Enforcement Order of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Cabinet Order No. 11).

This Cabinet Order, consisting of 83 articles divided into fourteen Chapters, regulates and enforces the Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical devices. Chapter III deals with Marketing and Manufacturing of Pharmaceuticals, Quasi-Pharmaceutical Products and Cosmetics including for veterinary purposes.
The Order is divided as follows: General Provisions (Chapter I ); Pharmacies (Chapter II); Marketing and Manufacturing of Pharmaceuticals, Quasi-Pharmaceutical Products and Cosmetics (Chapter III); Marketing and Manufacturing of Medical Devices and In-vitro Diagnostics (Chapter IV); Marketing and Manufacturing of Regenerative Medicine Products (Chapter V); Selling of Pharmaceuticals, Medical Devices and Regenerative Medicine Products (Chapter VI); Official Verification of Pharmaceuticals (Chapter VII); Handling of Pharmaceuticals (Chapter VIII); Advertisement of Pharmaceuticals (Chapter IX); Safety Measures for Pharmaceuticals (Chapter X); Special Provisions for Biological Products (Chapter XI); Supervision (Chapter XII); Designation of Orphan Drugs, Orphan Medical Devices and Orphan Regenerative Medicine Products (Chapter XIII); Miscellaneous Provisions (Chapter XIV).