Regulations for Registration of Medicinal Products Article 85

In the event that an applicant fails to pay the fees, fill out and submit an application form, prepare all required materials, or meet the other requirements set forth in the Regulations and, subsequently, has to take corrective actions, the central health competent authority shall notify the applicant to make the corrections within three months.If the applicant is not able to make corrections within the deadline, a written statement specifying the reasons shall be submitted before the expiration of the correction period to apply for an extension. The extended period is one month after the day following the expiration of the original correction period. Only one extension will be allowed. If the applicant fails to make corrections within the deadline, then the central health competent authority may reject the application based on the current materials available.