Regulations for Registration of Medicinal Products Article 98

The following documents and data are required for applications for registration of changes in the Chinese or English name of a Chinese medicine product:1. 1. Application form for post-approval changes;2. Original copy of the drug license;3. Assurance Statement (A); if a trademark is used, a photocopy of the trademark registration certificate or approval letter shall be submitted;4. Two copies each of the originally approved outer boxes, package inserts, and labels and the forms for sticking the outer boxes, package inserts, and labels to be used instead;5. 5. In the case of imported Chinese medicines, a letter of notification of post-approval changes issued by the original manufacturer and the original FSC from the country of origin are also required;