Regulations for Registration of Medicinal Products Article 63

The following documents are required for changes in package inserts, labels, outer boxes and aluminum blister foil or for the reissuance of the originally approved copy that was lost:1.Application form of post-approval changes;2.Photocopy of the drug license (front and back sides);3.Originally approved copy of the form for sticking label and package insert with the central health competent authority’s stamp on the seams. The above-mentioned documents can be exempted when the original copy was approved via the electronic submission platform. Applications of reissuance of the approved copy can be exempt from this submission;4.Two actual packaging materials (or color photos) or drafts of package inserts, labels, outer boxes, and aluminum blister foil sheets. If there is any change in the package insert, the changes should be highlighted in the draft package inserts, both in Chinese and in foreign language and the comparison table of changes of package inserts or drafts of package inserts with tracking revisions and comments. For imported drugs, the original package inserts and the draft of Chinese translation should be provided. The Chinese version should be precisely translated from the original version. If the changes only occurred in package inserts, then the applicant can just submit package inserts without other packaging materials;5.For applications of the reissuance of lost original license, an assurance statement should be submitted to certify that the document is missing;6.A notification letter of post-approval changes issued by original manufacture is required for imported drugs, except for applications of the reissuance of lost license.