药品包装说明书-en

Article 8 Pharmaceutical packages include inner packages and outer packages.(I) Inner packages refer to packages in immediate contact with drug products (e.g. ampoules, injection bottles, aluminium foils, etc.). Inner packages shall be able to ensure quality of drug products in manufacture, transportation, storage and use and be convenient to use for medical purposes.For changes of inner package materials and containers (pharmaceutical container closure systems) of drug products, stability testing shall be performed depending on material of the used container closure system to investigate compatibility of the container closure system with the pharmaceutical product.(II) Outer packages refer to packages other than inner packages and include middle packages and large packages from the inside to the outside. Rugged packages shall be selected depending on properties of drug products to ensure quality of products in transportation, storage and use.Article 9 Pharmaceutical labels include inner package labels and outer package labels.(I) Contents of inner package labels and outer package labels shall be restricted to those specified in the pharmaceutical directions approved by State Food and Drug Administration; literal expressions shall correspond to the directions.(II) The inner package label shall, depending on the size, address, as far as possible, the drug name, indications or functions, dosage and administration, strength, manufacturing date, lot number, shelf life, manufacturer, etc. The drug name, strength and lot number are items that must be covered.(III) The middle package label shall address the drug name, main ingredients, description, indications or functions, dosage and administration, contraindications, strength, storage, manufacturing date, lot number, shelf life, approval number, manufacturer, etc.(IV) The large package label shall address the drug name, strength, storage, manufacturing date, lot number, shelf life, approval number, manufacturer and other necessary information beyond the description such as quantity in the package, announcements about transportation or other marks. (V) The shelf life on the labels shall be expressed as: Valid to: (year) (month)(VI) Where all adverse reactions, contraindications and announcements cannot be indicated in the middle package label due to size restriction, words “See the description for details”shall be indicated.Article 10 For packages of drug substances, paragraph (I) of Article 8 shall be referred to for implementation and labels shall be made as per provisions for large package labels of drug products.Article 11 The package of each minimum marketing unit of drug products shall be printed or pasted with the label according to the requirements and attached with the direction.Article 12 Pharmaceutical directions shall cover basic scientific information about the drug products such as safety and efficacy.Pharmaceutical directions shall address the following items: drug names (generic name, English name, Chinese pinyin, chemical name), chemical formula, molecular weight, structure formulae (ingredients shall be specified for compound products and biological products) ), description,pharmacology, toxicology, pharmacokinetics, indications, dosage and administration, adverse reactions, contraindications, announcements (administration in pregnant and lactating women, administration in children, drug interactions and other types of interactions with, e.g. smoking, drinking, etc.), overdose (symptoms, emergency measures, detoxicants), shelf life, storage, approval number, manufacturer (including address and contact telephone). If an item is not clearly known, words “Not clearly known” shall be indicated; if indeed no influence may be produced, “No ne” shall be indicated.Pharmaceutical manufacturers shall initiatively follow post-marketing safety and efficacy information of drug products. Where the pharmaceutical direction is to be revised, an application shall be made in time. Directions shall be printed in the unified format (see Annex I and Annex II for the format of directions) and the contents shall be consistent with that approved by State Food and Drug Administration.Article 13 Except units and contents, dosage and administration of drug products shall be described using expressions that can be easily understood such as “×tablets per time, ×times daily”, “×vessels per time, ×times daily”, etc. for guiding correct drug use.Article 14 For drugs under particular management such as narcotics, psychotropics, toxic drugs for medical use and radioactive drugs, drugs for external use, OTC drugs, etc., marks complying with the related requirements shall be printed on the middle package, large package, label and direction; particular requirements for storage, if any, shall be indicated at an eye-catching place on the packages and label and also in the direction.Article 15 To apply for registration of a drug product, the review and approval procedure of the package, label and direction shall be carried out according to the management regulations depending on the drug category. For revising or changing packages, labels or directions of marketed drug products, application and approval shall be performed as per the original application procedure.Article 16 Pharmaceutical manufacturers violating these provisions shall be ordered by the drug regulatory authority or department to change the package, label or direction and recall marketed non-conforming drugs and, at the same time, punished according to applicable provisions of Pharmaceutical Administration Law of the People’s Republic of China and Regulation for the Implementation of Pharmaceutical Administration Law of the People’s Republic of China.Article 17 State Food and Drug Administration shall be responsible for interpreting these provisions.Article 18 These provisions shall enter into force as of January 1, 2001.Annex I:Format of Directions of Chemical Drugs and Biological ProductsDirection of ××××[Drug Name]Generic name:Trade name:English name:Chinese spelling:The principal ingredient and chemical name of this drug:Structural formula:Molecular formula:Molecular weight:(Notes: 1. For compound drug products, it shall be described as: “This drug is a compound product and it is composed of ”;2. For biological products, this item shall be “Principal ingredients”.)[Description][Pharmacology & Toxicology][Pharmacokinetics][Dosage and administration][Adverse reactions][Contraindications][Administration in pregnant and lactating women][Administration in children][Administration in senile patients][Drug interactions][Overdose][Strength][Shelf life][Storage][Approval number][Manufacturer (address, contact telephone)]Provisions on the Administration of Pharmaceutical Directions and Labels(SFDA Order No. 24)Chapter II Pharmaceutical DirectionsArticle 9 Pharmaceutical directions shall cover important scientific data, conclusions and information about safety and efficacy of drugs to guide safe and rational drug use. Detailed format, content and expression requirements of pharmaceutical directions are formulated and issued by the State Food and Drug Administration.Article 10 For expression of disease names, pharmaceutical terms, drug names, and names and results of clinical tests, officially issued or normalized special words and phases shall be used, and weights and measures shall comply with provisions of national standards.Article 11 Pharmaceutical directions shall indicate all active ingredients or all TCM ingredients in the prescription. For injections and OTC drugs, names of all excipients used shall also be indicated.Where the pharmaceutical prescription contains ingredients or excipients that may cause serious adverse reactions, the information shall be indicated.Article 12 Pharmaceutical manufacturers shall initiatively follow post-marketing safety and efficacy information of drugs. Where the pharmaceutical direction is to be revised, an application shall be made in time.According to data on adverse drug reaction monitoring, drug revaluation results, etc., the State Food and Drug Administration may also request pharmaceutical manufacturers to revise pharmaceutical directions.Article 13 After revision of a pharmaceutical direction is approved, the pharmaceutical manufacturer shall notify immediately related drug businesses, users and other departments of the revisions and use revised pharmaceutical direction and label timely following the requirements. Article 14 Pharmaceutical directions shall fully cover information about adverse drug reactions and specify adverse drug reactions. Where the pharmaceutical manufacturer has not timely revised the pharmaceutical direction according to post-marketing safety and efficacy information of the drug or specified adverse drug reactions in the pharmaceutical direction, adverse results incurred thereby shall be assumed by the manufacturer.Article 15 Approval date and revision date of pharmaceutical directions shall be clearly indicated in the pharmaceutical directions.Chapter III Pharmaceutical LabelsArticle 16 A pharmaceutical label means content printed or pasted on a pharmaceutical package and may be an inner label or an outer label. An inner label means the label in immediate contact with the pharmaceutical package, and an outer label means a label of the package other than the inner label.Article 17 An inner pharmaceutical label shall cover items such as generic name, indications or functions, strength, dosage and administration, manufacture date, product lot number, shelf life, manufacturer, etc. of the drug.Where the package size is too small to specify all of the above items, at least generic name, strength, product lot number, shelf life, etc. shall be indicated.Article 18 An outer pharmaceutical label shall cover items such as generic name, ingredients, description, indications or functions, strength, dosage and administration, adverse reactions, contraindications, precautions, storage, manufacture date, product lot number, shelf life, approval document number, manufacturer, etc. of the drug. Where all information of indications or functions, dosage and administration, adverse reactions, contraindications and precautions cannot be specified, primary content of these items shall be given and “See Direction for details” shall be indicated.Article 19 The label for shipment and storage packages shall cover at least generic name, strength, storage, manufacture date, product lot number, shelf life, approval document number and manufacturer of the drug and, as necessary, may also include quantity in the package, cautions for shipment or other signs.Article 20 Labels of drug substances shall indicate drug name, storage, manufacture date, product lot number, shelf life, executive standard, approval document number and manufacturer of the drug and also necessary items such as quantity in the package, precautions for shipment, etc. Article 21 As regards the same drug produced by the same pharmaceutical manufacturer, content, format and color of labels shall be consistent for the same drug strength and package strength, and labels shall differ notably or the strength shall be notably indicated for different drug strengths or package strengths.As regards the same drug produced by the same manufacturer, package colors shall notably differ for separate administration as a prescribed drug and an OTC drug.Article 22 Special storage requirements of drugs, if any, shall be indicated at an eye-catching position of the labels.Article 23 The shelf life in pharmaceutical labels shall be indicated in a year-month-day format, where the year shall be expressed with four figures; the month and day shall be expressed with two figures respectively. The indication format is “valid to XXXX year XX month” or valid to “XXX year XX month XX day”. Expressions using figures and other symbols such as “valid to XXXX.XX.” or “valid to XXXX/XX/XX” also apply.Indication of shelf life of prophylactic biological products shall be implemented in accordance with registration specifications approved by the State Food and Drug Administration. Indication of shelf life of curative biological products shall be calculated as of the date of repackaging, and indication of shelf life of other drugs shall be calculated as of the manufacture date.Shelf life indicated to day shall be the day before the corresponding year-month-day of the calculation starting date; shelf life indicated to month shall be the month before the corresponding year-month of the calculation starting month.Chapter IV Use of Pharmaceutical Names and Registered TrademarksArticle 24 Pharmaceutical names indicated in pharmaceutical directions and labels shall comply with nomenclatures of generic names and trade names of drugs published by the State Food and Drug Administration and be consistent with corresponding content in certificates of approval of drugs.Article 25 Generic names of drugs shall be notable and eye-catching; characters shall be in the same style, size and color and meet the following the requirements:(I) Generic names shall be indicated at a notable position in the upper 1/3 of labels in cross layout or in the right 1/3 of labels in vertical layout;(II) Character styles difficult to identify, e.g. cursive script, seal script, etc. shall not be used; characters shall not be modified into italic, hollow or shadowed forms;(III) Characters shall be black or white with intense contrast against the corresponding light or dark background.(IV) The generic name shall not be indicated in multiple lines unless restricted by the package size.Article 26 Trade name and generic name of a drug shall not be indicated in the same line; the character size and color of the trade name shall not be more notable and eye-catching than those of the generic name. Calculated by area of single characters, the character size shall not be half larger than character size of the generic name.Article 27 Unregistered trademarks and other pharmaceutical names having not been approved by the State Food and Drug Administration shall not be used in pharmaceutical directions or labels. Registered trademarks, if used in pharmaceutical labels, shall be printed in corners of the pharmaceutical labels. Where words are contained in the registered trademark, the character size shall not be 1/4 larger than character size of the generic name.。