This document is the order for enforcement of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices. The Cabinet hereby enacts this Cabinet Order pursuant to the provisions of Article 2, paragraph (4), Article 11 (including as applied mutatis mutandis pursuant to Article 38), Article 28, paragraph (2), Article 30, paragraph (3), Article 43, paragraph (2), Article 67, paragraph (1), Article 77, paragraph (3), Article 78, paragraph (1), Article 80 and Article 82 of the Pharmaceutical Affairs Act (Act No. 145 of 1960).
Chapter I General Provisions (Article 1 and Article 1-2)
Chapter II Pharmacies (Article 1-3 to Article 2-2)
Chapter III Marketing and Manufacturing of Pharmaceuticals, Quasi-Pharmaceutical Products and Cosmetics (Article 3 to Article 35)
Chapter IV Marketing and Manufacturing of Medical Devices and In-vitro Diagnostics
Chapter V Marketing and Manufacturing of Regenerative Medicine Products (Article 43-2 to Article 43-36)
Chapter VI Selling of Pharmaceuticals, Medical Devices, Regenerative Medicine Products (Article 44 to Article 57)
Chapter VII Official Verification of Pharmaceuticals (Article 58 to Article 62)
Chapter VIII Handling of Pharmaceuticals (Article 63)
Chapter IX Advertisement of Pharmaceuticals (Article 64)
Chapter X Safety Measures for Pharmaceuticals (Article 64-2 and Article 64-3)
Chapter XI Special Provisions for Biological Products (Article 65)
Chapter XII Supervision (Article 66 to Article 69)
Chapter XIII Designation of Orphan Drugs, Orphan Medical Devices and Orphan Regenerative Medicine Products (Article 70)
Chapter XIV Miscellaneous Provisions (Article 70-2 to Article 83)
Order for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices
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