The “Regulations on the Administration of Drug Instructions and Labels” was reviewed and approved by the Executive Meeting of the State Food and Drug Administration on March 10, 2006, and was hereby promulgated and shall come into force on June 1, 2006.
Chapter I General Provisions
Article 1 In order to standardize the management of drug instructions and labels, these Provisions are formulated in accordance with the Drug Administration Law of the Peoples Republic of China and the Implementation Regulations of the Drug Administration Law of the Peoples Republic of China.
Article 2 The instructions and labels of drugs marketed and sold within the territory of the Peoples Republic of China shall meet the requirements of these Provisions.
Article 3 Drug instructions and labels shall be approved by the State Food and Drug Administration. The label of a drug shall be based on the instruction manual, and its content shall not exceed the scope of the instruction manual, and it shall not be printed with words and logos that imply curative effect, mislead use or inappropriate promotion of the product.
Article 4 Pharmaceutical packaging must be printed or labeled in accordance with regulations, and shall not contain any other words, audio-visual and other materials introducing or promoting products and enterprises. The minimum packaging produced by pharmaceutical manufacturers for marketing must be accompanied by instructions.
Article 5 The written expression of drug instructions and labels shall be scientific, standardized and accurate. Instructions for over-the-counter drugs should also be expressed in easy-to-understand words, so that patients can make their own judgment, choice and use.
Article 6 The words in the instructions and labels of drugs shall be legible and easily identifiable, and the marks shall be clear and conspicuous, and there shall be no phenomena such as falling off of printed words or weak sticking, and no sticking, Modify or supplement by pasting, cutting, altering, etc.
Article 7 The drug instructions and labels shall use the standardized Chinese characters published by the State Language and Writing Committee. If other characters are added for comparison, the expression of Chinese characters shall prevail.
Article 8 For the purpose of protecting public health and guiding the correct and rational use of drugs, pharmaceutical manufacturers may take the initiative to propose to add warnings to the instructions or labels of drugs, and the State Food and Drug Administration may also require pharmaceutical manufacturers to add warnings to the instructions or labels
Chapter II Drug Instructions
Article 9 The drug instructions shall contain important scientific data, conclusions and information on the safety and effectiveness of drugs to guide the safe and rational use of drugs. The specific format, content and writing requirements of drug instructions shall be formulated and issued by the State Food and Drug Administration.
Article 10 The expression of disease names, pharmaceutical professional terms, drug names, clinical test names and results in drug instructions shall adopt special vocabulary uniformly promulgated or standardized by the state, and the units of weights and measures shall comply with the provisions of national standards.
Article 11 The drug instructions shall list all the active ingredients or all the flavors of traditional Chinese medicines in the prescription. Injections and over-the-counter drugs should also list the names of all excipients used. If a drug prescription contains ingredients or excipients that may cause serious adverse reactions, it shall be explained.
Article 12 Pharmaceutical manufacturers shall actively track the safety and effectiveness of drugs after they are marketed, and if they need to modify the drug instructions, they shall apply in a timely manner. According to information such as adverse drug reaction monitoring and drug re-evaluation results, the State Food and Drug Administration may also require drug manufacturers to modify drug instructions.
Article 13 After the amendment of the drug instructions is approved, the drug manufacturing enterprise shall establish the amended contents, that is, notify relevant drug dealers, users and other departments, and use the revised instructions and labels in a timely manner as required.
Article 14 The drug instructions shall fully contain the information of adverse drug reactions and indicate the adverse drug reactions in detail. If a drug manufacturer fails to modify the instructions in a timely manner according to the safety and effectiveness of the drug after it is marketed or fails to fully explain the adverse drug reactions in the instructions, the adverse consequences caused therefrom shall be borne by the manufacturer.
Article 15 The approval date and modification date of the drug insert shall be awakened in the insert
Chapter III Labeling of Drug Products
Article 16 The label of a drug refers to the content printed or affixed on the packaging of a drug, which is divided into an inner label and an outer label. The inner label of the drug refers to the label of the package that directly contacts the drug, and the outer label refers to the label of other packages other than the inner label.
Article 17 The internal label of a drug shall contain the generic name, indications or functional indications, specifications, usage and dosage, production date, product batch number, expiration date, manufacturer, etc. of the drug. If the package size is too small to mark all the above contents, at least the generic name, specifications, product batch number, expiration date, etc. of the drug should be marked.
Article 18 The outer label of a drug shall indicate the generic name, ingredients, properties, indications or functional indications, specifications, usage and dosage, adverse reactions, contraindications, precautions, storage, production date, product batch number, expiration date, approval document number, production enterprise, etc. If the indications or functional indications, usage and dosage, adverse reactions, contraindications, and precautions cannot be fully indicated, the main contents should be marked and the words “see the instructions for details” should be indicated.
Article 19 The label of the packaging used for transportation and storage shall at least indicate the generic name, specification, storage, production date, product batch number, expiry date, approval document number and manufacturing enterprise of the drug, or may indicate the generic name, specification, storage, production date, product batch number, expiry date, approval document number and manufacturing enterprise of the drugIf necessary, indicate the number of packages, transportation precautions or other marks and other necessary contents.
Article 20 The label of the API shall indicate the drug name, storage, production date, product batch number, validity period, implementation standard, approval number, manufacturer, and necessary contents such as packaging quantity and transportation precautions.
Article 21 If the same drug produced by the same drug manufacturer has the same drug specifications and packaging specifications, the content, format and color of its label must be consistent; If the specifications or packaging specifications of drugs are different, the labels should be clearly distinguished, or the specifications should be clearly marked. If the same drug produced by the same drug manufacturer is managed as prescription drugs and over-the-counter drugs respectively, the packaging colors of the two drugs should be obviously different.
Article 22 Drugs with special requirements for storage shall be marked in a conspicuous position on the label.
Article 23 The validity period in the drug label shall be marked in the order of year, month and day. The year shall be represented by four digits, and the month and day shall be represented by two digits. Its specific labeling format is “valid until XX month, XXXX” or “valid until XX day, XX month, XXXX”; Numbers and other symbols may also be used to represent “valid until XXXX.XX.” or “valid until XXXX/XX/XX” or similar. For preventive use, the marking of the validity period of biological products shall be carried out in accordance with the registration standards approved by the State Food and Drug Administration. The marking of the validity period of therapeutic biological products shall be calculated from the date of packaging, and the marking of the validity period of other drugs shall be calculated from the date of production. If the validity period is marked to date, it shall be the day before the year and month corresponding to the starting date. If it is marked to month, it shall be the day before the year and month corresponding to the starting month.
Chapter IV Use of Drug Names and Registered Trademarks
Article 24 The drug names marked in the drug Instructions and labels must comply with the naming principles of generic drug names and trade names published by the State Food and Drug Administration and be consistent with the corresponding contents of the drug approval documents.
Article 25 The generic name of a drug shall be prominent and prominent, and its font, font size and color must be consistent, and meet the following requirements: (1) For horizontal labels, it must be marked in a prominent position within the upper third; For vertical labels, they must be prominently marked within the right third; (two) do not use cursive script, seal script and other fonts that are not easily recognized, and do not use italic, hollow, shadow and other forms to decorate the fonts; (3) The font color should be black or white, forming a strong contrast with the corresponding light or dark background; (4) Except for those who cannot be written by peers due to the restriction of packaging size, they are not allowed to write in branches.
Article 26 The name of a drug trade shall not be written together with the generic name, and its font and color shall not be more prominent and prominent than the generic name, and its font shall not be greater than half of the font used in the generic name in terms of single-character area.
Article 27 The use of unregistered trademarks and other unregistered trademarks and other unregistered trademarks in drug instructions and labels is prohibited. Drug name approved by the Food and Drug Administration. If a drug label uses a registered trademark, it shall be printed on the corner of the drug label. If it contains words, the font shall not be larger than one-quarter of the font used in the common name in terms of single word area
Chapter V Other Provisions
Article 28 If narcotic drugs, psychotropic drugs, medical toxic drugs, radioactive drugs, external drugs and over-the-counter drugs have special labels stipulated by the state, their instructions and labels must be printed with the prescribed labels. Where the state has special regulations on drug instructions and labels, such regulations shall prevail.
Article 29 The regulations on the labeling management of Chinese herbal medicines and decoction pieces of Chinese herbal medicines shall be formulated separately by the State Food and Drug Administration.
Article 30 If the drug instructions and labels do not comply with these regulations, penalties shall be imposed in accordance with the relevant provisions of the Drug Administration Law of the Peoples Republic of China.
Chapter VI Supplementary Provisions
Article 31 These Provisions shall come into force as of June 1, 2006. The Regulations on the Administration of Drug Packaging, Labeling and Instructions (Provisional) promulgated by the National Medical Products Administration on October 15, 2000, shall be abolished at the same time.