People's Republic Of China Pharmaceutical Administration Law Regulations For The Implementation Of

Original Language Title: 中华人民共和国药品管理法实施条例

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(August 4, 2002 People's Republic of China promulgated as of September 15, 2002, promulgated by Decree No. 360) Chapter I General provisions article in accordance with the People's Republic of China Law on drug management (hereinafter referred to as the drug management law), this Ordinance is enacted.     Drug regulatory agency of the State Council shall set up the national drug control agency. The provinces, autonomous regions and municipalities directly under the drug regulatory agency of the Government can set the inspection institutions within their respective administrative areas.     Planning of local drug inspection institutions determined by provinces, autonomous regions and municipalities directly under the pharmaceutical supervisory and Administrative Department of the people's Government, provinces, autonomous regions and municipalities directly under the people's Government.     State Council and provinces, autonomous regions and municipalities directly under the drug regulatory agency of the Government as needed, determined in accordance with test conditions for drug testing agency drug testing. Chapter II article III established manufacturers of pharmaceutical producing enterprises shall, in accordance with the following provisions of the pharmaceutical production license: (a) the applicant shall be filed with the proposed location of provinces, autonomous regions and municipalities directly under the drug regulatory agency of the Government to apply.     The provinces, autonomous regions and municipalities the pharmaceutical supervisory and administrative departments shall, from the date of receipt of the application within 30 working days, according to the country's drug industry review development programs and policies, and make a decision on whether to agree to build. (B) the applicant completed after construction of LCS Enterprise shall be acceptance of an application to the approval authorities. Original examination and approval departments shall, from the date of receipt of the application within 30 working days, in accordance with the conditions provided for in the eighth of the drug administration law of organizational acceptance; acceptance, issue a production license.     Organizers with the drug manufacturing license to the Administrative Department for industry and commerce shall be registered according to law. Fourth drug manufacturers change the drug production licenses, licensing matters, should be in front of the license changed on 30th, to the issuing authority for the drug production licenses, registration of change without approval, shall not change licensing matters. License issuing authority shall, within 15 working days of receipt of the application to make a decision.     The pharmaceutical production license of the applicant was changed to the Administrative Department for industry and Commerce according to register the change. Fifth people's Governments above provincial level pharmaceutical supervisory and administrative departments shall, in accordance with the good manufacturing practices and pharmaceutical supervisory and administrative department under the State Council of measures for implementation and implementation procedures, organization on certification of drug manufacturers; meet good manufacturing practices, and issue a certificate.     Among them, production and injection, radioactive pharmaceuticals and pharmaceutical supervisory and administrative department under the State Council of biological products manufacturer certification, by the pharmaceutical supervisory and administrative departments of the State Council.     Of the good manufacturing practices certificate format by the pharmaceutical supervisory and administrative department under the State Council. Article new drug manufacturer, pharmaceutical production enterprises of new pharmaceutical production plant or released production forms, pharmaceutical production, shall prove file or with the date of approval for full production in the 30th, in accordance with the provisions applying to the pharmaceutical supervisory and Administrative Department of the good manufacturing practices certification.     Pharmaceutical supervisory and Administrative Department for accepting applications shall, within 6 months from the date of receipt of the application, and organization as to whether applicants meet the good manufacturing practice certification certified, issue a certificate. Seventh drug regulatory agency of the State Council shall set up a pharmaceutical manufacturing practices certification Inspector. The good manufacturing practices certification inspectors must comply with the conditions of the pharmaceutical supervisory and administrative department under the State Council.     The good manufacturing practices certification must be in accordance with the regulations of the pharmaceutical supervisory and administrative department under the State Council, from good manufacturing practices certification inspectors randomly certification through a certification inspection unit inspector certification examination. Article eighth drug manufacturing license is valid for 5 years.     Has expired, the need to continue the production of pharmaceuticals, certified enterprises should be 6 months before the expiry of the permit, in accordance with the regulations of the pharmaceutical supervisory and administrative department under the State Council to apply for renewal of the pharmaceuticals production license.     Drug manufacturers terminate production of pharmaceuticals or shut down, the drug production licenses by the original Licensing Department for cancellation.     Nineth manufacturer to produce the API you are using, must have the approval issued by the drug regulatory agency of the State Council, or imported drugs registration certificate, certificate of pharmaceutical product registration, however, is not implemented the approval number except for the management of Chinese herbal medicine, Chinese herbal medicine.     Underlying article tenth of the drug administration law of the 13th article, commissioned the production of pharmaceuticals, the trustee must hold its entrusted with the production of medicines by the drug manufacturing practices certificate of pharmaceutical manufacturers.     Vaccines, blood products and other drugs prescribed by the drug regulatory agency of the State Council may not delegate. Chapter III of pharmaceutical trading enterprises article 11th established wholesale business, the applicant shall provide the proposed location of provinces, autonomous regions and municipalities directly under the drug regulatory agency of the Government to apply. The provinces, autonomous regions and municipalities the pharmaceutical supervisory and administrative departments shall, from the date of receipt of the application within 30 working days, according to the pharmaceutical supervisory and administrative department under the State Council sets standards to make decision on whether to agree to build. After the applicant completed their enterprise to build, should be to the original examination and approval authority for approval. Original examination and approval departments shall, from the date of receipt of the application within 30 working days, according to the conditions provided for in section 15th of the drug administration law organizations acceptance; eligible, pharmaceutical business license will be issued.     Organizers with the drug business license to the Administrative Department for industry and commerce shall be registered according to law. 12th established retail enterprises, the applicant shall provide the proposed local districts or municipal medicine supervision and administration of provinces, autonomous regions and municipalities and Drug Administration directly setting drug regulatory bodies at the county level to apply. Drug regulatory authority accepting the application shall within 30 working days from the date of receipt of the application, based on the pharmaceutical supervisory and administrative department under the State Council, combined with the local resident population, geographical review, traffic conditions and the actual needs, make a decision on whether to agree to build. After the applicant completed their enterprise to build, should apply to the original examination and approval organ acceptance. The original approval authority shall, within 15 working days of receipt of the application, according to the conditions provided for in section 15th of the drug administration law organizations acceptance; eligible, pharmaceutical business license will be issued.     Organizers with the drug business license to the Administrative Department for industry and commerce shall be registered according to law. 13th of provinces, autonomous regions and municipalities directly under the drug regulatory agency of the Government is responsible for drug-handling enterprise certification. Drug distributors shall be stipulated by the pharmaceutical supervisory and administrative department under the State Council implemented measures and implementation steps, through the provinces, autonomous regions and municipalities directly under the drug regulatory agency of the Government Organization's certification of medicine quality control norms, access to the certificate.     The drug business quality management standard certificate format by the pharmaceutical supervisory and administrative department under the State Council. New pharmaceutical wholesale business and retail enterprises, the pharmaceutical business license should be obtained within 30th of, given its drug business of drug supervision and Management Department or drug regulatory body for certification of the medicine quality control specifications. Accepts the application for certification of retail drug enterprise by drug regulatory authority shall within 7 working days from the date of receipt of the application, refer the application is responsible for organizing drug-handling enterprise certification of provinces, autonomous regions and municipalities directly under the drug regulatory agency of the Government.     The provinces, autonomous regions and municipalities directly under the pharmaceutical supervisory and administrative departments shall within 3 months from the date of receipt of the application for certification, in accordance with the regulations of the pharmaceutical supervisory and administrative department under the State Council, the Organization to apply for certification of pharmaceutical wholesale enterprises or drug retailer compliance with the medicine quality control specifications for certification certified, issue a certificate. 14th of provinces, autonomous regions and municipalities directly under the pharmaceutical supervisory and administrative departments shall establish a pharmaceutical management quality management standard certification Inspector. The medicine quality control specifications of Certified inspectors must comply with the conditions of the pharmaceutical supervisory and administrative department under the State Council.     The drug business quality management standard certification must be in accordance with the regulations of the pharmaceutical supervisory and administrative department under the State Council, from the library of medicine quality control standard of certification inspectors randomly through a certification inspection unit inspector certification examination. 15th State practices of prescription and non-prescription drug classification system.     National security based on non-prescription drugs, non-prescription drugs are divided into category a non-prescription drugs and non-prescription drugs. Engaged in prescription drugs, non-prescription drug retailers should be staffed with licensed pharmacists or other by the qualification of pharmacy technicians.     Non-prescription drugs business of b class drug retailer, shall be equipped with the district municipal drug regulatory agencies or the provinces, autonomous regions and municipalities directly under the drug regulatory agency of the Government directly setting drug regulatory bodies at the county level examination by qualified service personnel. 16th pharmaceutical trading enterprises change the drug business licensing matters, should be in front of the license changed on 30th, the original issuing authority for business change in the drug registration without approval, shall not change licensing matters. License issuing authority shall, within 15 working days of receipt of the application to make a decision.     Drug business license of the applicant was changed to the Administrative Department for industry and Commerce according to register the change. 17th the drug business license is valid for 5 years.     Has expired, the continued existence of needed drugs, certified enterprises should be 6 months before the expiry of the permit, in accordance with the regulations of the pharmaceutical supervisory and administrative department under the State Council to apply for renewal of the pharmaceutical business license.     Drug business or close the termination of drugs, drug supply certificate by the issuing authority for cancellation.     18th traverse urban and rural fairs in remote areas without drug retailers, local retail drug enterprise by County (City) drug regulatory authority approval and register with the Administrative Department for industry and commerce registration, can be set up in the urban and rural fairs, and in the context of approved drug sold over the counter medicines. 19th via the Internet drug trade and drug manufacturers, drug-handling enterprises and medical institutions and its drug trade, must comply with the drug management law and the provisions of this Ordinance.     Internet drug trade services management approach, by the pharmaceutical supervisory and administrative department under the State Council together with the relevant departments under the State Council.     The fourth chapter 20th medical pharmacy management institutions of the medical establishment preparation room, to local health administrative departments of provinces, autonomous regions and municipalities to apply for examination and approval, drug supervision and management departments of the Government at the same level for approval; drug regulatory agency of provinces, autonomous regions and municipalities of acceptance, approval, issue a pharmaceutical preparation certificate for medical institution.     Governments of provinces, autonomous regions and municipalities directly under the Administrative Department of public health and the pharmaceutical supervisory and administrative departments shall, within their respective within 30 working days from the date of receipt of the application, make a decision on whether to consent or approval. 21st medical organizations changed the pharmaceutical preparation certificate for medical institution licensing matters, should be in front of the license changed on 30th, in accordance with the provisions of this section 20th to the original audit, approval authority for pharmaceutical preparation certificate for medical institution registration of change without approval, shall not change licensing matters.     The original audit, and approval authority shall, each within 15 working days of receipt of the application to make a decision.     New preparation dosage form or change places of preparation of medical institutions, should be the local provinces, autonomous regions and municipalities upon the acceptance of drug regulatory authorities, in accordance with the provisions of the preceding paragraph to the pharmaceutical preparation certificate for medical institution changes. The 22nd article of the pharmaceutical preparation certificate for medical institution is valid for 5 years.     Has expired, the need to continue to make medicinal preparations and medical institutions should be 6 months before the expiry of the permit, in accordance with the regulations of the pharmaceutical supervisory and administrative department under the State Council to apply for renewal of the pharmaceutical preparation certificate for medical institution.     Medical termination make preparations or closed, pharmaceutical preparation certificate for medical institution by the original licensing authority for cancellation.     23rd medical institutions make medicinal preparations must be in accordance with the regulations of the pharmaceutical supervisory and administrative department under the State Council submit the relevant materials and sample the local drug regulatory agency of provinces, autonomous regions and municipalities approved and issued after preparation approval number, can be prepared.     24th medical organizations of the medicinal preparations shall not be marketed or disguised cases of sale, shall publish the medical preparations ads.     Disasters, epidemics, emergencies or clinical needs and supply in the market, by the State Council or provincial, autonomous region or municipality approved by the pharmaceutical supervisory and Administrative Department, within the prescribed period, the medical establishment of the medicinal preparations can be used at designated medical institutions to transfer credits between.     Pharmaceutical supervisory and administrative department under the State Council special preparation of transfers as well as between provinces, autonomous regions and municipalities directly under the transfer of medical preparations, must be approved by the drug regulatory agency of the State Council.     25th medical institution and prescription dispensing pharmacists must be through the qualification of pharmacy technicians. 26th medical institutions buy drugs, there must be a true and complete drug purchase records.     Drug purchase records must indicate the drug's generic name, batch number, expiry date, dosage form, specifications, manufacturers, suppliers, purchase order number, purchase price, purchase date and other contents provided by the drug regulatory agency of the State Council.     27th medical institutions to provide patients with the drugs should be commensurate with the scope of diagnosis and treatment, and by practitioners or assistant medical practitioners of prescription dispensing.     Purchase family planning technical service institutions and providing drugs to patients, its scope should be consistent with the approved scope of services, and by practitioners or assistant medical practitioners of prescription dispensing. Personal settings in outpatient departments, clinics and other medical institutions which are equipped with commonly used drugs and drugs other than emergency medicine.     The scope and variety of medicines and first-aid medicines, the local provinces, autonomous regions, municipalities and health administrative departments of people's Governments of the pharmaceutical supervisory and administrative department. Drug management in the fifth chapter the 28th pharmaceutical non-clinical safety evaluation agencies must implement the non-clinical research and the quality control standard of drug clinical trial Agency must implement the code for quality management of drug clinical trials.     The non-clinical research and the quality control standard code for quality management of clinical trials, the drug by the pharmaceutical supervisory and administrative departments of the State Council of State Science and Technology Administration Department and the Health Administration Department under the State Council. 29th article drug clinical test, and production drug and imports drug, should meet drug management method and the this Ordinance of provides, by State drug supervision management sector review approved; State drug supervision management sector can delegate province, and autonomous regions, and municipalities government drug supervision management sector on declared drug of development situation and the conditions for review, on declared information for form review, and on trial of samples for test.     Specific measures shall be formulated by the drug regulatory agency of the State Council.     30th the development of new drugs, clinical trials is needed, should be in accordance with the provisions of article 29th of the drug administration law, approved by the drug regulatory agency of the State Council.     Clinical drug trials after the application is approved by the drug regulatory agency of the State Council, the applicant shall be determined by the law in the shape of a clinical drug trial in qualified institutions chose to take drug clinical trial Agency and clinical trial of the drug supervision and management by the State Department and the Administrative Department of health under the State Council for filing.     Medical clinical trial of drug clinical trial Agency, shall inform the subject or his guardian and obtain their written consent. 31st production has standards of drugs shall be in accordance with the regulations of the pharmaceutical supervisory and administrative department under the State Council, to Governments of provinces, autonomous regions and municipalities directly under the pharmaceutical supervisory and administrative department or apply to the drug regulatory Department under the State, submit relevant technical information and provide the relevant supporting documents. The provinces, autonomous regions and municipalities the pharmaceutical supervisory and administrative departments shall within 30 working days from the date of acceptance of the application for review, comments submitted after the pharmaceutical supervisory and administrative department under the State Council, and will review the opinion declared.     Pharmaceutical supervisory and administrative departments audited in conformity with the provisions of the State Council, drug approval number. 32nd article production has pilot period standard of drug, should according to State drug supervision management sector of provides, in pilot expires Qian 3 months, proposed positive application; state drug supervision management sector should since pilot expires of day up 12 months within on the pilot period standard for review, on meet state drug supervision management sector provides of positive requirements of, to official standard; on pilot standard expires not according to provides proposed positive application or original pilot standard not meet positive requirements of,     The pharmaceutical supervisory and administrative departments shall revoke the pilot standard and according to the tentative standards and drug approval number.     33rd article changes the development of new drugs, drug production and imported drugs had been set out in the approval certificate and its annexes, shall apply to the supplement to the drug regulatory Department under the State Council; drug administration audited in conformity with the provisions of the State Council, should be approved.     34th drug regulatory agency of the State Council according to the requirements of the protection of public health, pharmaceutical production enterprises in the production of drugs can be set up not more than 5-year monitoring period; during the monitoring period, shall not be approved for other production and import.     35th state access to production or sales with new chemical drugs licensed producers or sellers submit their own access and protect undisclosed test data and other data, no person shall, for the undisclosed test data and other data from unfair commercial use.     Since drug manufacturers or sellers access to production, sales of new chemical drugs within 6 years from the date the license documentation, without the consent of applicants licensed for other applicants, using the data in the preceding paragraph apply for a permission from the chemical composition of production and marketing of new drugs, pharmaceutical supervisory and Administrative Department must not permit, except as other applicants to submit data on their own.     Except for the following cases, the pharmaceutical supervisory and administrative departments shall not disclose data specified in the first paragraph of this article: (a) the public interest, (ii) has taken measures to ensure that such data is not being unfair to commercial exploitation.     Article 36th for import of medicines, should be in the production countries or regions to obtain market approval of drugs; is not listed in the production countries or regions to obtain permits, by the pharmaceutical supervisory and administrative department under the State Council confirmed the drug safe and effective clinical needs and, in accordance with the drug management law and the provisions of this Ordinance to authorize imports. Imported drugs, in accordance with the regulations of the pharmaceutical supervisory and administrative department under the State Council shall be applied for registration.     Made drug importation of drugs manufactured by a foreign registration certificate, China, Hong Kong, Macao and Taiwan enterprises producing drugs after obtaining the certificate of registered pharmaceutical products, to be imported. 37th medical institutions for clinical needs to import a small amount of drugs, the practising certificate for medical institution should be held to apply to the drug regulatory agency of the State Council; upon approval, may be imported.     Import of medicines should be used for specific medical purposes at designated medical institutions. Article 38th after CIF of imported drugs, imported entities shall take the imported drug registration certificate or pharmaceutical product registration certificate, and the certificate of origin, original and copy of the purchase contract, packing lists, waybill, freight invoices, inspection reports, brochures and other materials, drug regulatory authorities of the port is located. Local drug regulatory authorities of the port, upon examination, the submission meets the requirements, issued a customs clearance of imported drugs.     Importer of the customs clearance of imported drugs go through the formalities of Customs Declaration and examination procedures.     Seat pharmaceutical supervisory and administrative departments shall notify the port drug inspection agency for lot-by-lot inspection of imported drugs, but the drug management law except in circumstances prescribed in the 41st.     39th vaccine products, blood products, blood source screening of in vitro diagnostic reagents and other biological products as prescribed by the drug regulatory agency of the State Council before being sold or imported shall be tested in accordance with the regulations of the pharmaceutical supervisory and administrative department under the State Council or approval; failed or failing to pass the examination approved shall not be sold or imported. 40th article country encourages the cultivation of medicinal herbs.     To focus on large-scale cultivation cultivation, quality control pharmaceutical supervisory and administrative department under the conditions and in accordance with the State Council of the varieties of Chinese herbal medicines and approval management.     41st drug regulatory agency of the State Council has approved re-evaluation, sales of the drug, according to the drug evaluation results, and can take the mandate changes directions, a moratorium on the production, distribution and use measure; adverse drug reactions or have other reason harmful to human health, shall revoke the approval documents. 42nd drug approval issued by the drug regulatory agency of the State Council, the imported drugs registration certificate and the certificate of pharmaceutical product registration will be valid for 5 years. Has expired, the need to continue production or import, shall be applied for registration before the expiry of 6 months. When the re-registration of pharmaceuticals, should be in accordance with the regulations of the pharmaceutical supervisory and administrative department under the State Council to submit relevant information.     Expires, no further registration or review is not in compliance with the provisions relating to the registration of the drug regulatory agency, cancellation of its drug approval number, the imported drug registration certificate or the certificate of pharmaceutical product registration.     Article 43rd drug may not be in their packaging, labels and instructions and related information on the prevention, treatment and diagnosis of human diseases, such as content-related publicity; but, except as otherwise provided in laws and administrative regulations.     Sixth chapter management article 44th of pharmaceutical packaging manufacturer to use direct contact with drugs packaging materials and containers, must meet the medical requirements and the standards of protection of human health, safety, and registered by the drug regulatory agency of the State Council.     Packing material direct contacted with drugs and container management, product catalogs and medical requirements and standards set by the pharmaceutical supervisory and administrative departments of the State Council and published. 45th production of Chinese herbal medicine, should be used and adapted to the nature of drug packing materials and containers packaging does not meet the requirements of Chinese herbal medicine, may not be sold.     Chinese herbal medicine packaging must be printed or affixed with a label.     Herbal labels must indicate the name, size, country of origin, manufacturer, product, batch number, production date, implement management herbal also must indicate the approval number approval number.     Article 46th drugs packaging, labels and instructions must be in accordance with the drug administration law of the 54th and pharmaceutical supervisory and administrative department under the State Council printed.     Drug trade names shall conform to the regulations of the pharmaceutical supervisory and administrative department under the State Council.     47th medical institutions preparation used in the preparation of direct contact with the pharmaceuticals packaging materials and containers, labels and instructions should be consistent with preparation of the drug administration law of the sixth chapter and the relevant provisions of this Ordinance, by the drug regulatory agency of provinces, autonomous regions and municipalities for approval.     Seventh chapter drug prices and advertising management of the 48th State on drug prices the Government pricing or Government guided or market-regulated prices.     Included in the national basic medical insurance drug list of medicines and basic medical insurance drug list has a monopoly of the State production, management of drugs, Government pricing or Government guidance pricing; for other drugs, the implementation of market-regulated prices. 49th drugs subject to Government pricing, Government guided by law, by Government price departments in accordance with the law on drug management principles provided for in the 55th, formulation and adjustment of prices which, when the formulation and adjustment of drug price should reflect the average social cost of sales of drugs rate, return on sales and circulation rate control.     Specific pricing approach by the Department in charge of price under the State Council in accordance with the People's Republic of China Law on prices (hereinafter referred to as the law on prices) of the relevant provisions.     50th Government pricing or Government guidance prices according to law after the enactment of drug prices, Government price departments in accordance with the provisions of article 24th of the price law, published in the specified publication and clearly the date of the execution price.     51st medicines prices subject to Government pricing or Government guidance prices, Government price departments when developing and adjusting the price of drugs, should be organized, such as pharmacy, medicine, economics expert review and demonstration when necessary, shall hear pharmaceutical producing enterprises, trading enterprises and medical institutions, the views of citizens, as well as other relevant units and personnel.     52nd Government pricing departments in accordance with the price law when the 28th article of drug price monitoring, mastering, analysis of changes in drug prices and trends, you can specify a part of pharmaceutical producing enterprises, trading enterprises and medical organizations as a price monitoring Sentinel units; fixed-point units should be given help and support, and provide relevant information. 53rd release drug advertising, pharmaceutical production enterprises are located should be provinces, autonomous regions, municipalities directly under the drug regulatory agency of the Government to submit relevant materials. The provinces, autonomous regions and municipalities the pharmaceutical supervisory and administrative departments shall within 10 working days from the date of receipt of materials make their drug ad approval number issued by decision of issuing drug ad approval number, pharmaceutical supervisory and administrative departments shall be concurrently submitted to the State Council for the record.     Specific measures shall be formulated by the drug regulatory agency of the State Council.     Import drug advertising should be in accordance with the provisions of the preceding paragraph the imported drugs agency is located provincial, autonomous regional and municipal people's Government drug regulatory authority for drug advertisements approval number. In pharmaceutical production enterprises are located and imported drugs agencies located outside the provinces, autonomous regions and municipalities issued drug advertising, advertising enterprises shall, before publishing to publish provinces, autonomous regions and municipalities directly under the pharmaceutical supervisory and administrative departments for the record.     Accept the filing of provinces, autonomous regions and municipalities approved the drug supervision and Management Department finds that drug advertising content does not meet the requirements of management of drug advertisement, should be referred to the original issued by the Department.     54th by the State Council or provincial, autonomous region, municipality directly under the drug regulatory agency of the Government decision, ordered a moratorium on the production, sale and use of drugs, during the period of suspension shall not release the drug advertising have been advertising, must be stopped immediately.     The 55th without the province, autonomous region or municipality approved by drug regulatory authorities and drug advertising, use forged or fraudulent use, failure of drug advertising approval number of ads or other advertising activities be revoked approval of drug advertisements, ads, advertising companies, advertising agents and advertisement publishers must immediately cease the publication of drug advertisements.     To publish illegal drug advertisements, if the circumstances are serious, drug regulatory agency of provinces, autonomous regions and municipalities shall be published.     Eighth chapter drug 56th pharmaceutical supervisory and administrative departments (including the provincial drug supervision and Management Department of the Government drug regulatory bodies established by law, the same below) according to law on pharmaceutical development, production, distribution, use, supervision and inspection.     57th the sampling must consist of two or more drug supervision and inspection personnel, and sample in accordance with the regulations of the pharmaceutical supervisory and administrative department under the State Council; sampling sampling should be provided samples shall not be refused.     Drug sampling units without good reason, refuse inspection, pharmaceutical supervisory and administrative departments of the State Council and the sampling units of provinces, autonomous regions and municipalities can stop the unit denied the drug regulatory agency sampling drugs sale and use.     Article 58th on doping, suspected adulterated drugs at the national drug standard specifies test methods and inspection when a project does not check for drug inspection agencies can supplement testing method and testing for drug testing; upon approval by the pharmaceutical supervisory and administrative departments of the State Council, using supplementary examination method and examination test results of projects, can be used as a drug based on the quality of the drug regulatory agency. The 59th State Council and provinces, autonomous regions and municipalities of the pharmaceutical supervisory and administrative departments shall according to pharmaceutical quality and inspection results, published drug quality bulletin on a regular basis. Drug quality announcement shall include the sampling of drug name, source of seized goods, production enterprises, the production batch number, specifications, inspection, inspection of medicines based on content, test results, non-conformance.     Of poor drug quality bulletin, improperly issuing authority shall confirm the notice date in the 5th, in the context of the original notice be corrected. Party disagrees with the results of the inspection institutions, file an application for re-inspection shall be submitted to the drug testing agencies responsible for retest written application, the original inspection report.     Re-inspection of samples drawn from the original sample drug testing agencies. The 60th Drug supervision management sector law on has evidence proved may against human health of drug and about evidence material take seized, and seized of administrative forced measures of, should since take administrative forced measures of day up 7th within made whether filed of decided; need test of, should since test report book issued of day up 15th within made whether filed of decided; not meet filed conditions of, should lifted administrative forced measures; need suspended sales and using of, should by State or province, and autonomous regions, and     Pharmaceutical supervisory and Administrative Department of the municipality to make a decision.     61st pharmaceutical and inspection shall not charge any fee. Party disagrees with the drug test results, file an application for re-inspection, shall, in accordance with relevant departments under the State Council or provincial, autonomous region, municipality directly under the departments concerned under the provisions of prior to re-inspection to pay inspection fees.     Reinspect the conclusion is inconsistent with original conclusions, to reinspect the inspection fee shall be borne by the original drug testing agency. 62nd according to the pharmaceutical administration law and the provisions of this Ordinance, issue certificates, pharmaceutical registration, certification and implement drug approval testing and mandatory testing, you can charge.     Specific standards developed by the financial Department of the State Council, the State Council Department in charge of price. Nineth chapter legal responsibility 63rd article drug production enterprise, and drug business enterprise has following case one of of, by drug supervision management sector in accordance with drug management method 79th article of provides give punishment: (a) opened drug production enterprise, and drug production enterprise new drug production workshop, and added production formulations, in State drug supervision management sector provides of time within not through drug production quality management specification certification, still for drug production of; (ii) opened drug business enterprise,     Within the time stated in the drug regulatory agency of the State Council does not pass the drug business quality management standard certification, drug supply is still underway.     64th in violation of the provisions of the drug administration law of 13th, arbitrarily appointed or commissioned the production of pharmaceuticals, the principal and the trustee in accordance with the drug management law provides for punishment of the 74th.     65th without approval, without authorization, in urban and rural market fairs set up selling drugs or pharmaceuticals sold in the urban and rural market fairs set up beyond the scope of drug approval, in accordance with the provisions of 73rd of the drug administration law are punished.     66th unapproved, unauthorized use of the medicinal preparations in other medical institutions in medical institutions, in accordance with the provisions of 80th of the drug administration law are punished.     67th, personal settings of outpatient departments, clinics and other medical institutions providing drugs to patients outside the scope and variety, in accordance with the provisions of 73rd of the drug administration law are punished.     The 68th medical institutions using fake medicines and medicines of inferior quality, in accordance with the drug administration law of the 74th, 75th, penalty shall be imposed.     69th in violation of provisions of article 29th of the pharmaceutical administration law, unauthorized clinical trials, drug clinical trial agency assume, in accordance with the provisions of the drug administration law of the 79th punished.     70th when reported in the reporting of clinical drug trials, submit false research methods, quality standards, Pharmacology and toxicology test results and other relevant information and samples, pharmaceutical supervisory and administrative department under the State Council not to grant the prescribed drug clinical trials on drugs reported in a warning in serious cases, will not be accepted within 3 years of the drug application clinical trial application for declaration of the breed.     71st production of herbal without national drug standards, does not conform to the provinces, autonomous regions and municipalities directly under the drug regulatory agency of the Government to develop processing specification; medical institutions according to provinces, autonomous regions and municipalities of standards approved by drug regulatory authorities made preparations, in accordance with the provisions of article 75th of the drug administration law are punished.     72nd article drug supervision management sector and staff violation provides, leaked producers, and sellers for get production, and sales contains new chemical components drug license and submitted of not disclosure test data or other data, caused applicants loss of, by drug supervision management sector law bear compensation responsibility; drug supervision management sector compensation loss Hou, should ordered deliberately or has major fault of staff bear part or all compensation costs, and on directly responsibility personnel law give administrative sanctions.     73rd pharmaceutical producing enterprises, trading enterprises production, management of medicines and medical institutions of the medicinal preparations, their packaging, labels and instructions in violation of the drug administration law and the provisions of this Ordinance, in accordance with the provisions of the drug administration law of the 86th penalty.     74th article drug production enterprise, and drug business enterprise and medical institutions change drug production business license matters, should handle change registration procedures and not handle of, by original sent card sector give warning, ordered deadline replacement change registration procedures; late not replacement of, announced its drug production license, and drug business license and medical institutions preparations license invalid; still engaged in drug production business activities of, in accordance with drug management method 73rd article of provides give punishment.     75th in violation of this Ordinance, the 48th, 49th, 50th, 51st, 52nd, on drug price control provisions, in accordance with the relevant provisions of the law on price punished.     76th tampered with the approved drug advertising content, immediately by the pharmaceutical supervisory and administrative departments shall order the advertiser to stop the publication of drug advertisements and by the original approval of the drug supervision and management departments in accordance with the provisions of the drug administration law of the 92nd penalty. Pharmaceutical supervisory and administrative departments to withdraw drug advertising after approval, shall make a decision of administrative handling within 5 working days of the date notice advertising regulatory bodies.     Advertising regulatory authority shall receive the pharmaceutical supervisory and administrative department within 15 working days from the date of notification, in accordance with the People's Republic of China advertisement law the relevant provisions of the administrative decision.     77th article released drug advertising of enterprise in drug production enterprise location or imports drug agent institutions location yiwai of province, and autonomous regions, and municipalities released drug advertising, not according to provides to released to province, and autonomous regions, and municipalities government drug supervision management sector record of, by released to of drug supervision management sector ordered deadline corrected; late not corrected of, stop the drug varieties in released to of advertising released activities.     78th without the drug regulatory agency of provinces, autonomous regions and municipalities approved publishing drug advertisements without authorization, after the discovery of the drug regulatory agency, it shall notify the advertising supervision and Administration Department shall investigate and deal with. 79th article violation drug management method and this Ordinance of provides, has following behavior one of of, by drug supervision management sector in drug management method and this Ordinance provides of punishment range within from heavy punishment: (a) to anesthesia drug, and spirit drug, and medical with toxicity drug, and radioactive drug posing as other drug, or to other drug posing as above drug of; (ii) production, and sales to pregnancy maternal, and infant and the children for main using object of counterfeit, and bad drug of; (three) production, and sales of biological products, and     Blood products belongs to counterfeit, and bad drug of; (four) production, and sales, and using counterfeit, and bad drug, caused personnel hurt consequences of; (five) production, and sales, and using counterfeit, and bad drug, by processing Hou repeated of; (six) refused to, and escape supervision check, or forged, and destroyed, and hidden about evidence material of, or unauthorized use seized, and seized items of.     80th pharmaceutical supervisory and administrative departments of the Agency, the power to make the drug management law and the provisions of this Ordinance, warnings, fines, confiscation of illegal production and sale of drugs and administrative punishment of the illegal gains.     81st pharmaceutical trading enterprises, drug management in medical institutions is not in violation of the law and the relevant provisions of this Ordinance, and there is sufficient evidence to prove that it did not know the selling or using drugs are counterfeit and substandard drugs shall be confiscated the sale or use of counterfeit and substandard drugs and illegal income; however, may be exempted from administrative penalty.     Drug management in the 82nd, in line with the law and of the Ordinance provides for the confiscation of goods, processed by the pharmaceutical supervisory and administrative department in accordance with the provisions for the monitoring.     83rd of the tenth schedule in these regulations the following expressions mean: drug certification and other marks, refers to the pharmaceutical production and approval documents, inspection reports, medicine packaging, labels and instructions.     The new drug, was never marketed medicines in China.     Prescription medicine, refers to medical practitioners and Assistant medical practitioners of prescriptions may purchase, deployment and use of medicines.     Non-prescription drugs, is published by the drug regulatory agency of the State Council, do not have to resort to medical practitioners and Assistant medical practitioners of prescriptions, the consumer can judge for themselves, purchase and use of drugs.     Medical preparations, refers to medical institutions based on the clinical needs for approval of the preparation, the fixed prescription preparations for personal use.     Drug certification, refers to the drug regulatory Department on drug development, production, operation, and use of relevant quality management standard for inspection, evaluation and decide whether to issue the relevant certificates.     Drug mode of operation refers to drug wholesale and retail.     Drug scope, refers to the varieties of drug supervision and management departments approved drugs category.     Drug wholesaler, refers to the purchase of medicines sold to drug manufacturers, drug-handling enterprises and medical institutions of drug distributors.     Pharmaceutical retail enterprise, refers to the purchasing of pharmaceutical drug distributors direct sales to consumers.     84th article 41st of the drug administration law "drugs sold in China for the first time" refers to domestic or foreign drug manufacturers drug sales in China for the first time, including different drug manufacturers in the production of the same species. 85th article drug management method 59th article second paragraph "ban drug of production enterprise, and business enterprise or its agent to any name give using its drug of medical institutions of head, and drug procurement personnel, and physician, about personnel to property or other interests" in the of "property or other interests", is refers to drug of production enterprise, and business enterprise or its agent to medical institutions of head, and drug procurement personnel, and     Provided by physicians and other relevant personnel aimed at affecting their drug purchases or prescriptions of illegitimate interests.  86th article of the regulations come into force on September 15, 2002.

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