PHARMACEUTICAL ADMINISTRATION LAW OF THE PEOPLE'S REPUBLIC OFCHINA
PHARMACEUTICAL ADMINISTRATION LAW OF THE PEOPLE'S REPUBLIC OFCHINA
PHARMACEUTICAL ADMINISTRATION LAW OF THE PEOPLE'S REPUBLIC OF CHINA
September 20, 1984
Contents
Chapter I General Provisions
Chapter II Administration of Pharmaceutical Producing Enterprises
Chapter III Administration of Pharmaceutical Trading Enterprises
Chapter IV Administration of Pharmaceuticals at Medical Units
Chapter V Pharmaceutical Administration
Chapter VI Packaging and Repackaging of Pharmaceuticals
Chapter VII Pharmaceuticals Under Special Control
Chapter VIII Administration of Trademarks and Advertisements of Pharmaceuticals
Chapter IX Supervision over Pharmaceuticals
Chapter X Legal Responsibility
Chapter XI Supplementary Provisions
Chapter I General Provisions
Article 1 This Law is formulated with a view to enhancing the supervision and control of pharmaceuticals, ensuring their quality, improving their curative effects, guaranteeing safety in medication and safeguarding the health of the people.
Article 2 The administrative department of health under the State Council shall be responsible for the supervision and control of pharmaceuticals throughout the country.
Article 3 The state shall develop both modern and traditional medicines and give full play to their role in the prevention and treatment of diseases and in health care. The state shall protect the resources of wild medicinal materials and encourage the domestic cultivation of Chinese traditional medicinal crops.
Chapter II Administration of Pharmaceutical Producing Enterprises
Article 4 The establishment of a pharmaceutical producing enterprise must be sanctioned by the competent authorities for the production and trading of pharmaceuticals of the province, autonomous region, or municipality directly under the Central Government in which the enterprise is located, and approved by the administrative department of health of the same province, autonomous region or municipality, which will issue a Pharmaceuticals Producer Licence. The administrative authorities for industry and commerce shall not issue business licences to any enterprises producing pharmaceuticals without the Pharmaceutical Producer Licence. The Pharmaceutical Producer Licence shall have a period of validity, upon expiration of which a new licence shall be issued after an examination for its renewal. Detailed measures for the renewal of such licences shall be stipulated by the administrative department of health under the State Council.
Article 5 To establish a pharmaceutical producing enterprise, the following requirements must be met:
1. It shall be staffed with the necessary personnel required for producing the medicines concerned, that is, pharmacists or technical personnel with a qualification equivalent to or higher than assistant engineer as well as skilled workers. If an enterprise processing Chinese traditional medicines into ready-to-use mixture and powder forms does not have pharmacists or technical personnel with a qualification equivalent to or higher than assistant engineer, it shall be staffed instead with skilled pharmaceutical workers who are familiar with the properties of the medicines processed and are registered with the administrative department of health at or above the county level.
2. It shall have factory premises, facilities and a sanitary environment suitable for the medicines produced.
3. It shall have a unit or competent personnel capable of inspecting the quality of the medicines produced, as well as necessary instruments and equipment.
Article 6 Pharmaceuticals must be produced in accordance with the technological procedure, and the record of production must be complete and accurate. The process for preparing traditional Chinese medicines in ready-to-use forms must conform to the Pharmacopoeia of the People's Republic of China or the Processing Norms stipulated by the administrative departments of health of the provinces, autonomous regions, or municipalities directly under the Central Government.
Article 7 The raw and supplementary materials used for the production of pharmaceuticals and containers and packaging materials in direct contact with pharmaceuticals must conform to the requirements for medicinal use.
Article 8 Pharmaceuticals must go through quality inspection before they leave the factory; products which do not meet the standards shall not leave the factory.
Article 9 Pharmaceutical producing enterprises must draw up and carry out rules and regulations and sanitary requirements for ensuring the quality of pharmaceuticals in accordance with the Standards for Quality Control of Pharmaceutical Production stipulated by the administrative department of health under the State Council.
Chapter III Administration of Pharmaceutical Trading Enterprises
Article 10 The establishment of a pharmaceutical trading enterprise must be sanctioned by the local competent authorities for the production and trading of pharmaceuticals and approved by the administrative department of health at or above the county level, which will issue a Pharmaceutical Trading Enterprise Licence. The administrative authorities for industry and commerce shall not issue business licences to any enterprises without the Pharmaceutical Trading Enterprise Licence. The Pharmaceutical Trading Enterprise Licence shall have a period of validity, upon expiration of which a new licence shall be issued after an examination for its renewal. Detailed measures for the renewal of such licences shall be stipulated by the administrative department of health under the State Council.
Article 11 To establish a pharmaceutical trading enterprise, the following requirements must be met:
1. It shall be staffed with pharmaceutical technicians qualified for the handling of the pharmaceuticals. If an enterprise trading in Chinese traditional medicines or an enterprise concurrently trading in medicines does not have pharmaceutical technicians, it shall be staffed instead with pharmaceutical workers who are familiar with the properties of the medicines it trades in and are registered with the administrative department of health at or above the county level.
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