According to Decree No.23 of the State Administration of Pharmaceutical Products, we will further strengthen and standardize the management of drug packaging and labeling to ensure that
These rules are formulated in order to implement the Provisions on the Administration of Drug Packaging, Labelling and Instructions (Provisional).
aggregate demand
First, drug packaging and labels must be printed in accordance with the requirements of the State Administration of Pharmaceutical Products, and their words and patterns shall not contain any unapproved contents. The packaging of drugs is divided into inner packaging and outer packaging. The contents of drug packaging and labeling shall not exceed those specified in the drug instructions approved by the State Pharmaceutical Product Supervision and Administration.
Second, the contents printed on drug packaging and labels should accurately describe the products. Except for words used to express safe and rational drug use, words and labels that improperly publicize products such as "national new drugs", "protected varieties of traditional Chinese medicine", "GMP certification", "repackaging imported raw materials", "producer", "honorary products" and "quality of insurance companies" shall not be printed.
Three, the name of the drug must be approved by the State Administration of pharmaceutical products before it can be used on the packaging and labels. A trade name may not be associated with a generic name, but it should be branched. After the trademark is registered, the firm must still conform to the principles of firm management. The ratio of common name to trade name shall not be less than 1: 2 (referring to the area). The font size of common names should be the same, without brackets. A registered trademark used as a trade name without the approval of the State Administration of Pharmaceutical Products may be printed in the upper left corner or the upper right corner of the packaging label, and its font shall not be larger than the words used in the generic name.
Four, the same enterprise, the same drug specifications (drug instructions and packaging instructions), the format and color of the packaging and labeling must be consistent, and different trademarks shall not be used. If the same product of the same enterprise has different specifications, the packaging and label of its smallest sales unit should be obviously different or clearly marked with specifications.
Five, the minimum sales unit of drugs, refers to the minimum packaging of drugs directly facing the market. The packaging of each smallest sales unit must be labeled and accompanied by instructions in accordance with regulations.
Six, narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs and other special management drugs, external drugs, over-the-counter drugs must be printed on their large packaging, medium packaging, minimum sales units and labels that meet the requirements; Drugs with special storage requirements must be clearly marked on the packaging and labels.
Seven, the packaging and labeling of imported drugs, in addition to the provisions of these rules, should also indicate the "imported drug registration certificate number".
Or "drug registration certificate number" and the name of the manufacturer; The packaging and labels of imported repackaged drugs shall indicate the enterprise name, production date, batch number, expiration date and the name of domestic repackaged enterprises in the original production country or region.
Eight, approved off-site production of drugs, the packaging and labels should also indicate the name of the group, production enterprises, production sites; The name of the entrusting party and the place of processing shall also be indicated on the package and label of the drug that is approved to be commissioned for processing.
Nine, all drugs sold and used in China, the language of packaging and labeling must be mainly Chinese, and use the current standards published by the State Language Committee. National medicine can increase its nationality. Enterprises can use bar codes and foreign language controls on their drug packaging according to their needs; Products patented in China can also be marked with patent mark and patent number, and indicate the types of patent license.
Ten, the expression method of the validity of the packaging label, in chronological order. General expressions can be valid until a certain year or month, or they can be expressed only by numbers. For example, the validity period is 200 1 year 10 month, or expressed as 2001.10,20010,2001-/kloc. The year should be represented by four digits, the number from 1 to September should be preceded by 0, and the month should be represented by two digits.
Contents of various drug packages and labels
I. Chemical and biological products and preparations:
(a) The contents of the inner packaging label include:
Name, specifications, indications, usage and dosage, storage and production date, production batch number, expiration date and production enterprise of the drug. If all the above contents cannot be marked due to the size of the package, it can be reduced appropriately, but at least three pieces (such as ampoules, eye drops bottles, injection bottles, etc. ) must be marked.
(two) the contents of the outer packaging label that directly touches the inner packaging include:
Name, ingredients, specifications, indications, usage and dosage, storage,
Adverse reactions, contraindications, precautions, packaging, production date, production batch number, expiration date, approval number and production enterprise. Adverse reactions, contraindications and precautions that cannot be indicated due to the size of the package should be indicated with the words "See the instructions for details".
For preventive biological products, the above indications should be listed as vaccination targets.
(3) The contents of the large package label include:
The name, specifications, production batch number, production date, expiration date, storage, packaging, approval number, matters needing attention in the production enterprise and transportation or other signs of the drug.
Two. The contents of API label include:
Drug name, packaging specifications, production batch number, production date, expiration date, storage, approval number, production enterprise and transportation precautions or other signs.
Three, traditional Chinese medicine preparation:
(a) The contents of the inner packaging label include:
Name, specification, functional indications, usage and dosage, storage, production date, production batch number, expiration date and production enterprise of the drug. If all the above contents cannot be indicated due to the size limit of the label, it may be appropriately reduced, but at least three items such as drug name, specification and production batch number must be indicated, such as ampoules and injection bottles. The wax shell of Chinese medicine honey pills should be marked with the name of the medicine at least.
(two) the contents of the outer packaging label that directly touches the inner packaging include:
Drug name, composition, specification, functional indications, usage and dosage, storage, adverse reactions, contraindications, precautions, packaging, production date, production batch number, expiration date, approval number and production enterprise. Adverse reactions, contraindications and precautions that cannot be indicated due to the size of the package should be indicated with the words "See the instructions for details".
(3) The contents of the large package label include:
The name, specifications, production batch number, production date, expiration date, storage, packaging, approval number, matters needing attention in the production enterprise and transportation or other signs of the drug.
Detailed rules for the implementation of drug administration law
Chapter I General Provisions
Article 1 These Measures are formulated in accordance with the Drug Administration Law of People's Republic of China (PRC) (hereinafter referred to as the Drug Administration Law).
Article 2 These Measures shall apply to all units and individuals engaged in drug production, trading, use, inspection and scientific research.
These Measures shall apply to military pharmaceutical production enterprises that produce civilian drugs.
Article 3 The production and marketing of drugs should focus on social benefits, and the production, marketing and use of counterfeit and inferior drugs are strictly prohibited.
It is strictly forbidden to produce and sell drugs and prepare preparations without permission.
Chapter II Duties of Drug Supervision and Administration
Article 4 The administrative department of health of the State Council is in charge of the national drug supervision and administration, and its main responsibilities are:
(1) Implementing the Drug Administration Law and these Measures;
(2) Drafting laws and regulations on drug supervision and administration, and formulating supporting separate measures;
(three) the promulgation of China Pharmacopoeia and drug standards;
(4) Examining and approving new drugs and issuing drug approval numbers;
(5) to supervise the production, sale and use of drugs;
(six) to organize the investigation and re-evaluation of the efficacy and side effects of the produced drugs, and to provide and publish relevant quality information in a timely manner;
(seven) to decide on administrative punishment in accordance with the Drug Administration Law and these Measures.
The drug supervision and administration institutions of local health administrative departments at or above the county level shall be in charge of drug supervision and administration within their respective administrative areas.
Article 5 Drug inspection institutes set up by health administrative departments at or above the county level shall, under the leadership of health administrative departments at the same level, conduct drug inspection in accordance with national drug standards and drug standards of provinces, autonomous regions and municipalities directly under the Central Government.
Sixth health administrative departments at or above the county level shall set up drug supervisors, and the national drug supervisors shall be audited and issued certificates by the health administrative department of the State Council; Drug supervisors of provinces, autonomous regions and municipalities directly under the Central Government and drug supervisors of autonomous prefectures, cities and counties shall be nominated by the administrative department of health, and the people's government at the same level shall examine and issue certificates.
The duties of drug supervisors shall be stipulated separately by the administrative department of health of the State Council.
Article 7 When performing their duties, drug supervisors shall produce their certificates, take samples, obtain relevant information and make a list in accordance with relevant state regulations. Confidential technical data provided by pharmaceutical production enterprises and scientific research units shall be kept confidential.
The drug supervisor shall indicate the shelf life of the temporarily sealed drugs to be processed, which shall generally not exceed 15 days.
Chapter III License Approval Procedures
Article 8 The examination and approval procedures stipulated in the first paragraph of Article 4 of the Drug Administration Law refer to the following procedures for setting up pharmaceutical production enterprises (including various forms of joint ventures, Chinese-foreign joint ventures, Chinese-foreign cooperative enterprises and foreign-funded enterprises), in addition to going through the examination and approval procedures for capital construction in accordance with state regulations:
(a) the enterprise or the superior department of the enterprise shall report to the competent department of drug production and marketing in the province, autonomous region or municipality directly under the Central Government, and send it to the health administrative department at the same level after examination and approval;
(2) Upon examination and approval by the local health administrative department of the province, autonomous region or municipality directly under the Central Government, a Pharmaceutical Production Enterprise License shall be issued.
After receiving all the application materials, the competent department of pharmaceutical production and marketing and the administrative department of health shall make a decision on whether to approve or not within 30 days.
Article 9 Where a pharmaceutical production enterprise sets up another branch factory or workshop outside the factory, it shall report to the competent department of pharmaceutical production and operation in the province, autonomous region or municipality directly under the Central Government where the branch factory or workshop is located, and send it to the health administrative department at the same level for application for the Pharmaceutical Production Enterprise License after examination and approval.
The License of Pharmaceutical Manufacturing Enterprise shall indicate the branch factory (workshop) and production scope.
Article 10 The examination and approval procedure stipulated in the first paragraph of Article 10 of the Drug Administration Law refers to that a pharmaceutical trading enterprise (including franchised or run wholesale and retail shops or companies) applies for a Pharmaceutical Trading Enterprise License in accordance with the following provisions:
(1) An enterprise engaged in pharmaceutical wholesale business shall be examined by the competent department of pharmaceutical production and operation of the province, autonomous region or municipality directly under the Central Government, and approved by the administrative department of health of the province, autonomous region or municipality directly under the Central Government, and issued with a Pharmaceutical Trading Enterprise License;
(two) enterprises engaged in drug retail business shall be examined by the competent departments of drug production and operation in local autonomous prefectures, cities and counties, and approved by the health administrative departments at the same level, and issued with the License for Drug Trading Enterprises.
After receiving all the application materials, the competent department of pharmaceutical production and marketing and the administrative department of health shall make a decision on whether to approve or not within 30 days.
Article 11 The competent department of drug production and marketing mentioned in Articles 4, 10 and 22 of the Drug Administration Law refers to the centralized drug administration department at or above the county level or the department designated by the people's government.
Article 12 A medical unit must apply to the administrative department of health of a province, autonomous region or municipality directly under the Central Government for preparing preparations by itself, and issue a preparation license after examination and approval.
The health administrative department that accepts the examination shall make a decision on whether to approve or not within 30 days after receiving all the application materials.
Article 13 The validity period of the License for Pharmaceutical Manufacturing Enterprises, the License for Pharmaceutical Trading Enterprises and the License for Preparations is 5 years.
If the drug or preparation continues to be produced or sold after the expiration of the period, the holder shall reapply six months before the expiration of the period, and the procedures for reapplication are the same as those for the first time.
If the enterprise goes bankrupt or closes down, the original license issuing department shall cancel the above license.
Fourteenth "Pharmaceutical Production Enterprise License", "Pharmaceutical Trading Enterprise License" and "Preparation License" are uniformly printed by the administrative department of health of the State Council.
Chapter IV Approval of New Drugs
Article 15 The State encourages the research and creation of new drugs, and qualified medical research units, institutions of higher learning, pharmaceutical production enterprises, medical units or individuals can engage in the research and creation of new drugs.
Article 16 Measures for the examination and approval of new drugs shall be formulated by the administrative department of health of the State Council.
Article 17 When applying for clinical trials of new drugs, research units of new drugs must submit relevant materials and samples in accordance with the provisions of the Measures for the Examination and Approval of New Drugs.
Article 18 Clinical trials or clinical verification of new drugs shall be conducted in medical units approved by the health administrative departments of provinces, autonomous regions and municipalities directly under the Central Government.
Nineteenth new drugs that have completed clinical trials or clinical verification and passed the preliminary examination by the health administrative departments of provinces, autonomous regions and municipalities directly under the Central Government shall be reported by the research unit to the health administrative department of the State Council for examination and approval. Approved by the administrative department of health of the State Council, a new drug certificate was issued.
After receiving all the application materials, the administrative department of health of the State Council shall organize the drug review committee to review as soon as possible, and make a decision on whether to approve or not within two months after the review.
Article 20 The administrative department of health of the State Council and the administrative departments of health of provinces, autonomous regions and municipalities directly under the Central Government may set up a drug evaluation committee composed of medical and pharmaceutical experts in medical treatment, scientific research, production and teaching.
Twenty-first clinical trial or verification units, examination and approval departments and their staff shall be responsible for keeping confidential the relevant information, data and technology submitted by new drug development units or individuals.
Chapter V Drug Approval Number
Twenty-second production of new drugs by the production unit to the health administrative department of the State Council, approved by the examination and approval number, except for the production of traditional Chinese medicine pieces.
To produce drugs with national standards or standards of provinces, autonomous regions and municipalities directly under the central government, the production unit shall apply to the health administrative department of the province, autonomous region or municipality directly under the central government. The administrative department of health shall, after consulting the competent department of drug production and operation at the same level, decide whether to issue the approval number, except for the production of Chinese herbal pieces.
Article 23 When applying for the approval number, a pharmaceutical production enterprise shall submit the inspection samples and necessary materials to the drug inspection institute designated by the health administrative department of the province, autonomous region or municipality directly under the Central Government, and the drug inspection institute shall prepare the inspection report in time and submit it to the health administrative department in charge of examination. After receiving the inspection report, the health administrative department shall make a decision on whether to issue the approval number within 30 days.
Article 24 The drug approval number may not be changed within five years, but the drug approval number that has been discontinued for more than three years is invalid.
Twenty-fifth the State Council health administrative departments shall organize the investigation of drugs that have been approved for production; After review by the Drug Review Committee, the approval number of drugs with uncertain curative effect, large adverse reactions or other reasons that endanger people's health is revoked.
Chapter VI Administration of Pharmaceutical Production Enterprises
Article 26 The State promotes good manufacturing practice. The health administrative department of the State Council formulated the good manufacturing practice and supervised its implementation; The competent department of pharmaceutical production and operation may, according to the requirements of good manufacturing practice, formulate an implementation plan to guide the gradual implementation of good manufacturing practice.
Twenty-seventh new pharmaceutical production enterprises and the expansion and reconstruction of existing enterprises must meet the requirements of good manufacturing practice. Existing enterprises shall, in accordance with the requirements of good manufacturing practice, formulate and implement rules and regulations to ensure the quality of drugs and hygiene requirements, and gradually meet the requirements of good manufacturing practice in a planned way.
Article 28 A pharmaceutical production enterprise shall have full-time technicians and skilled workers, and meet the following conditions:
(1) The factory director in charge of pharmaceutical production technology and quality must be familiar with pharmaceutical production business knowledge;
(two) the person in charge of the pharmaceutical production technology and quality inspection institutions shall be held by the corresponding assistant engineers and technicians above Chinese pharmacists according to the different varieties of production;
(3) The technical person in charge of the workshop must have a technical secondary school education or above and have more than 5 years of practical production experience;
(4) Production technicians should receive technical training in this production process, and those without training should not operate alone;
(five) Chinese herbal pieces processing enterprises can not meet the requirements of item (two), must be equipped with pharmaceutical staff who are familiar with the characteristics of medicinal materials, can identify the authenticity of medicinal materials, master the production process and have been examined and registered by the health administrative department at or above the county level.
Twenty-ninth pharmaceutical production enterprises must have factories, facilities and sanitary environment to ensure the quality of drugs and keep them clean and tidy. The preparation of infusion and powder injection must meet the ultra-clean conditions.
Article 30 A pharmaceutical production enterprise must have independent institutions and personnel capable of quality inspection of the drugs it produces, and have corresponding instruments and equipment.
Thirty-first Chinese medicine factory (including the workshop of western medicine factory) shall, in addition to implementing the provisions of Articles 28, 29, 30 and 32 of these Measures, also do the following:
(a) in accordance with the provisions of different raw materials for sorting, sorting, cleaning, drying, processing and other pretreatment;
(two) the production process of traditional Chinese medicine preparation (ingredients, crushing, internal packaging, etc.). ) shall not be carried out in an environment that may contaminate drugs;
(three) the production of traditional Chinese medicine preparations in western pharmaceutical factories should be equipped with Chinese medicine technicians responsible for quality management.
Article 32 All kinds of drugs produced by pharmaceutical production enterprises must be produced in accordance with the originally approved drug standards and technological procedures. Changes in pharmaceutical production procedures that may affect drug standards must be reported to the health administrative departments of provinces, autonomous regions and municipalities directly under the Central Government for examination and approval before they can be carried out.
Article 33 A pharmaceutical production enterprise shall have complete production records and inspection records. The records shall be kept until 1 year after the expiration of the validity period of this batch of drugs; If there is no expiration date, it shall be kept for 3 years.
Article 34 Raw materials, auxiliary materials, containers and packaging materials that are in direct contact with drugs required for the production of drugs shall meet the requirements of the State Pharmacopoeia or other medicinal purposes. The use of goods without the above requirements shall be filed with the local health administrative department.
Article 35 Pharmaceutical production enterprises shall strengthen quality management. Before leaving the factory, drugs must pass the quality inspection by the drug inspection agency of the enterprise. If it meets the standards, the conformity mark or test report must be affixed to the inner container. Those that do not meet the standards shall not leave the factory.
Chapter VII Administration of Pharmaceutical Trading Enterprises
Article 36 A pharmaceutical trading enterprise shall be equipped with full-time pharmaceutical technicians and meet the following conditions:
(1) A pharmaceutical wholesale enterprise shall set up a quality inspection institution, which shall be in charge of technical personnel with a master's degree or above in traditional Chinese medicine;
(2) Pharmaceutical retail enterprises shall be equipped with technicians above Chinese medicine practitioners and pharmacists, or with full-time pharmaceutical personnel registered by the health administrative department at or above the county level;
(3) Newly recruited and transferred non-pharmaceutical technicians engaged in drug dispensing, procurement, storage and sales must be trained in pharmaceutical knowledge of the enterprise, and those who have not been trained may not work alone.
Article 37 The business premises, equipment, storage facilities and sanitary environment of a pharmaceutical trading enterprise shall meet the following requirements:
(1) The storage and custody of drugs must meet the physical and chemical performance requirements of all kinds of drugs. Measures should be taken to prevent dust, moisture, pollution, insects, rats and mildew. Drugs that need to be stored away from light and at low temperature should be stored in appropriate special warehouses (cabinets);
(2) Where a pharmaceutical trading enterprise concurrently engages in non-pharmaceuticals, it must set up counters that concurrently engage in commodities and shall not mix them with pharmaceuticals.
Article 38 pharmaceutical trading enterprises shall not sell drugs by themselves except for processing Chinese herbal pieces according to prescriptions and preparing preparations on behalf of patients.
Article 39 pharmaceutical trading enterprises must establish and improve strict quality acceptance, warehousing acceptance, warehousing maintenance and ex-factory inspection systems when purchasing and selling drugs.
Article 40 The purchased drugs must be checked and accepted. The contents of inspection and acceptance include: drug name, manufacturer, production batch number, approval certificate, approval number, registered trademark, packaging and drug appearance quality. The packaging of Chinese herbal medicines must be inspected, and each package must be marked with the name, place of origin, and transfer unit, and accompanied by quality conformity marks.
Chapter VIII Drug Management in Medical Units
Article 41 A medical unit preparing preparations must meet the following conditions:
(a) hospitals at or above the county level (including 100 beds of factories, mines and medical institutions), the person in charge of the preparation and drug inspection business shall be a pharmacist or above;
The personnel in charge of preparations and drug inspection in hospitals below the county level shall be technical personnel with bachelor degree or above in pharmaceutical preparations;
(2) The preparation site shall have buildings and equipment that can ensure the quality of drugs, and be kept clean and tidy. The sterilization preparation room should have suitable conditions such as changing clothes, buffering, washing, preparation, filling and sealing, sterilization packaging and air conditioning facilities. The preparation of infusion must meet the ultra-clean conditions.
Forty-second preparations should strictly implement the operating rules, quality inspection and hygiene system. Each batch of preparation must have a detailed and complete record.
Article 43 Medical units that prepare preparations must have corresponding drug testing rooms.
A qualified preparation shall be issued by the Institute for Drug Control and used according to the doctor's prescription; Unqualified products are not allowed for clinical use.
Forty-fourth preparations prepared by medical units are limited to pharmaceutical preparations that are not available or in short supply in the market for clinical and scientific research needs of the unit.
Preparations prepared by medical units shall not be sold in the market or in disguised form.
Article 45 When preparing preparations, medical units must make preparations in accordance with the hospital preparation standards formulated by the health administrative departments of provinces, autonomous regions and municipalities directly under the Central Government, and report them to the local health administrative departments for the record.
Forty-sixth medical units in addition to the pharmacy department (room), isotope room (nuclear medicine department) can prepare and supply drugs, other departments may not prepare and supply drugs.
Chapter IX Punishment
Article 47 Except for the administrative punishment in violation of Article 15 and Chapter VIII of the Drug Administration Law, the administrative punishment stipulated in the Drug Administration Law and these Measures shall be decided by the health administrative department at or above the county level, and a written notice of punishment shall be issued. The notice of punishment for counterfeit and inferior drugs shall specify the quality inspection results of the drug inspection office.
All the proceeds from the fine shall be turned over to the state treasury.
Article 48 Whoever produces, sells or uses fake medicines shall have their fake medicines and illegal income confiscated, and the administrative department of health may, according to the circumstances, impose a fine of less than five times the fake price of the batch of fake medicines.
Article 49 Whoever produces, sells or uses inferior drugs shall have their inferior drugs and illegal income confiscated, and the administrative department of health may, according to the circumstances, impose a fine of less than three times the price of this batch of inferior drugs.
Article 50 If any of the following circumstances occurs in the production, sale and use of counterfeit and inferior drugs, it shall be regarded as a serious case, and the administrative department of health shall give a heavier administrative penalty:
(1) passing narcotic drugs, psychotropic drugs, toxic drugs and radioactive drugs off as other drugs, or passing other drugs off as the above-mentioned drugs;
(two) the production and sale of counterfeit drugs and inferior drugs are mainly used for infants;
(three) the production, sale and use of counterfeit drugs and inferior drugs cause personal injury;
(four) the production, sale and use of counterfeit drugs and inferior drugs, and the recidivism after treatment;
(five) other laws and regulations of the state shall be given a heavier punishment.
Article 51 Where a pharmaceutical manufacturer's license, a pharmaceutical trading enterprise's license or a pharmaceutical preparation license are not obtained, the administrative department of health shall order him to stop production, trading and preparation immediately, confiscate all drugs and illegal income, and impose a fine of less than five times the value of the drugs or preparations produced and sold according to the circumstances.
Article 52 Under any of the following circumstances, the health administrative department may give a warning or impose a fine of less than 20,000 yuan according to the circumstances:
(a) the drugs imported for the first time have not been approved by the administrative department of health of the State Council;
(2) The imported drugs have not been inspected by the frontier port drug inspection office;
(3) conducting clinical trials or verification of new drugs without authorization;
(four) without the approval of the administrative department of health, the production process regulations are changed without authorization, resulting in changes in drug standards;
(5) Self-made preparations made by medical units are sold in the market or in disguised form.
Article 53 Under any of the following circumstances, the health administrative department may give a warning or impose a fine of less than 6,543,800 yuan according to the circumstances:
(a) the drugs that should be marked with the expiration date are not marked;
(two) in violation of drug packaging or in violation of the provisions of Chinese herbal medicine packaging;
(three) the drug packaging is not labeled in accordance with the provisions, or the contents of the labels and instructions are not in conformity with the provisions;
(4) purchasing and selling newly discovered or imported Chinese herbal medicines without examination and approval.
Article 54 If the staff members and drug supervisors of drug inspection institutes abuse their powers, engage in malpractices for selfish ends and accept bribes, if the circumstances are minor, the administrative department of health shall give them administrative sanctions; If the circumstances are serious enough to constitute a crime, criminal responsibility shall be investigated according to law.
Chapter X Supplementary Provisions
Article 55 The labeling provisions of narcotic drugs, psychotropic drugs, toxic drugs, radioactive drugs and drugs for external use are as follows (see attached figure).
Article 56 The administrative department of health of the State Council shall be responsible for the interpretation of these Measures.
Article 57 These Measures shall come into force as of the date of promulgation.
Finally! Pick me!