Hottest news tracking pharmaceutical packaging pri

2022-08-20
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Tracking: the printing standards of pharmaceutical packaging remain unchanged

at the beginning of May, after the release of the industry column "foreign businessmen are optimistic about China's high-quality pharmaceutical packaging market" in the 80 issue of "printing, trade and commerce", label printing manufacturers in the industry paid attention to it, and some manufacturers called the headquarters to inquire about relevant matters. Recently, the author has interviewed the State Food and drug administration, the registration office and Market Office of Beijing food and drug administration, the Beijing Institute for the inspection of pharmaceutical packaging materials and other relevant institutions. The answers to the questions concerned in employment are as follows:

the nationwide audit of pharmaceutical primary packaging suppliers mentioned in the first chapter is mainly aimed at pharmaceutical packaging suppliers, that is, container production suppliers who have direct contact with drugs

the printing standard of the second printing materials, namely, printed products (drug instructions and labels), is still implemented in accordance with the provisions on the administration of drug instructions and labels (i.e. Order No. 24 of the State Food and Drug Administration) issued on March 15, 2006

relevant printing standard policies:

order No. 24 of the State Food and Drug Administration

regulations on the administration of drug instructions and labels

Chapter I General Provisions

Article 1 is to standardize the administration of drug instructions and labels, and these Regulations are formulated in accordance with the drug administration law of the people's Republic of China and the regulations for the implementation of the drug administration law of the people's Republic of China

Article 2 the instructions and labels of drugs marketed within the territory of the people's Republic of China shall meet the requirements of these provisions

Article 3 the instructions and labels of drugs shall be approved by the State Food and drug administration

the label of drugs should be based on the instructions, and its content should not exceed the scope of the instructions, and should not be printed with words and signs that imply efficacy, mislead use, and improperly publicize the product

Article 4 drug packages must be printed or labeled in accordance with regulations, and shall not carry any other words, audio-visual and other materials that introduce or publicize products and enterprises

the minimum package produced by a drug manufacturer for marketing must be accompanied by instructions

Article 5 the wording of drug instructions and labels shall be scientific, standardized and accurate. Over the counter drug instructions should also use easy to understand words, so that patients can judge, select and use them by themselves

Article 6 the words in the instructions and labels of drugs shall be clear and legible, the marks shall be clear and eye-catching, and there shall be no phenomena such as falling off of printing or weak pasting, and no modification or supplement shall be made by pasting, cutting, erasing, etc

Article 7 the standardized Chinese characters published by the state language and writing working committee shall be used in the instructions and labels of drugs. If other words are added, the Chinese characters shall prevail

Article 8 for the purpose of protecting public health and guiding the correct and rational use of drugs, drug manufacturers may take the initiative to put warnings on the instructions or labels of drugs, and the State Food and drug administration may also require drug manufacturers to put warnings on the instructions or labels

Chapter II drug instructions

Article 9 the drug instructions shall contain important scientific data, conclusions and information on the safety, safety and effectiveness of drugs to guide the safe and rational use of drugs. The specific format, content and writing requirements of the drug instructions shall be formulated and issued by the State Food and drug administration

Article 10 the description of disease names, pharmaceutical professional terms, drug names, clinical test names and results in the drug instructions shall adopt the special vocabulary uniformly issued or standardized by the state, and the unit of measurement shall comply with the provisions of national standards

Article 11 the drug description shall list all the active ingredients or all the traditional Chinese medicine flavors in the prescription. The names of all excipients used in injections and over-the-counter drugs shall also be listed

if the drug prescription contains ingredients or excipients that may cause serious adverse reactions, it shall be explained

Article 12 drug manufacturing enterprises should take the initiative to track the safety and effectiveness of drugs after they are listed on the market. If it is necessary to modify the drug instructions, they should apply in time

according to the adverse drug reaction monitoring, drug re evaluation results and other information, the State Food and drug administration can also require drug manufacturers to modify the drug instructions

Article 13 after the approval of the modification of the drug instructions, the drug manufacturing enterprise shall immediately notify the relevant drug handling enterprises, user units and other departments of the modified contents, and use the modified instructions and labels in a timely manner as required

Article 14 the drug instructions shall fully contain the information of adverse drug reactions and specify 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 drugs after listing, or fails to fully explain the adverse reactions of drugs in the instructions, the adverse consequences arising therefrom shall be borne by the manufacturer

Article 15 the approval date and revision date of the drug description shall be clearly marked in the description

Chapter III labels of drugs

Article 16 labels of drugs refer to the contents printed or pasted on the drug package, which are divided into internal labels and external labels. The inner label of drugs refers to the label of the package that directly contacts the drugs, 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 general name of the drug, indications or functions, specifications, usage and dosage, production date, product batch number, expiry date, manufacturer, etc

if the package size is too small to indicate all the above contents, at least the generic name, specification, product batch number, expiry date and other contents of the drug should be marked

Article 18 the external label of a drug shall indicate the general name of the drug, ingredients, properties, indications or functions, specifications, usage and dosage, adverse reactions, taboos, precautions, storage, production date, product batch number, expiry date, approval number, production enterprise, etc. If the indications or functions, usage and dosage, adverse reactions, taboos and precautions cannot be fully indicated, the main service content with a smile shall be marked and the words for details in the instructions shall be indicated

Article 19 the label of the package used for transportation and storage shall at least indicate the general name, specification, storage, production date, product batch number, expiry date, approval number, production enterprise of the drug, and may also indicate the necessary contents such as the number of packages, transportation precautions or other marks as needed

Article 20 the label of API shall indicate the name of the drug, storage, production date, product batch number, expiry date, executive standard, approval number, manufacturer, as well as the packaging quantity, transportation precautions and other necessary contents

Article 21 for the same drug produced by the same drug production enterprise, if the drug specifications and packaging specifications are the same, the content, format and color of its label must be consistent; If the drug specifications or packaging specifications are different, the labels shall be clearly different or the specification items shall be clearly marked

if the same drug produced by the same drug manufacturing enterprise is managed according to prescription drugs and over-the-counter drugs, the packaging color of the two should be significantly different

Article 22 for drugs with special storage requirements, the breakpoint of the sample shall be clearly marked in the eye-catching position of the label

Article 23 the period of validity in the drug label shall be marked in the order of year, month and day. The year is represented by four digits, and the month and day are represented by two digits. The specific marking format is valid until XX month, XXXX or until XX month, XXXX; It can also be expressed by numbers and other symbols as the expiration date Or valid until xxxx/xx/xx, etc

the validity period of biological products for prevention shall be marked according to the registration standards approved by the State Food and drug administration. The validity period of biological products for treatment shall be calculated from the sub packaging date, and the validity period of other drugs shall be calculated from the production date

if the validity period is marked to date, it should be the day before the starting date corresponding to the month and year. If it is marked to month, it should be the month before the starting month corresponding to the month and year

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 the general drug names and commodity 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 drugs shall be prominent and prominent, and its font, size and color must be consistent, and meet the following requirements:

(1) for horizontal labels, they must be marked in a prominent position within the upper third of the range; For vertical labels, they must be marked in a prominent position within the right third of the range

(II) it is not allowed to use cursive script, seal script and other fonts that are not easy to recognize, and it is not allowed to use italic, hollow, shadow and other forms to modify the fonts

(III) the font color should be black or white, which forms a strong contrast with the corresponding light or dark background

(IV) unless it is impossible to write in the same line due to the limitation of package size, it shall not be written in separate lines

the twentieth is to see what the materials it inspects. Article 6 the drug trade name shall not be written with the general name, its font and color shall not be more prominent and prominent than the general name, and its font shall not be greater than half of the font used in the general name in terms of single word area

Article 27 unregistered trademarks and other drug names not approved by the State Food and drug administration are prohibited from being used in drug instructions and labels

if a drug label uses a registered trademark, it shall be printed on the corners of the drug label. If it contains words, the font shall not be greater than one quarter of the font used for the general name in terms of single word area

other provisions in Chapter V

Article 28 If narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, drugs for external use and over-the-counter drugs have special labels as stipulated by the state, their instructions and labels must be printed with the prescribed labels

if the state has special regulations on drug instructions and labels, such regulations shall prevail

Article 29 the regulations on the label management of traditional Chinese medicine and prepared pieces of traditional Chinese medicine shall be formulated separately by the State Food and drug administration

Article 30 if the instructions and labels of drugs do not comply with these Provisions, they shall be punished in accordance with the relevant provisions of the drug administration law of the people's Republic of China

Article 31 these Provisions shall enter into force as of June 1st, 2006. The provisions on the administration of drug packaging, labeling and instructions (Provisional) issued by the State Drug Administration on October 15, 2000 shall be repealed at the same time

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