Drug Administration Comprehensive Drug Injection Letter [2019] No.237

Zhejiang Provincial Drug Administration:

We have received your request for instructions on issues related to the change of the production site of the group company's centralized possession of drug approval number as the holder of drug listing license (Zhejiang drug administration note [2019] No.2). After study, we hereby reply as follows:

The Notice of the General Office of the State Council on Printing and Distributing the Pilot Scheme of Drug Listing Permit Holder System (Guo Ban Fa [2016] No.41) requires the entrusted production enterprises to have the good manufacturing practice (GMP) certification of the corresponding production scope, but does not stipulate the situation where the holder builds the new production site by himself. If the holder builds his own production site and changes the site, he/she may apply in accordance with the 18 supplementary applications approved by the State Administration of Drug Registration in the current Measures for the Administration of Drug Registration, and the drug examination center shall review the application in accordance with the technical requirements required for the change. When applying for a supplementary application, the applicant may not be required to submit a GMP certificate, but the applicant must obtain the approval of the supplementary application and pass the GMP certification before producing and selling the drug. If it is necessary to initiate on-site inspection during the review, your bureau can organize and carry out the GMP certification inspection work simultaneously in accordance with the requirements of "putting out the administration clothes".

General Department of State Food and Drug Administration

8 May 2019