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2003-94-EC与EU2017-1572对比解析
浏览: 六合开奖记录:2018-02-08
Article 1
Scope范围
This Directive lays down the principles and guidelines of goodmanufacturing practice in respect of medicinal products for human use whose manufacture requires the authorisation referred to in Article 40 of Directive 2001/83/EC and in respect of investigational medicinal products for human use whose manufacture requires the authorisation referred to in Article 13 of Directive 2001/20/EC
This Directive lays down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use whose manufacture or import A1 requires the authorisation referred to in Article 40 of Directive 2001/83/EC A2
本指令制定了有关人用医药产品的GMP的原则和引导,其生产或进口需要2001/83/EC指令中的第40章中提及的授权。
A1:增加“进口”
A2删掉了旧版中适用于研究性药物的语句。即新版仅适用于medicinal products
Article 2
Definitions定义
For the purposes of this Directive, the following definitions shall apply:
1. ‘medicinal product’ means any product as defined in Article1(2) of Directive 2001/83/EC;
2. ‘investigational medicinal product’ means any product as defined in Article 2(d) of Directive 2001/20/EC;
3. ‘manufacturer’ means any person engaged in activities for which the authorisation referred to in Article 40(1) and (3) of Directive 2001/83/EC or the authorisation referred to in Article 13(1) of Directive 2001/20/EC is required;
4. ‘qualified person’ means the person referred to in Article 48 of Directive 2001/83/EC or in Article 13(2) of Directive 2001/20/EC;
5. ‘pharmaceutical quality assurance’ means the total sum of the organised arrangements made with the object of ensuring that medicinal products or investigational medicinal products are of the quality required for their intended use;
6. ‘good manufacturing practice’ means the part of quality assurance which ensures that products are consistently produced and controlled in accordance with the quality standards appropriate to their intended use;
7. ‘blinding’ means the deliberate disguising of the identity of an investigational medicinal product in accordance with the instructions of the sponsor;
8. ‘unblinding’ means the disclosure of the identity of a blinded product.
 
For the purposes of this Directive, the following definitions shall apply: A3
(1) ‘manufacturer’ means any person engaged in activities for which the authorisation referred to in Article 40(1) and (3) of Directive 2001/83/ECA4 is required; 
“制造商”是指参与在2001/83/EC指令中第40段(1)和(3)中提及的授权所要求的活动的任何人员。
A3删掉了“医药产品”、“研究性药品”、”质量授权人”、“ 研究性药物”以及研究性药品中的“blinding”和“unblinding”的定义
A4删除了2001/20/EC指令的语句
 
(2) ‘pharmaceutical quality system’ means the total sum of the organised arrangements made with the objective of ensuring that medicinal products are of the quality required for their intended use; 
“制药质量系统”是指所有为了确保药品达到其预定用途所要求的质量需求而进行的有组织的安排的总和。
(3) ‘good manufacturing practice’ means the part of the quality assurance which ensures that medicinal products are consistently produced, imported A5and controlled in accordance with the quality standards appropriate to their intended use. 
“良好生产规范GMP”是指确保药品依照适于其预定用途的质量标准而持续地生产、进口和控制的质量保证部分。
A5:增加“进口”
Article 3
Inspections检查
1. By means of the repeated inspections referred to in Article 111(1) of Directive 2001/83/EC and by means of the inspections referred to in Article 15(1) of Directive 2001/20/EC, the Member States shall ensure that manufacturers respect the principles and guidelines of good manufacturing practice laid down by this Directive. Member States shall also take into account the compilation, published by the Commission, of Community procedures on inspections and exchange of information
1. By means of the repeated inspections referred to in Article 111(1a) of Directive 2001/83/ECA6, the Member States shall ensure that manufacturers authorised in accordance with Article 40(1) and (3) of Directive 2001/83/EC respect the principles and guidelines of good manufacturing practice laid down by this Directive. 
Member States shall also take into account the compilation, published by the Commission, of Union procedures on inspections and exchange of information. 
依靠2001/83/EC指令中第111章(1a)所述的重复检查,成员国应当保证制造商的授权依照2001/83/EC指令中第40章(1)和(3),遵守该指令中的GMP原则和引导。
A6删除了有关2001/20/EC指令的语句
 
成员国应当同时考虑欧盟委员会发布的有关检查规程和信息交流的编辑。
2. For the interpretation of the principles and guidelines of good manufacturing practice, the manufacturers and the competent authorities shall take into account the detailed guidelines referred to in the second paragraph of Article 47 of Directive 2001/83/EC, published by the Commission in the‘Guide to good manufacturing practice for medicinal products and for investigational medicinal products’.
2. For the interpretation of the principles and guidelines of good manufacturing practice, manufacturers and the competent authorities shall take into account the detailed guidelines referred to in the second paragraph of Article 47 of Directive 2001/83/EC. In the case of advanced therapy medicinal products, the guidelines on good manufacturing practice specific to advanced therapy medicinal products referred to in Article 5 of Regulation (EC) No 1394/2007 on 
advanced therapy medicinal products shall be taken into account. A7
为了说明GMP的原则和引导,制造商和主管当局应当考虑2001/83/EC指令中第47章第二段的详细引导。对于先进治疗药品,应当考虑法令(EC)No1394/2007中有关先进治疗药品的第5段中针对先进治疗药品的GMP的引导。
A7删除了“欧盟有关药品和研究性药品GMP”语句,增加有关“先进治疗药品”部分。
 
3. Member States shall establish and implement in their inspectorates a properly designed quality system that shall be complied with by inspectorates' personnel and management. The quality system shall be updated as appropriate. A8
A8新增内容部分:成员国应当在其检查团内设立并实施经过适当设计的质量体系,检查团人员和管理层应当遵守该体系。该质量体系应当适当更新。
Article 4
Conformity with good manufacturing practice符合GMP
1. The manufacturer shall ensure that manufacturing operations are carried out in accordance with good manufacturing practice and with the manufacturing authorisation. This provision shall also apply to medicinal products intended only for export.
1. The Member StatesA9 shall ensure that the manufacturing operations are carried out by manufacturers in accordance with good manufacturing practice and with the manufacturing authorisation. This provision shall also apply to medicinal products intended only for export. 
成员国应当保证生产活动是由生产商依照GMP和生产授权。该条款应当同样适用于只用于出口的药品。
A9:主语由生产商变成现版成员国,责任归属有变化。
2. For medicinal products and investigational medicinal products imported from third countries, the importer shall ensure that the products have been manufactured in accordance with standards which are at least equivalent to the good manufacturing practice standards laid down by the Community.
In addition, an importer of medicinal products shall ensure that such products have been manufactured by manufacturers duly authorised to do so. An importer of investigational medicinal products shall ensure that such products have been manufactured by a manufacturer notified to the competent authorities and accepted by them for that purpose.

3.For medicinal productsA10 imported from third countries, the Member States shall ensure that the products have been manufactured in accordance with standards which are at least equivalent to the good manufacturing practice standards laid down in the Union and that such products have been manufactured by manufacturers duly authorised to do so.A11
对于进口自第三国家的药品,成员国应当保证该产品是依照至少与欧盟颁布的GMP标准相等的标准生产,且该产品是由经过正式授权的生产商生产的。
A10: 删除了“研究性药品”语句。
A11: 将旧版中第二段的该句挪到这里。并删除了旧版中有关研究性药品进口的语句。
Article 5
Compliance with marketing authorisation符合上市授权
1. The manufacturer shall ensure that all manufacturing operations for medicinal products subject to a marketing authorisation are carried out in accordance with the information provided in the application for marketing authorisation as accepted by the competent authorities.
In the case of investigational medicinal products, the manufacturer shall ensure that all manufacturing operations are carried out in accordance with the information provided by the sponsor pursuant to Article 9(2) of Directive 2001/20/EC as accepted by the competent authorities.
1. The Member States A12shall ensure that all manufacturing or importA13 operations for medicinal products subject to a marketing authorisation are carried out by manufacturers in accordance with the information provided in the application for that marketing authorisation.A14
成员国应当确保所有服从于上市授权的药品的生产和进口活动都是根据上市授权申请中提供的信息进行。
A12: 主语由生产商变成现版成员国,责任归属有变化。
A13: 增加“进口”
A14:删除了旧版中对于上市申请“被监管部门所接受”的语句。删除了有关研究性药品的内容。
 
2. The manufacturer shall regularly review his manufacturing methods in the light of scientific and technical progress and the development of the investigational medicinal product.
If a variation to the marketing authorisation dossier or an amendment to the request referred to in Article 9(2) of Directive 2001/20/EC is necessary, the application for modification shall be submitted to the competent authorities.
2. The Member States shall oblige the manufacturer A15 to regularly review his manufacturing methods in light of scientific and technical progress. A16
If a variation to the marketing authorisation dossier is necessary, the variation shall take place by the arrangements established in accordance with Article 23b of Directive 2001/83/EC. A17
成员国应当责成生产商根据科技的进步定期回顾其制造方法。
如果上市许可档案需要变更,该变更需要根据2001/83/EC指令中23b章规定的安排进行。
A15:旧版是制造商自己,新版是成员国要求制造商进行。
A16:删除了研究性药品的内容
A17:此处将变更的依据明确规定到2001/83/EC指令中的具体条款。旧版是“变更申请提交给监管部门”
Article 6
Quality assurance system质量保证体系
The manufacturer shall establish and implement an effective pharmaceutical quality assurance system, involving the active participation of the management and personnel of the different departments.
The Member States A18shall ensure that the manufacturers establish, implement and maintain an effective pharmaceutical quality system, involving the active participation of the senior A19management and the personnel of the different departments.
成员国应当确保生产商建立、实施并维持一个有效的制药质量体系,包括了高层管理和不同部门人员的积极参与。
A18:主语由生产商变成现版成员国,责任归属有变化。
A19:增加了“高层”
Article 7
Personnel人员
1. At each manufacturing site, the manufacturer shall have a sufficient number of competent and appropriately qualified personnel at his disposal to achieve the pharmaceutical quality assurance objective.
1. The manufacturer shall be obliged toA20 have at each manufacturing or import site a sufficient number of competent and appropriately qualified personnel at his disposal to achieve the objective of the pharmaceutical quality system. 
生产商应当有义务在每个生产或进口现场有足够数量且能力合格的有资质的人员来达到制药质量体系的目标。
A20:改变了句式,强调了有资质人员的强制性。
 
2. The duties of the managerial and supervisory staff, including the qualified persons, responsible for implementing and operating good manufacturing practice, shall be defined in job descriptions. Their hierarchical relationships shall be defined in an organisation chart. Organisation charts and job descriptions shall be approved in accordance with the manufacturer's internal procedures.
2.The duties of the managerial and supervisory staff, including the qualified persons referred to in Article 48 of Directive 2001/83/EC,A21 responsible for implementing and operating good manufacturing practice, shall be defined in job descriptions. Their hierarchical relationships shall be defined in an organisation chart. Organisation charts and job descriptions shall be approved in accordance with the manufacturer's internal procedures. 
管理和监督工作人员的职责,包括2001/83/EC指令第48章中提及的有资质的人员,负责实施和实行GMP的,应当在工作描述中定义。他们的层级关系应当在一个组织结构图中定义。组织结构图和工作描述应当在制造商内部规程中进行批准。
A21:增加了对合格的,有资质人员规定的出处。
 
3. The staff referred to in paragraph 2 shall be given sufficient authority to discharge their responsibility correctly.
3. The staff referred to in paragraph 2 shall be given sufficient authority to discharge their responsibility correctly. 
第二段中所述的工作人员应当给予足够的权力,以便正确履行其职责。
4.The personnel shall receive initial and ongoing training, the effectiveness of which shall be verified, covering in particular the theory and application of the concept of quality assurance and good manufacturing practice, and, where appropriate, the particular requirements for the manufacture of investigational medicinal products.
4. The personnel shall receive initial and ongoing training, the effectiveness of which shall be verified, covering in particular the theory and application of the concept of quality assurance and good manufacturing practice. A22
人员应当接受初始的和持续的培训,其效果应当被验证,培训包含了质量保证和GMP观念的理论和应用。
A22:此处删除了旧版中“研究性药品的特殊要求”
 
5. Hygiene programmes adapted to the activities to be carried out shall be established and observed. These programmes shall, in particular, include procedures relating to health, hygiene practice and clothing of personnel.
5.Hygiene programmes adapted to the activities to be carried out shall be established and observed. These programmes shall, in particular, include procedures relating to health, hygiene practice and clothing of personnel. 
适用的卫生程序应当制定并遵守。这些程序应当特别包括有关健康、卫生习惯和员工服装。
Article 8
Premises and equipment场地和设备
1. Premises and manufacturing equipment shall be located, designed, constructed, adapted and maintained to suit the intended operations.
1. As regards the premises and manufacturing equipment the manufacturer shall be obliged A23to ensure that they are located, designed, constructed, adapted and maintained to suit the intended operations. 
有关场地和生产设备,制造商应当有义务确保他们的定位、设计、建造、调试和维修都适用于目标操作。
A23:修改句式强调生产商的强制责任
 
2. Premises and manufacturing equipment shall be laid out, designed and operated in such a way as to minimise the risk of error and to permit effective cleaning and maintenance in order to avoid contamination, cross contamination and, in general, any adverse effect on the quality of the product.
2. The Member StatesA24 shall require that the premises and manufacturing equipment are laid out, designed and operated in such a way as to minimise the risk of error and to permit effective cleaning and maintenance in order to avoid contamination, cross contamination and, in general, any adverse effect on the quality of the product. 
成员国应当要求场地和生产设备的布置、设计和操作采用尽量减少出现错误的风险的方式,并允许进行有效清洁和维护,以避免污染、交叉污染以及总体上对产品质量的不利影响。
A24主语改为成员国,强调了责任归属。
 
3. Premises and equipment to be used for manufacturing operations, which are critical to the quality of the products, shall be subjected to appropriate qualification and validation.
3. Premises and equipment to be used for manufacturing or import A25operations, which are critical to the quality of the products, shall be subjected to appropriate qualification and validation. 
对产品质量是关键因素的用于生产或进口活动的场地和设备,应当经过确认和验证。
A25:增加了“进口”
Article 9
Documentation文件
1. The manufacturer shall establish and maintain a documentation system based upon specifications, manufacturing formulae and processing and packaging instructions, procedures and records covering the various manufacturing operations performed. Documents shall be clear, free from error and kept up to date. Pre-established procedures for general manufacturing operations and conditions shall be kept available, together with specific documents for the manufacture of each batch. That set of documents shall enable the history of the manufacture of each batch and the changes introduced during the development of an investigational medicinal product to be traced.
For a medicinal product, the batch documentation shall be retained for at least one year after the expiry date of the batches to which it relates or at least five years after the certification referred to in Article 51(3) of Directive 2001/83/EC, whichever is the longer period.
For an investigational medicinal product, the batch documentation shall be retained for at least five years after the completion or formal discontinuation of the last clinical trial in which the batch was used. The sponsor or marketing authorisation holder, if different, shall be responsible for ensuring that records are retained as required for marketing authorisation in accordance with the Annex I to Directive 2001/83/EC, if required for a subsequent marketing authorisation.
1. The manufacturer shall be obliged A26 to establish and maintain a documentation system based upon specifications, manufacturing formulae and processing and packaging instructions, procedures and records covering the various manufacturing operations performed. The documentation system shall ensure data quality and integrity. Documents shall be clear, free from error and kept up to date. Pre-established procedures for general manufacturing operations and conditions shall be kept available, together with specific documents for the manufacture of each batch. That set of documents shall enable the history of the manufacture of each batch to be traced. A27
制造商应当有义务制定和维持一个文件系统,基于规格、制造公式和工艺,以及包装指令、规程和记录,包含了各种生产中实行的操作。文件系统应当保证数据的质量和完整性。文件应当清楚、无误并保持最新。一般生产操作和条件的预设置规程应当连同每一批次生产的具体文件一同保持有效。这套文件应能追溯每一批次的生产历史。
A26:强调强制责任
A27:删除了旧版中“研究性药物的发展过程中的变化的先容”
 
A28The manufacturer shall be required to retain the batch documentation for at least 1 year after the expiry date of the batches to which it relates or at least 5 years after the certification referred to in Article 51(3) of Directive 2001/83/EC, whichever is the longer period. 
制造商应当被要求在每一批次的有效期到期后继续保持文件至少一年,或2001/83/EC指令中第51章(3)中提及的验证后至少5年,以其中较长的为准。
A28:此处删除了“药品”字样,且后文删除了研究性药品的内容,此处删除了“药品”字样
 
2. When electronic, photographic or other data processing systems are used instead of written documents, the manufacturer shall first validate the systems by showing that the data will be appropriately stored during the anticipated period of storage. Data stored by those systems shall be made readily available in legible form and shall be provided to the competent authorities at their request. The electronically stored data shall be protected, by methods such as duplication or back-up and transfer on to another storage system, against loss or damage of data, and audit trails shall be maintained.
2. When electronic, photographic or other data processing systems are used instead of written documents, the manufacturer shall be required toA29 first validate the systems by showing that the data will be appropriately stored during the anticipated period of storage. Data stored by those systems shall be made readily available in legible form and shall be provided to the competent authorities upon request. The electronically stored data shall be protected, by techniques such as duplication or back-up and transfer to another storage system, against unlawful access, loss or damage of data, and audit trails shall be maintained. 
当使用电子、照相或其他数据处理系统来代替书面文件时,制造商应当被要求首先验证系统,证明在预期的周期内数据可以妥善保存。这些系统内储存的数据应当以易读的格式随时提供,并应要求可提供给主管部门。电子储存的数据应当通过例如复制或备份的形式保护,并且转移到其他储存系统,防止数据的非法访问、丢失或损坏,并保持审计追踪。
A29:加入“被要求”,强调了被强制性。
 
Article 10 
Production生产
1. The different production operations shall be carried out in accordance with pre-established instructions and procedures and in accordance with good manufacturing practice. Adequate and sufficient resources shall be made available for the inprocess controls. All process deviations and product defects shall be documented and thoroughly investigated.
1. The Member States A30shall ensure that the manufacturers carry out the different production operations in accordance with pre-established instructions and procedures and in accordance with good manufacturing practice. Adequate and sufficient resources shall be made available by the manufacturer for the in-process controls. All process deviations and product defects shall be documented and thoroughly investigated. 
成员国应当确保制造商按照预先制定的说明和规程并依照GMP进行不同的生产操作。制造商应当为工艺内控制提供适当的和充分的资源。所有流程偏差和产品缺陷应当被记录并彻底调查。
A30:加入“成员国”强调责任归属
 
2. Appropriate technical or organisational measures shall be taken to avoid cross contamination and mix-ups. In the case of investigational medicinal products, particular attention shall be paid to the handling of products during and after any blinding operation.
2. The manufacturers shall be required to A31take appropriate technical and organisational measures to avoid cross contamination and mix-ups.A32
制造商应有责任采取适当的技术和组织措施以避免交叉污染和混淆。
A31:加入“制造商被要求”强调被强制性和责任归属
A32:删除研究性药物的语句
 
3. For medicinal products, any new manufacture or important modification of a manufacturing process of a medicinal product shall be validated. Critical phases of manufacturing processes shall be regularly re-validated.
4. For investigational medicinal products, the manufacturing process shall be validated in its entirety in so far as is appropriate, taking into account the stage of product development. At least the critical process steps, such as sterilisation, shall be validated. All steps in the design and development of the manufacturing process shall be fully documented.
3.  A33Any new manufacturing or important modification of a manufacturing process of a medicinal product shall be validated. Critical phases of manufacturing processes shall be regularly revalidated.  A34
药品的任何新的生产或重要的生产工艺修订应当被验证。生产工艺的关键阶段应当定期重新验证。
A33:此处删除“对药物产品”字样
A34:旧版第4.段的研究性药物相关内容删除
Article 11 
Quality control质量控制
1. The manufacturer shall establish and maintain a quality control system placed under the authority of a person who has the requisite qualifications and is independent of production. 
That person shall have at his disposal, or shall have access to, one or more quality control laboratories appropriately staffed and equipped to carry out the necessary examination and testing of the starting materials and packaging materials and the testing of intermediate and finished products.
1. The manufacturer shall be obliged to A35 establish and maintain a quality control system placed under the authority of a person who has the requisite qualifications and is independent of production.
That person shall have at his disposal, or shall have access to, one or more quality control laboratories appropriately staffed and equipped to carry out the necessary examination and testing of starting materials and packaging materials and the testing of intermediate and finished medicinal A36products. 
制造商应当有义务建立和维护一个质量控制系统,由具有必备资质并且独立于生产的人员授权。
该人员应当可处理或可利用一个或多个质量控制实验室,该实验室配备有合适的人员和设备,可以对起始原料和包装材料进行必要的检查和检测,以及对中间体和最终医药产品进行检测。
A35:强调被强制性
A36:加入“医药”字样强调是医药产品。
 
2. For medicinal products, including those imported from third countries, contract laboratories may be used if authorised in accordance with Article 12 of this Directive and point (b) of Article 20 of Directive 2001/83/EC.
For investigational medicinal products, the sponsor shall ensure that the contract laboratory complies with the content of the request referred to in Article 9(2) of Directive 2001/20/EC, as accepted by the competent authority. When the products are imported from third countries, analytical control shall not be mandatory.
2. For medicinal products, including those imported from third countries, contract laboratories may be used if authorised in accordance with Article 12 of this Directive and point (b) of Article 20 of Directive 2001/83/EC.  A37
对于医药产品,包括那些进口自第三国的,可根据本指令中第13章和2001/83/EC指令中第20章(b)点,使用经过授权的合约实验室。
A37:删除旧版中有关研究性药物的段落
 
3. During the final control of the finished product before its release for sale or distribution or for use in clinical trials, the quality control system shall take into account, in addition to analytical results, essential information such as the production conditions, the results of in-process controls, the examination of the manufacturing documents and the conformity of the product to its specifications, including the final finished pack.
3. During the final control of the finished medicinal A38 product before its release for sale or distribution, A39 the quality control system shall take into account, in addition to analytical results, essential information such as the production conditions, the results of in-process controls, the examination of the manufacturing documents and the conformity of the product to its specifications, including the final finished pack. 
在最终医药产品出售或分销之前的最终控制中,质量控制系统不但要考虑分析结果,还应考虑基本信息,例如生产条件、工艺内控制结果、生产文件的检查和产品与其规格的一致性,包括最终完成的包装。
A38:增加“医药”字样
A39:删除“用于临床实验”字样
 
4. Samples of each batch of finished medicinal product shall be retained for at least one year after the expiry date.
For an investigational medicinal product, sufficient samples of each batch of bulk formulated product and of key packaging components used for each finished product batch shall be retained for at least two years after completion or formal discontinuation of the last clinical trial in which the batch was used, whichever period is the longer.
Unless a longer period is required under the law of the Member State of manufacture, samples of starting materials, other than solvents, gases or water, used in the manufacturing process shall be retained for at least two years after the release of product. That period may be shortened if the period of stability of the material, as indicated in the relevant specification, is shorter. All those samples shall be maintained at the disposal of the competent authorities.
Other conditions may be defined, by agreement with the competent authority, for the sampling and retaining of starting materials and certain products manufactured individually or in small quantities, or when their storage could raise special problems.
4. Samples of each batch of finished medicinal product shall be retained for at least 1 year after the expiry date.  A40
 A41Samples of starting materials, other than solvents, gases or water, used in the manufacturing process shall be retained for at least 2 years after the release of the product. That period may be shortened if the period of stability of the material, as indicated in the relevant specification, is shorter. All those samples shall be maintained at the disposal of the competent authorities. 
Other conditions may be defined, by agreement with the competent authority, for the sampling and retaining of starting materials and certain products manufactured individually or in small quantities, or when their storage could raise special problems. 
每批最终医药产品的样品应当在其有效期到期后至少保留1年。
在生产过程中使用的原始材料的样品,除了溶液、气体或水之外,应当在产品放行后保存至少两年。如果相关说明中指出材料的稳定性更短,则该周期可以缩短。所有这些样品应当保持在监管部门管理。
当与主管部门就初始原料和某些特定的单独生产的或少量生产的产品的取样和留存达成协议,或其储存可能引起特殊问题时,可以定义其他条件。
A40:此处删除有关研究性药物内容
A41: 删除了旧版中“除非成员国对生产的法律要求更长的周期
Article 12 
Outsourced operations外包业务
1. Any manufacturing operation or operation linked thereto which is carried out under contract shall be the subject of a written contract.
1. The Member States A42 shall require that any manufacturing or import A43operation or operation linked thereto which is outsourced is the subject of a written contract. 
成员国应当要求任何生产或进口活动或与之相关的活动须在书面合同下进行外包。
A42: 增加“成员国”强调责任归属
A43: 增加“进口”
 
2. The contract shall clearly define the responsibilities of each party and shall define, in particular, the observance of good manufacturing practice to be followed by the contract-acceptor and the manner in which the qualified person responsible for certifying each batch is to discharge his responsibilities.
2. The contract shall clearly define the responsibilities of each party and shall define, in particular, the observance of good manufacturing practice to be followed by the contract-acceptor and the manner in which the qualified person referred to in Article 48 of Directive 2001/83/EC responsible for certifying each batch is to discharge his responsibilities. 
合同应当清楚定义各方的责任,尤其是合同承接人应当遵守GMP,以及2001/83/EC指令中第48章提及的质量人员负责的应证明每批次都履行其职责。
3. The contract-acceptor shall not subcontract any of the work entrusted to him under the contract without written authorisation from the contract-giver.
3. The contract-acceptor shall not subcontract any of the work entrusted to him under the contract without written authorisation from the contract-giver. 
未经合同授权人书面授权,合同承接人不得将合同中任何委托给他的工作分包。
4. The contract-acceptor shall comply with the principles and guidelines of good manufacturing practice and shall submit to inspections carried out by the competent authorities pursuant to Article 111 of Directive 2001/83/EC and Article 15 of Directive 2001/20/EC.
4. The contract-acceptor shall comply with the principles and guidelines of good manufacturing practice applicable to the operations concerned laid down in the Union A44 and shall submit to inspections carried out by competent authorities pursuant to Article 111 of Directive 2001/83/EC. A45
合同承接人应当遵守欧盟颁布的GMP的原则和引导,并接受2001/83/EC指令中第111章规定的监管部门提出的检查。
A44: 增加“欧盟内制定的有关行动”字样
A45:删除了“2001/20/EC指令中第15章”字样
Article 13
Complaints, product recall and emergency unblinding投诉、产品召回和紧急揭盲
Complaints and product recall A46 投诉和产品召回
A46:删除了“揭盲”
1. In the case of medicinal products, the manufacturer shall implement a system for recording and reviewing complaints together with an effective system for recalling, promptly and at any time, medicinal products in the distribution network. Any complaint concerning a defect shall be recorded and investigated by the manufacturer. The manufacturer shall inform the competent authority of any defect that could result in a recall or abnormal restriction on supply and, in so far as is possible, indicate the countries of destination.
Any recall shall be made in accordance with the requirements referred to in Article 123 of Directive 2001/83/EC.
1. The Member States A47shall ensure that manufacturers implement a system for recording and reviewing complaints together with an effective system for recalling, promptly and at any time, medicinal products in the distribution network. Any complaint concerning a defect shall be recorded and investigated by the manufacturer. The manufacturer shall be required to inform the competent authority and, if applicable, the marketing authorisation holder A48of any defect that could result in a recall or an abnormal restriction on supply and, in so far as possible, indicate the countries of destination. 
成员国应当确保制造商施行记录和投诉回顾系统,同时在分销商网络中施行迅速的和随时的有效召回系统。任何有关缺陷的投诉都应当由生产商记录并调查。任何可导致召回或异常供货限制的缺陷生产商都应被要求通知主管部门和上市授权持有人(如果适用),并尽可能的指明目的国。
A47:删除“对于医药产品”,加入“成员国”
A48:增加了“上市授权持有人”
 
2. In the case of investigational medicinal products, the manufacturer shall, in cooperation with the sponsor, implement a system for recording and reviewing complaints together with an effective system for recalling promptly and at any time investigational medicinal products which have already entered the distribution network. The manufacturer shall record and investigate any complaint concerning a defect and shall inform the competent authority of any defect that could result in a recall or abnormal restriction on supply.
In the case of investigational medicinal products, all trial sites shall be identified and, in so far as is possible, the countries of destination shall be indicated.
In the case of an investigational medicinal product for which a marketing authorisation has been issued, the manufacturer of the investigational medicinal product shall, in cooperation with the sponsor, inform the marketing authorisation holder of any defect that could be related to the authorised medicinal product.
3.The sponsor shall implement a procedure for the rapid unblinding of blinded products, where this is necessary for a prompt recall as referred to in paragraph 2. The sponsor shall ensure that the procedure discloses the identity of the blinded product only in so far as is necessary.
2. Any recall shall be made in accordance with the requirements referred to in Article 123 of Directive 2001/83/EC. A49
任何召回都应根据2001/83/EC中第123段中所述的要求进行。 
A49:这一段在旧版中归于第一部门。旧版中的后两段有关研究性药物的在新版中被删除。
 
Article 14
Self-inspection自检
The manufacturer shall conduct repeated self-inspections as part of the quality assurance system in order to monitor the implementation and respect of good manufacturing practice and to propose any necessary corrective measures. Records shall be maintained of such self-inspections and any corrective action subsequently taken.
The manufacturer shall be required to A50conduct repeated self-inspections as part of the pharmaceutical quality system in order to monitor the implementation and respect of good manufacturing practice and to propose any necessary corrective measures and/or preventive actions. A51Records shall be maintained of such self-inspections and any corrective actions subsequently taken. 
生产商应被要求进行重复的自检,作为制药质量体系的一部分,以监督GMP的实施和遵守,并提出必要的纠正和/或预防措施。这些自检和后续纠正措施的记录应当保留。
A50:增加“被要求”
A51:增加“预防措施”
 
Article 15 A52
Repeal of Directive 2003/94/EC撤销2003/94/EC指令
A52:旧版的第15条是有关研究性药物的标签,新版中已删除。改为如下条款
Directive 2003/94/EC is repealed with effect from 6 months after the date of publication in the Official Journal of the European Union of the notice referred to in Article 82(3) of Regulation (EU) No 536/2014 or 1 April 2018, whichever is the later. 
References to the repealed Directive shall be construed as references to this Directive and to Commission Delegated Regulation (EU) 2017/1569 (1) and read in accordance with the correlation table in the Annex. 
(EU)No536/2014条例中第82章(3)提及的欧盟官方公报上公布日期起6个月后或2018年4月1日后废止2003/94/EC指令,以较晚者为准。
有关被废除指令应说明为对本指令和委员会授权法规(EU)2017/1569(1)的引用,并根据附件中的相关表格进行阅读。
Article 16 A53
Transposition调换
A53:旧版第16条是替代更早的91/356/EC指令,以调为现在第15条
1. Member States shall adopt and publish, by 31 March 2018 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions. 
成员国最迟应在2018年3月31日之前通过并公布符合本指令所必需的法律,法规和行政规定。 他们应马上向欧盟委员会通报这些规定的文字内容。
 
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