【正文】 administrative sanctionsdrug distributorscounterfeit drugs control over drug price and advertisement control over drug distributors 1.《中華人民共和國(guó)藥品管理法》 Drug Control Law of the People39。 control over medicines in medical institutions inspection of drugsinferior drugsmedical institutionscriminal liabilities Drug Supply CertificateNew Drug Certificates republic of China. The drug regulatory agencies of the governments of provinces, autonomous regions, and municipalities directly under the Central Government shall be responsible for drug regulation in their administrative areas. Any newly established pharmaceutical manufacturer shall be subject to approval by the local drug regulatory agency of the government of the province, autonomous region or municipality directly under the Central Government and be granted the Drug Manufacturing Certificate, and, with the certificate, the manufacturer shall be registered with the administrative agency for industry and merce. When giving approval to the newlyestablished manufacturer, the drug regulatory agency shall see to it that the development programs and policies set by the State for the pharmaceutical industry shall be plied with so as to prevent duplicate construction. (3) having quality management and control units and personnel capable of quality management of and testing for drugs to be produced and the necessary instruments and equipment。 Drug manufacturers shall conduct production according to the Good Manufacturing Practice Products (GMP) formulated by the drug regulatory agency of the State Council based on this Law. The drug regulatory agency shall inspect a drug manufacturer as to its pliance with the GMP requirements and issue a certificate to the manufacturer passing the inspection. conformity with the production processes approved by，必須報(bào)原批準(zhǔn)部門審核批準(zhǔn)。Drug manufacturers shall perform quality test of their products.、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準(zhǔn)，藥品生產(chǎn)企業(yè)可以接受委托生產(chǎn)藥品。Any newly established drug retailer shall be subject to approval and be granted the above certificate by the local drug regulatory agency at or above the county level. No one is permitted to distribute drugs without the certificate. A drug distributor to be established shall meet the following requirements:(1) staffed with legally qualified pharmaceutical professionals?！端幤方?jīng)營(yíng)質(zhì)量管理規(guī)范》經(jīng)營(yíng)藥品。，必須建立并執(zhí)行進(jìn)貨檢查驗(yàn)收制度，驗(yàn)明藥品合格證明和其他標(biāo)識(shí)；不符合規(guī)定要求的，不得購(gòu)進(jìn)。Drug distributors shall keep a real and perfect records of purchasing and selling drugs. Drug distributors shall indicate the habitat of Chinese crude drugs to be sold. An examination system shall be followed for storing drugs in warehouse and releasing them from warehouse. No drugs other than the Chinese crude drugs may be sold at fairs in urban and rural areas, but drug retailers holding the Drug Supply Certificate may, within the specified business scope, sell such drugs at the stores they set up at the fairs. No medical institution is permitted to dispense pharmaceutical preparations without the Pharmaceutical Preparation Certificate for Medical Institution.The pharmaceutical preparations to be dispensed by the medical institution shall be those satisfying the clinic need of the institution but not available on the market. It shall be subject to approval in advance by the local drug regulatory agency of the government of the province, autonomous region or municipality directly under the Central Government.A full description of a new drug research and development including the manufacturing process, quality specifications, results of pharmacological and toxicological study, and the related data as well as the samples shall, in accordance with the regulations of the drug regulatory agency of the State Council, be truthfully submitted to the above agency for reviewing and approval. The institutions for nonclinical safety evaluation and study and for clinical study institutions shall respectively follow the Good Laboratory Practice for NonClinical Laboratory Studies (GLP) and Good Clinical Practice (GCP).The list of the Chinese crude drugs and the prepared slices of the Chinese crude drugs to be controlled by the approval number shall be piled by the drug regulatory agency of the State Council, jointly with the administrative agency for traditional Chinese medicines of the State Council.Drugs shall ply with the National Drug Standards.，負(fù)責(zé)國(guó)家藥品標(biāo)準(zhǔn)的制定和修訂。、藥品經(jīng)營(yíng)企業(yè)、醫(yī)療機(jī)構(gòu)必須從具有藥品生產(chǎn)、經(jīng)營(yíng)資格的企業(yè)購(gòu)進(jìn)藥品；但是，購(gòu)進(jìn)沒(méi)有實(shí)施批準(zhǔn)文號(hào)管理的中藥材除外。，須經(jīng)國(guó)務(wù)院藥品監(jiān)督管理部門組織審查，經(jīng)審查確認(rèn)符合質(zhì)量標(biāo)準(zhǔn)、安全有效的，方可批準(zhǔn)進(jìn)口，并發(fā)給進(jìn)口藥品注冊(cè)證書。、疫情及其他突發(fā)事件時(shí)，國(guó)務(wù)院規(guī)定的部門可以緊急調(diào)用企業(yè)藥品。，為假藥： A drug falling into the following categories is deemed as a counterfeit drug:（一）藥品所含成份與國(guó)家藥品標(biāo)準(zhǔn)規(guī)定的成份不符的； The ingredients in the drug are different from those specified by the National Drug Standards。（二）依照本法必須批準(zhǔn)而未經(jīng)批準(zhǔn)生產(chǎn)、進(jìn)口，或者依照本法必須檢驗(yàn)而未經(jīng)檢驗(yàn)即銷售的； It is produced or imported without approval, or marketed without being tested, as required by the Law。 （五）使用依照本法必須取得批準(zhǔn)文號(hào)而未取得批準(zhǔn)文號(hào)的原料藥生產(chǎn)的； It is produced by using active pharmaceutical ingredients without approval number as required by this Law。 Production and distribution of drugs of inferior quality are prohibited.（二）不注明或者更改生產(chǎn)批號(hào)的； The batch number is not indicated or is altered。 or（六）其他不符合藥品標(biāo)準(zhǔn)規(guī)定的。 A drug name listed in the National Drug Standards is an adopted name in China. Such an adopted name is not permitted to be used as a trademark. Those who suffer from infectious diseases or any other diseases that may cause drug contamination are not permitted to undertake any job in direct contact with drugs. A label shall be printed or stuck on the drug package with an insert sheet attached as required by regulations. Specified marks shall be printed in the label of narcotic drugs, psychotropic substances, toxic drugs for medical use, radioactive pharmaceuticals, drugs for topical use, and nonprescription drugs.