Drug packaging does not require QS, pharmaceutical packages do not fall within the scope of technical supervision, and drugs are QTC certified
According to the State Drug Administration Order No. 23, further strengthen and standardize drugs These detailed rules are specially formulated to ensure the implementation of the "Provisions on the Management of Drug Packaging, Labeling and Instructions" (Interim).
General requirements
1. Drug packaging and labels must be printed in accordance with the requirements stipulated by the State Food and Drug Administration, and any content that has not been approved by the State Food and Drug Administration must not be added to the text and graphics. The packaging of medicines is divided into inner packaging and outer packaging. The content of drug packaging and labels shall not exceed the content limited by the drug instructions approved by the State Food and Drug Administration.
2. The content printed on drug packaging and labels must describe the product accurately. In addition to words describing safe and rational use of drugs, any inappropriate words and logos that promote the product must not be printed. Such as "national new drugs", "protected varieties of traditional Chinese medicine", "GMP certification", "imported raw material packaging", "supervisory production", "honorary production", "award-winning products", "insurance company quality insurance", "public expense reimbursement" , "modern technology", "precious medicinal materials", etc.
3. The trade name of a drug must be approved by the State Food and Drug Administration before it can be used on packaging and labels. The product name must not be written in conjunction with the common name and must be written separately. After a trade name is registered as a trademark, it must still comply with the principles of trade name management. The ratio of common names to trade names should not be less than 1:2 (referring to area). Common names should be of the same font size without parentheses. Registered trademarks that are used as trade names without the approval of the State Food and Drug Administration may be printed on the upper left corner or upper right corner of the packaging label, and the font size shall not be larger than the generic name.
4. For the same enterprise and the same drug of the same specifications (referring to both drug specifications and packaging specifications), the format and color of the packaging and labels must be consistent, and different trademarks are not allowed. If the same product of the same enterprise has different specifications, the packaging and labeling of the smallest sales unit should be clearly differentiated or the specifications should be clearly marked.
5. The minimum sales unit of a drug refers to the smallest package of a drug directly for sale. The packaging of each minimum sales unit must be labeled and accompanied by instructions in accordance with regulations.
6. Narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs and other specially managed drugs, external drugs and over-the-counter drugs must be printed on their large packages, medium packages, minimum sales units and labels. Marks that comply with regulations; drugs that have special requirements for storage must be marked in a conspicuous position on the packaging and labels.
7. In addition to complying with the provisions of these rules, the packaging and labels of imported drugs should also be marked with the "Imported Drug Registration Certificate Number"
or the "Pharmaceutical Product Registration Certificate Number", production Company name, etc.; the packaging and labels of imported repackaged drugs should indicate the name of the company in the original country or region of production, production date, batch number, expiration date, and the name of the domestic repackaging company, etc.
8. The packaging and labels of drugs approved for production in other places should also indicate the name of the group, production enterprise, and production location; the packaging and labels of drugs approved for entrustment processing should also indicate the names of both entrusting companies. , processing location.
9. For all drugs sold and used in China, the text used in packaging and labels must be mainly in Chinese and use the current standard text promulgated by the National Language Working Committee. Ethnic medicines can add their ethnic characters. Enterprises can use bar codes and foreign language comparisons on their pharmaceutical packaging according to needs; products that have obtained Chinese patents can also be marked with patent marks and patent numbers, and indicate the type of patent license.
10. How to express the validity period on packaging labels, in order of year and month. Generally, the expression can be valid until a certain year and a certain month, or it can only be expressed by numbers. For example, it is valid until October 2001, or expressed as valid until 2001.10, 2001/10, 2001-10, etc. The year must be represented by four digits, and the numbers from January to September must be preceded by 0 to represent the month by two digits.
Packaging and labeling contents of various types of drugs
1. Chemical drugs, biological products and preparations:
(1) Inner packaging label contents include:
Drug name, specifications, indications, usage and dosage, storage and production date, production batch number, expiration date and manufacturer. If it is impossible to label all the above contents due to packaging size, it can be reduced appropriately, but at least three items must be labeled: drug name, specifications, and production batch number (such as ampoules, eye drop bottles, injection bottles, etc.).
(2) The contents of outer packaging labels that directly contact the inner packaging include:
drug name, ingredients, specifications, indications, usage and dosage, storage,
Adverse reactions, contraindications, precautions, packaging, production date, production batch number, validity period, approval number and production company. If adverse reactions, contraindications, and precautions cannot be stated due to packaging size, the words "see instructions for details" should be noted.
For preventive biological products, the above indications should be listed as vaccination targets.
(3) Large package label content includes:
Drug name, specifications, production batch number, production date, validity period, storage, packaging, approval number, production company and transportation precautions or other marks.
2. API label content includes:
Drug name, packaging specifications, production batch number, production date, expiry date, storage, approval number, production company and transportation precautions or other mark.
3. Traditional Chinese Medicine Preparations:
(1) Inner packaging label content includes:
Drug name, specifications, functions and indications, usage and dosage, storage, production Date, production batch number, expiration date and production company. If it is impossible to indicate all the above contents due to label size restrictions, it can be reduced appropriately, but at least three items, such as ampoules, injection bottles, etc., must be marked: drug name, specifications, and production batch number. The wax shell of traditional Chinese medicine honey pills must at least be labeled with the name of the drug.
(2) The contents of outer packaging labels that directly contact the inner packaging include:
Drug name, ingredients, specifications, functions and indications, usage and dosage, storage, adverse reactions, contraindications, Precautions, packaging, production date, production batch number, validity period, approval number and production company. If adverse reactions, contraindications, and precautions cannot be stated due to packaging size, the words "see instructions for details" should be noted.
(3) Large package label content includes:
Drug name, specifications, production batch number, production date, validity period, storage, packaging, approval number, production company and transportation precautions or other marks.
Details for the Implementation of the Drug Administration Law
Chapter 1 General Provisions
Article 1 In accordance with the "Drug Administration Law of the People's Republic of China" (hereinafter referred to as " These Measures are formulated in accordance with the provisions of the Drug Administration Law).
Article 2 These Measures apply to all units and individuals involved in the production, operation, use, inspection, and scientific research of pharmaceuticals.
These Measures shall apply to military pharmaceutical manufacturers that produce civilian pharmaceuticals.
Article 3: Social benefits should be given top priority in the production and operation of drugs, and the production, operation, and use of counterfeit or substandard drugs are strictly prohibited.
It is strictly prohibited to produce, operate drugs and prepare preparations without a license.
Chapter 2 Drug Supervision and Administration Responsibilities
Article 4 The health administration department of the State Council is in charge of national drug supervision and administration, and its main responsibilities are:
(1) Implement the "Drug Administration Law" and these Measures;
(2) Draft regulations related to drug supervision and management, and formulate supporting separate measures;
(3) Promulgate the "Chinese Pharmacopoeia" and Drug standards;
(4) Approving new drugs and issuing drug approval numbers;
(5) Supervising the production, operation and use of drugs;
(6) Organize investigations and re-evaluations of the efficacy and side effects of drugs that have been produced, and provide and publish relevant quality information in a timely manner;
(7) In accordance with the "Drug Administration Law" and these Measures Determine administrative penalties.
The pharmaceutical administration agencies of the local health administrative departments at the county level and above are responsible for the drug supervision and management of the administrative areas under their jurisdiction.
Article 5: Drug testing institutes set up by health administrative departments at or above the county level, under the leadership of the health administrative departments at the same level, shall inspect drugs in accordance with national drug standards and drug standards of provinces, autonomous regions, and municipalities directly under the Central Government.
Article 6: The health administrative department at or above the county level shall establish a drug supervisor, and the national drug supervisor shall be examined and issued a certificate by the health administrative department of the State Council; Drug supervisors are nominated by the health administrative department, and the people's government at the same level reviews and issues certificates.
The responsibilities of drug supervisors shall be separately stipulated by the health administration department of the State Council.
Article 7 When performing their duties, drug supervisors shall present their certificates, take samples and obtain relevant information and issue lists in accordance with relevant national regulations. Pharmaceutical manufacturers and scientific research institutions shall bear the responsibility for keeping confidential the confidential technical information provided by them.
Drug supervisors should indicate the storage period for drugs that are temporarily sealed for processing, which should generally not exceed 15 days.
Chapter 3 Procedures for Review and Approval of Licenses
Article 8 The review and approval procedures stipulated in Paragraph 1 of Article 4 of the "Drug Administration Law" refer to the establishment of drug production enterprises (including Various forms of joint ventures, Sino-foreign joint ventures, Sino-foreign cooperative enterprises and foreign-funded enterprises), in addition to performing the capital construction approval procedures in accordance with national regulations, must also perform the following procedures in sequence:
(1) By the enterprise or the enterprise The superior department shall declare to the drug production and operation department of the province, autonomous region, or municipality where it is located, and after review and approval, send it to the health administrative department at the same level;
(2) Review by the health administrative department of the province, autonomous region, or municipality where it is located Approval and issue a "Drug Manufacturing Enterprise License".
The drug production and operation department and the health administrative department shall make a decision on whether to agree or approve within 30 days after receiving all application materials.
Article 9 If a pharmaceutical manufacturer sets up another branch factory or sets up a workshop outside the factory area, the pharmaceutical manufacturer shall apply to the pharmaceutical production and operation department of the province, autonomous region, or municipality directly under the Central Government where the branch factory or workshop is located. After review and approval, the application will be sent to the health administrative department at the same level to apply for a "Drug Production Enterprise License".
The "Drug Manufacturing Enterprise License" should indicate the branch factory (workshop) and production scope.
Article 10 The approval procedure stipulated in Paragraph 1 of Article 10 of the "Drug Administration Law" means that drug operating enterprises (including exclusive or concurrent wholesale and retail stores or companies) apply for processing in accordance with the following provisions "Pharmaceutical Business Enterprise License":
(1) Enterprises engaged in drug wholesale business shall be reviewed and approved by the drug production and trading departments of the provinces, autonomous regions and municipalities directly under the Central Government, and shall be reviewed and approved by the health administrative departments of the provinces, autonomous regions and municipalities directly under the Central Government. After approval, a "Pharmaceutical Business Enterprise License" will be issued;
(2) Enterprises engaged in drug retail business shall be reviewed and approved by the drug production and trading department of the autonomous prefecture, city or county where they are located, and approved by the health department at the same level. The administrative department reviews and approves and issues a "Pharmaceutical Business Enterprise License".
The drug production and operation department and the health administrative department shall make a decision on whether to agree or approve within 30 days after receiving all application materials.
Article 11 The term “drug production and operation authorities” as mentioned in Articles 4, 10, and 22 of the Drug Administration Law refers to the centralized pharmaceutical management departments at all levels above the county level. or departments designated by the people's government.
Article 12 Medical units that prepare their own preparations must apply to the health administrative department of the province, autonomous region, or municipality where they are located, and a "Preparation License" will be issued after review and approval.
The health administrative department that accepts the review shall make a decision on whether to approve it within 30 days after receiving all application materials.
Article 13 The validity period of the "Pharmaceutical Manufacturing Enterprise License", "Pharmaceutical Business Enterprise License" and "Preparation License" is 5 years.
If the license holder continues to produce, sell drugs or prepare preparations after the expiration, the license holder shall re-apply 6 months before expiration. The re-application procedures are the same as those for the first application.
If the enterprise goes bankrupt or closes down, the above-mentioned license shall be canceled by the original issuing department.
Article 14 The "Pharmaceutical Manufacturing Enterprise License", "Pharmaceutical Business Enterprise License" and "Preparation License" shall be uniformly printed by the health administration department of the State Council.
Chapter 4 Approval of New Drugs
Article 15 The state encourages the research and creation of new drugs. All qualified drug research units, universities, pharmaceutical manufacturers, medical units or Anyone can engage in the research and creation of new drugs.
Article 16: New drug approval procedures shall be formulated by the health administrative department of the State Council.
Article 17 When a new drug research and development unit applies for new drug clinical trials, it must submit relevant materials and samples in accordance with the new drug approval methods.
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.
Article 19: New drugs that have completed clinical trials or clinical verification and passed the preliminary review by the health administrative department of the province, autonomous region, or municipality directly under the Central Government shall be submitted by the research and development unit to the health administrative department of the State Council for approval. After approval by the health administrative department of the State Council, a new drug certificate will be issued.
The health administrative department of the State Council shall organize a review by the Drug Review Committee as soon as possible after receiving all application materials, and make a decision on whether to approve it within two months after the review.
Article 20 The health administrative department of the State Council and the health administrative departments of provinces, autonomous regions, and municipalities directly under the Central Government may establish a drug review committee. The members of the committee shall be composed of medical and pharmaceutical experts in medical treatment, scientific research, production, teaching, etc.
Article 21: For relevant information, data, processes, etc. submitted by new drug development units or individuals, clinical trial or verification units, approval departments and their staff shall bear the responsibility of confidentiality.
Chapter 5 Approval Number of Drugs
Article 22: The production unit shall submit an application to the health administration department of the State Council for the production of new drugs. Upon review and approval, an approval number will be issued, but Except for the production of traditional Chinese medicine pieces.
To produce drugs that have national standards or provincial, autonomous region, or municipality standards, the production unit shall submit an application to the health administrative department of the province, autonomous region, or municipality directly under the Central Government. The health administrative department shall decide whether to issue an approval number after soliciting the opinions of the drug production and operation department at the same level, except for the production of traditional Chinese medicine pieces.
Article 23 When a pharmaceutical manufacturer applies for an approval number, it shall submit test samples and necessary materials to the drug testing institute designated by the health administrative department of the province, autonomous region, or municipality directly under the Central Government, and the drug testing institute shall make a timely decision The inspection report shall be submitted to the health administrative department responsible for review. The health administrative department shall make a decision on whether to issue an approval number within 30 days of receiving the inspection report.
Article 24 The approval number of a drug shall not be changed within 5 years, but the approval number of a drug that has been discontinued for more than 3 years shall be invalidated.
Article 25 The health administrative department of the State Council shall organize investigations into drugs that have been approved for production; after evaluation by the Drug Review Committee, those with uncertain efficacy, severe adverse reactions, or other reasons endangering people’s health For drugs, their approval number should be revoked.
Chapter 6 Management of Pharmaceutical Manufacturing Enterprises
Article 26 The state implements the "Good Manufacturing Practices for Pharmaceuticals". The health administrative department of the State Council formulates the Good Manufacturing Practice for Drugs and supervises its implementation; the competent department for drug production and distribution may formulate implementation plans in accordance with the requirements of the Good Manufacturing Practice and guide the gradual implementation of the Good Manufacturing Practice.
Article 27 New pharmaceutical manufacturing enterprises and expansion and reconstruction parts of existing enterprises must comply with the requirements of the "Good Manufacturing Practice for Pharmaceutical Products". Existing enterprises should formulate and implement rules and regulations and hygienic requirements to ensure drug quality in accordance with the requirements of the Good Manufacturing Practice for Drugs, and gradually and in a planned manner meet the requirements of the Good Manufacturing Practice for Drugs.
Article 28 Pharmaceutical manufacturing enterprises shall have full-time technical personnel and skilled workers and meet the following conditions:
(1) The factory director responsible for pharmaceutical production technology and quality must be familiar with Knowledge of drug production business;
(2) The person in charge of the drug production technology and quality inspection agency shall be a pharmacist, assistant engineer, or technical personnel above the level of traditional Chinese medicine pharmacist according to the different production varieties;
(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) The production technical workers should go through this production process Technical training is required, and those without training are not allowed to operate alone;
(5) If a traditional Chinese medicine piece processing enterprise cannot meet the requirements of item (2), it must be equipped with personnel who are familiar with the properties of the medicine and can identify the authenticity of the medicine. Pharmaceutical workers who have mastered production technology and have been reviewed and registered by the health administrative department at or above the county level.
Article 29 Pharmaceutical manufacturing enterprises must have factories, facilities and sanitary environments that can ensure the quality of pharmaceuticals, and keep them clean and tidy. Those who prepare infusions and powder injections must meet ultra-clean conditions.
Article 30: Drug manufacturing enterprises must have independent institutions and personnel capable of conducting quality inspections on the drugs they produce, and have appropriate instruments and equipment.
Article 31 Traditional Chinese medicine factories (including workshops of Western medicine factories that produce traditional Chinese medicine) shall not be exempt from the provisions of Articles 28, 29, 30 and 32 of these Measures. In addition to execution, the following should also be done:
(1) Select, organize, wash, dry, process and other pre-processing of different raw medicinal materials in accordance with regulations;
(2) ) The process of producing traditional Chinese medicine preparations (batching, crushing, inner packaging, etc.) must not be carried out in an environment that may contaminate the medicine;
(3) Western medicine factories producing traditional Chinese medicine preparations should be equipped with traditional Chinese medicine technicians to be responsible for quality management .
Article 32: Various drugs produced by drug manufacturers must be produced in accordance with the original approved drug standards and process procedures. If any changes to the drug production process procedures may affect drug standards, a report must be made to the province or autonomous region. , it can only be carried out after review and approval by the municipal health administrative department.
Article 33 Pharmaceutical manufacturers should have complete production records and inspection records. The records shall be kept until 1 year after the expiration of the validity period of the batch of drugs; if there is no validity period, the records shall be kept for 3 years.
Article 34 The raw materials and excipients required for the production of drugs, as well as containers and packaging materials that are in direct contact with drugs, should comply with the national pharmacopoeia or other medicinal requirements. The use of items that do not meet the above requirements should be reported to the local health administrative department.
Article 35 Pharmaceutical manufacturers shall strengthen quality management. Drugs must undergo quality inspection by the drug inspection agency of the enterprise before leaving the factory. If they meet the standards, they shall have a qualification mark or laboratory report attached to the inner package. ; Those that do not meet the standards will not be allowed to leave the factory.
Chapter 7 Management of Pharmaceutical Trading Enterprises
Article 36 Pharmaceutical trading enterprises shall have full-time pharmaceutical technicians and meet the following conditions:
(1) Drug wholesale enterprises shall set up quality inspection agencies, which shall be in charge of technical personnel with a degree of Chinese herbalists, pharmacists or above;
(2) Drug retail enterprises shall be equipped with technical personnel with a degree of Chinese herbalists, pharmacists or above, or shall Equipped with full-time pharmaceutical personnel who have been reviewed and registered by the health administrative department at or above the county level;
(3) Newly recruited and transferred non-pharmaceutical technical personnel engaged in drug dispensing, acquisition, storage, and sales must go through this department The company provides pharmaceutical knowledge training, and those who have not received training are not allowed to work alone.
Article 37 The business premises, equipment, storage facilities and sanitary environment of pharmaceutical trading enterprises shall meet the following requirements:
(1) The storage and custody of pharmaceuticals must comply with various Physical and chemical performance requirements of pharmaceuticals. Measures should be taken to prevent dust, moisture, pollution, insects, rats and mildew. Medicines that need to be protected from light and stored at low temperatures should be stored in appropriate special warehouses (cabinets);
(2) If a pharmaceutical operating enterprise concurrently sells non-drugs, it must set up a separate special counter for concurrently selling commodities, which must not be used in conjunction with pharmaceuticals. Mixed.
Article 38: Except for the processing and processing of traditional Chinese medicine pieces and the preparation of preparations for patients according to prescriptions, pharmaceutical operating enterprises are not allowed to make their own medicines for sale.
Article 39: Pharmaceutical operating enterprises must establish and improve strict quality inspection, warehousing acceptance, in-warehouse maintenance, and out-warehouse inspection and distribution systems when purchasing and selling drugs.
Article 40 The purchase of drugs must be inspected and accepted. The inspection and acceptance contents include: drug name, production company, production batch number, certificate of conformity, approval number, registered trademark, packaging, and appearance quality of the drug, etc. The packaging of Chinese medicinal materials must be inspected, and each package must be marked with the product name, place of origin, and dispatching unit, and must be accompanied by a quality mark.
Chapter 8 Pharmaceutical Management in Medical Units
Article 41 Medical units preparing preparations must meet the following conditions:
(1) County level or above The person in charge of preparation and drug testing business in hospitals (including medical units in factories, mines, enterprises and institutions with more than 100 beds) must be technicians above the level of pharmacists;
The person in charge of preparation and drug testing business in hospitals below the county level must be It must be held by technicians above the level of pharmaceutical pharmacist;
(2) The preparation place should have buildings and equipment that can ensure the quality of the drugs, and should be kept clean and tidy. The sterilization preparation room must have appropriate conditions for changing, buffering, washing, preparation, potting, sterilization, packaging, etc. and facilities such as air conditioning. Those who prepare infusions must meet ultra-clean conditions.
Article 42 When preparing preparations, operating procedures, quality inspection and hygiene systems must be strictly followed. Detailed and complete records must be kept for each batch of preparations.
Article 43 Medical units that prepare preparations must have corresponding drug testing rooms.
Preparations that pass the quality inspection will be issued a preparation certificate by the Drug Testing Office and can be used with a doctor's prescription; those that fail are not allowed for clinical use.
Article 44: Preparations prepared by medical units are limited to pharmaceutical preparations that meet the clinical and scientific research needs of the unit but are not available or in short supply on the market.
Preparations prepared by medical units shall not be sold in the market or in disguised form.
Article 45 Medical units must prepare preparations in accordance with the hospital preparation specifications formulated by the health administration departments of provinces, autonomous regions, and municipalities directly under the Central Government, and file with the local health administration department.
Article 46 Except for the pharmacy department (room) and isotope room (nuclear medicine room), which can prepare and supply drugs, other departments in medical units are not allowed to prepare and supply drugs.
Chapter 9 Punishments
Article 47 Except for administrative penalties for violating Article 15 of the Drug Administration Law and Chapter 8 on advertising management, the industrial and commercial administration In addition to decisions made by the management department, administrative penalties 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 penalty notice shall be issued. Notices of punishment for counterfeit and substandard drugs shall state the quality inspection results of the drug testing institute.
All proceeds from fines will be turned over to the state treasury.
Article 48 For those who produce, sell, or use counterfeit drugs, the counterfeit drugs and illegal income will be confiscated. Depending on the circumstances, the health administrative department may impose a fine of not more than 5 times the price of the batch of counterfeit drugs passed off as genuine products. .
Article 49 For those who produce, sell, or use inferior drugs, the inferior drugs and illegal income will be confiscated. Depending on the circumstances, the health administrative department may impose a fine of not more than three times the price of the genuine products of the batch of inferior drugs. .
Article 50: Anyone who produces, sells, or uses counterfeit or inferior drugs under any of the following circumstances shall be deemed to be serious, and the health administrative department shall impose severe administrative penalties:
(1) Using narcotic drugs, psychotropic drugs, toxic drugs, and radioactive drugs as other drugs, or using other drugs to pass off the above-mentioned drugs; (2) Producing and selling counterfeit drugs and inferior drugs for infants and young children as the main target of use;
(3) Producing, selling, and using counterfeit drugs or inferior drugs that have caused personal injury;
(4) Producing, selling, and using counterfeit drugs , substandard drugs, and repeat the crime after treatment;
(5) Other national laws and regulations stipulate that severe punishment should be imposed.
Article 51: For those who produce and sell drugs or prepare preparations without obtaining the "Drug Manufacturing Enterprise License", "Drug Trading Enterprise License", and "Preparation License", the health administrative department shall In addition to ordering them to immediately cease production, business, and preparation of preparations, all drugs and illegal income will be confiscated, and depending on the circumstances, a fine of not more than five times the genuine price of the drugs or preparations they produce or operate will be imposed.
Article 52: For units or individuals who have any of the following circumstances, the health administrative department may issue a warning or impose a fine of not more than 20,000 yuan according to the circumstances:
( 1) The drugs imported for the first time have not been approved by the health administrative department of the State Council;
(2) The imported drugs have not been inspected by the border port drug inspection institute;
(3) The drugs have been imported without authorization Clinical trials or verification of new drugs;
(4) Changing the production process procedures without the approval of the health administrative department, resulting in changes in drug standards;
(5) Self-made by medical units Preparations are sold in the market or in disguised form.
Article 53: For units or individuals who have any of the following circumstances, the health administrative department may issue a warning or impose a fine of not more than 10,000 yuan according to the circumstances:
( 1) Drugs that should be marked with an expiration date are not marked with an expiration date;
(2) Violations of drug packaging or packaging regulations for shipping Chinese medicinal materials;
(3) Drug packaging is not in accordance with the regulations Regulations on labeling or labeling or instructions that do not comply with regulations;
(4) Purchasing or selling newly discovered or imported Chinese medicinal materials from abroad without approval.
Article 54 If the staff of the drug testing institute and drug supervisors take advantage of their authority to engage in malpractice or accept bribes, and the circumstances are minor, they shall be given administrative sanctions by the health administrative department; if the circumstances are serious and constitute a crime, criminal prosecution shall be pursued in accordance with the law. responsibility.
Chapter 10 Supplementary Provisions
Article 55 The labeling of narcotic drugs, psychotropic drugs, toxic drugs, radioactive drugs and external drugs is as follows (see attached figure).
Article 56 The health administrative department of the State Council is responsible for the interpretation of these Measures.
Article 57 These Measures shall come into effect on the date of promulgation.
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