Prevention of Rare Diseases and Orphan Drug Act Article 19

When orphan drugs have not yet received registration and market approval, or fall under the conditions specified in Subparagraph 3 or Subparagraph 4 of Paragraph 1 of the preceding Article, government organizations, medical care institutions, rare disease patients and their families, relevant foundations, societies and associations may apply to the central competent authority for a permit on an ad hoc basis. However, said permit may not be used for profit-making ventures.The central competent authority may, where necessary, commission or designate relevant institutions or groups to process the ad hoc applications referred to in the preceding Paragraph.The central competent authority shall stipulate required documents, review procedures, and other items to be complied with in applying for the ad hoc application process referred to in the preceding two Paragraphs.