【正文】 益。 Drug manufacturers, drug distributors and medical institutions shall ply with the prices fixed or guided by the government. No one is permitted to raise prices in any manner without authorization. In the label or insert sheet shall be indicated the adopted name of the drug, its ingredients, strength, manufacturer, approval number, product batch number, production date, date of expiry, indications or functions, usage, dosage, contraindications, drug adverse reactions, and precautions. Immediate packaging materials and containers shall meet the requirements for medicinal use and ply with the standards for ensuring human health and safety. They along with the drugs shall be subject to reviewing and approval by the drug regulatory agency.Staff members of drug manufacturers, drug distributors and medical institutions who make a direct contact with drugs shall receive physical examination annually.。（四）直接接觸藥品的包裝材料和容器未經(jīng)批準(zhǔn)的； No approval certificate is obtained for the immediate packaging material or container。 A drug with content not up to the National Drug Standards is a drug of inferior quality. The indications or functions indicated are beyond the specified scope.（四）被污染的； It is contaminated。 It is not the same drug which is claimed by its name or in reality it is not a drug at all.82. 禁止生產(chǎn)（包括配制）、銷(xiāo)售假藥。、精神藥品、醫(yī)療用毒性藥品、放射性藥品，實(shí)行特殊管理。、對(duì)照品。The Pharmacopoeia of the People39。 A drug manufacturer is permitted to produce the drug only after an approval number has been granted to it.Production of a new drug or production of a drug plying with National Drug Standards shall be subject to the approval by the drug regulatory agency of the State Council, and a drug approval number shall be issued for it, with the exception of the Chinese crude drugs and the prepared slices of Chinese crude drugs in which no control by approval number is exercised. When a new drug has gone through clinical trials and passed the reviewing, a New Drug Certificate shall be issued upon approval by the drug regulatory agency of the State Council. No pharmaceutical preparations dispensed by medical institutions are permitted to be marketed. The term of validation shall be noted in the Pharmaceutical Preparation Certificate for Medical Institution. For renewal of the certificate upon expiration, reviewing and approval again is required.Dispensing pharmaceutical preparations by a medical institution shall be subject to reviewing and permission by the health administration agency of the government of the province, autonomous region or municipality directly under the Central Government, and upon approval by the drug regulatory agency of the government. A Pharmaceutical Preparation Certificate for Medical Institution shall be issued by the above drug regulatory agency. Chinese crude drugs may be sold at fairs in urban and rural areas, except those otherwise specified by the State Council. A drug distributor shall pass the established system for drug storage, and take necessary measures to ensure drug quality, such as cold storing, protecting from being frozen and moisture and guarding against insects and rodents. In the record shall be indicated the adopted name of drugs, dosage form, strength or size, batch number, date of expiry, manufacturer, purchaser (or seller), amount of the drug purchased (or sold), purchase or selling price, date of purchase (or sale) , and other items specified by the drug regulatory agency of the State Council. no drugs that fail to meet the requirements are permitted to be purchased.《藥品經(jīng)營(yíng)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(shū)。(3) having the quality control units or personnel adaptable the drugs to be distributed。 The valid period and the scope of business shall be indicated in the Drug Supply Certificate. For renewal of the certificate upon expiration, reviewing and approval again is required.With the Drug Supply Certificate , the wholesaler and the retailer shall be registered with the administrative agency for industry and merce.，須經(jīng)企業(yè)所在地省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門(mén)批準(zhǔn)并發(fā)給《藥品經(jīng)營(yíng)許可證》.Any newly established drug wholesaler shall be subject to approval of the local drug agency of the government of the province, autonomous region or municipality directly under the Central Government and be granted the Drug Supply Certificate. No products that do not meet the Active pharmaceutical ingredients (API) and recipients for the manufacture of pharmaceutical products shall meet the requirements for medicinal use.、輔料，必須符合藥用要求。 drug regulatory the With the exception of the processing of prepared slices of《藥品生產(chǎn)質(zhì)量管理規(guī)范》組織生產(chǎn)。 Any drug manufacturer to be established shall meet the following requirements: (1) stuffed with legally qualified pharmaceutical and engineering professionals and the necessary technical workers。 The term of validation and the scope of manufacturing shall be noted in the Drug Manufacturing Certificate. For renewal of the certificate on expiration, reviewing and approval again is required. The drug quality control laboratories established or designated by drug regulatory agencies shall undertake the responsibility for drug testing required for conducting drug review and approval and controlling drug quality pursuant to the law.The drug regulatory agency of the State Council shall be responsible for drug administration and supervision nationwide. 、生產(chǎn)、經(jīng)營(yíng)、使用和監(jiān)督管理的單位或者個(gè)人，必須遵守《中華人民共和國(guó)藥品管理法》 All institutions or individuals engaged in research, production, distribution, use, and administration and supervision of drugs in the People39。Import Drug LicenseGood Supply Practice for Pharmaceutical Products (GSP)drug approval documentsdrug manufacturerslabels or marks of the drugs control over drug packaging control over drug manufacturerss Republic of China control over drugs legal liabilitiesdrug quality control la