Regulations for Registration of Medicinal Products Article 29

In situations where the applicant proceeds with drug testing prior to the acquirement of license, if the dossiers later fail the review, the applicant shall not request for a refund or return of drug samples.In situations where the applicant receives a drug license and starts selling the products before the applicant proceeds with drug testing or before the test results are through, the applicant should make an exact list of the manufacturing dates, batch numbers, trading parties and quantities for each batch of products. The list should be submitted to the central health competent authority and local health authorities at 10-day intervals.In the above-mentioned situations, if the applicant does not comply with related regulations to proceed with drug testing or if the test results are not in accordance with the contents of the applications or for any other reasons it fails the assessment; then, upon receipt of the notice, the applicant should stop manufacturing the products involved and return the drug license immediately. The applicants shall be punished according to the Act.