药品说明书和签管理(英文版)---24号令.doc

Provisions for Drug Insert Sheets and Labels (SFDA Decree No.24) The Provisions for Drug Insert Sheets and Labels, adopted at the executive meeting of the State Food and Drug Administration on March 10, 2006, is hereby promulgated and shall go into effect as of June 1, 2006. Shao Mingli Commissioner of SFDA March 15, 2006 Provisions for Drug Insert Sheets and Labels Chapter I General Provisions Article 1 The Provisions are enacted with a view to regulating drug insert sheets and labels in accordance with the Drug Administration Law of the People’s Republic of China and the Regulations for Implementation of the Drug Administration Law of the People’s Republic of China. Article 2 The insert sheets and labels of drugs marketed within the territory of the People’s Republic of China shall meet the requirements of the Provisions. Article 3 Drug insert sheets and labels shall be reviewed and approved by the State Food and Drug Administration. A drug shall be labeled on the basis of its insert sheet. The content of the label shall be within the scope of the insert sheet. Any words and marks with implied therapeutic effects, misleading information on usage, or inappropriate promotion of the product shall not be printed. Article 4 A drug label shall be printed on or affixed to the drug package, and no other written words, audio and/or visual materials or other information are attached to introduce or publicize the product or the enterprise. An insert sheet shall be attached to the smallest package provided by the drug manufacturer for marketing. Article 5 The wording in drug insert sheets and labels shall be scientific, standardized and accurate. The insert sheet of a non-prescription drug shall be written intelligibly and convenient for patients to judge, choose and use