Regulations on Management of Medicament Samples and Gifts Article 4

To import or manufacture a medicament sample or gift as defined in Article 55,paragraph 1, shall fill out the application form; detail the product name, manufacturer name, place of origin, specification, package form and quantity; state the reason and purpose for application; and use and submit a photocopy of the applicant's qualification document and the materials prescribed in the stipulations of Articles 7 to 15 to the central health competent authority. However, the applications of importing laboratory consumables, which are used for collecting specimens in clinical trial, are eligible for the facilitated customs procedure, which the central health competent authority announced.The medicament can only be manufactured, imported or collected after approval. The qualification document mentioned in the preceding paragraph refers to the patient's ID card or passport, alien resident certificate or alien permanent resident certificate, pharmaceutical license, or agency, institution or corporate body registration certificate. However, this qualification document is waived if the applicant applies via an official letter affixed with the government (agency), public or private hospital's seal.