【技术交流】EU进口人用原料药的的问答（中英文）

1.   QUESTION:   WHEN DO THE NEW RULES FOR THE WRITTEN CONFIRMATION APPLY?
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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.

问：什么时候申请书面确认的新规则？

答：它们适用于2013年7月2日。自该日起进口到欧盟的任何活性物质，是须以书面确认的规则。

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2.   QUESTION:   DO THE RULES ON THE WRITTEN CONFIRMATION ALSO APPLY TO ACTIVE SUBSTANCES FOR VETERINARY MEDICINAL PRODUCTS ?

Answer: No. The rules apply only to active substances for medicinal products for human use.
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Ref. Ares(2012)836450 - 10/07/2012

2。问：你的书面确认的规则也适用于兽药产品的活性物质？
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答：编号规则只适用于人用药品的活性物质。

文献参考（2012）836450 - 2012年10月7日

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3.   QUESTION:   DO THE RULES ON THE WRITTEN CONFIRMATION APPLY TO ACTIVE SUBSTANCES FOR MEDICINAL PRODUCTS INTENDED FOR RESEARCH AND DEVELOPMENT TRIALS ?

Answer: No. Active substances used for investigational medicinal products or for medicinal products intended for research and  development trials are excluded from the rules.

3。问：你的书面确认的规则适用于活性物质用于研究和开发试验的医药产品？

答：研究药用产品或用于研究和开发试验的医药产品中使用的活性物质编号规则排除在外。

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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.

Answer: No. The rules on the written confirmation only apply to the  import  of active substances for medicinal products for human use.

4。问：做的书面确认的规则适用到欧盟带来不被导入（'引进'活性物质）的活性物质？一个例子是一个活跃的物质，它是随后出口的引言。
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答：第书面确认该规则只适用于进口供人类使用医药产品的活性物质。

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 ?

Answer: If the consignment is not accomp anied by a written confirmation, the active substance cannot be used in a medicinal product for human use.

5。问：如果，在一种活性物质对欧盟出口时，不知道是否有活性物质，是在一个医药产品供人使用或不使用？
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答：如果货物是不伴奏书面确认anied，活性物质不能被人用医药产品在使用。

6.   QUESTION:   IS THE WRITTEN CONFIRMATION EXPECTED TO CONFIRM COMPLIANCE WITH EU- RULES?

Answer: No. The written confirmation has  to confirm compliance with GMP rules 'equivalent' to the rules applied in the EU.

6。问：是否书面确认，以确认是否符合欧盟规则的遵守？
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答：不用。书面确认，确认符合GMP规则“相当于”适用于欧盟的规则。

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7.   QUESTION:   IN MY NON-EU  COUNTRY , THE APPLICABLE STANDARDS FOR MANUFACTURING OF ACTIVE SUBSTANCES ARE THE  G OOD MANUFACTURING PRACTICES FOR ACTIVE SUBSTANCES OF THE WORLD H EALTH  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?

Answer: Yes.
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7。问：在我的非欧盟国家，制造活性物质，适用的标准，世界卫生组织（WHO）的活性物质的良好生产规范 - 第四十四技术报告，没有。 957，2010，附件2。这些标准相当于欧盟，根据欧盟的立法吗？

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?

Answer: Yes.

8。问：我的非欧盟国家中，适用的标准ICH Q7的。这些标准相当于欧盟，根据欧盟的立法吗？
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答：是的。

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9.   QUESTION:   DOES THE WRITTEN CONFIRMATION HAVE TO BE ISSUED BY A CENTRAL , REGIONAL OR LOCAL AUTHORITY ?

Answer: Each non-EU country decides aut onomously 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.
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9。问：是否书面确认，由中央，地区或地方当局发行的？
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答：每个非欧盟国家决定引渡onomously在该国的身体问题的书面确认。非欧盟国家可能会决定在中央，地区或地方一级发出的书面确认。

10.  QUESTION:   DO THE RULES APPLY ALSO TO ACTIVE SUBSTANCES CONTAINED IN AN IMPORTED FINISHED MEDICINAL PRODUCT?

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.

10。问：那些规则也适用于在导入完成医药产品中含有的活性物质？

答：号关于完成的药用产品，进口成品药产品的规则（输入一个合格的人的授权和批签发，请参阅第40（3）和2001/83/EC指令的第51号）申请。这些规则保持不变。

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11.  QUESTION:   I S THE WRITTEN CONFIRMATION ALSO REQUIRED FOR IMPORTED ACTIVE SUBSTANCES WHICH HAVE ALREADY BEEN MIXED WITH EXCIPIENTS , WITHOUT YET BEING THE FINISHED MEDICINAL PRODUCT?

Answer: No. Such partial manufacturing of the finished product is not included in the rules on the written confirmation.

11。问：是否书面确认，也为进口活跃，已与辅料混合物质，而不然而，作为成品药品呢？
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答：号这种部分成品制造不包含在规则上的书面确认。

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12.  QUESTION:   WHO CHECKS THAT THE IMPORTED ACTIVE SUBSTANCE IS ACCOMPANIED BY THE WRITTEN CONFIRMATION?

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. 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

- by the relevant authority upon importation; and/or

- in the context of an inspection of the  importer of the active substance, and/or
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- in the context of an inspec tion of the manufacturer of the medicinal product that uses the imported active substance.
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12。问题：谁检查，进口的活性物质，是伴随着以书面确认？
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答：这应该由成品药用产品制造商接受检查。它也可以被检查的活性物质时，其进口的进口商。核查等检查是否发生取决于移调法的会员国，其中的活性物质是进口。它可能会被证实

- 有关当局在进口及/或

- 在检查活性物质的进口商的情况下，和/或

- 在药用产品，采用进口的活性物质的制造商的检查范围内。

13.  QUESTION:   HOW CAN I  CHECK IF THE WRITTEN CONFIRMATION IS AUTHENTIC ?

Answer: You should contact the manufacturer  of the active substance or the issuing authority in the non-EU country.

13。问题：我如何检查是否书面确认是真实的吗？
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答：您应该联络活性物质的制造商或在非欧盟国家的发证机关。

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14.  QUESTION:   IS THE WRITTEN CONFIRMATION SENT TO AN  EU REGULATORY AGENCY?

Answer: No. The written confirmation accompanies the imported active substance.
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14。问题：是对发送到欧盟监管机构的书面确认？

答：号书面确认，伴随着进口的活性物质。

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15.  QUESTION:   DOES THE WRITTEN CONFIRMATION HAVE TO BE SUBMITTED WITH A REQUEST FOR AUTHORISATION OF A MARKETING AUTHORISATION OF A MEDICINAL PRODUCT?

Answer: No.
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15。问：是否必须随着的药用产品的营销授权的授权书的要求提交书面确认？

答：不可以。

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16.  QUESTION:   IS THE WRITTEN CONFIRMATION TO BE ISSUED FOR EACH BATCH/ CONSIGNMENT'?

Answer: No. The written confirmation is issued per manufacturing plant and the active substance(s) manufactured on this site.

16。问题：是对每批/托运“发出的书面确认？

答：不需要。发出书面确认，每生产厂和制造本网站上的活性物质

[size=15.238096237182617px]此贴来自蒲公英制药技术论坛，发帖者蒲公英论坛ID： 一沙一叶 发帖）此贴仅代表原作者观点。更多精彩内容欢迎关注蒲公英论坛。欢迎跟帖讨论。

17.  QUESTION:   DOES EACH IMPORTED CONSIGNMENT HAVE TO BE ACCOMPANIED BY THE WRITTEN CONFIRMATION?
Answer: Yes.
17。问：每个输入货物已经由书面确认的陪同下吗？
# C, F. n+ N5 Y- b2 y答：是的。

18.  QUESTION:   IS IT ACCEPTABLE THAT THE WRITTEN CONFIRMATION ACCOMPANYING THE IMPORTED CONSIGNMENT OF THE ACTIVE SUBSTANCE IS A COPY ?
Answer: Yes, provided that the original written confirmation is still valid.
; ~$ v/ S1 y) D. n$ n5 w18。问：是可接受的书面确认，伴随着进口的活性物质托运是一个副本吗？
答：是的，只要原来的书面确认仍然是有效的。

- J. w1 z2 k/ g2 y19.  QUESTION:   WHAT IS THE VALIDITY PERIOD OF THE WRITTEN CONFIRMATION?
! T7 h' ?1 W; s3 \Answer: The validity of the written confirmation is established by the issuing authority of the non-EU country.
4 b+ i% z9 N: S0 ]# S3 C6 z7 V19。问：什么是“的书面确认的有效期？
5 B  x$ W- [8 z6 ]答：由发证机关的非欧盟国家设立的书面确认的有效性。

) p* S; N* ], \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 ?
Answer: The written confirmation accompanying the imported active substance has to be issued by the non-EU country where the activ e substance is manufactured (i.e. non-EU country 'A').
+ H: l& C1 |! }/ _. i20。问：如果活性物质制造一个非欧盟国家“A”，但威盛的非欧盟国家的“B”，世卫组织已发出书面确认，在欧盟进口的吗？
$ P0 a* s1 I5 w& T1 f( U) ]& a答：活性E物质制造的非欧盟国家发出的书面确认，伴随着进口的活性物质（即非欧盟国家“A”）
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21.  QUESTION:   THE TEMPLATE FOR THE WRITTEN CONFIRMATION REFERS TO A ' CONFIRMATION NUMBER'.   DOES THIS NUMBER HAVE TO BE A SEQUENTIAL NUMBER PER COUNTRY ?
Answer: No. This number would be attributed by the issuing authority of the non-EU country.
21。问：书面确认的模板，是指一个'确认号码“。这个数字是有一个序列号，每个国家吗？
5 s7 P. _; p  x5 p7 Z答：这个数字将由发证机关的非欧盟国家的分配。
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% E. }0 z  [) m) a22.  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?
Answer: No. The 'responsible person' in this context is the person responsible within the administration for issuing the written confirmation.
- N, y+ d+ w' |+ T6 I22。问：书面确认的模板，是指一个'发证机关负责人的。这位负责人必须有一个特定的资格呢？
1 N* r& a1 V0 m* c5 P- l+ d答：在这方面的“负责人”号是内部管理的负责人发出书面确认。
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/ O/ s% w- g+ w& g8 s0 D23.  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?
: q9 s, e" l# MAnswer: The information should be sent  to the European Medicines Agency ( qdefect@ema.europa.eu ).
23。问：据“模板 - 遵守的书面确认，有关不调查资料向欧盟提供。获此信息应发送到吗？
答：信息应送到欧洲药品管理局（qdefect@ema.europa.eu）。

24.  QUESTION:   IS THE WRITTEN CONFIRMATION ALSO REQUIRED WHERE THERE IS A ' MUTUAL RECOGNITION AGREEMENT'  BETWEEN A NON-EU  COUNTRY AND THE EU?
Answer: Yes. The process of a written confirmation is independent of the existence of 'mutual recognition agreements'.
24。问：是否还需要那里是一个“相互承认协议的非欧盟国家和欧盟之间的书面确认？
答：是的。书面确认的过程是独立存在的“相互承认协议”。

# i3 }- E5 T7 @; A& K0 j* c, K25.  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')?
( o, y7 D4 o8 W& q2 x) |- T9 d. XAnswer: No.
25。问：如果一个制造工厂位于在一个非欧盟国家“A”，可以通过在另一个非欧盟国家（非欧盟国家的“B”）管理局发出书面确认？
答：不可以。

26.  QUESTION:   ARE THERE EXCEPTIONS FROM THE REQUIREMENT OF A WRITTEN CONFIRMATION?
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 NO. 27 and 28.
0 {  d4 ~6 ?5 E8 E. c- a+ \  J# s26。问：是否有书面确认要求的例外？
答：该委员会发布的，他们的要求后，已进行评估，并认为具有良好生产规范的等效规则在欧盟的国家的名单。在这些国家生产的活性物质，不需要书面确认。
; ^% ~( p0 o! n) W另见问题NO.27和28。
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27.  QUESTION:   WHERE CAN I  FIND THE LIST OF NON-EU  COUNTRIES TO WHICH THE REQUIREMENT OF A WRITTEN CONFIRMATION DOES NOT APPLY ?
Answer: The list is published in the Official Journal of the European Union and also reproduced here: http://ec.europa.eu/health/human-use/quality/index_en.htm  .
27。问：在哪里可以找到该作者的书面确认的要求不适用于非欧盟国家的名单？
, @' Y+ m% O4 F' d4 u: _  r答：该名单公布在欧盟官方杂志也转载：http://ec.europa.eu/health/human-use/quality/index_en.htm 。

+ ?# ?) y& x( b' ~9 h; o* e28.  QUESTION:  HOW MANY NON-EU  COUNTRIES HAVE SO FAR REQUESTED TO BE LISTED?
Answer: A list of non-EU countries which have  so far requested to be listed is available here: http://ec.europa.eu/health/human-use/quality/index_en.htm .
* ?. `7 L8 z3 {6 p( L1 \' d! N6 W) |28。问：许多非欧盟国家有这么远的要求将上市？
. r/ E- s- ^* ~( T5 O: s4 m- _- O" I6 G0 i答：非欧盟迄今已要求被列为国家的名单可以在这里找到：http://ec.europa.eu/health/human-use/quality/index_en.htm 。

29.  QUESTION:   WHEN IS THE LIST GOING TO BE PUBLISHED BY THE COMMISSION?
  W/ R. e  x0 F4 E+ H1 G  sAnswer: 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.
; o  x& ^- u$ E29。问：清单什么时候由委员会发表？
答：该委员会将公布名单上的一个额外的非欧盟国家，一旦它的等效性评估已经完成。等价评估需要几个月从非欧盟国家的要求。
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) T' }, x' o! ~: }" [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?
/ W5 w/ [% N; H3 W* ~/ S& LAnswer: Yes. The process of a written confir mation is independent of such inspection activities. See also Question NO. 31.
& j- W# p5 c% G: k5 O30。问：我是否需要书面确认，即使我的制造基地，近日被欧洲首长的欧洲理事会（EDQM的）药品的质量检查？
- v# l  v+ _0 B5 j5 g# r4 P答：是的。书面确认的过程是这样的视察活动无关。也看到无问题NO.31。

31.  QUESTION:   DO I  NEED A WRITTEN CONFIRMATION, EVEN THOUGH MY MANUFACTURING SITE HAS RECENTLY BEEN INSPECTED BY AN  EU  MEMBER STATE ?
Answer: Yes. The process of a written confir mation 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').
31。问：我需要一个书面确认，即使我的制造基地，最近被欧盟中号余烬状态检查？
: S! S5 z! }3 Q! B7 d# c* |2 \答：是的。书面确认的过程是这样的视察活动无关。然而，分外后，由欧盟成员国的视察，以确保医药产品的可用性，并在必要时，会员国可能决定放弃需要书面确认为不超过GMP证书的有效期期间（“豁免”）。
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- z; K5 L5 s, f- e: N9 {$ i32.  QUESTION:   I  WOULD LIKE TO BE INSPECTED BY AN EU  MEMBER  STATE .  WHERE DO  I   ' APPLY'  FOR SUCH AN INSPECTION ?
Answer: You should address through
•  any registered importer of the active substance;
% `% V+ M( Y5 I- n' O1 l7 \•  any holder of a manufacturing authorisation that uses the active substance;
•  any holder of a marketing authorisation that lists the active substance manufacturer to the national competent authority of the EU Member State where they are established.
" f# E& A& P0 o+ M# p32。问：我想成为欧盟成员国检查。能告诉我“应用”对于这样一个检查吗？
答：您应通过
l       任何活性物质的注册进口商;
l       任何一个制造许可的持有人使用的活性物质;
l       营销列出了活性物质的制造商在他们建立的欧盟成员国的国家主管机关授权的任何人。
# v6 n; t9 x; }9 s" \+ P此贴来自蒲公英制药技术论坛，发帖者蒲公英论坛ID： 一沙一叶 发帖）此贴仅代表原作者观点。更多精彩内容欢迎关注蒲公英论坛。欢迎跟帖讨论。

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