【正文】 n are not permitted to undertake any job in direct contact with drugs.91. 直接接觸藥品的包裝材料和容器，必須符合藥用要求，符合保障人體健康、安全的標(biāo)準(zhǔn)，并由藥品監(jiān)督管理部門在審批藥品時(shí)一并審批。 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.、藥品經(jīng)營企業(yè)和醫(yī)療機(jī)構(gòu)直接接觸藥品的工作人員，必須每年進(jìn)行健康檢查。 Other cases where the drug standards are not plied with.。（五）擅自添加著色劑、防腐劑、香料、矯味劑及輔料的； Colorants, preservatives, spices, flavorings, or other recipients have been added without authorization。（三）超過有效期的； It is beyond the date of expiry。 A drug with content not up to the National Drug Standards is a drug of inferior quality.，按劣藥論處： A drug falling into the following categories shall be deemed as a drug of inferior quality:（一）未標(biāo)明有效期或者更改有效期的； The date of expiry is not indicated or is altered。 The indications or functions indicated are beyond the specified scope.85. 禁止生產(chǎn)、銷售劣藥。 （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。（三）變質(zhì)的； It is deteriorated。 It is not the same drug which is claimed by its name or in reality it is not a drug at all.，按假藥論處： A drug falling into the following categories shall be deemed as a counterfeit drug:（一）國務(wù)院藥品監(jiān)督管理部門規(guī)定禁止使用的； It’s use is prohibited by the provisions of the drug regulatory agency of the State Council。 Production (including dispensing) and distribution of counterfeit drugs are prohibited.，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。The State adopts a policy for drug storage for future use.、疫情及其他突發(fā)事件時(shí)，國務(wù)院規(guī)定的部門可以緊急調(diào)用企業(yè)藥品。 The State adopts a system of classified management for prescription and nonprescription drugs. ，須經(jīng)國務(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。The State exercises special control over narcotic drugs, psychotropic substances, toxic drugs for medical use and radioactive pharmaceuticals.。 The drug control institution affiliated to the drug regulatory agency of the State Council is responsible for standardizing the National Drug Standard Substance and Reference Substance.、藥品經(jīng)營企業(yè)、醫(yī)療機(jī)構(gòu)必須從具有藥品生產(chǎn)、經(jīng)營資格的企業(yè)購進(jìn)藥品；但是，購進(jìn)沒有實(shí)施批準(zhǔn)文號(hào)管理的中藥材除外。s Republic of China and the Drug Standards issued by the drug regulatory agency of the State Council shall serve as the National Drug Standards.，負(fù)責(zé)國家藥品標(biāo)準(zhǔn)的制定和修訂。Drugs shall ply with the National Drug Standards.《中華人民共和國藥典》和藥品標(biāo)準(zhǔn)為國家藥品標(biāo)準(zhǔn)。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.，方可生產(chǎn)該藥品。 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).，須經(jīng)國務(wù)院藥品監(jiān)督管理部門批準(zhǔn)，并發(fā)給藥品批準(zhǔn)文號(hào)；但是，生產(chǎn)沒有實(shí)施批準(zhǔn)文號(hào)管理的中藥材和中藥飲片除外。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.，由國務(wù)院藥品監(jiān)督管理部門批準(zhǔn)，發(fā)給新藥證書。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.，不得在市場(chǎng)銷售。 No medical institution is permitted to dispense pharmaceutical preparations without the Pharmaceutical Preparation Certificate for Medical Institution.62.《醫(yī)療機(jī)構(gòu)制劑許可證》應(yīng)當(dāng)標(biāo)明有效期，到期重新審查發(fā)證。 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. ，須經(jīng)所在地省、自治區(qū)、直轄市人民政府衛(wèi)生行政部門審核同意，由省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準(zhǔn)，發(fā)給《醫(yī)療機(jī)構(gòu)制劑許可證》。 An examination system shall be followed for storing drugs in warehouse and releasing them from warehouse.，國務(wù)院另有規(guī)定的除外。 Drug distributors shall indicate the habitat of Chinese crude drugs to be sold.，采取必要的冷藏、防凍、防潮、防蟲、防鼠等措施，保證藥品質(zhì)量。Drug distributors shall keep a real and perfect records of purchasing and selling drugs.、劑型、規(guī)格、批號(hào)、有效期、生產(chǎn)廠商、購（銷）貨單位、購（銷）貨數(shù)量、購銷價(jià)格、購（銷）貨日期及國務(wù)院藥品監(jiān)督管理部門規(guī)定的其他內(nèi)容。 After receiving the drug purchased, drug distributors shall pass the established examination and acceptance system, and check the certificate of drug quality, labels and others marks。Drug distributors shall conduct business according to the Good Supply Practice for Pharmaceutical Products (GSP) set by the drug regulatory agency of the State Council based on this Law.《藥品經(jīng)營質(zhì)量管理規(guī)范》的要求進(jìn)行認(rèn)證；對(duì)認(rèn)證合格的，發(fā)給認(rèn)證證書。(3) having the quality control units or personnel adaptable the drugs to be distributed。 A drug distributor to be established shall meet the following requirements:(1) staffed with legally qualified pharmaceutical professionals。 No one is permitted to distribute drugs without the certificate.48.《藥品經(jīng)營許可證》應(yīng)當(dāng)標(biāo)明有效期和經(jīng)營范圍，到期重新審查發(fā)證。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.47. 藥品批發(fā)、零售企業(yè)憑《藥品經(jīng)營許可證》到工商行政管理部門辦理登記注冊(cè)。 No products that do not meet the National Drug Standards or that are not produced according to the processing procedures for the prepared slice