production of medicines for civilian use.Article 3In the production and selling of pharmaceuticals, social benefit shall betaken as the prime concern. The production, selling or use of fake orinferior medicines is strictly prohibited.Without authorization no production or sales of pharmaceuticals orpreparation of medicaments shall be allowed.
【章名】Chapter II Responsibility for the Supervision and Administration of Pharmaceuticals
Article 4The administrative department of health under the State Council is incharge of the nationwide supervision over and administration ofpharmaceuticals. Its principal responsibilities are as follows:(1) to enforce the pharmaceutical Administration Law and these Measures;(2) to draft laws and regulations related to the supervision andadministration of pharmaceuticals, and to formulate provisions for theimplementation of each law or regulations;(3) to promulgate the Pharmacopoeia of China and the national standardsfor medicines;(4) to examine and approve new medicines and to verify and issue approvalcertificates thereof;(5) to exercise supervision over the production, trading and use ofpharmaceuticals;(6) to make investigation and appraisal of the curative effect and sideeffect of the medicines already put into production and to provide andpublish information related to the quality;(7) to make decisions on disciplinary sanctions in accordance with thepharmaceutical Administration Law and these Measures.Pharmaceutical administration organs in the administrative departments ofhealth at or above the county level are in charge of the supervision overand administration of pharmaceuticals within their respectivejurisdiction.Article 5The medicine inspection organs set up by the administrative departments ofhealth at or above the county level shall, under the latter's leadership,conduct medicine inspection in accordance with the standards for medicinesset by the state and by the administrative department of health at thelevel of province, autonomous region or municipality directly under theCentral Government.Article 6Medicine supervisor(s) shall be appointed in the administrative departmentof health at or above the county level. Medicine supervisors at the statelevel shall be entrusted by the administrative department of health underthe State Council by credentials. Medicine supervisors at the provincial,autonomous region or municipal government (directly under the CentralGovernment) level and at the autonomous prefecture, municipality or countylevel shall be nominated respectively by the administrative departments ofhealth and entrusted with credentials by the people's governments at thecorresponding levels. The duties of medicine supervisors at all levelsshall be defined separately by the administrative department of healthunder the State Council.
Article 7When carrying out their duties, the medicine supervisors are required topresent their credentials before they take sample testing and ask forrelevant technical data, with a receipt in accordance with the statestipulations. They are required to keep confidential the technical dataprovided by the production enterprise and scientific research unit. Themedicine supervisors may temporarily seal up some medicine pending furthersettlement. It is required of them to state the term of sealing up whichshall not normally exceed 15 days.
【章名】Chapter III Procedure for the Verification and Approval of Li- censes
Article 8The procedures for examination and approval as stipulated in Paragraph 1of Article 4 of the Pharmaceutical Administration Law denote that theestablishment of a pharmaceutical producing enterprise (including allforms of inland associated enterprises, Chinese-foreign equity jointventures and contractual joint ventures and foreign invested enterprises)shall involve, in addition to applying for approval for the capitalconstruction of the enterprise in accordance with state stipulation, thefollowing steps: (1) the enterprise or its leadership organ submits anapplication to the competent department for the production and trading ofpharmaceuticals of the province, autonomous region or municipalitydirectly under the Central Government where the enterprise is located forexamination and approval and then refer it to the administrativedepartment of health at the same level. (2) upon approval by theadministrative department of health of the province, autonomous region ormunicipality directly under the Central Government, a PharmaceuticalProducer License shall be issued. The department in charge of theproduction and trading of pharmaceuticals and the administrativedepartment of health are required to make a decision within 30 days ofreceipt of complete application materials.Article 9If a pharmaceutical production enterprise desires to set up a branchfactory or any additional workshops outside the premise of the factory, itis required to submit an application to the department in charge of theproduction and trading of pharmaceuticals at the level of the province,autonomous region or municipality directly under the Central Governmentfor examination and approval and then refer it to the administrativedepartment of health at the same level for a Pharmaceutical ProducersLicense, on which the status of the new set-up (a branch factory or aworkshop) and its production scope must be clearly stated.
Article 10The procedures for examination and approval stipulated in Paragraph 1 ofArticle 10 of the Pharmaceutical Administration Law denote that apharmaceutical trading enterprise (including specialized and non-specialized whole-sale or retail drug stores or companies) should applyfor a Pharmaceutical Trading Enterprise License in accordance with thefollowing provisions:(1) for a wholesale drug enterprise, an application must be submitted tothe department in charge of the production and trading of pharmaceuticalsat the level of the province, autonomous region or municipality directlyunder the Central Government for examination and approval and then bereferred to the administrative department of health at the same governmentlevel for verification and approval before a Pharmaceutical TradingEnterprise License is issued;(2) for a retail drug enterprise, an application must be submitted to thedepartment in charge of the production and trading of pharmaceuticals atthe autonomous prefecture, municipality or county government level forexamination and approval and then be referred to the administrativedepartment of health at the same government level for verification andapproval before a Pharmaceutical Trading Enterprise License is issued.The department in charge of the production and trading of pharmaceuticalsand the administrative department of health are required to make adecision within 30 days of receipt of complete application materials.Article 11The competent department for the production and trading of pharmaceuticalsstated in Articles 4, 10 and 22 of the Pharmaceutical Administration Lawrefers to those pharmaceutical administration organs or departmentsappointed by the people's government at or above the county level.
Article 12If a medical treatment unit needs to prepare some medicaments, it isrequired to submit an application to an administrative department ofhealth at the level of the province, autonomous region or municipalitydirectly under the Central Government for examination and approval beforea Dispensing Permit is granted.The administrative department of health is required to make a decisionwithin 30 days of receipt of complete application materials.Article 13The term of validity for a Pharmaceutical Producer Licence, aPharmaceutical Trading Enterprise Licence, or a Dispensing Permit is 5years. If the licensee wishes to continue its production or trading ormaking medicament preparation upon expiration of the licence, it mustreapply for permission. The entire application procedures must berepeated.If an enterprise has gone bankrupt or has wound up busin