Prevention of Rare Diseases and Orphan Drug Act Article 17

Drug permits issued for orphan drugs that have received registration and market approval under this Act will have a ten-year validity period. During this period, the central competent authority shall not accept applications for registration and market approval of pharmaceuticals of the same kind.Application for extension must be made in advance to the central competent authority if the manufacturing or importation of the orphan drugs referred to in the preceding Paragraph needs to be continued after the ten-year permit expires. Each extension period shall not exceed five years. During the extension period, applications for registration and market approval of pharmaceuticals of the same kind may be made to the central competent authority.When orphan drugs have been issued permit licenses under this Act, and central competent authority proclaims that such drugs shall no longer be designated as orphan drugs, extensions for these licenses will be subjected to the requirements stipulated in the Pharmaceutical Affairs Act.The holders of a permit obtained under the provisions of Paragraph 1, unless otherwise due to force majeure circumstances, shall continuously offer orphan drugs within the valid period; they shall notify the central competent authority in writing, six months before the termination if decide to terminate the manufacturing or importation of orphan drugs within the valid period.