3月20日，欧盟委员会发布GMP附录21药品进口草案，该附录为新增文件，并向公众咨询意见，咨询期间为2020年3月20日至6月20日。

此文件针对药品供应链中的所有行为者，并定义了他们在欧盟药品进口中的角色，以确保药品供应链的完整性。

全文翻译如下：

Annex 21: Importation of medicinal products

附录21：药品进口

1. Scope 范围

1.1. This Annex summarizes the GMP requirements applicable to a Manufacturing Import Authorisation (MIA) holder which imports medicinal products (human and veterinary) from outside the EU/EEA. The guidancein the main chapters and annexes of the EU GMP also apply, as appropriate forthe activities carried out, and should be consulted for more detailed guidance.

本附录总结了适用于生产进口许可（MIA）持有者的GMP要求，该持有者从欧盟/欧洲经济区（EU/EEA）之外进口了药品（人和兽用）。欧盟GMP的主要章节和附录中的指南也适用于所开展的活动，如果需要更详细的指南，请查阅这些要求。

Medicinal products which enter EU/EEA with theintention of export only and which are not processed nor released for placingon the EU/EEA market, are not covered by this Annex

仅出于出口目的而进入EU / EEA、且未经加工或放行到EU / EEA市场的药品，不属于本附录的范围

2. Principles原则

2.1. For the purpose of this annex, the term importation refers to the action of physically bringing medicinal product, from outside the territory of EEA/EU what implies the necessity of clearing it into the customs territory of an EU/EEA state QP certification of a batch of medicinal product takes place after physical importation and custom clearance. Imported dosage forms and intermediates may undergo further manufacturing operations in accordance with the marketing authorisation, prior to QP certification orconfirmation, as appropriate. The sites which are considered to have specific importation responsibilities in relation to a medicinal product or importeddosage form are:

就本附录而言，进口一词是指将药品从EEA / EU领土外实物进入的行为，这意味着实物进口和通关之后，有必要对药品批次进行QP认证，在EU / EEA国家清关。在适当的QP认证或确认之前，进口的制剂和中间体可能会根据上市许可进行进一步的生产操作。被认为对药品或进口剂型负有特定进口责任的场所是：

a) Site ofPhysical Importation.

b) Site of QP certification of imported medicinalproducts or QP confirmation for intermediate products undergoing furtherprocessing, as appropriate.

a）实物进口场所。

b）QP认证进口药品的场所，或正在接受进一步加工的中间体的QP确认场所（视情况而定）。

The above importation responsibilities must becarried out by entities appropriately authorized under a MIA.

上述进口责任必须由MIA适当授权的实体承担。

2.2. All stages of manufacture of imported medicinal products which are carried out in thirdcountries should be conducted in accordance with EU GMP or equivalent standardsand in conformance with the Marketing Authorisation (MA), the clinical trial authorization(CTA) and the relevant quality agreement, as applicable.

在第三国进行的进口药品的所有制造阶段，均应按照欧盟GMP或同等标准进行，并符合上市许可（MA），临床试验许可（CTA）和相关的质量协议（适用时）。

2.3. For products authorized in the EU/EEA, the overall responsibility for placing the medicinalproducts on the market lies with the marketing authorization holder (MAH).

对于欧盟/欧洲经济区（EU / EEA）许可的产品，将药品推向市场的总体责任在于MAH。

2.4. The Qualified Person certifying the batch has to ensure that all the medicinal products for human or veterinary use that are imported into the Union from a third country were manufactured in accordance with EU GMP or equivalent standard and tested in the Union, unless there are appropriate arrangement in place between the Union and thethird country (e.g. Mutual Recognition Agreement or ACAA). See also Annex 16for further guidance.

认证批次的质量受权人必须确保：从第三国进口到欧盟的所有人用或兽用药品均按照EU GMP或同等标准生产，并在欧盟进行检验，除非在欧盟与第三国之间建立适当的协议（例如相互承认协议MRA或ACAA）。另见附录16。

2.5. Testing in an EU/EEA state covers all the tests needed to demonstrate that the medicinalproduct meets the specifications that are set out in the marketing authorization.

欧盟/欧洲经济区（EU / EEA）国家检验：涵盖了所有检验，以证明药品符合上市许可中所规定的质量标准。

2.6. Written agreements should be in placebetween the site(s) performing manufacturing, importation activities and theMAH, as appropriate, in accordance with Chapter 7 of the EU GMP.

根据欧盟GMP第7章的规定，在进行制造、进口活动的场所与MAH之间应达成书面协议。

3. Pharmaceutical Quality System 药品质量体系

3.1. The site(s) conducting importation activities should have an appropriately detailed documented Pharmaceutical Quality System in accordance with Chapter 1 of the EU GMP Guide and reflecting the scope of the activities carried out.

根据EU GMP指南第1章的规定，进行进口活动的场所应具有适当详细文档化的药物质量体系，并反映所开展活动的范围。

3.2. Product Quality Reviews should be performed by the site performing QP certification for the products imported, including products imported for export.

产品质量回顾（PQR）应由对进口产品（包括进口用于出口的产品）执行QP认证的场所进行。

o Written agreements should be in place to define the relative responsibilities of the MAH, the importer(s) and the third country manufacturers, as appropriate, inrelation to compiling of the Product Quality Reviews as outlined in Chapter 1of the EU GMP.

应制定书面协议，针对MAH、进口商和第三国制造商，适当定义它们在编制产品质量回顾方面的相对责任，该责任在欧盟GMP第1章进行了概述。

o In addition to the PQR requirements described in Chapter 1, where sampling of the imported product is conducted in a third country in accordance to Annex 16, then the PQR should include assessment of the basis for continued reliance on this sampling practice. PQRs should also include a review of deviations relating totransportation. Specific requirements for sampling and transportation of importedproducts are detailed further in Annex 16.

o除第1章所述的PQR要求外，当根据附录16在第三国对进口产品进行抽样时，对于继续依赖该抽样实践的依据，PQR应对此进行评估。 PQR还应包括对与运输有关偏差的回顾。对于进口产品进行抽样和运输的具体要求，附录16有进一步详细说明。

o As part of this review, the analytical resultsfrom importation testing should becompared with those in the Certificate of Analysis generated by the thirdcountry manufacturer. Any trends or discrepancies should be documented andinvestigated.

作为回顾的一部分，应将进口检验的分析结果与第三国制造商生成的分析证书中的结果进行比较。任何趋势或差异都应记录下来，并进行调查。

4. Premises and equipment 厂房和设备

4.1. The site(s)involved in importation activities should have adequate premises and equipment in order to perform their respective activities in accordance with EU GMP.

进口活动所涉及的场所应具有足够的厂房和设备，以便根据欧盟GMP进行相应的活动。

4.2. Imported medicinal products should be storedunder quarantine after receipt, until their release for further processing orfollowing QP certification or confirmation as appropriate, in accordance withAnnex 16. Segregated areas should exist for quarantined products. Any system replacing the physical quarantine should give equivalentsecurity.

根据附录16的规定，进口药品应在收到后进行隔离，直至放行以进行进一步处理，或经过QP认证或确认（如适用）为止。隔离的产品应位于隔离区。任何替代物理隔离的系统都应具有同等的安全性。

5. Documentation 文件要求

5.1. The MIA holder responsible for QPcertification of the batch should have access to full batch documentation atall times. Other MIA holders involved in the importation process should haveaccess to batch documentation as necessary in accordance with the activitiesfor which the site is responsible, and as reflected in under written agreementsbetween the parties involved in the importation process.

负责批次QP认证的MIA持有人，应始终有权访问完整的批文件。参与进口过程的其他MIA持有人，应有权访问必要的批文件，其必要性应根据场所负责的活动确定，并在进口各方之间的书面协议中反映。

5.1.1. The MIAholder responsible for QP certification should have access to those documentswhich would support batch certification as defined in Annex 16. The frequencyat which full batch documentation is reviewed by the QP certifying the productshould be justified and defined in the Pharmaceutical Quality System. Documentaryevidence should be available to demonstrate that the QP has certified the batchin accordance with the MA and any other regulatory restrictions that may apply(e.g. where an EU GMP certificate restricts activities to specificmanufacturing units/buildings at the third country manufacturing site).

负责QP认证的MIA持有人，应有权访问支持批认证的相关文件（附录16定义）。对于QP认证产品需要完整批文件的频率，应在药品质量体系中加以说明和定义。应该有书面证据证明，QP已根据上市许可和可能适用的任何其他法规限制，对批次进行了认证（例如，欧盟GMP证书将活动限制在第三国生产基地的特定制造单位/建筑物）。

5.1.2. The site of physical importation shouldhave, at minimum, details of transportation and receipt of the product (seealso Annex 16).

实物进口场所应至少具有产品运输和接收的详细信息（另见附录16）。

5.1.3. Relevant purchasing and deliverydocumentation should be available for inspection at MIA holder responsible forQP certification and clearly indicate:

o The site fromwhich the product has been dispatched (the origin of the product).

o The site ofphysical importation.

o Shipping details (including, transportationroute and temperature monitoring records) and customs documentation, asapplicable.

有关采购和运输文件应可供负责QP认证的MIA持有人查阅，并明确指出：

o产品发运的场所（产品来源）。

o实物进口场所。

o运送细节（包括运输路线和温度监控记录）和海关文件（如适用）。

5.2. Documentation must be retained in accordance with the requirements of Chapter 4 of the EU GMPGuide. The MIA holder responsible for QP certification should ensure that the third country manufacturing site has a record retention policy equivalent to EUrequirements.

必须按照欧盟GMP指南第4章的要求保存文件。负责QP认证的MIA持有人，应确保第三国制造场所的记录保存政策等同于欧盟要求。

5.3. Batch documentation, including batch certificates, supplied by the third country manufacturing site should be in a language understood by the importer. It may be necessary toprovide documents in more than one language to facilitate understanding.

第三国制造场所提供的批文件（包括批证书）应使用进口商能够理解的语言。可能需要以多种语言提供文档，以帮助理解。

5.4. There should be documentary evidence that the site performing QP certification has qualified the third country manufacturer and regularly monitors its performance by periodicon-site audits, to ensure that the imported products are manufactured in accordance with EU GMP or equivalent requirements and the MA.

应当有书面证据表明，执行QP认证的场所已经对第三国制造商进行资质认证，并通过定期的现场审计来定期监视其性能，以确保进口产品的生产符合EU GMP或同等要求，以及上市许可要求。

5.5. Where batches have been subdivided and theindividual quantities imported separately, documentation confirming reconciliationof the quantities should be made available at the site where QP certificationtakes place.. Any discrepancy should be investigated.

如果将批次进行了分割，并单独进口了部分数量，则应在进行QP认证的场所提供确认数量对账的文件。应调查任何差异。

6. Operations 运营

6.1. Themanufacturing site where QP certification occurs should ensure that an ongoing stability program is in place, as required in Chapter 6. The ongoing stability program maybe carried out at a third country site as an outsourced activity provided thatthe QP has all the necessary information to assure ongoing product quality. Details of the ongoing stability program, suchas protocols, results and reports should be available for inspection at the MIA holder responsible for QP certification.

按照第6章的要求，进行QP认证的生产场所应确保制定持续的稳定性计划。如果QP拥有所有必要的信息，则可以在第三方国家/地区将正在进行的稳定性计划（作为外包活动执行），以确保持续的产品质量。正在进行的稳定性计划的详细信息，例如草案、结果和报告，应可供负责QP认证的MIA持有人检查。

6.2. The QP certifying the batch is responsible for ensuring that, whererequired, the safety features have been affixed to the packaging.

在必要时，对该批次进行质量认证的QP负责确保在包装上附加安全功能。

6.3. The certifying QP is also responsible forensuring that reference and retention samples have been taken in accordancewith the requirements in Annex 19.

进行认证的QP，还负责确保对照品和留样的取样符合附录19的要求。

7. Complaints, Quality Defects and Product Recalls投诉、质量缺陷和产品召回

7.1. Adequate provisions should be in placebetween the site(s) performing importation activities, the third country manufacturer and the MAH for handling complaints, quality defects and product recalls as required in Chapter 8 of the EU GMP Guide. This should be defined in contractual arrangements.

根据欧盟GMP指南第8章的要求，在进行进口活动的场所，第三国制造商和MAH之间应有足够的规定来处理投诉、质量缺陷和产品召回。这应该在合同协议中定义。