Enable the 'export of EU APIcertification documents' and 'pharmaceutical export salescertificate' electronic proof

Since December 1, 2022, the official launchof the "export of EU API certification documents" and"pharmaceutical export sales certificate" electronic proof, therelevant matters are announced as follows.

　　First, since December 1, 2022, theissuance of "export of EU API documents" and "drug export salescertificate" to enable electronic proof. Electronic proof and paper proofhas the same effect.

　　Second, combined with China'spharmaceutical export practices and the latest WHO guidelines, the new templatefor the export of pharmaceutical products sales certificate (see annex). SinceDecember 1, 2022, the provincial drug regulatory authorities should be issuedin accordance with the updated template "drug export sales certificate.

　　Third, do a good job to enable theelectronic proof of publicity and guidance. The use of the State DrugAdministration application system issued by the electronic certificate, theapplicant must first register in the State Drug Administration online officehall and real name authentication, enter the online office hall corporate space"my license" section, you can also log in the "China DrugAdministration APP". View and download the corresponding electroniccertificate. Applicants should be properly stored electronic proof. State DrugAdministration issued by the electronic certificate of frequently askedquestions and answers, see the State Drug Administration online office hallelectronic license help section.

　　Fourth, the use of the provincialapplication system issued by the electronic certificate, the provincial drugregulatory authorities should be clear to the administrative region of thebusiness guidelines, guidance and services.

　　Notice is hereby given.

　　State Drug Administration