Regulations for Registration of Medicinal Products Article 109

Applications for a license extension shall be filed within six months prior to the expiration date.If an application is not filed before the deadline set forth in the preceding paragraph, the applicant shall reapply for registration. However, if the applicant reapplies for registration within six months after the expiration of the original license, he/she may submit an original copy of the application form for registration and proceed in accordance with Article 109-1.If an application for a license extension also involves post-approval changes, then a separate application shall be submitted.