Regulations for Registration of Medicinal Products Article 92-1

Any person submitting the application specified in Paragraph 1 of the preceding article may remove any Chinese medicine materials or ingredients banned by the importing country from the formula listed in the license held for a domestically manufactured Chinese medicine and may use the revised formula as the formulation basis set forth in Subparagraph 4 of Paragraph 1 of the preceding article when applying for registration of the Chinese medicine, without being subject to the restrictions set forth in Paragraphs 1 and 2 of Article 75.The manufacturer listed in the drug license issued upon the registration specified in the preceding paragraph is limited to the one listed in the license for the domestically manufactured Chinese medicine specified in the preceding paragraph. However, this does not apply in the event of a change of the manufacturer in accordance with Paragraph 1 of Article 106 or Article 107.For applications for registration in accordance with Paragraph 1, the batch records required in Subparagraph 5 of Paragraph 1 of the preceding article may be replaced by the Manufacturing and Control Standard. Moreover, submission of the records of general inspection for finished products, testing report for finished products, and the identification test results (including chromatographic maps or other documents sufficient for confirmations), as set forth in Subparagraph 6 of Paragraph 1 of the preceding article, as well as the reports of stability tests, as set forth in Subparagraph 7, is not required.