1. Copy of drug approval document and its attachments:
Including drug registration approval, supplementary application approval, trade name approval, drug standard promulgation approval, drug standard revision approval and unified renewal of drug approval number, new drug certificate, import drug registration certificate, pharmaceutical product registration certificate and other application-related documents. Attachments include attachments of the above-mentioned approval documents, such as drug standards, instructions, sample labels and other attachments.
2. Supporting documents:
(1) If the applicant is a pharmaceutical manufacturer, it shall provide a copy of the Pharmaceutical Production License and its change filing page, business license and good manufacturing practice certification certificate. If the applicant is not a pharmaceutical production enterprise, it shall provide a copy of the legal person registration certificate of its institution.
(2) provide a copy of the document that the relevant administrative organ agreed to change its name, a copy of the business license before and after the name change, a pharmaceutical production license and a good manufacturing practice certification certificate.
In addition to changing the drug instructions, changing the place of origin, and changing the name and registered address of the drug production enterprise, if the drug management institution in the producing country or region cannot issue relevant certification documents, it may make an explanation according to the provisions of local laws and regulations.
3. A sample of the revised drug instructions, with detailed revision instructions.
4 revised drug label samples, with detailed revision instructions.