The pharmaceutical dealer shall submit the Periodic Drug Safety Update Report (See Appendix 1) to the central competent health authority within five years following the issuance of the Drug Permit for new drugs under Article 7 of the Act by the said authority and the Drug Safety Summary Report (See Appendix 2) upon expiration of the said Permit.The data lock point (DLP) for the periodic report in the preceding paragraph shall be once every six months for the first and the second years following issuance of the Permit and once every year for the remaining three years.The pharmaceutical dealer may enclose the following materials within three months from the next date upon receipt of the notification for picking up the Permit indicated in Paragraph 1 and apply with the central competent health authority for re-calculation of the DLP:1. The international birth date (IBD) or the start date of the Periodic Safety Update Report (PSUR) approved by one of the A10 countries.2. The planning of the DLP for the collection of data for the reports respective term reports. The interval between terms, however, shall not exceed one year.The periodic and summary reports indicated in Paragraph 1 shall be submitted within 90 days of the expiration of the DLP for data of the respective terms.Appendix 1 Periodic Drug Safety Update Report.pdfAppendix 1 Periodic Drug Safety Update Report.docAppendix 2 Drug Safety Summary Report.pdfAppendix 2 Drug Safety Summary Report.doc