Regulations for Registration of Medicinal Products Article 107

Articles 47, 57, and 60 to 63 shall apply mutatis mutandis to post-approval changes in Chinese medicine licenses, including letters of notification of post-approval changes issued by the original manufacturer, changes in testing specifications and methods, changes in the name or address of the drug company (including the manufacturer), changes in labels, package inserts, outer boxes, and aluminum blister foils (packets), and the reissuance of the approved copies due to loss.