 'B', WHO HAS TO ISSUE THE WRITTEN CONFIRMATION? 问:如果原料药由一个非欧盟国家“A”生产，但通过另一个非欧盟国家“B”进口，谁来颁发书面确认? Answer: The written confirmation accompanying the imported active substance has to be issued by the non-EU country where the active substance is manufactured (i.e. non-EU country 'A'). 答:伴随进口原料药的书面确认将由生产原料药的非欧盟国家颁发(即，非欧盟国家“A”)。 21.QUESTION: THE TEMPLATE FOR THE WRITTEN CONFIRMATION REFERS TO A 'CONFIRMATION NUMBER'. DOES THIS NUMBER HAVE TO BE A SEQUENTIAL NUMBER PER COUNTRY? 问:书面确认模板提到了“确认书编号”。是否这个编号每个国家的序列号吗? Answer: No. This number would be attributed by the issuing authority of the non-EU country. 答:不是。这一数字编号将会由非欧盟国家的颁发机构来规定。 22.QUESTION: THE TEMPLATE FOR THE WRITTEN CONFIRMATION REFERS TO A 'RESPONSIBLE PERSON' IN THE ISSUING AUTHORITY. DOES THIS RESPONSIBLE PERSON HAVE TO HAVE A SPECIFIC QUALIFICATION? 问:书面确认模板中提到了颁发机构“负责人”。这位负责人是否必须具有有特定资质? Answer: No. The 'responsible person' in this context is the person responsible within the administration for issuing the written confirmation. 答:不是。在此上下文中的“负责人”是颁发书面确认机构的负责人。 23.QUESTION: ACCORDING TO THE TEMPLATE FOR THE WRITTEN CONFIRMATION, INFORMATION OF FINDINGS RELATING TO NON-COMPLIANCE ARE SUPPLIED TO THE EU. TO WHOM THIS INFORMATION SHOULD BE SENT TO? 问:根据书面确认模板，发现有关不符合结果的信息要提供给欧盟。应当将此信息发送给谁? 24.QUESTION: IS THE WRITTEN CONFIRMATION ALSO REQUIRED WHERE THERE IS A 'MUTUAL RECOGNITION AGREEMENT' BETWEEN A NON-EU COUNTRY AND THE EU? 问:如果非欧盟国家与欧盟之间有“相互承认协议”时，是否同样需要一个书面确认? Answer: Yes. The process of a written confirmation is independent of the existence of 'mutual recognition agreements'. 答:是的。书面确认过程是独立于“相互承认协议”而存在的。 25.QUESTION: IF A MANUFACTURING PLANT IS LOCATED IN A NON-EU COUNTRY 'A', CAN THE WRITTEN CONFIRMATION BE ISSUED BY AN AUTHORITY IN ANOTHER NON-EU COUNTRY (NON-EU COUNTRY 'B')?.问:如果一座生产工厂坐落于一个非欧盟国家“A”，是否可以由另一个非欧盟国家(非欧盟国家“B”) 机构颁发书面确认吗? Answer: No. 答:不能。 26.QUESTION: ARE THERE EXCEPTIONS FROM THE REQUIREMENT OF A WRITTEN CONFIRMATION? 问:有豁免书面确认要求的情况吗? Answer: The Commission publishes a list of countries which, following their request, have been assessed and are considered as having equivalent rules for good manufacturing practices to those in the EU. Active substances manufactured in these countries do not require a written confirmation. See also Questions n° 27 and 28. 答:欧盟委员会将应出口国的申请，对这些国家进行评估并且认为有等效于欧盟的药品生产质量管理规范的规定，发布国别目录。从列入该名单的国家进口活性物质可豁免出具书面确认。参见问题27与28。 27.QUESTION: WHERE CAN I FIND THE LIST OF NON-EU COUNTRIES TO WHICH THE REQUIREMENT OF A WRITTEN CONFIRMATION DOES NOT APPLY? 问: 在哪里可以找到豁免书面确认的非欧盟国家名单? 28.QUESTION: HOW MANY NON-EU COUNTRIES HAVE SO FAR REQUESTED TO BE LISTED? 问:到目前为止有多少非欧盟国家申请列入该名单中? 29.QUESTION: WHEN IS THE LIST GOING TO BE PUBLISHED BY THE COMMISSION? 问:什么时候欧盟委员会公布名单? Answer: The Commission is going to publish an additional non-EU country on the list once its equivalence assessment has been finalised. The equivalence-assessment takes several months from the request from the non-EU country. 答:一旦等同性评估结束，欧盟委员会将要在名单上增加一个非欧盟国家。从非欧盟国家申请开始，等同性评估需要几个月的时间。 29A QUESTION: HOW DOES A NON-EU COUNTRY REQUEST TO BE LISTED? 问:非欧盟国家如何申请加入名单？ In the alternative, the request is made by way of a short letter to the responsible Director-General, and the relevant information is sent as follow-up information to the responsible service within the Commission (sanco-pharmaceuticals-d6@ec.europa.eu). 29B QUESTION: BY WHEN SHOULD THE REQUEST TO BE LISTED BE MADE? 问:被加入名单申请何时制定？ Answer: The request should be listed as soon as possible. It is strongly recommended to make the request before end-2012. If the request is made late, it may be impossible to conclude the equivalence-assessment before the date of application of the rules in July 2013.答:申请应尽快，强烈建议申请在2012年底前递交。如果申请晚了，在2013年7月法规生效前将有可能没有做出等同评估的结论。 30. QUESTION: DO I NEED A WRITTEN CONFIRMATION, EVEN THOUGH MY MANUFACTURING SITE HAS RECENTLY BEEN INSPECTED BY THE EUROPEAN DIRECTORATE FOR THE QUALITY OF MEDICINES (EDQM) OF THE COUNCIL OF EUROPE?问:我的生产现场最近曾经由欧洲药品质量与卫生保健理事会( EDQM)检查过，是否还需要书面确认? Answer: Yes. The process of a written confirmation is independent of such inspection activities. See also Question n° 31.答:是的。书面确认过程独立于这类检查活动。请参阅问题31。 31.QUESTION: DO I NEED A WRITTEN CONFIRMATION, EVEN THOUGH MY MANUFACTURING SITE HAS RECENTLY BEEN INSPECTED BY AN EU MEMBER STATE?问:我的生产现场最近曾由欧盟成员国检查过，是否还需要书面确认? Answer: Yes. The process of a written confirmation is independent of such inspection activities. However, exceptionally and where necessary to ensure the availability of medicinal products, following inspections by a EU Member State, a Member State may decide to waive the need for a written confirmation for a period not exceeding the validity of the GMP certificate ('waiver').答: 是的。书面确认的过程是独立于这类检查活动。不过，例外的情况下，为保障某一欧盟成员国境内的药品的可及性，有关生产工厂在通过欧盟成员国核查后，由该成员国决定是否豁免书面确认，但是豁免期不得超过其所获的欧盟GMP证书的有效期。 32.QUESTION: I WOULD LIKE TO BE INSPECTED BY AN EU MEMBER STATE.WHERE DO I 'APPLY' FOR SUCH AN INSPECTION?问:我想要某一个欧盟成员国进行检查。我如何“申请”这种检查? Answer: You should address through 答:您应该通过下列途径提出申请: ·any registered importer of the active substance;任何已经注册的原料药进口企业; ·any holder of a manufacturing authorisation that uses the active substance;任何使用原料药的生产许可持有人; ·any holder of a marketing authorisation that lists the active substance manufacturer;任何列出了原料药制造企业的上市许可持有人; to the national competent authority of the EU Member State where they are established.并联系该欧盟成员国相关监管部门。
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发表于 2013-10-12 08:10:37
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