State Food and Drug Administration Order of the State Food and Drug Administration No. 24 The Provisions Governing Pharmaceutical Directions and Labels, which were deliberated and adopted at the executive meeting of the Director General Shao Mingli March 15, 2006 Provisions Governing Pharmaceutical Directions and Labels Chapter I General Provisions Article 1 For the purpose of regulating the administration of pharmaceutical directions and labels, the present Provisions are formulated in Article 2 The directions and labels of the pharmaceuticals sold on market within the territory of the People’s Republic of China shall meet 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, 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 The smallest packages produced by a pharmaceutical manufacturing enterprise for sale on the market must be attached with directions. Article 5 The literal expression in pharmaceutical directions and labels shall be scientific, regular and accurate. The directions of an OTC Article 6 The words in pharmaceutical directions and labels shall be clear and easily identifiable, and the marks shall be clear and eye-catching, Article 7 Pharmaceutical directions and labels shall use regular Chinese characters promulgated by the State Language Commission. If the same Article 8 With a view to protecting public health and guiding correct use of medicine, a pharmaceutical manufacturing enterprise may take initiative Chapter II Pharmaceutical Directions Article 9 The directions of a pharmaceutical shall include important scientific data, conclusion and information on its safety and effectiveness, Article 10 The expression in the directions of a pharmaceutical for the name of a disease, the professional pharmacological terms, the name of Article 11 The directions of a pharmaceutical shall list all active ingredients or the medical herbs of composite prescriptions. The injections Where a pharmaceutical prescription contains any ingredient or supplementary material that might cause a serious adverse reaction, Article 12 A pharmaceutical manufacturing enterprise shall actively trace the safety and effectiveness of a pharmaceutical on market, and shall The State Food and Drug Administration may also require the pharmaceutical manufacturing enterprise to amend the pharmaceutical directions Article 13 After the amendment of directions of a pharmaceutical are approved, the pharmaceutical manufacturing enterprise shall immediately Article 14 The directions of a pharmaceutical shall contain full information on adverse reactions of the pharmaceutical, and indicate the adverse Article 15 The dates of ratification and amendment of the directions of a pharmaceutical shall be both indicated on an eye-catching position Chapter III Labels of Pharmaceuticals Article 16 The labels of a pharmaceutical shall refer to the contents printed or affixed on the packages of the pharmaceutical, which includes Article 17 The interior labels of a pharmaceutical shall include such contents as the general name of the pharmaceutical, indications or functions, Where the package size is too small and the aforesaid contents cannot be fully indicated, the contents such as the general name of Article 18 The exterior labels of a pharmaceutical shall indicate such contents as the general name of the pharmaceutical, ingredients, character, Article 19 The labels of the packages used for transport and storage shall at least indicate the general name of the pharmaceutical, specifications, Article 20 The labels of a raw material medicine shall indicate the name of the medicine, storage, date of production, product batch number, Article 21 For the same pharmaceutical manufactured by the same pharmaceutical manufacturing enterprise, the contents, format and color of the Where the same pharmaceutical manufactured by the same pharmaceutical manufacturing enterprise is managed separately as both prescription Article 22 For a pharmaceutical with particular storage requirements, such requirements shall be indicated at an eye-catching position on the Article 23 The valid term on a pharmaceutical label shall be indicated in a sequence of “year, month and date”. The year shall be expressed with If the year, month and date of a valid term are all indicated, the indicated expiry date shall be the day corresponding to that before Chapter IV Use of Names and Registered Trademarks of Pharmaceuticals Article 24 The name of pharmaceutical indicated in pharmaceutical directions and labels must conform to the principles promulgated by the State Article 25 The general name of a pharmaceutical shall be distinct and prominent, and the style, size and color of the characters shall conform (1) The general name must be indicated at a distinct position within the scope of the upper one-third part for those with horizontal labels; (2) No grass style, seal character or other style difficult to identify shall be used, nor shall any italic, hollow or shadow form, etc. (3) The color of the characters shall be black or white, so as to form an intense contrast with their corresponding light or dark background; (4) It shall not be written in different lines unless it is unable to be written in one line due to restriction of the package size. Article 26 The commodity name of a pharmaceutical shall not be written with the general name in the same line, its style or color shall not be Article 27 It is prohibited to use any unregistered trademark or any other pharmaceutical name not approved by the State Food and Drug Administration Where a pharmaceutical label uses a registered trademark, the said trademark shall be printed at the border corner of the pharmaceutical Chapter V Other Provisions Article 28 Where a narcotic drug, psychotropic drug, toxic drug for medical use, radioactive drug, pharmaceutical for external use, or nonprescription Where the state has particular provisions on pharmaceutical directions and labels, such provisions shall prevail. Article 29 The provisions on the administration of labels of traditional Chinese medicinal materials, herbal medicines for decoction shall be Article 30 Where the directions or labels of a pharmaceutical do not conform to the present Provisions, the pharmaceutical manufacturing enterprise Chapter VI Supplementary Provisions Article 31 The present Provisions shall come into force as of the date of June 1, 2006. The Provisions on the Administration of Pharmaceutical |
State Food and Drug Administration
2006-03-15