【正文】 ge and protection against freezing, moisture, insects and rodents to ensure pharmaceutical quality. 藥品入庫和出庫必須執(zhí)行檢查制度。 Article 23 To make medicinal preparations, a medical anization must be examined and approved by the administrative departments of health of the provinces, autonomous regions, or municipalities directly under the central government where the anization is located , and approved and issued a Dispensing Permit for Medical Organizations by the pharmaceutical supervisory and administrative departments of the provinces, autonomous regions or municipalities directly under the central government. No medicinal preparations shall be made without a Dispensing Permit for Medical Organizations. 《醫(yī)療機構制劑許可證》應當標明有效期，到期重新審查發(fā)證。對有配伍禁忌或者超劑量的處方，應當拒絕調配；必要時，經處 方醫(yī)師 更正或者重新簽字，方可調配。實施批準文號管理的中藥材、中藥飲片品種目錄由國務院藥品監(jiān)督管理部門會同國務院中醫(yī)藥管理部門制定。 The Pharmacopoeia Committee anized by the pharmaceutical supervisory and administrative department under the State Council shall be responsible for the formulation and revision of the State pharmaceutical standards. 國務院藥品監(jiān)督管理部門的藥品檢驗機構負責標定國家藥品標準品、對照品。具體辦法由國務院制定。無《進口藥品通關單》的，海關不得放行。 The inspection fee and charge standards for the abovementioned pharmaceuticals shall be jointly checked, ratified and promulgated by th。 Medicines to be imported in small quantities for urgent clinical needs by medical anizations or for personal use shall go through import formalities according to relevant regulations of the State. 第四十條 藥品必須從允許藥品進口的口岸進口，并由進口藥品的企業(yè)向口岸所在地藥品監(jiān)督管理部門登記備案。具體辦法由國務院制定。39。 13 Article 30 The pharmaceutical nonclinical safety appraisal and research units and the clinical test units must respectively carry out the quality control standard for pharmaceutical nonclinical research and the quality control standard for pharmaceutical clinical test. 藥物非臨床研究質量管理規(guī)范、藥物臨床試驗質量管理規(guī)范由國務 院確定的部門制定。 Medicinal preparations made by medical anizations may not be sold on the market. 第二十六條 醫(yī)療機構購進藥品，必須建立并執(zhí)行進貨檢查驗收制度，驗明藥品合格證明和其他標識；不符合規(guī)定要求的，不得購進和使用。 Article 22 Medical anizations must be staffed with legally certified pharmaceutical technical personnel. Nonpharmaceutical technical personnel may not be directly engaged in the technical work of the pharmacy. 第二十三條 醫(yī)療機構配制制劑，須經所在地省、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，發(fā)給《醫(yī)療機構制劑許可證》。 Article 19 It is imperative for pharmaceutical trading enterprises, in the sale of pharmaceuticals, to be accurate and free of mistakes, and to provide correct directions for use, dosage and precautions. Prescriptions being dispensed must be checked. Pharmaceutical products listed in the prescription must not be presumptuously changed or substituted. Prescriptions containing inpatible substances or excessive dosages shall be rejected by the dispensary. If necessary, such prescriptions can be dispensed after they have been corrected or resigned by the doctors who wrote them. 藥品經營企業(yè)銷售中藥材，必須標明產地。 Article 16 Pharmaceutical producing enterprises must trade in pharmaceuticals in accordance with the Standards for Quality Control of Pharmaceutical Trading stipulated by the pharmaceutical supervisory and administrative departments under the State Council on the basis of this Law. Pharmaceutical supervisory and administrative departments shall certify whether pharmaceutical trading enterprises meet the requirements of the Standards for Quality Control of Pharmaceutical Trading in accordance with relevant regulations, and issue certifications to qualified enterprises. 《藥品經營質量管理規(guī)范》的具體實施辦法、實施步驟由國務院藥品監(jiān)督 管理部門規(guī)定。 products which do not meet national pharmaceutical standards or are not prepared in conformity with the processing standards stipulated by the pharmaceutical supervisory and administrative departments of the provinces, autonomous regions, or municipalities directly under the central government shall not leave the factory. 第十三條 經國務院藥品監(jiān)督管理部門或者國務院藥品監(jiān)督管理部門授權的省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準，藥品生產企業(yè)可以接受委托生產藥品。 Article 9 Pharmaceutical producing enterprises must anize production in accordance with the Standards for Quality Control of Pharmaceutical Production formulated by the pharmaceutical supervisory and administrative departments under the State Council on the basis of this Law. Pharmaceutical supervisory and administrative departments shall confirm whether the pharmaceutical producing enterprises have met the requirements of the Standards, and shall issue certificates to those qualified ones. 《藥品生產質量管理規(guī)范》的具體實施辦法、實施步驟由國務院藥品監(jiān)督管理部門規(guī)定。 The pharmaceutical supervisory and administrative departments under the State Council shall cooperate with the general administrative department of the economy under the State Council to carry out pharmaceutical development plans and industrial policies formulated by the State. 第六條 藥品監(jiān)督管理部門設置或者確定的藥品檢驗機構，承擔依法實施藥品審批和藥品質量監(jiān)督檢查所需的藥品檢驗工作。s Republic of China. 第三條 國家發(fā)展現(xiàn)代藥和傳統(tǒng)藥，充分發(fā)揮其在預防、醫(yī)療和保健中的作用。s Republic of China has been revised at the Twentieth Meeting of the Standing Committee of the Ninth National People39。 The Pharmaceutical Administration Law of the People39。39。 The pharmaceutical supervisory and administrative departments of the provinces, autonomous regions and municipalities directly under the central government shall be responsible for the supervision and control of pharmaceuticals within their administrative regions. Other relevant departments of the provinces, autonomous regions and municipalities directly under the central government shall be responsible for the supervision and control of pharmaceuticals related to the scope of their functions. 國務院藥品監(jiān)督管理部門應當配合國務院經濟綜合主管部門，執(zhí)行國家制定的藥品行業(yè)發(fā)展規(guī)劃和 產業(yè)政策。藥品監(jiān)督管理部門按照規(guī)定對藥品生產企業(yè)是否符合《藥品生產質量管理規(guī)范》的要求進行認證；對認證合格的，發(fā)給認證證書。 Article 12 The pharmaceutical producing enterprises must conduct quality inspections on the pharmaceuticals they produce。藥品監(jiān)督管理部門按照規(guī)定對藥品經營企業(yè)是