Regulations for Registration of Medicinal Products Article 72

Applications for license extension should be filed within six months prior to the expiration date. Applications filed after the deadline will not be processed and the applicants will have to re-apply for drug registration. Those re-applying for drug registration within three months from the expiration of a license are eligible for a simplified procedure as stated in Article 73.If an application of license extension also involves other post-approval changes, then these applications should be made separately.If the space on the license for specifying the expiration date is full, the manufacturer can apply for a new copy of license by submitting the original copy of the application form for drug registration.