Regulations for Approval of Specific Medicinal Products' Manufacturing or Importing as a Special Case Article 5

The central competent authority may approve the validity duration of the specific medicinal products' manufacturing or importing in accordance with Article 2, based on the situation of individual case.The central competent authority may approve the validity duration no more than two years of the specific medicinal products' manufacturing or importing in accordance with Article 3. Where it is necessary to continue the manufacturing or importation of the specific medicinal products' upon permit license expiration, applications for license extension should be filed within three months prior to the expiration date.Application for the above extension can be submitted in accordance with Articles 3.