重磅通知，EU GMP/GDP证书有效期再次自动延期至2022年年底！

2021年9月30日，欧盟委员会（EC）、欧洲药品管理局（EMA）和药品机构负责人 (HMA)联合发布了《NOTICE TO STAKEHOLDERS QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC》第四版，其中提及新冠疫情期间GMP证书延期的问题，早在 2020 年 4 月，欧盟委员会（EC）、欧洲药品管理局（EMA）和药品机构负责人 (HMA) 宣布，由于与大流行相关的安全措施和旅行限制以及相关的检查限制，过期的GMP 和 GDP证书和临时制造、进口和批发许可将延长至 2021 年底，现在，这一期间再次延期至2022年。

翻译如下：

Sites located in the EEA

欧洲经济区内工厂

The validity of GMP certificates formanufacturing/importing sites of active substances and/or finished products inthe EEA should be extended until the end of 2022 without the need for furtheraction from the holder of the certificate.6 This automatic extension does not apply where restrictions on the validity period are stated in the clarifyingremarks of the GMP certificate and does not cover changes in the scope of theGMP certificate (e.g. new buildings, new medicinal products).

欧洲经济区内API和/或制剂生产/进口商的GMP证书的有效期延长至2022年底，而无需证书持有人采取进一步行动。该自动延期不适用于在 GMP 证书的澄清说明中已对有效期进行限制者，且不包括 GMP 证书范围的变更（例如新建筑、新医药产品）。

The validity of time-limited authorisations/registrations to manufacture/import should also be extendeduntil the end of 2022 without the need for further action from theauthorisation/registration holder. This automatic extension does not coverchanges in the scope of the authorisation/registration (e.g. new premises, newmedicinal products).

有时间限制的生产/进口许可/注册的有效期也延长至 2022 年底，无需许可/注册持有人采取进一步行动。该自动延期不包括批准/注册范围的变更（例如新的场所、新的医药产品）。

For new sites/facilities in the EEA thathave never been inspected and authorised, a distant assessment may be conductedin order to evaluate if the site could be authorised without a pre-approvalinspection. In such cases, it should be indicated that the certificate has beengranted on the basis of a distant assessment. Moreover, an on-site inspectionshould be conducted when circumstances permit. If the outcome of the distantassessment does not permit the granting of the GMP certificate, a clock-stopwill be triggered until an on-site inspection is possible.

对于 EEA 中从未接受过检查和许可的新场址/设施，可以进行远程评估，以评估该场址是否可以在未经预先批准检查的情况下获得许可。在这种情况下，应表明证书是根据远程评估授予的。此外，在情况允许可的情况下，应进行现场检查。如果远程评估的结果显示不允许授予 GMP 证书，则会中止，直到可以进行现场检查。

Sites located outside the EEA

欧洲经济区外工厂

The validity of GMP certificates formanufacturing sites of active substances and/or finished products locatedoutside the EEA should be extended until the end of 2022 without the need forfurther action from the holder of the certificate, unless theissuing/supervisory authority takes any action that affects the validity of thecertificate. This automatic extension does not apply where restrictions on thevalidity period are stated in the clarifying remarks on the GMP certificate and does not cover changes in the scope of the GMP certificate (e.g. new buildings,new medicinal products).

欧洲经济区以外的API和/或制剂生产场地的 GMP 证书的有效期延长至 2022 年底，证书持有者无需采取进一步行动，除非颁发/监管机构采取任何行动从而影响证书的有效性。该自动延期不适用于在 GMP 证书的澄清说明中已对有效期进行限制者，且不包括 GMP 证书范围的变更（例如新建筑、新医药产品）。

For new sites/facilities in third countrieswhere an inspection is required, and where there is no operational mutualrecognition agreement (MRA) or the scope is not covered by the MRA, a distantassessment by an EEA supervisory authority may be conducted. A GMP certificatemay be granted depending on the outcome of the assessment. In such cases, itshould be indicated that the certificate has been granted on the basis of adistant assessment. Moreover, an on-site inspection should be conducted whencircumstances permit. If the outcome of the distant assessment does not permitthe granting of the GMP certificate, a clock-stop will be triggered until anon-site inspection is possible.

对于需要检查的第三国的新场地/设施，如果没有互认协议 (MRA) 或 MRA 未涵盖范围，则可以由 EEA 监管机构进行远程评估。可能会根据评估结果授予 GMP 证书。在这种情况下，应表明证书是根据远程评估授予的。此外，在情况允许的情况下，应进行现场检查。如果远程评估的结果不允许授予 GMP 证书，则会中止，直到可以进行现场检查。

       文章来源：允咨GMP制药技术

       本网站刊载的所有内容，包括文字、图片、音频、视频、软件等，如非标注为“原创”，则相关版权归原作者所有，如原作者不愿意在本网站刊登相关内容，请及时通知本站，我们将第一时间予以删除。

曜分享

分享精彩资讯