Be careful! Mah changed the place of production, and the reply letter from the State Food and drug administration came

On May 9, the State Food and Drug Administration issued a reply on the issues related to the change of the production site with the drug approval number held by the holder of the drug listing license, pointing out that when applying for a supplementary application, the applicant may not be required to submit a GMP certificate, but the applicant must not produce and sell the drug until the supplementary application is approved and passes the GMP certification Zhejiang Drug Administration: we have received your request for instructions on the change of production site by the group company as the holder of drug listing license (zyjz [2019] No 2) After research, the reply is as follows: the notice of the general office of the State Council on printing and distributing the pilot scheme of the drug listing license holder system (GBF [2016] No 41) requires that the entrusted production enterprise must have the certificate of GMP in the corresponding production range, but does not stipulate the situation of the holder's own new production site If the holder has built his own production site and changed the site, he / she can apply in accordance with 18 supplementary application items approved by the State Administration in the current measures for the administration of drug registration, and the drug examination center shall review them in accordance with the technical requirements for the change When applying for supplementary application, the applicant may not be required to submit GMP certificate, but the applicant must not produce and sell the drug until the supplementary application is approved and passes GMP certification If on-site inspection is required during the review, your bureau can organize and carry out GMP certification inspection in accordance with the requirements of "release management service" General Department of State Food and drug administration may 8, 2019