Pharmaceutical Affairs Act Article 71

Competent health authorities may assign their respective officials to inspect the facilities and relevant business operations of pharmaceutical manufacturers and/or dealers. They may sample-test the medicaments concerned by issuing a receipt for such purpose. Manufacturers and dealers shall not refuse such inspections without valid reasons. However, the quantity of samples to be taken shall be limited to the extent sufficient for the use of testing.Where it seems necessary, as the case may be, an inspection of manufacturers of medicaments may be conducted in conjunction with the competent industry authority.Regulations governing the performance of the inspections set forth in this Article shall be established by the central competent health authority in conjunction with the central competent industry authority.