20131105 2013/C 343/01 欧盟GDP （中英文2/2）

囊萤映雪

20131105 2013/C 343/01 欧盟GDP （中英文2/2）

CHAPTER 5 — OPERATIONS

第五章---运行

5.1. Principle 总则

All actions taken by wholesale distributors should ensure that the identity of the medicinal product is not lost and that the wholesale distribution of medicinal products is performed according to the information on the outer packaging. The wholesale distributor should use all means available to minimise the risk of falsified medicinal products entering the legal supply chain.

批发分销商所有行动应能保证药品的标识不会丢失，因为批发分销商是根据外包装上的信息来操作的。批发分销商应采取所有可能的手段来将假药进入合法供应链的风险降低至最小。

All medicinal products distributed in the EU by a wholesale distributor must be covered by a marketing authorisation granted by the EU or by a Member State ([1]).

批发分销商在所有欧盟范围内分销的药品必须具有由欧盟或其成员国颁发的上市许可。

Any distributor, other than the marketing authorisation holder, who imports a medicinal product from another Member State must notify the marketing authorisation holder and the competent authority in the Member State to which the medicinal product will be imported of their intention to import that product ([2]). All key operations described below should be fully described in the quality system in appropriate documentation.

所有的分销商，除上市许可持有人外，如果从另一个成员国进口药品，必须通知上市许可持有人和进口成员国药监当局，告知其进口意向。以下所有关键操作必须在质量体系的适当文件中进行完整描述。

5.2. Qualification of suppliers 供应商确认

Wholesale distributors must obtain their supplies of medicinal products only from persons who are themselves in possession of a wholesale distribution authorisation, or who are in possession of a manufacturing authorisation which covers the product in question ([3] ).

批发分销商只能从持有批发分销许可的人那里采购药品，或从持有包括该产品生产许可的公司采购。

Wholesale distributors receiving medicinal products from third countries for the purpose of importation, i.e. for the purpose of placing these products on the EU market, must hold a manufacturing authorisation ([4]).

从第三国进口药品在欧盟市场上销售的批发分销商必须持有生产许可。

Where medicinal products are obtained from another wholesale distributor, the receiving wholesale distributor, must verify that the supplier complies with the principles and guidelines of good distribution practices and that they hold an authorisation for example by using the Union database. If the medicinal product is obtained through brokering, the wholesale distributor must verify that the broker is registered and complies with the requirements in Chapter 10 ([5]).

如果药品来自于另一个批发分销商，收货的批发分销商必须确认，例如通过使用欧盟数据库确认，供应商符合GDP原则和指南要求，并且应持有许可。如果药品是通过中间商采购，则批发分销商必须确认中间商已进行了登记，且符合第10章的要求。

Appropriate qualification and approval of suppliers, should be performed prior to any procurement of medicinal products. This should be controlled by a procedure and the results documented and periodically rechecked.

在采购任何药品前，应对供应商资质进行适当确认和批准。该确认应有程序规定，并有文件记录，进行定期复查。

When entering into a new contract with new suppliers, the wholesale distributor should carry out ‘due diligence’ checks in order to assess the suitability, competence and reliability of the other party. Attention should be paid to:

(i) the reputation or reliability of the supplier;

(ii) offers of medicinal products more likely to be falsified;

(iii) large offers of medicinal products which are generally only available in limited quantities; and

(iv) out-of-range prices.

在与新的供应商签订新的合同时，批发销售商应实施“尽职调查”检查，以评估另一方的适用性、资质和可靠性。以下情况需要注意：

i.         供应商的信誉和可靠性

ii.       提供的药品有否可能是假药

iii.      一般只能得到有限数据的药品较大量供货

iv.     超范围价格

5.3. Qualification of customers 客户确认

Wholesale distributors must ensure they supply medicinal products only to persons who are themselves in possession of a wholesale distribution authorisation or who are authorised or entitled to supply medicinal products to the public.

批发销售商必须保证只供货给有经销权的批发销售商，或有授权可以向公众提供药品的人员。

Checks and periodic rechecks may include: requesting copies of customer’s authorisations according to national law, verifying status on an authority website, requesting evidence of qualifications or entitlement according to national legislation.

对客户的检查和定期再检查可以包括：根据国家法规索取客户的授权证明、在药监网站上确认其状态、根据国家法规索取资质证明或授权证明。

Wholesale distributors should monitor their transactions and investigate any irregularity in the sales patterns of narcotics, psychotropic substances or other dangerous substances. Unusual sales patterns that may constitute diversion or misuse of medicinal product should be investigated and reported to competent authorities where necessary. Steps should be taken to ensure fulfilment of any public service obligation imposed upon them.

批发分销商应对麻醉类、精神类物质或其它危险类物质的交易进行监控，对销售模式异常情况进行调查。异常销售模式包括转移或滥用药品应进行调查，必要时报告药监当局。应采取措施保证其承担的为公众服务的义务。

5.4. Receipt of medicinal products 药品接收

The purpose of the receiving function is to ensure that the arriving consignment is correct, that the medicinal products originate from approved suppliers and that they have not been visibly damaged during transport.

接收检查的目的是保证所收到的货物是正确的，药品是来自批准的供应商，且在运输途中没有可见损坏。

Medicinal products requiring special storage or security measures should be prioritised and once appropriate checks have been conducted they should be immediately transferred to appropriate storage facilities.

需要特殊存贮或安保措施的药品应优先检查，一旦检查完成，应立即转入适当的存贮场所中。

Batches of medicinal products intended for the EU and EEA countries should not be transferred to saleable stock before assurance has been obtained in accordance with written procedures, that they are authorised for sale. For batches coming from another Member State, prior to their transfer to saleable stock, the control report referred to in Article 51(1) of Directive 2001/83/EC or another proof of release to the market in question based on an equivalent system should be carefully checked by appropriately trained personnel.

将要销往欧盟和EEA国家的药品批次在根据书面程序检查其可以用于销售，不得转入可销售库存。从另一个成员国发来的批次，在转入可销售库存前，要由经过适当培训人员仔细检查其根据指令2001/83/EC第51（1）条要求出具的检验报告，或根据等同的体系做出的放行销售的其它证明文件。

5.5. Storage 存贮

Medicinal products and, if necessary, healthcare products should be stored separately from other products likely to alter them and should be protected from the harmful effects of light, temperature, moisture and other external factors. Particular attention should be paid to products requiring specific storage conditions.

药品和，必要时，保健品应与其它可能对其产生影响的产品分开存放，要保护其不受到光照、温度、温度和其它外界因素的有害影响。特别要注意那些需要特殊存贮条件的药品。

Incoming containers of medicinal products should be cleaned, if necessary, before storage.

必要时，在存贮前，应对收到药品包装进行清洁。

Warehousing operations must ensure appropriate storage conditions are maintained and allow for appropriate security of stocks.

仓库操作必须保证维持适当的存贮条件，给在库货物提供适当的安全保障。

Stock should be rotated according to the ‘first expiry, first out’ (FEFO) principle. Exceptions should be documented.

在库货物应根据“先到效期先发FEFO”的原则发货。如有例外，应记录。

Medicinal products should be handled and stored in such a manner as to prevent spillage, breakage, contamination and mix-ups. Medicinal products should not be stored directly on the floor unless the package is designed to allow such storage (such as for some medicinal gas cylinders).

处理和存贮药品时应防止撒落、破损、污染和混淆。除非其包装允许（例如有些药用气瓶），药品不应直接放置在地面上。

Medicinal products that are nearing their expiry date/shelf life should be withdrawn immediately from saleable stock either physically or through other equivalent electronic segregation.

接近其效期/货架期的药品应立即从可销售库存出撤出，进行物理或其它相当的电子隔离。

Stock inventories should be performed regularly taking into account national legislation requirements. Stock irregularities should be investigated and documented.

应参照国家法规要求定期盘库。库存异常应进行调查和记录。

5.6. Destruction of obsolete goods 过期产品的销售

Medicinal products intended for destruction should be appropriately identified, held separately and handled in accordance with a written procedure.

要销售的药品应根据书面程序进行适当的鉴别，单独存贮和处置。

Destruction of medicinal products should be in accordance with national or international requirements for handling, transport and disposal of such products.

应根据国家或国际关于处置、运输和处理这类药品的要求对其进行销毁。

Records of all destroyed medicinal products should be retained for a defined period.

所有药品销售记录应按既定期限保存。

5.7. Picking 取货

Controls should be in place to ensure the correct product is picked. The product should have an appropriate remaining shelf life when it is picked.

取货产品应有控制以保证取货的产品是正确的。产品在被取出时，应具备有适当的货架期限。

5.8. Supply 销售

For all supplies, a document (e.g. delivery note) must be enclosed stating the date; name and pharmaceutical form of the medicinal product, batch number at least for products bearing the safety features; quantity supplied; name and address of the supplier, name and delivery address of the consignee ([6]) (actual physical storage premises, if different) and applicable transport and storage conditions. Records should be kept so that the actual location of the product can be known.

在销售时，应附有一份文件（例如发货单），其中列明日期、品名、剂型，有安全性特点的药品需要批号，销售的数量、供应商名称和地址、收货人名称和收货人地址（如果收货人地址与实际的物理存贮设施不同，则应写明实际送达地址），以及所需的运输和存贮条件。要保存记录，这样才可以知道药品实际所在地点。

5.9. Export to third countries 出口至第三国

The export of medicinal products falls within the definition of ‘wholesale distribution’ ([7]). A person exporting medicinal products must hold a wholesale distribution authorisation or a manufacturing authorisation. This is also the case if the exporting wholesale distributor is operating from a free zone.

药品出口归属“批发分销”的定义。一个出口药品的人必须持有批发销售许可，或生产许可。该要求同样适用于出口批发分销商在自由贸易区的操作。

The rules for wholesale distribution apply in their entirety in the case of export of medicinal products. However, where medicinal products are exported, they do not need to be covered by a marketing authorisation of the Union or a Member State ([8]). Wholesalers should take the appropriate measures in order to prevent these medicinal products reaching the Union market. Where wholesale distributors supply medicinal products to persons in third countries, they shall ensure that such supplies are only made to persons who are authorised or entitled to receive medicinal products for wholesale distribution or supply to the public in accordance with the applicable legal and administrative provisions of the country concerned.

对批发分销的规定适用于药品出口的整个过程。但是，出口的药品不需要持有欧盟或其成员国的上市许可。批发商应采取适当的措施以防止这些药品在欧盟市场出售。如果批发分销商将药品销售给第三国的人，则他们应保证该产品只是销售给持许可证的人，或被授权接收药品用于批发销售的人，或根据相关国家适用的法规和行政条款可以向公众售卖的人。

CHAPTER 6 — COMPLAINTS, RETURNS, SUSPECTED FALSIFIED MEDICINAL PRODUCTS AND MEDICINAL PRODUCT RECALLS

第六章---客诉、退货、疑伪药品和药品召回

6.1. Principle 总则

All complaints, returns, suspected falsified medicinal products and recalls must be recorded and handled carefully according to written procedures. Records should be made available to the competent authorities. An assessment of returned medicinal products should be performed before any approval for resale. A consistent approach by all partners in the supply chain is required in order to be successful in the fight against falsified medicinal products.

所有的客诉、退货、疑假药品和召回必须进行记录，并根据书面程序谨慎处理。记录应保存备相关药监当局检查。在对退回的药品进行再次销售前，需要进行评估及批准。供应链中所有合作方应协调一致，方可在与假药的斗争中取胜。

6.2. Complaints 客诉

Complaints should be recorded with all the original details. A distinction should be made between complaints related to the quality of a medicinal product and those related to distribution. In the event of a complaint about the quality of a medicinal product and a potential product defect, the manufacturer and/or marketing authorisation holder should be informed without delay. Any product distribution complaint should be thoroughly investigated to identify the origin of or reason for the complaint.

应记录客诉的所有原始详细信息均。应区分与药品质量相关的投诉和与销售相关的投诉。关于药品质量和潜在产品缺陷的客诉，应立即通知生产商和/或上市许可持有人。关于产品销售的投诉应进行彻底调查，识别来源或找出投诉的原因。

A person should be appointed to handle complaints and allocated sufficient support personnel.

要任命一个人处理客诉，并配备充分的人员支持其工作。

If necessary, appropriate follow-up actions (including CAPA) should be taken after investigation and evaluation of the complaint, including where required notification to the national competent authorities.

必要时，在客诉调查和评估后要采取适当的跟踪措施（包括CAPA），包括必要时通知国家药监当局。

6.3. Returned medicinal products 退回药品

Returned products must be handled according to a written, risk- based process taking into account the product concerned, any specific storage requirements and the time elapsed since the medicinal product was originally dispatched. Returns should be conducted in accordance with national law and contractual arrangements between the parties.

退回的药品必须根据基于风险的书面流程进行操作，并考虑所处理产品的特殊存贮条件，以及药品从初始发货开始所经历的时长。退货必须符合国家法规要求，符合双方合同约定。

Medicinal products which have left the premises of the distributor should only be returned to saleable stock if all of the following are confirmed:

如果药品离开了分销商的存贮设施，则只在满足以下条件情况下方可退入可销售库存：

(i) the medicinal products are in their unopened and undamaged secondary packaging and are in good condition; have not expired and have not been recalled;

(ii) medicinal products returned from a customer not holding a wholesale distribution authorisation or from pharmacies authorised to supply medicinal products to the public should only be returned to saleable stock if they are returned within an acceptable time limit, for example 10 days;

(iii) it has been demonstrated by the customer that the medicinal products have been transported, stored and handled in compliance with their specific storage requirements;

(iv) they have been examined and assessed by a sufficiently trained and competent person authorised to do so;

(v) the distributor has reasonable evidence that the product was supplied to that customer (via copies of the original delivery note or by referencing invoice numbers, etc.) and the batch number for products bearing the safety features is known, and that there is no reason to believe that the product has been falsified.

i.         药品外包装情况良好，未被打开，未被损坏，未过期，未被召回

ii.       如果药品是从不持有批发销售许可的客户那里退回，或从一个授权向公众销售药品的药房退回，则只有在可接受时限，例如10天，内退回的药品方可退入可销售库存。

iii.      客户已证明药品是在其特定的存贮条件下进行运输、存贮和处置的

iv.     被退回的药品经过有资质的人员的检查和评估

v.       分销商有合理的证据证明药品被销给客户（通过原始发货凭证复印件，或通过发票编号等），知道具有安全特征的产品批号，没有理由认为产品是假药

Moreover, for medicinal products requiring specific temperature storage conditions such as low temperature, returns to saleable stock can only be made if there is documented evidence that the product has been stored under the authorised storage conditions throughout the entire time. If any deviation has occurred, a risk assessment has to be performed, on which basis the integrity of the product can be demonstrated. The evidence should cover:

另外，对于需要特殊温度，如低温，存贮条件的药品，只有当存在书面证据证明药品在整个时间段均被存贮在所要求的存贮条件下时，方可退入可销售库存。如果存在任何偏差，则需要进行风险评估，根据该风险评估，论述产品的完整性。证据应涵盖：

(i) delivery to customer;

(ii) examination of the product;

(iii) opening of the transport packaging;

(iv) return of the product to the packaging;

(v) collection and return to the distributor;

(vi) return to the distribution site refrigerator.

i.         发运给客户

ii.       检查产品

iii.      打开运输包装

iv.     将产品重新返入包装

v.       收集并退回给分销商

vi.     退回销售场所的冰箱

Products returned to saleable stock should be placed such that the ‘first expired first out’ (FEFO) system operates effectively.

退回可销售存贮的药品应按照“先到效期先出FEFO”的系统进行有效操作。

Stolen products that have been recovered cannot be returned to saleable stock and sold to customers.

被盗后找回的药品不能退回可销售库存销售给客户。

6.4. Falsified medicinal products 假药

Wholesale distributors must immediately inform the competent authority and the marketing authorisation holder of any medicinal products they identify as falsified or suspect to be falsified ([9]). A procedure should be in place to this effect. It should be recorded with all the original details and investigated.

如果发现任何药品被认为是假药，或疑为假药，批发分销商必须立即通知药监当局和上市许可持有人。针对该情况应制订程序，所有原始细节均应进行记录且调查。

Any falsified medicinal products found in the supply chain should immediately be physically segregated and stored in a dedicated area away from all other medicinal products. All relevant activities in relation to such products should be documented and records retained.

所在供应链中发现的假药应立即进行物理隔离，存贮在专用区域，与其它药品分开。所有与这类药品相关的活动均应进行记录，记录应留存。

6.5. Medicinal product recalls 药品召回

The effectiveness of the arrangements for product recall should be evaluated regularly (at least annually).

产品召回安排的有效性应定期进行评估（至少每年）。

Recall operations should be capable of being initiated promptly and at any time.

召回流程应能保证在任何时候都能及时发起召回。

The distributor must follow the instructions of a recall message, which should be approved, if required, by the competent authorities.

分销商必须遵守召回指令，必要时，召回指令应由药监当局批准。

Any recall operation should be recorded at the time it is carried out. Records should be made readily available to the competent authorities.

所有召回执行情况均应及时记录，药监当局应可以很容易获得这些记录。

The distribution records should be readily accessible to the person(s) responsible for the recall, and should contain sufficient information on distributors and directly supplied customers (with addresses, phone and/or fax numbers inside and outside working hours, batch numbers at least for medicinal products bearing safety features as required by legislation and quantities delivered), including those for exported products and medicinal product samples.

负责召回的人应很容易获得分销记录。记录中应包括分销商和直接供货客户的完整信息（地址、工作时间和非工作时间的电话和/或传真号、法规要求有安全特点的药品的批号和销售数量），包括用于出口的产品和药品样品。

The progress of the recall process should be recorded for a final report.

召回进展应进行记录，以形成最终报告。

CHAPTER 7 — OUTSOURCED ACTIVITIES

7.1. Principle 总则

Any activity covered by the GDP guide that is outsourced should be correctly defined, agreed and controlled in order to avoid misunderstandings which could affect the integrity of the product. There must be a written contract between the contract giver and the contract acceptor which clearly establishes the duties of each party.

GDP指南覆盖的所有活动如有外包，则应进行正确界定，签订协议并进行控制，以避免误解，从而影响产品的完整性。委托方和受托方之间应有书面合同，其中清楚说明双方的义务。

7.2. Contract giver 委托方

The contract giver is responsible for the activities contracted out.

委托方对外包的活动承担责任。

The contract giver is responsible for assessing the competence of the contract acceptor to successfully carry out the work required and for ensuring by means of the contract and through audits that the principles and guidelines of GDP are followed. An audit of the contract acceptor should be performed before commencement of, and whenever there has been a change to, the outsourced activities. The frequency of audit should be defined based on risk depending on the nature of the outsourced activities. Audits should be permitted at any time.

委托方有责任对受托方的能力进行评估，以保证所委托工作能顺利完成。委托方可以通过合同方式，通过审计方式保证受托方遵守GDP原则和指南。在正式委托工作开始前，以及外包活动有变更时，委托方应对受托方进行审计。审计的频次应依据外包活动的风险水平确定。受托方应保证随时接受审计。

The contract giver should provide the contract acceptor with all the information necessary to carry out the contracted operations in accordance with the specific product requirements and any other relevant requirements.

委托方应根据产品需求，以及其它相关需求向承包方提供实施外包活动所需的所有信息。

7.3. Contract acceptor 受托方

The contract acceptor should have adequate premises and equipment, procedures, knowledge and experience, and competent personnel to carry out the work ordered by the contract giver.

受托方应具备足够的设施和设备、程序、知识和经验，以及具备相应能力的人员来完成委托方交给的任务。

The contract acceptor should not pass to a third party any of the work entrusted to him under the contract without the contract giver’s prior evaluation and approval of the arrangements and an audit of the third party by the contract giver or the contract acceptor. Arrangements made between the contract acceptor and any third party should ensure that the wholesale distribution information is made available in the same way as between the original contract giver and contract acceptor.

未经委托方事前评估，未经委托方或受托方对第三方进行审计，双方对转包事项安排进行批准前，受托方不得将根据合同接受委托的工作转包给第三方。受托方和第三方之间的安排应保证批发分销信息沟通情况与原委托方和受托方之间的信息沟通相同。

The contract acceptor should refrain from any activity which may adversely affect the quality of the product(s) handled for the contract giver.

受托方应避免从事任何可能对委托方的产品造成负面影响的活动。

The contract acceptor must forward any information that can influence the quality of the product(s) to the contract giver in accordance with the requirement of the contract.

受托方必须根据合同的要求，将可能对委托方的产品造成负责影响的信息及时转达给委托方。

CHAPTER 8 — SELF-INSPECTIONS

第八章----自检

8.1. Principle 总则

Self-inspections should be conducted in order to monitor implementation and compliance with GDP principles and to propose necessary corrective measures.

为监控实施GDP情况和GDP符合性，应进行自检，并拟定必要的纠正措施。

8.2. Self-inspections 自检

A self-inspection programme should be implemented covering all aspects of GDP and compliance with the regulations, guidelines and procedures within a defined time frame. Self- inspections may be divided into several individual self- inspections of limited scope.

所实施的自检程序应包括GDP的所有方面，并符合在该时间段内的法规、指南和程序要求。自检可以分成几次有限范围的单个自检。

Self-inspections should be conducted in an impartial and detailed way by designated competent company personnel. Audits by independent external experts may also be useful but may not be used as a substitute for self-inspection.

自检应公正、细致，由有能力的公司人员实施。由外部专家进行的独立审计也会很有帮助，但不能用于替代自检。

All self-inspections should be recorded. Reports should contain all the observations made during the inspection. A copy of the report should be provided to the management and other relevant persons. In the event that irregularities and/or deficiencies are observed, their cause should be determined and the corrective and preventive actions (CAPA) should be documented and followed up.

所有自检活动均需要进行记录。报告应包括检查中发现的所有缺陷。应向管理层和其它相关人员提供报告副本。如果发现异常和/或缺陷，则应找出其原因，制订书面纠正和预防措施（CAPA）并进行跟踪。

CHAPTER 9 — TRANSPORTATION

第九章---运输

9.1. Principle 总则

It is the responsibility of the supplying wholesale distributor to protect medicinal products against breakage, adulteration and theft, and to ensure that temperature conditions are maintained within acceptable limits during transport.

批发分销商有责任保护药品不被损坏、掺假和被盗，保证运输过程中维持温度条件处于可接受限度内。

Regardless of the mode of transport, it should be possible to demonstrate that the medicines have not been exposed to conditions that may compromise their quality and integrity. A risk-based approach should be utilised when planning transportation.

不管运输方式如何，必须要能证明药品未曾暴露在对其质量和完整性有影响的条件下。制订运输计划时应采用基于风险的方法。

9.2. Transportation 运输

The required storage conditions for medicinal products should be maintained during transportation within the defined limits as described by the manufacturers or on the outer packaging.

在运输途中应保持药品存贮条件处于生产商或外包装上描述的既定限度内。

If a deviation such as temperature excursion or product damage has occurred during transportation, this should be reported to the distributor and recipient of the affected medicinal products. A procedure should also be in place for investigating and handling temperature excursions.

如果在运输过程中，发现了温度偏离或产品损坏，则需要报告给受影响产品的分销商和接收方。应制订对温度偏离情况进行调查和处理的程序。

It is the responsibility of the wholesale distributor to ensure that vehicles and equipment used to distribute, store or handle medicinal products are suitable for their use and appropriately equipped to prevent exposure of the products to conditions that could affect their quality and packaging integrity.

批发分销商有责任保证用于分销、存贮或处理药品的车辆和设备适用于用途，并适当装备以防止产品暴露于可能影响其质量和包装完整性的条件下。

There should be written procedures in place for the operation and maintenance of all vehicles and equipment involved in the distribution process, including cleaning and safety precautions.

应对用于分销流程的所有车辆和设备的操作和维保，包括清洁和安全预防措施制订书面程序。

Risk assessment of delivery routes should be used to determine where temperature controls are required. Equipment used for temperature monitoring during transport within vehicles and/or containers should be maintained and calibrated at regular intervals at least once a year.

如果对温度控制有要求，则确定运输路径时应使用风险评估。用于运输途中监测车内和/或集中箱内温度的设备应进行维护，并进行周期性校正，校正周期至少一年一次。

Dedicated vehicles and equipment should be used, where possible, when handling medicinal products. Where non- dedicated vehicles and equipment are used, procedures should be in place to ensure that the quality of the medicinal product will not be compromised.

在处理药品时，应尽可能使用专用车辆。如果没有专用车辆和设备，应制订程序保证不会对药品质量产生影响。

Deliveries should be made to the address stated on the delivery note and into the care or the premises of the consignee. Medicinal products should not be left on alternative premises.

药品应运送至发货单上指定的地点，卸至收货人的设施内，或送至收货人管理的场所。药品不能被留置在替代设施内。

For emergency deliveries outside normal business hours, persons should be designated and written procedures should be available.

对于非工作时间的紧急运送，应指定专门责任人，并制订书面程序。

Where transportation is performed by a third party, the contract in place should encompass the requirements of Chapter 7. Transportation providers should be made aware by the wholesale distributor of the relevant transport conditions applicable to the consignment. Where the transportation route includes unloading and reloading or transit storage at a transportation hub, particular attention should be paid to temperature monitoring, cleanliness and the security of any intermediate storage facilities.

如果运输由第三方承担，则就有合同说明第7章中的要求。批发分销商应使承运人知晓该托运货物相关的运输条件。如果运输路线需要卸货和重新装运，或在运输港转运暂存，则需要特别注意所有中转存贮设施中的温度监测、清洁和安保。

Provision should be made to minimise the duration of temporary storage while awaiting the next stage of the transportation route.

应有条款规定使得转运期间临时存贮时间降至最短。

9.3. Containers, packaging and labelling 容器、包装和贴标

Medicinal products should be transported in containers that have no adverse effect on the quality of the products, and that offer adequate protection from external influences, including contamination.

药品运输时应置于容器内，该容器应对产品质量没有负面影响，可以给产品提供充分的保护，防止外界影响，包括污染。

Selection of a container and packaging should be based on the storage and transportation requirements of the medicinal products; the space required for the amount of medicines; the anticipated external temperature extremes; the estimated maximum time for transportation including transit storage at customs; the qualification status of the packaging and the validation status of the shipping containers.

对容器和包装的选择应依据该药品的存贮和运输要求、药品数量所需的空间、期望的外部最高最低温度、预估运输最长时间，包括在海关转运存贮时间，包装的验证状态和运输集装箱的验证状态。

Containers should bear labels providing sufficient information on handling and storage requirements and precautions to ensure that the products are properly handled and secured at all times. The containers should enable identification of the contents of the containers and the source.

容器上应贴有标签，提供充分的处置信息和存贮要求，保证产品被适当处置及在所有时间内均保证其安全的注意事项。通过包装应可以识别包装内容物和其来源。

9.4. Products requiring special conditions 需要特殊条件的产品

In relation to deliveries containing medicinal products requiring special conditions such as narcotics or psychotropic substances, the wholesale distributor should maintain a safe and secure supply chain for these products in accordance with requirements laid down by the Member States concerned. There should be additional control systems in place for delivery of these products. There should be a protocol to address the occurrence of any theft.

在运送有特殊条件要求的药品，如麻醉类或精神类物质时，批发分销商应保持供应链的安全性受到保障，符合相关成员国设定的要求。这些药品运输时应有额外的控制系统。应制订针对盗窃发生时的预案。

Medicinal products comprising highly active and radioactive materials should be transported in safe, dedicated and secure containers and vehicles. The relevant safety measures should be in accordance with international agreements and national legislation.

具有高活性和辐射性物料的药品应采用安全的专用容器和车辆运输。相关安全措施应符合国际条约和国家法律要求。

For temperature-sensitive products, qualified equipment (e.g. thermal packaging, temperature-controlled containers or temperature-controlled vehicles) should be used to ensure correct transport conditions are maintained between the manufacturer, wholesale distributor and customer.

对温度敏感的产品，应使用经过确认的设备（例如，隔热包装、温控容器或温控车辆），以保证产品在生产商、批发分销商和客户间运输时处于正确的运输条件下。

If temperature-controlled vehicles are used, the temperature monitoring equipment used during transport should be maintained and calibrated at regular intervals. Temperature mapping under representative conditions should be carried out and should take into account seasonal variations.

如果使用的是控温车辆，运输途中所用的温度监测设备应进行维护，并定期进行校正。对代表性条件下的温度分布情况要进行测试，并考虑季节性变化情况。

If requested, customers should be provided with information to demonstrate that products have complied with the temperature storage conditions.

如客户提要求，则应向客户提供资料证明产品符合存贮温度条件要求。

If cool-packs are used in insulated boxes, they need to be located such that the product does not come in direct contact with the cool-pack. Staff must be trained on the procedures for assembly of the insulated boxes (seasonal configurations) and on the reuse of cool-packs.

如果在隔热盒中使用了冷却包，则其放置方法应能保证产品不会直接与冷却包接触。员工必须接受过如何装配隔热箱（季节性参数）及如何重复使用冷却包的培训。

There should be a system in place to control the re-use of cool- packs to ensure that incompletely cooled packs are not used in error. There should be adequate physical segregation between frozen and chilled ice packs.

应有系统控制重复使用冷却品，以保证不会错误使用未完全冷却的冷却品。冻冰包和冷冰包之间应有充分的物理分隔。

The process for delivery of sensitive products and control of seasonal temperature variations should be described in a written procedure.

对于敏感产品运送的流程，及对季节性温度变化的控制应在书面程序中进行描述。

CHAPTER 10 — SPECIFIC PROVISIONS FOR BROKERS ([10])

第十章----中间商特定条款

10.1. Principle 总则

A ‘broker’ is a person involved in activities in relation to the sale or purchase of medicinal products, except for wholesale distribution, that do not include physical handling and that consist of negotiating independently and on behalf of another legal or natural person ([11]).

“中间商”是指一个涉入药品采购和销售活动（但不是批发销售）的人，不对药品进行实质性操作，而只是代表另一个法人或自然人进行独立谈判。

Brokers are subject to a registration requirement. They must have a permanent address and contact details in the Member State where they are registered ([12]). They must notify the competent authority of any changes to those details without unnecessary delay.

中间商需要进行登记，他们必须在其登记所在成员国内具有永久地址和联系信息，如果这些信息有变，则必须立即通知药监当局。

By definition, brokers do not procure, supply or hold medicines. Therefore, requirements for premises, installations and equipment as set out in Directive 2001/83/EC do not apply. However, all other rules in Directive 2001/83/EC that apply to wholesale distributors also apply to brokers.

根据定义，中间商不进行采购、供应或持有药品。因此，指令2001/83/EC中对于设施、安装和设备的要求不适用于中间商。但是，指令2001/83/EC中的所有其它适用批发商的条款均适用于中间商。

10.2. Quality system 质量体系

The quality system of a broker should be defined in writing, approved and kept up-to-date. It should set out responsibilities, processes and risk management in relation to their activities.

中间商的质量体系应采用书面形式制订，经过批准并保持更新。质量体系应设定人员职责、工作流程和与其活动相关的风险管理。

The quality system should include an emergency plan which ensures effective recall of medicinal products from the market ordered by the manufacturer or the competent authorities or carried out in cooperation with the manufacturer or marketing authorisation holder for the medicinal product concerned ([13]). The competent authorities must be immediately informed of any suspected falsified medicines offered in the supply chain ([14]).

质量体系应包括应急计划，保证在生产商或相关药监当局命令下从市场召回药品的有效性，或配合生产商或上市许可持有人对相关药品召回。如在供应链中发现任何可疑假药，应立即通知相关药监当局。

10.3. Personnel 人员

Any member of personnel involved in the brokering activities should be trained in the applicable EU and national legislation and in the issues concerning falsified medicinal products.

所有涉及供销活动的人员均应培训使知晓适用的欧盟和国家法规，以及假药知识。

10.4. Documentation 文件记录

The general provisions on documentation in Chapter 4 apply.

适用第四章“文件记录”的通用条款。

In addition, at least the following procedures and instructions, along with the corresponding records of execution, should be in place:

另外，至少应建立以下所实施的程序及相应记录：

(i) procedure for complaints handling;

(ii) procedure for informing competent authorities and marketing authorisation holders of suspected falsified medicinal products;

(iii) procedure for supporting recalls;

(iv) procedure for ensuring that medicinal products brokered have a marketing authorisation;

(v) procedure for verifying that their supplying wholesale distributors hold a distribution authorisation, their supplying manufacturers or importers hold a manufacturing authorisation and their customers are authorised to supply medicinal products in the Member State concerned;

(vi) records should be kept either in the form of purchase/sales invoices or on computer, or in any other form for any transaction in medicinal products brokered and should contain at least the following information: date; name of the medicinal product; quantity brokered; name and address of the supplier and the customer; and batch number at least for products bearing the safety features.

i.         客诉处理程序

ii.       通知有关药监当局和上市许可持有人关于可疑假药的程序

iii.      支持召回的程序

iv.     保证所经销的药品具备上市许可证的程序

v.       确认其供货批发销售商持有销售许可，其供应生产商或进口商持有生产许可，其客户被授权可以在相关成员国供应药品

vi.     要保存记录，可以是采购/销售发票，也可以是计算机或其它形式药品交易记录，这些记录应至少包括以下信息：日期、产品名称、交易数量、供应商和客户的名称和地址，以及至少具有安全特点的产品批号

Records should be made available to the competent authorities, for inspection purposes, for the period stated in national legislation but at least five years.

药监当局在现场检查要求时，应能提供在保存期限内的记录。记录保存期限应按国家法规要求，但不少于5年。

CHAPTER 11 — FINAL PROVISIONS

第十一章-----附则

These Guidelines replace the Guidelines on Good Distribution Practice of medicinal products for human use, published on 1 March 1994 ([15]) and the Guidelines of 7 March 2013 on Good Distribution Practice of medicinal products for human use ([16]).

本指南替代1994年3月1日发布的“人用药品GDP指南”和2013年3月7日发布的“人用药品GDP指南”。

These Guidelines will be applied from the first day following their publication in the Official Journal of the European Union.

本指南自其在欧盟官方期刊上发布之日起实施。

ANNEX（翻译略）

Glossary of terms

Terms

Definition

Good Distribution Practice (GDP)

GDP is that part of quality assurance which ensures that the quality of medicinal products is maintained throughout all stages of the supply chain from the site of manufacturer to the pharmacy or person authorized or entitled to supply medicinal products to the public.

Export procedure

Export procedure: allow Community goods to leave the customs territory of the Union. For the purpose of these guidelines, the supply of medicines from EU Member States to a contracting State of the European Economic Area is not considered as export.

Falsified medicinal product ([17])

Any medicinal product with a false representation of

(a）  Its identity, including its packaging and labeling, its name or its composition as regards any of the ingredients including excipients and the strength of those ingredients.

(b） Its source, including its manufacturer, its country of manufacturing, its country of origin or its marketing authorization holder, or

(c） It history, including the records and documents relating to the distribution channels used.

Free zones and free warehouse ([18])

Free zones and free warehouses are parts of the customs territory of the Community or premises situated in that territory and separated from the rest of it in which:

(a）  Community goods are considered, for the purpose of import duties and commercial policy import measures, as not being on Community customs territory, provided they are not released for free circulation or placed under another customs procedure or used or consumed under conditions other than those provided for in customs regulations.

(b） Community goods for which such provision is made under Community legislation governing specific fields qualify, by virtue of being placed in a free zone or free warehouse, for measures normally attaching to the export of goods.

Holding

Storing medicinal products

Transport

Moving medicinal products between two locations without storing them for unjustified periods of time

Procuring

Obtaining, acquiring, purchasing or buying medicinal products from manufactures, importers or other wholesale distributors

Qualification

Action of proving that any equipment works correctly and actually leads to the expected results.

The work “validation” is sometimes widened to incorporate the concept of qualification.

(Defined in Eudralex Volume 4 Glossary to the GMP Guidelines)

Supplying

All activities of providing, selling, donating medicinal products to wholesalers, pharmacist, or persons authorized or entitled to supply medicinal products to the public

Quality risk management

A systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal) product across the product lifecycle

Quality system

The sum of all aspects of a system that implements quality policy and ensures that quality objectives are met (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Q9)

Validation

Action of providing that any procedure, process, equipment, material, activity or system actually leads to the expected results (see also “qualification”).

(Defined in Eudralex Volume 4 Glossary to the GMP Guidelines)

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[1] Article 76(1) and (2) of Directive 2001/83/EC.

[2] Article 76(3) of Directive 2001/83/EC.

[3] Article 80(b) of Directive 2001/83/EC.

[4] Article 40(3) of Directive 2001/83/EC

[5] Article 80, fourth paragraph of Directive 2001/83/EC.

[6] Article 82 of Directive 2001/83/EC.

[7] Article 1(17) of Directive 2001/83/EC.

[8] Article 85a of Directive 2001/83/EC.

[9] Article 80(i) of Directive 2001/83/EC.

[10] Article 85b(3) of Directive 2001/83/EC.

[11] Article 1(17a) of Directive 2001/83/EC.

[12] Article 85b of Directive 2001/83/EC.

[13] Article 80(d) of Directive 2001/83/EC.

[14] Article 85b(1), third subparagraph of Directive 2001/83/EC.

[15] OJ C 63, 1.3.1994, p. 4.

[16] OJ C 68, 8.3.2013, p. 1.

[17] Ariticle 1(33) of Directiv 2001/83/EC.

[18] Articles 166 to 181 of Councile Eegulation (EEC) No.2913/92 of 12 October 1992 establishing the Community Customs Code (OJ 1.302, 19.10.1992.p. 1)

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