我们在CEP初始递交文件中有递交公司GMP符合性声明，后续未对此声明进

We submitted the company's GMP compliance statement in the initial submission documents of CEP, and we did not update this statement afterwards, including the update of the R1-CEP 2015-065-Rev 00 version, nor did we submit relevant statement documents. <br><br>According to the relevant requirements of EMA on "The QP declaration template": A QP declaration is required from each registered EEA manufacturer and Importer Authorisation Holder (MIAH) that uses the active substance as a starting material and/or is responsible for QP certification of the finished batch of a human or veterinary medicinal product. Should the <br><br>manufacturer of the preparation submit a QP statement? <br><br>If you have other questions, please communicate with us in time.

We submitted the company's GMP compliance statement in the initial submission document of CEP, but we did not update this statement later, including the update of r1-cep 2015-065-rev 00, nor did we submit relevant statement documents.<br>A QP declaration is required from each registered EEA manufacturer and importer authorization holder (Miah) that uses the active substance as a starting material and / or is responsible for QP certification of the finished batch of a human or veterinary medical product<br>Should the QP statement be submitted by the preparation manufacturer?<br>If you have any other questions, please communicate with us in time.<br>

我们在圆概率误差(circular error probable)初始递交文件中有递交公司良好操作规范符合性声明,后续未对此声明进行更新,包括此次R1-CEP 2015-065-修订版00版本的更新也未提交相关声明文件。根据导弹电子搜索系统关于“QP宣言模板”的相关要求:使用活性物质作为起始原料和/或负责人用或兽用药物成品QP认证的每个注册欧洲经济区制造商和进口商授权持有人(MIAH)都需要提交QP声明。是否应由制剂生产商提交静等离子区(quiescent plasma)声明？若有其他问题,请及时与我们沟通。