Regulations for Approval of Specific Medicinal Products' Manufacturing or Importing as a Special Case Article 2

Teaching hospitals which are higher level than regional hospital or psychiatric teaching hospitals may submit the following documents when applying to the central competence authority for approval of specific medicinal products’ manufacturing or importing as a special case in accordance with Subparagraph 1 of Paragraph 1 of Article 48-2 of the Act:1. Diagnosis certificate;2. Verification of the approval of the application for the specific medicinal products from the IRB of the submission hospital;3. A complete therapy protocol and related references;4. The patient's informed consent form;5. The amounts of the medicinal products and the calculation basis;6. Instructions of the medicinal products; and7. Medicinal products' certificates of the market approval or a photocopy of the reference country’s pharmacopeia.Contents in Subparagraph 1 and Subparagraph 2 of preceding Paragraph shall include the intention that it is for the purpose of prevention, diagnosed as life-threatening, severely disability diseases, and there is no domestic appropriate drug or alternative treatment. Whereas the drug applying in accordance with Paragraph 1 and cannot submit documents listed in Subparagraph 7 of Paragraph 1, it shall submit product's manufacturing and quality control documents, the animal safety test report, human body usage data and risk-benefit assessment report as the substitution.