Chapter 1 General Provisions
Article 1
In order to strengthen drug supervision and management, ensure drug quality, ensure the safety of human drug use, and safeguard people's health and drug use Legitimate rights and interests, this law is specially formulated.
Article 2
Units or individuals engaged in the development, production, operation, use, supervision and management of drugs within the territory of the People's Republic of China must abide by this law.
Article 3
The state develops modern medicines and traditional medicines and gives full play to their role in prevention, medical treatment and health care.
The state protects wild medicinal resources and encourages the cultivation of traditional Chinese medicinal materials.
Article 4
The state encourages the research and creation of new drugs and protects the legitimate rights and interests of citizens, legal persons and other organizations in the research and development of new drugs.
Article 5
The drug regulatory department of the State Council is responsible for the national drug regulatory work. Relevant departments under the State Council are responsible for drug-related supervision and management within their respective scope of responsibilities.
The drug supervision and administration departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government are responsible for the supervision and administration of drugs within their respective administrative regions. Relevant departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government are responsible for drug-related supervision and management within the scope of their respective responsibilities.
The drug regulatory department of the State Council shall cooperate with the comprehensive economic department of the State Council to implement the development plan and industrial policies for the pharmaceutical industry formulated by the state.
Article 6
The drug inspection agency established or determined by the drug regulatory department shall be responsible for the drug inspection work required to implement drug approval and drug quality supervision and inspection in accordance with the law.
Chapter 2 Management of Pharmaceutical Manufacturing Enterprises
Article 7
To establish a pharmaceutical manufacturing enterprise, it must go through the drug supervision and administration of the people's government of the province, autonomous region, or municipality directly under the Central Government where the enterprise is located. The department approves and issues a "Drug Production License", and with the "Drug Production License" go to the industrial and commercial administration department for registration. Without a "Drug Production License", no drugs may be produced.
The "Drug Production License" should indicate the validity period and production scope, and the license will be re-examined and issued upon expiration.
When the drug regulatory department approves the establishment of a pharmaceutical manufacturing enterprise, in addition to the conditions stipulated in Article 8 of this Law, it must also comply with the national pharmaceutical industry development plan and industrial policies to prevent duplication of construction.
Article 8
To open a pharmaceutical manufacturing enterprise, the following conditions must be met:
(1) Have pharmaceutical technicians and engineering technicians who have been qualified in accordance with the law and corresponding skilled workers;
(2) Have workshops, facilities and sanitary environments suitable for the production of its drugs;
(3) Have the ability to conduct quality management and management of the drugs produced. Quality inspection institutions, personnel and necessary instruments and equipment;
(4) Having rules and regulations to ensure drug quality.
Article 9
Drug manufacturing enterprises must organize production in accordance with the "Good Manufacturing Practices for Drugs" formulated by the drug regulatory department of the State Council in accordance with this law. The drug regulatory department shall certify whether drug manufacturers meet the requirements of the Good Manufacturing Practice for Drugs in accordance with regulations; and issue certification certificates to those that pass the certification.
The specific implementation methods and implementation steps of the "Good Manufacturing Practice for Drugs" shall be stipulated by the drug regulatory department of the State Council.
Article 10
Except for the processing of traditional Chinese medicine pieces, drugs must be produced in accordance with national drug standards and production processes approved by the drug regulatory department of the State Council, and production records must be complete and accurate. If a pharmaceutical manufacturer changes the production process that affects drug quality, it must report to the original approval department for review and approval.
Chinese medicine pieces must be processed in accordance with national drug standards; if there are no national drug standards, they must be processed in accordance with the processing specifications formulated by the drug regulatory departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government. The processing specifications formulated by the drug regulatory departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government shall be reported to the drug regulatory department of the State Council for record.
Article 11
The raw materials and excipients required for the production of drugs must meet medicinal requirements.
Article 12
Pharmaceutical manufacturers must conduct quality inspections on the drugs they produce; if the drugs do not meet the national drug standards or do not comply with the requirements of the drug regulatory authorities of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government, Those prepared according to the prescribed processing standards for traditional Chinese medicine pieces shall not leave the factory.
Article 13
With the approval of the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government, pharmaceutical manufacturers may accept entrustment to produce drugs. [4]
Chapter 3 Management of Pharmaceutical Business Enterprises
Article 14
To open a pharmaceutical wholesale enterprise, it is necessary to obtain approval from the people of the province, autonomous region, or municipality directly under the Central Government where the enterprise is located. The government drug regulatory department shall approve and issue a "Pharmaceutical Business License"; to open a drug retail enterprise, it must be approved by the local drug regulatory department at or above the county level where the enterprise is located and issued a "Pharmaceutical Business License". The industrial and commercial administration department handles registration. Without a "Pharmaceutical Business License", no pharmaceuticals are allowed to be sold.
The "Drug Business License" should indicate the validity period and business scope, and the license will be re-examined and issued upon expiration.
The drug regulatory department shall, in addition to complying with the conditions stipulated in Article 15 of this Law when approving the establishment of a pharmaceutical business enterprise, also follow the principles of rational layout and convenience for the public to purchase medicines.
Article 15
To open a pharmaceutical business enterprise, the following conditions must be met:
(1) Have pharmaceutical technicians who have been qualified in accordance with the law;
(2) Have business premises, equipment, storage facilities, and sanitary environment that are suitable for the drugs it operates;
(3) Have quality management institutions or personnel that are suitable for the drugs it operates;
(4) Have rules and regulations to ensure the quality of the drugs it operates.
Article 16
Pharmaceutical trading enterprises must operate drugs in accordance with the "Pharmaceutical Distribution Quality Management Practices" formulated by the drug regulatory department of the State Council in accordance with this law. The drug regulatory department shall certify whether pharmaceutical operating enterprises meet the requirements of the "Good Manufacturing Practices for Pharmaceutical Distribution" in accordance with regulations; and issue certification certificates to those that pass the certification.
The specific implementation methods and implementation steps of the "Good Manufacturing Practices for Pharmaceutical Products" shall be stipulated by the drug regulatory department of the State Council.
Article 17
Pharmaceutical trading enterprises must establish and implement a purchase inspection and acceptance system when purchasing drugs, and verify drug qualification certificates and other identifications; if they do not meet the prescribed requirements, they shall not purchase.
Article 18
Pharmaceutical business enterprises must have true and complete purchase and sale records when purchasing and selling drugs. The purchase and sale records must indicate the generic name, dosage form, specification, batch number, validity period, manufacturer, purchase (sales) unit, purchase (sale) quantity, purchase and sale price, purchase (sale) date, and the drug regulatory department of the State Council. Other content as specified.
Article 19
Pharmaceutical business enterprises selling drugs must be accurate and correctly explain the usage, dosage and precautions; the prescription must be checked, and the drugs listed in the prescription must not be modified without authorization Change or substitute. Prescriptions with incompatibility or excessive dosage shall be refused to be dispensed; if necessary, they may be dispensed only after being corrected or re-signed by the prescribing physician.
Pharmaceutical business enterprises selling traditional Chinese medicinal materials must indicate the place of origin.
Article 20
Pharmaceutical trading enterprises must formulate and implement drug storage systems and take necessary measures such as refrigeration, anti-freeze, moisture-proof, insect-proof, and rodent-proof to ensure the quality of drugs.
An inspection system must be implemented when drugs are put into and out of the warehouse.
Article 21
Traditional Chinese medicinal materials may be sold in urban and rural bazaars, unless otherwise specified by the State Council.
Pharmaceuticals other than traditional Chinese medicinal materials are not allowed to be sold in urban and rural market trade markets, but pharmaceutical retail enterprises holding a "Pharmaceutical Business License" can set up outlets to sell traditional Chinese medicinal materials in urban and rural market trade markets within the prescribed scope. other than medicines. Specific measures shall be prescribed by the State Council.
Chapter 4 Pharmacy Management in Medical Institutions
Article 22
Medical institutions must be equipped with pharmaceutical technicians who have been qualified in accordance with the law. Non-pharmaceutical technicians are not allowed to directly engage in pharmaceutical technical work.
Article 23
The preparation of preparations by medical institutions must be reviewed and approved by the health administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government where they are located, and the drug supervision and administration department of the people's government of the province, autonomous region, or municipality directly under the Central Government must The management department approves and issues a "Medical Institution Preparation License". Without a "Medical Institution Preparation License", preparations are not allowed.
The "Medical Institution Preparation License" should indicate the validity period, and the license will be re-examined upon expiration.
Article 24
Medical institutions preparing preparations must have facilities, management systems, inspection instruments and sanitary conditions that can ensure the quality of preparations.