【原创】happyjyl的翻译（四）－－药品证书、一般指南和主管药师承诺书

Medicinal product certificate

This certificate complies with the format recommended by the World Health Organisation 1
(see general instructions and explanatory notes attached)

Exporting country (certifying): ** Certificate number: **
Importing country (applicant): **

1.    Name and pharmaceutical form of the medicinal product: **
1.1    Active ingredient(s) 2 and amount(s) per unit dose or unit volume3.
The full composition of the medicinal product including excipients4 is as follows:
**
For a capsule n° ** of ** mg
Description of the capsule shell: **
Composition of the capsule shell: **
1.2    Is this medicinal product the subject of a marketing authorization in the exporting country?
a)    Yes/no
b)    Application pending: yes/no
(Circle the appropriate response and complete it, if applicable)
1.3    Is this medicinal product marketed in the exporting country? Yes/no
(Circle the appropriate response)
If the response to 1.2 a) is yes, fill in section 2A.
Fill in section 2B in other cases.

2A Medicinal product with marketing authorization in the certifying country5
2A.1 Marketing authorization number and date of issue: **
2A.2 Marketing authorization holder (name and address): **
2A.3 Status of the marketing authorization holder: a/b/c
(Circle the appropriate response(s)) 6
a)    is the manufacturer or the importer in the exporting country (delete whichever
is not applicable) responsible for batch release
b)    is involved in one of the steps of the finished product manufacturing without
being the manufacturer or the importer in the certifying country (delete whichever is not applicable) in charge of the batch release
c)    is involved in none of the operations mentioned in a) and b)
2A.3.1 For categories b and c, name and address of the manufacturer or the importer in the certifying country (delete whichever is not applicable) in charge of the batch release7:
2A.4 Is a public assessment report appended 8? Yes/no (Circle the appropriate response)
2A.5 Is the information of the medicinal product (officially approved and included in the marketing authorization) appended to the present certificate?
Yes9/no10 (circle the appropriate response)
2A.6 Applicant for the certificate if the latter is not the holder of the marketing authorization (name and address)11:

2B Medicinal product with no marketing authorization in the certifying country5
2B.1 Applicant for the certificate (name and address):
2B.2 State of the applicant: a/b/c (circle the appropriate response)6
a)    is the manufacturer or the importer in the exporting country (delete whichever is not applicable) responsible for batch release
b)    is involved in one of the steps of the finished product manufacturing without being the manufacturer or the importer in the certifying country (delete whichever is not applicable) in charge of the batch release
c)    is involved in none of the operations mentioned in a) and b)
2B.2.1 For categories b and c, name and address of the manufacturer or the importer in the exporting country (delete whichever is not applicable) responsible for batch release:
2B.3 Reason why the marketing authorization is lacking:
Not required (in that case, fill in 2B.4)/under consideration/refused
Circle the appropriate response)
2B.4 Reasons why the marketing authorization has not been required12:
a)    The medicinal product has been exclusively developed for treatment of diseases – especially for tropical diseases – which are not endemic in the exporting country
b)    The medicinal product has been reformulated in order to improve its stability under tropical conditions
c)    The medicinal product has been reformulated to exclude excipients which are not approved in the importing country
d)    The medicinal product has been reformulated to comply with a requirement regarding the dosage of an active ingredient
e)    The medicinal product has a marketing authorization for another dose, another pharmaceutical form or a different formulation
f)    Other reason (specify)
2B.5 The Export Statement which has been sent to the certifying authority in accordance with the regulations relating to the export of medicinal products without marketing authorization in the certifying country is appended to the present certificate.

3. Does the certifying authority arrange for periodic inspections of the pharmaceutical site manufacturer of the importer in the exporting country (delete whichever is not applicable) responsible for batch release?
Yes/no/applicable13 (circle the appropriate response)
Alternative site (fill if relevant):
Name and address of the manufacturer or the importer in certifying country (delete whichever is not applicable) responsible for batch release:
3.1 Periodicity of routine inspections (year): at last once every ** years
3.2 Has the manufacture of this type of dosage form been inspected?
Yes/no (circle the appropriate response)
3.3 The pharmaceutical site is subject to the European Union rules for GMP recognized in perfect agreement with GMP recommended by the WHO14.
Yes/no/not applicable13 (circle the appropriate response)

Commitment of the responsible pharmacist (see appended annex)

(Section 4 filled in by the certifying authority)

4. Does the information submitted by the applicant satisfy the certifying authority on parts 1 and 2 as well as on part 3 as far as all the aspects of the medicinal product manufacturing are concerned?15
Yes/no (circle the appropriate response). If the response is no, explain why:

Address of the certifying authority:

Signature:

Stamp and date:

药品证书
该证书符合世界卫生组织推荐的格式1
（详见所附一般指南和注释）

出口国（证明人所在国）：××                        证明编号： ××
进口国（申请人所在国）：××

1.    药品名称和剂型：××

1.1.        每剂3主成分2与含量
包括辅料4在内的药品处方如下：××

××号胶囊，装量×× mg
胶囊壳性状：××
胶囊壳组成：××

1.2        该药品在出口国是否有销售许可证?
a)    是／否
b)    申请待批准：是／否
（圈出适当答案，如有可能请完善）。

1.3.        该药品在出口国是否已上市销售？是／否
（圈出适当答案）
如果1.2 a)的回答为肯定，请填写2A部分。
其它情况下请填写2B部分。

2A         药品在证明人所在国有销售许可证5

2A.1.     销售许可证编号和颁发日期：××

2A.2    销售许可证持有者（名称和地址）：××
   
2A.3.     销售许可证持有者身份：a/b/c
(圈出适当答案)6
a)    为出口国负责药品批次放行的生产商或进口商（删除不适用部分）
b)    参与成品生产过程，但不是出口国负责药品批次放行的生产商或进
口商（删除不适用部分）
c) 不参与a)和b)中所述活动。

2A.3.1.    对于b类和c类，应注明证明人所在国负责药品批次放行7的生产商或进口商（删除不适用部分）的名称和地址：

2A.4.    是否附有公众评估报告8？ 是／否（圈出适当答案）

2A.5.    该证明是否附有官方批准且包含在销售许可证中的药品信息？是9/否10
（圈出适当答案）

2A.6.    若该证明申请人非销售许可证持有者，应注明其名称和地址11：


2B.        该药品在证明人所在国5没有销售许可证

2B.1.    证明申请人（名称和地址）：
       
2B.2.    申请人身份；a/b/c（圈出适当答案）6

a)    为出口国负责药品批放行的生产商或进口商（删除不适用部分）
b)    参与成品生产过程，但不是出口国负责药品批次放行的生产商或进
口商（删除不适用部分）
c)    不参与a)和b)中所述活动。

2B.2.1    对于b类和c类，应注明负责药品批次放行7的出口国生产商或进口商（删除不适用部分）的名称和地址：

2B.3.    无销售许可证的原因
无需申请（请填写2B.4部分）/ 审核中/ 申请被拒绝（圈出适当答案）

2B.4.    未申请销售许可证的原因12：

a)    该药品专为治疗某些疾病－尤其是热带病－而生产，不用于治疗出
口国的地方病
b)    为改善该药品在热带条件下的稳定性而对处方进行了修改
c)    为去除在进口国未获批准的辅料而对处方进行了修改
d)    为适应对某一主成分剂量的要求而对处方进行了修改
e)    该药品已获得其它规格、剂型或处方的销售许可证
f)    其它原因（请详细说明）：

2B.5.    本证书后附有该药品的出口情况说明。根据有关法规对未在证明人所在国获得销售许可证药品的出口要求，该出口情况说明已提交给认证当局。


3.    认证当局是否定期组织检查证明人所在国负责药品批次放行的生产商或进口商（删除不适用部分）？
是／否／不适用13（圈出适当答案）
检查地址（若有请填写）：

证明人所在国负责药品批次放行的生产商或进口商（删除不适用部分）的名称和地址
是／否／不适用（圈出适当答案）


3.1.    常规检查周期（年）： 至少每××年一次

3.2.        该剂型的生产是否已经过检查？
是／否（圈出适当答案）

3.3.    药品生产场所应符合欧盟GMP的要求，欧盟GMP完全符合世界卫生组织推荐的GMP14。
是／否／不适用13（圈出适当答案）

*主管药师的承诺（见附件）


（第4部分由证明机关填写）

4.        证明机关是否对申请人在第1、2、3部分提供的药品生产信息满意15？
是／否（圈出适当答案）。如果回答是否定的，解释原因：
……………………………………………………………………………………
……………………………………………………………………………………

证明机关地址：

签字
盖章及日期

General instructions

1.    Please refer to the guidelines for full instructions on how to complete this form and information on the implementation of the scheme.
2.    These forms may be produced by computer. They must always be submitted in typeface.
3.    Additional sheets should be appended, as necessary, to accommodate remarks and explanations.

Explanatory notes
1.    In accordance with the format recommended by the WHO, this certificate indicates the status of the medicinal product and of the applicant for the certificate in the exporting country. Each certificate applies to a single medicinal product only, as the manufacturing process and the approved information for different pharmaceutical forms and different concentrations may vary.
2.    Use, whenever possible, the international non-proprietary name (INN) or the national non-proprietary name.
3.    The formulation (full composition) of the pharmaceutical form should be specified on the certificate or appended.
4.    The quantitative composition of excipients should be indicated subject to the agreement of the marketing authorization holder.
5.    As section 2Aconcerns medicinal products with a marketing authorization and section B concerns medicinal products without a marketing authorization, sections 2A and 2B are mutually exclusive.
6.    Specify whether the marketing authorization holder or, for medicinal products without a marketing authorization, the applicant for the certificate:
a)    is the manufacturer or the importer in the exporting country responsible for batch release,
b)    is involved in one of the steps of the finished product manufacturing without being the manufacturer or the importer in the exporting country responsible for batch release,
c)    is involved in none of the operations mentioned in a) and b).
7.    This information can only be provided with the consent of the marketing authorization holder. If no response is given in this section (2A.3.1), this will indicate that the concerned party has refused the inclusion of this information. Please note that the information relating to the manufacturer or the importer in the exporting country responsible for the batch release is provided in the marketing authorization.
8.    This refers to the document prepared by some national regulatory authorities which summarizes the technical data leading to the marketing authorization issue.
9.    This refers to the information on the medicinal product approved by the competent national authority such as the Summary of Product Characteristics (SPC), the patient information leaflet and the labeling. The SPC specifies the conditions for delivery and use of the medicinal product in particular (special precautions for storage and use, contra-indications).
10.    Only if the applicant is not the marketing authorization holder. The conditions of delivery and use of the medicinal product (special precautions for storage and use, contra-indications) should be specified. In all other cases, the copy of the marketing authorization must be provided.
11.    In this case, the consent of the marketing authorization holder is required for the certificate to be issued. This consent must be communicated to the authority by the applicant.
12.    Please indicate the reason(s) why the applicant has not submitted an application for marketing authorization:
a) The medicinal product has been exclusively developed for the treatment of diseases – especially for tropical diseases – which are not endemic in the exporting country
b) The medicinal product has been reformulated in order to improve its stability under tropical conditions
c) The medicinal product has been reformulated to exclude excipients which are not approved in the importing country
d) The medicinal product has been reformulated to comply with a requirement regarding the dosage of an active ingredient
e) The medicinal product has a marketing authorization for another dose, another pharmaceutical form or a different formulation
f) Other reason (specify)
13.    “Not applicable” indicates that the medicinal product is manufactured in a country other than the one which issues the certificate and that the inspection is carried out on the responsibility of the competent authority in the country where the medicinal product is manufactured.
14.    The rules of Good Practices applicable to the manufacture of medicinal products and to their quality control mentioned in the certificate are those which are provided in the thirty-second report of the WHO Experts Committee on specifications relating to pharmaceutical preparations (WHO, Technical Reports Series, N° 823, 1992). Recommendations specifically applicable to biological products have been formulated by the WHO Experts Committee on biological standardization and are published in the WHO Technical Report Series.
15.    These data have particular importance when foreign suppliers or when several manufacturers are involved in the medicinal product manufacture. In this case, the applicant must provide to the certifying authority information identifying the contractual parties responsible for each step of the manufacture of the finished pharmaceutical form and defining the nature and the extent of all controls applied on each of these parties. All additional information about these manufacture sites, which may be required by the certifying authority, should be provided by the applicant.

填写说明
1．    关于填写表格和执行办法的详细信息，请参考说明。
2．    表格可由计算机生成，但提交时须打印。
3．    必要时请附备注和注释。
注释
1．    该证明符合世界卫生组织推荐的形式，说明了药品和出口国申请人的情况。每份证明只适用于一个药品，因不同剂型、不同浓度药品的生产工艺和批准信息可能有所不同。
2．    尽可能使用国际通用名或国内通用名。
3．    制剂的处方（所有成分）应在证明书或附件上注明。
4．    在销售许可证持有者同意的前提下，应注明辅料含量。
5．    2A部分关注对象为有销售许可证的药品，2B部分关注对象为无销售许可证的药品，因此2A部分与2B部分互不干涉。
6．    无论是销售许可证持有者还是无销售许可证药品的证明申请人，请注明为以下何种情况：
a)    为出口国负责药品批放行的生产商或进口商（删除不适用部分）
b)    参与成品生产过程，但不是出口国负责药品批放行的生产商或进口商（删除不适用部分）
c)    不参与a)和b)中所述活动。
7．    仅在销售许可证持有者同意的情况下才能提供该部分（2A.3.1）信息．如果无答复，则说明有关方面拒绝添加该部分信息。请注意，出口国负责药品批放行的生产商或进口商的有关信息已提供在销售许可证中。
8．    指由某些国家管理机构准备的文件。该文件总结了获得销售许可证所需的技术数据。
9．    指由国家权力机关批准的药品信息，如产品特性概要、说明书和标签。产品特性概要应注明药品运输条件和特殊用途（贮存与使用特殊注意事项、禁忌症）。
10．仅当申请人非销售许可证持有者时。应注明药品运输条件和特殊用途（贮存与使用特殊注意事项、禁忌症）。其它情况下应提供销售许可证复印件。
11．此种情况下，证书的颁发需征得销售许可证持有者的同意。该意向应由证书申请人向主管部门通报。
12．请注明证书申请人未申请销售许可证的原因12：
a)    该药品专为治疗某些疾病－尤其是热带病－而生产，不用于治疗出口国的地方病
b)    为改善该药品在热带条件下的稳定性而对处方进行了修改
c)    为去除在进口国未获批准的辅料而对处方进行了修改
d)    为适应对某一主成分剂量的要求而对处方进行了修改
e)    该药品已获得其它规格、剂型或处方的销售许可证
f)    其它原因（请详细说明）：
13．“不适用”指药品是在证书颁发国以外的国家生产，对药品生产的检查是由药品生产国的主管部门负责执行。
14．本证书所述适用于药品生产和质量控制的管理规范见世界卫生组织专家委员会有关药品制备的第32份报告（世界卫生组织第823号技术报告，1992年）。专门适用于生物制品的建议由世界卫生组织生物标准专家委员会提出并发表在世界卫生组织的技术报告集。
15．当有国外供应商或多个生产商参与药品生产时，这些数据尤为重要。在这种情况下，申请人应向证明机构提供有关信息，以认定负责每一步成品生产的契约方，限定对各契约方控制的性质和程度。对于证明机构可能要求提供的有关生产场所的附加信息，应全部由证书申请人负责提供。

Responsible Pharmacist’s Commitment
Appendix to the Medicinal Product Certificate

Name of the medicinal product:
Export trade name:
Active ingredient(s) (INN):
Intended for:
(Applicant country)
I, the undersigned,
(Forename, SURNAME)
Temporally responsible pharmacist for the company:
(name of applicant company)

-certify that the information provided in the attached certificate is accurate and I undertake to apply for a new medicinal product certificate in the event of any changes to pharmaceutical and clinical data and to the conditions of prescription and delivery related to the product having obtained the marketing authorization in the exporting country.

-certify that the following items are attached to the certificate (*):

1) copy of the authorization of the exporting pharmaceutical site,
2) copy of the certificate of Good Manufacturing Practice (GMP) and copy of the authorization of the manufacturer or of the importer in the exporting country responsible for the batch release,
3) medicinal product with a marketing authorization
copy of the marketing authorization
I certify that the copy of the marketing authorization is complete and I undertake to apply for a new medicinal product certificate in the event of any changes to pharmaceutical and clinical data and to the conditions of prescription and delivery related to the product having obtained the marketing authorization.
And/or, if the applicant is not the marketing authorization holder:
Authorization of the marketing authorization holder for issuing the certificate (in duplicate)
medicinal product without a marketing authorization
copy of the export statement required by article ** of the Public Health Code
I undertake to apply for a new medicinal product certificate if a modification is made to the expert statement.
(*) the appropriate box(es) must be ticked for the third item
-certify that, if necessary, the following item is attached to this commitment:
4) list of the manufacturers (name, address) and certificates equivalent to the GMP certificate for the corresponding manufacture sites, if more than one manufacturer is involved in the manufacturing of the medicinal product.

Commitment in duplicate

At ** on ** Signature

主管药师承诺书
药品证书附件

药品名称：   
出口商品名：
活性成分（国际通用名）：   
提供给：
（申请人所在国）
本签字人：
（名，姓）
作为以下公司的现任主管药师：
（申请公司名称）

―证明所附信息确凿。对已在出口国取得销售许可证的药品，若其药学数据、临床数据、处方和运输条件有任何改动，我将申请新的药品证书。

－证明本证书含以下附件（*）：
1）    出口地批准文件的复印件
2）    出口国负责药品批放行的生产商或进口商的GMP 证书复印件和授权书复印件
3）   
有销售许可证的产品
销售许可证复印件：
我证明销售许可证复印件完整。对已在法国取得销售许可证的药品，若其药学数据、临床数据、处方和运输条件有任何改动，我承诺申请新的药品证书。
并且/或者，若证书申请人非销售许可证持有者：
则提交销售许可证持有者委托进行认证的委托书（一式两份）。
无销售许可证的产品
公众健康法第** 号条文所要求的出口说明复印件。
如果出口说明有所修改，我承诺申请新的药品证书。
*填写第三项时, 须在适当的方格内加上剔号
－在此证明，必要时该承诺书将附带以下项目：
4）    若药品生产企业不止一家，则列表说明各生产厂的名称、地址和效力等同于生产场所GMP 证书的其他证书。

本承诺书一式二份

于** 日期 签名

Referring to 4/F, I would like to share my views on the translation of “General Instruction - 一般指南”

Instruction is an uncountable noun and means teaching etc. (see Oxford Advanced Learner’s dictionary of Current English). When instruction is in plural form, instructions means an order, something mandatory, or something strongly recommended (i.e. 指令,指示,训令,批示,训词,批件 see http://www.sentbase.com/default.aspx?q=instructions ).

(There was a contractual claim in a building project, and the focus of argument was whether the “Site Instruction” issued by the Engineer was an order, which the Contractor had to follow. Unfortunately, the Engineer forgot to add the “s” after “Instruction”.)

For translating a technical paper, the difference between “instruction” and “instructions” may not be significant. However, when drafting something related to business (i.e. may related to commercial laws, contract law etc), we should be careful.

“General” is also an interesting word. It may mean 一般, but it is also used to describe something important, essential etc. (such as general manager, see http://dictionary.reference.com/browse/general)

I found that “general” is sometimes inappropriately translated as “普通, 一般”. For example, a university course “General Chemistry” is commonly translated as “普通化学”. However, I consider that “基础化学” may be better, as “General Chemistry” is in fact a compulsory course providing the fundamental and essential knowledge of chemistry that all science and engineering students should have in their university study.

It is widely accepted that “General Instructions” can be translated as “一般指南” (although sometimes it may be substantially an important, mandatory direction). However, is there any better translation?

谢谢。其实在这份GMP证书里，它指的是对各选项的填写说明。要不我就翻译成“填写说明”吧。

挑刺的又来了！

I was called 表叔 because I have designed many forms for the implementation of ISO9000 and 17025; furthermore, I have filled numerous forms in my life. With my aforesaid experience, I would like to share my views on the translation of this “填写说明”

Quoted:
1.3 Is this medicinal product marketed in the exporting country? Yes/no
(Circle the appropriate response)

1.3    该药品在出口国是否已上市销售？是／否
（选择正确答案）

Comment:
选择正确答案 may be by means of putting a tick at the appropriate answer or putting a cross at the inappropriate answer. However, the original instructions is “circle the appropriate response”.
For an ordinary form, the translation of “选择正确答案” is acceptable. But for some important documents, the translation must be precise. Otherwise, the document may be considered as invalid if the one does not fill in the form strictly follow the instructions. (for example, invalid vote 废票 due to using a tick instead of a required circle).
I encountered a 官僚, he returned my form and rejected my application simply because I crossed out the inappropriate answer instead of putting a tick at the appropriate.
Suggestion:
圈出适当答案

(to be cont.)