Regulations for Registration of Medicinal Products Article 27

Upon the receipt of the notice of license collection, apart from proceeding with drug testing, the applicant should pay the fees within the deadline for license collection. The procedure for license collection is as follows:1. Two copies of actual printing materials or color drafts each of drug labels, package inserts and packaging materials that are printed in accordance with the approved draft should be provided. The application submitted via the electronic submission platform may only provide one copy of actual printing materials or color drafts.2.The notification letter stamped with the applicant’s official seal and the signet of managing director;3.The approved draft copy of labels, package inserts and outer packaging that were attached to the license collecting notice should be returned.4.The photocopy of the application form of drug registration that was attached to the license collecting notice should be returned.5.A photocopy of drug license that was attached to the license collecting notice should be returned.License should be collected within three months of the notice date. If the applicant is requested to make corrections due to mistakes in the information on the labels, package inserts, packaging or other related materials required for license collection, the applicant should make corrections within the deadline specified by the central health competent authority before the license can be collected.Except for the reissuance of damaged or lost drug licenses, all approved post-approval changes will be certified by the central health competent authority through noting down the changes on the original drug license with date and official stamps, then returned to the license holder. Fees for the reissuance of a new license copy will be charged.After the license was collected, if the applicant does not follow related regulations to proceed with drug testing, or the test results are not in accordance with the contents of the application or are disqualified for some reasons, then the license has to be returned according to the central health competent authority’s notice.