Regulations on Management of Medicament Samples and Gifts Article 13

For applications for medicament samples in accordance with the stipulations of Article 2, Subparagraph 3, the following materials shall be submitted:I. A written consent from the Institutional Review Board of the hospital applying.II. Complete treatment method, course of treatment and related literature.III. The patient Informed Consent Form.IV. A photocopy of the medicament's Certificate for Foreign Government issued by the country of origin, package insert, or portfolio of drugs from various countries.Where the indications, methods of use and quantities of use for the medicament sample applied for are inconsistent with those originally approved, then in addition to the materials stipulated in the subparagraphs of the preceding paragraph, the central health competent authority may order the applicant to attach relevant clinical literature.If the sample mentioned in Paragraph 1 is a biological drug, the stipulations of Article 9, Paragraph 2 apply.