Provisions on the Administration of Pharmaceutical Directions and Labels

Provisions on the Administration of Pharmaceutical Directions and Labels Order No. 24 of the State Food and Drug Administration The “Provisions on the Administration of Pharmaceutical Directions and Labels”, which were deliberated and adopted at the working meeting of the State Food and Drug Administration on March 10, 2006, are hereby promulgated, and shall come into force on June 1, 2006. Director General Shao Mingli March 15, 2006 Provisions on the Administration of Pharmaceutical Directions and Labels Chapter I General Provisions Article 1 The present provisions are formulated in accordance with the “ Pharmaceutical Administration Law of the People's Republic of China ” and the “ Regulation for the Implementation of the Pharmaceutical Administration Law of the People's Republic of China ” for the purpose of regulating the administration of pharmaceutical directions and labels. Article 2 The directions and labels of the pharmaceuticals sold on market within the territory of the People's Republic of China shall meet the requirements in the present provisions. Article 3 Pharmaceutical directions and labels shall be subject to the ratification of the State Food and Drug Administration. The labels of a pharmaceutical shall be based on the directions, and the contents thereof shall not exceed the scope of directions, and may not be printed with any word or mark implying the curative effect, misleading the use or inappropriately advertising the product. Article 4 The package of a pharmaceutical must be printed or affixed with the label according to the provisions, and shall not carry any other introduction or advertising product, or any literal or video materials or other information of the enterprise. The smallest packages produced by a pharmaceutical manufacturing enterprise for sale on the market must be attached with directions. Article 5 The literal expression of pharmaceutical directions and labels shall be scientific, regular and accurate. The directions of a nonprescription pharmaceutical shall, in addition, use the literal expression easy to understand, so that the patients may identify, choose and use the pharmaceutical by themselves. Article 6 The words in pharmaceutical directions and labels shall be clear and easily identifiable, while the marks shall be eye-catching, and no printed word shall be missing or unfirmly affixed, nor shall any mark be amended or supplemented by means of affixation, cutting or alteration, etc. Article 7 Pharmaceutical directions and labels shall use the regular Chinese characters promulgated by the State Language Commission. If the same contents are simultaneously expressed in another language, the Chinese expression shall prevail. Article 8 For the purpose of protecting public health and guiding correct use of medicine, a pharmaceutical manufacturing enterprise may propose on its initiative to add cautions on the pharmaceutical directions or labels, and the State Food and Drug Administration may also require pharmaceutical manufacturing enterprises to add cautions on directions or labels. Chapter II Pharmaceutical Directions Article 9 The directions of a pharmaceutical shall include important scientific data, conclusion and information on the safety and effectiveness of the pharmaceutical, so as to guide the safe and reasonable use of the pharmaceutical. The specific format, contents and writing requirements of the pharmaceutical directions shall be formulated and promulgated by the State Food and Drug Administration. Article 10 For expressing the name of a disease, the professional pharmacological terms, the name of a pharmaceutical, and the name and result of the clinical examination, the pharmaceutical directions shall use the special words uniformly promulgated or regularized by the state, and the metrological units shall meet the national standards. Article 11 The directions of a pharmaceutical shall list the medical herbs of all active ingredients or composite prescriptions. The injections and nonprescription pharmaceuticals shall, in addition, list the names of all supplementary......