g theircurative effects, guaranteeing safety in medication and safeguarding thehealth of the people.Article 2The administrative department of health under the State Council shall beresponsible for the supervision and control of pharmaceuticals throughoutthe country.Article 3The state shall develop both modern and traditional medicines and givefull play to their role in the prevention and treatment of diseases and inhealth care. The state shall protect the resources of wild medicinalmaterials and encourage the domestic cultivation of Chinese traditionalmedicinal crops.
【章名】Chapter II Administration of Pharmaceutical Producing Enterprises
Article 4The establishment of a pharmaceutical producing enterprise must besanctioned by the competent authorities for the production and trading ofpharmaceuticals of the province, autonomous region, or municipalitydirectly under the Central Government in which the enterprise is located,and approved by the administrative department of health of the sameprovince, autonomous region or municipality, which will issue aPharmaceuticals Producer Licence. The administrative authorities forindustry and commerce shall not issue business licences to any enterprisesproducing pharmaceuticals without the Pharmaceutical Producer Licence.The Pharmaceutical Producer Licence shall have a period of validity, uponexpiration of which a new licence shall be issued after an examination forits renewal. Detailed measures for the renewal of such licences shall bestipulated by the administrative department of health under the StateCouncil.Article 5To establish a pharmaceutical producing enterprise, the followingrequirements must be met:(1) It shall be staffed with the necessary personnel required forproducing the medicines concerned, that is, pharmacists or technicalpersonnel with a qualification equivalent to or higher than assistantengineer as well as skilled workers. If an enterprise processing Chinesetraditional medicines into ready-to-use mixture and powder forms does nothave pharmacists or technical personnel with a qualification equivalent toor higher than assistant engineer, it shall be staffed instead withskilled pharmaceutical workers who are familiar with the properties of themedicines processed and are registered with the administrative departmentof health at or above the county level.(2) It shall have factory premises, facilities and a sanitary environmentsuitable for the medicines produced.(3) It shall have a unit or competent personnel capable of inspecting thequality of the medicines produced, as well as necessary instruments andequipment.Article 6Pharmaceuticals must be produced in accordance with the technologicalprocedure, and the record of production must be complete and accurate.The process for preparing traditional Chinese medicines in ready-to-useforms must conform to the Pharmacopoeia of the People's Republic of Chinaor the Processing Norms stipulated by the administrative departments ofhealth of the provinces, autonomous regions, or municipalities directlyunder the Central Government.
Article 7The raw and supplementary materials used for the production ofpharmaceuticals and containers and packaging materials in direct contactwith pharmaceuticals must conform to the requirements for medicinal use.Article 8Pharmaceuticals must go through quality inspection before they leave thefactory; products which do not meet the standards shall not leave thefactory.Article 9Pharmaceutical producing enterprises must draw up and carry out rules andregulations and sanitary requirements for ensuring the quality ofpharmaceuticals in accordance with the Standards for Quality Control ofPharmaceutical Production stipulated by the administrative department ofhealth under the State Council.
【章名】Chapter III Administration of Pharmaceutical Trading Enterprises
Article 10The establishment of a pharmaceutical trading enterprise must besanctioned by the local competent authorities for the production andtrading of pharmaceuticals and approved by the administrative departmentof health at or above the county level, which will issue a PharmaceuticalTrading Enterprise Licence. The administrative authorities for industryand commerce shall not issue business licences to any enterprises withoutthe Pharmaceutical Trading Enterprise Licence.The Pharmaceutical Trading Enterprise Licence shall have a period ofvalidity, upon expiration of which a new licence shall be issued after anexamination for its renewal. Detailed measures for the renewal of suchlicences shall be stipulated by the administrative department of healthunder the State Council.Article 11To establish a pharmaceutical trading enterprise, the followingrequirements must be met:(1) It shall be staffed with pharmaceutical technicians qualified for thehandling of the pharmaceuticals.If an enterprise trading in Chinese traditional medicines or an enterpriseconcurrently trading in medicines does not have pharmaceuticaltechnicians, it shall be staffed instead with pharmaceutical workers whoare familiar with the properties of the medicines it trades in and areregistered with the administrative department of health at or above thecounty level.(2) It shall have business premises, equipment, storage facilities and asanitary environment suitable for the pharmaceuticals in which it trades.Article 12The quality of pharmaceuticals must be inspected on purchasing.Pharmaceuticals that do not meet the required standards must not bepurchased.Article 13It is imperative, in the sale of pharmaceuticals, to be accurate and freeof mistakes, and to provide correct directions for use, dosage andprecautions. Prescriptions being dispensed must be checked.Pharmaceuticals listed in prescriptions must not be presumptuously changedor substituted. Prescriptions containing incompatible substances orexcessive dosages shall be rejected by the dispensary. If necessary, suchprescriptions can be dispensed after they have been corrected or resignedby the doctors who wrote them out.When famous traditional Chinese medicinal materials are offered for sale,their origin must be indicated.
Article 14Rules for storage of pharmaceuticals shall be formulated and implementedby pharmaceutical warehouses, which must adopt necessary measures tofacilitate cold storage and protection against moisture, insects androdents.An inspection system shall be carried out for pharmaceuticals entering orleaving warehouses.Article 15Unless otherwise stipulated by the state, traditional Chinese medicinalmaterials may be marketed at urban or rural fairs.Pharmaceuticals other than traditional Chinese medicinal materials may notbe sold at urban or rural fairs, except by those who have PharmaceuticalsTrading Enterprise Licences.
【章名】Chapter IV Administration of Pharmaceuticals at Medical Units
Article 16Medical units must be staffed with pharmaceutical technical personnelcommensurate with their medical functions. Non-pharmaceutical technicalpersonnel may not engage directly in pharmaceutical technical work.Article 17To make medicinal preparations, a medical unit must be examined, approvedand issued a Dispensing Permit by the administrative department of healthof the province, autonomous region, or municipality directly under theCentral Government in which the units is located.The Dispensing Permit shall have a period of validity, upon expiration ofwhich a new permit shall be issued after an examination for its renewal.Detailed measures for the renewal of such permits shall be stipulated bythe administrative department of health under the State Council.Article 18Medical units making medicinal preparations must be equipped withfacilities, inspection instruments and sanitary conditions capable ofensuring the quality of the preparations.Article 19The quality of the medicinal preparations made by medical units must beinspected in accordance with relevant regulations and clinical needs.Those up to standard can be used as the doctor pr