【正文】 The nomination of the ports allowable for import of pharmaceuticals shall be jointly conducted by the pharmaceutical supervisory and administrative department under the State Council and the Customs Headquarters, and be reported to the State Council for approval. 第四十一條 國務(wù)院藥品監(jiān)督管理部門對下列藥品在銷售前或者進(jìn)口時，指定藥品檢驗機構(gòu)進(jìn)行檢驗；檢驗不合格的，不得銷售或者進(jìn)口： Article 41 The pharmaceutical supervisory and administrative department under the State Council shall appoint inspection institutions to carry out inspections before the sale and import of the following pharmaceuticals. Those having not passed the inspection shall not be allowed to be sold or imported. （一）國務(wù)院藥品監(jiān)督管理部門規(guī)定的生物制品； (1) Bioproducts prescribed by the pharmaceutical supervisory and administrative department of the State Council. （二）首次在中 國銷售的藥品； (2) Pharmaceuticals to be sold for the first time in China. （三）國務(wù)院規(guī)定的其他藥品。39。 Article 34 Pharmaceutical producing enterprises, pharmaceutical trading enterprises and medical anizations must purchase pharmaceuticals from the qualified enterprises with the certificates for production and trade of pharmaceuticals. However, this does not apply to the purchase of the traditional Chinese medicinal herbs which are not controlled under the registered document of approval. 第三十五條 國家 對麻醉藥品、精神藥品、醫(yī)療用毒性藥品、放射性藥品，實行特殊管理。中藥飲片依照本法第十條第二款的規(guī)定執(zhí)行。藥物臨床試驗機構(gòu)資格的認(rèn)定辦法，由國務(wù)院藥品監(jiān)督管理部門、國務(wù)院衛(wèi)生行政部門共同制定。配制的制劑必須按照規(guī)定進(jìn)行質(zhì)量檢驗；合格的，憑醫(yī)師處方在本醫(yī)療機構(gòu)使用。具體辦法由國務(wù)院規(guī)定。39。 The approval of the establishment of pharmaceutical trading enterprises by the pharmaceutical supervisory and administrative departments shall adhere to the principle of reasonable positioning and convenience for buying of pharmaceuticals, and in addition must conform to Article 15 of this Law. 第十五條 開辦藥品經(jīng)營企業(yè)必須具備以下條件： Article 15 To establish a pharmaceutical trading enterprise, the following requirements must be met （一）具有依法經(jīng)過 資格認(rèn)定的藥學(xué)技術(shù)人員； (1) 1 It shall be staffed with legally certified pharmaceutical technical personnel. （二）具有與所經(jīng)營藥品相適應(yīng)的營業(yè)場所、設(shè)備、倉儲設(shè)施、衛(wèi)生環(huán)境； (2) It shall have business premises, equipment, storage facilities and a sanitary environment suitable for the pharmaceuticals in which it trades. 8 （三）具有與所經(jīng)營藥品相適應(yīng)的質(zhì)量管理機構(gòu)或者人員； (3) It shall have a quality control an or personnel suitable for the pharmaceuticals in which it trades. （四）具有保證所經(jīng)營藥品質(zhì)量的規(guī)章制度。 The process for preparing traditional Chinese medicines into readytouse forms 6 must conform to the national pharmaceutical standards, and in the absence of such standards, the process must conform to the processing standards stipulated by the supervisory and administrative departments of pharmaceuticals of the provinces, autonomous regions, or municipalities directly under the central government. The processing standards stipulated by the supervisory and administrative departments of pharmaceuticals of the provinces, autonomous regions, or municipalities directly under the central governments shall be placed on record at the pharmaceutical supervisory and administrative department under the State Council. 第十一條 生產(chǎn)藥品所需的原料、輔料，必須符合藥用要求。 The approval of the establishment of pharmaceutical producing enterprises by the pharmaceutical supervisory and administrative departments shall be in conformity with Article 8 of this law, as well as the pharmaceutical development plan and the industrial policies formulated by the State to avoid the instance of a repeat establishment. 第八條 開辦藥品生產(chǎn)企業(yè)，必須具備以下條件： Article 8 To establish a pharmaceutical producing enterprise, the following requirements must be met: （一）具有依法經(jīng)過資格認(rèn)定的藥學(xué)技術(shù)人員、工程技術(shù)人員及相應(yīng)的技術(shù)工人； (1) It shall be staffed with legally certified pharmaceutical technical personnel, engineering technical personnel, as well as corresponding skilled workers. （二）具有與其藥品生產(chǎn)相適應(yīng)的廠房、設(shè)施和衛(wèi)生環(huán)境； (2) It shall have factory premises, facilities and a sanitary environment suitable for the medicines produced. （三）具有能對所生產(chǎn)藥品進(jìn)行質(zhì)量管理和質(zhì)量檢驗的機構(gòu)、人員以及必要的儀器設(shè)備； (3) It shall have a unit or petent personnel capable of inspecting the quality of the medicines produced, as well as necessary instruments and equipment. 5 （四）具有保證藥品質(zhì)量的規(guī)章制度。 Article 5 The pharmaceuticals supervisory and administrative departments under the State Council shall be responsible for the supervision and control of pharmaceuticals throughout the country. Other relevant departments under the State Council shall be responsible for the supervision and control of pharmaceuticals related to the scope of their functions. 省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門負(fù)責(zé)本行政區(qū)域內(nèi)的藥品監(jiān)督管理工作。 Article 1 This law is formulated to enhance the supervision and control of pharmaceuticals, ensure their quality, guarantee safety in medication, and safeguard the health and legal rights and interests of the people. 第二條 在中華人民共和國境內(nèi)從事藥品的研制、生產(chǎn)、經(jīng)營、使用和監(jiān)督管理的單位或者個人，必須遵守本法。s Republic of China 中華共和國主席令第 45號 Order of the President of the People39。s Republic of China, and shall enter into force as of December 1, 2020. 中華人民共和國主席 江澤民 Jiang Zemin, President of the People39。 The State shall protect the resources of wild medicinal resources and encourage the domestic cultivation of Chinese traditional medicinal crops. 第四條 國家鼓勵研究和創(chuàng)制新藥，保護(hù)公民、法人和其他組織研究、開發(fā)新藥的合法權(quán)益。無《藥品生產(chǎn)許可證》的，不得生產(chǎn)藥品。藥品生產(chǎn)企業(yè)改變影響藥品質(zhì)量的生產(chǎn)工藝的，必須報原批準(zhǔn)部門審核批準(zhǔn)。無《藥品經(jīng)營許可證》的，不得經(jīng)營藥品。 Article 17 Pharmaceutical trading enterprises must formulate and implement check and approval rules for the purchase of pharmaceuticals, and check pharmaceutical certifications and other marks while purchasing pharmaceuticals. Pharmaceuticals that do not meet the required standards must not be purchased. 第十八條 藥品經(jīng)營企業(yè)購銷藥品，必須有真實完整的購銷記錄。 Article 20 Rules for storage of pharmaceuticals shall be formulated and implemented by pharmaceutical trading enterprises, which must adopt necessary measures to facilitate cold stora