Regulations for Registration of Medicinal Products Article 105-1

Except for the situations described in the preceding article, the following information shall be submitted for application for change registration where domestically manufactured Chinese medicine preparations are making “export only” changes or adding “export only” drug name, maximum package quantity, packaging materials, efficacy, indications, administration and dosage, label, package insert, or packaging:1.Application form for post-approval changes;2.Assurance Statement for Export Only (C);3.For changes in the drug name, maximum package quantity, packaging materials, efficacy or indications, the original copy of the drug license is required;4.For changes in the administration and dosage, label, package insert, or packaging, the photocopy of the drug license (front and back) are required;5.For changes in the drug name, the Assurance Statement (A) is required;6.For changes in the packaging materials, photocopies of the documentation procedures and reports of stability tests, as well as the batch records are required;7.For changes in the efficacy or indications of the drug, photocopy of the references that support changes is required;8.For changes of the label, package insert, or packaging, two copies each of the forms for sticking outer box, package insert, and label are required.