Regulations on Management of Medicament Samples and Gifts Article 14

For applications for medicament samples for personal use in accordance with the stipulations of Article 2, Subparagraph 4, the following materials shall be submitted:I. An international parcel claim or customs bill of lading where the recipient is the patient.II. Outer box, instructions, package insert or catalog for the medicament.III. An affidavit stating that the approved medicament sample will absolutely not be sold, transferred or re-supplied to other patients.Where the sample applied for is a prescription drug or medical device, the diagnosis certificate and prescription issued by a domestic medical institution or the diagnosis certificate and prescription issued by the original foreign medical institution recognized by the central health competent authority shall also be submitted.In addition to the material prescribed in the stipulations of the preceding two paragraphs, when necessary, the central health competent authority may order the applicant to attach the Certificate for Foreign Government for the medicament issued by the country of origin.