Commissioner of SFDA


Provisions for Supervision of Drug Distribution



(SFDA Decree No.26)

The Provisions for Supervision of Drug Distribution, adopted at the executive meeting of the State Food and Drug Administration on December 8, 2006, is hereby promulgated and shall go into effect as of May 1, 2007.


Shao Mingli
Commissioner of SFDA
January 31, 2007





Provisions for Supervision of Drug Distribution


Chapter I

Article 1 These Provisions are formulated for the purposes of strengthening drug supervision, regulating drug distribution order and ensuring drug quality in accordance with the Drug Administration Law of the People’s Republic of China (hereinafter referred to as Drug Administration Law), the Regulations for Implementation of the Drug Administration Law of the People’s Republic of China (hereinafter referred to as Regulations for Implementation of the Drug Administration Law) and the requirements of the relevant law and regulations.

Article 2 Any institutions or individuals engaged in the purchase, sales and supervision of drugs in the People’s Republic of China shall abide by the Provisions.

Article 3 Drug manufacturers, distributors and medical institutions shall be responsible for the quality of the drugs that they produce, distribute or use.

Drug manufacturers and distributors shall carry out reforms and innovations in the direction of pharmaceutical logistics provided that drug quality is assured.

Article 4 The drug regulatory departments encourage individuals and organizations to involve in the social supervision on drug distribution. Individuals or organizations have the right to report or accuse of any violation of the Provisions to the drug regulatory departments.


Chapter II Supervision on Drug Purchase and Sales by Manufacturers and Distributors

Article 5 Drug manufacturers or distributors shall be responsible for their drug purchases and sales, and liable for the purchases and sales activities of their sales staff or offices in the name of their enterprise.

Article 6 Drug manufacturers or distributors shall train their purchase and sales staff on drug related laws, regulations and professional knowledge, and establish training records including time, venue, content and trainees.

Article 7 Drug manufacturers or distributors shall strengthen the management of the sales staff and set up specific rules for their sales behaviors.

Article 8 Drug manufacturers or distributors shall not store or spot trade drugs on the premises not approved by the drug regulatory departments.

Article 9 Drug manufacturers shall sell drugs that they produce in the name of themselves, and shall not sell any drug that they produce for contract manufacturing or any drugs produced by others.

Article 10 Where a drug manufacturer or wholesaler sells drugs, it shall provide the following materials:
(1) Copies of the Drug Manufacturing Certificate or Drug Supply Certificate, stamped with the seal of the enterprise, and the business license;
(2) Copies of the approval documents for the drug to be sold, stamped with the seal of the enterprise ;
(3) For import drug sales, relevant proof documents should be provided in accordance with the related provisions of the State.

Where a drug manufacturer or wholesaler sends any of its sales staff to sell drugs, it shall, in addition to the materials prescribed in the previous paragraph of this Article, provide a copy of the authorization letter with the seal of the enterprise. The original authorization letter shall contain the authorized drugs, regions and time of validity for drug sales, indicate the identity card numbers of the sales staff, and be stamped with the enterprise seal and legal representative seal (or signature). The sales staff shall show the original authorization letter and identity card for the check by drug purchasers.

Article 11 Where a drug manufacturer or wholesaler sells drugs, it shall provide sales document indicating supplier’s name, drug name, manufacturer, batch number, quantity, price, etc.

Where a drug retailer sells drugs, it shall provide sales document indicating drug name, manufacturer, quantity, price, batch number, etc.

Article 12 Where a drug manufacturer or distributor purchases drugs, it shall request, examine and retain the relevant certificates and documents of the supplier in accordance with the requirements set forth in Article 10 of the Provisions, and request and retain sales document in accordance with the requirements set forth in Article 11 of the Provisions.

The documents retained by the drug manufacturer or distributor in accordance with the previous paragraph of this Article shall be kept till one year after the date of expiry, but not less than three years.

Article 13 Where a drug manufacturer or distributor knows or should know that any person without certificates produces or distributes drugs, it shall not provide the person with any drug.

Article 14 A drug manufacturer or distributor shall not provide premises, qualifications documents, notes, etc. as conveniences for others to distribute drugs in its own name.

Article 15 A drug manufacturer or distributor shall not spot trade drugs by means of exhibition, exposition, trade fair, commodity fair or product promotion event.

Article 16 A drug distributor shall not purchase or sell pharmaceutical preparations prepared by medical institutions.

Article 17 A drug distributor shall not change its distribution mode without approval of the drug regulatory department.

A drug distributor shall operate within the approved distribution scope in the Drug Supply Certificate.

Article 18 A drug retailer shall, pursuant to the requirements of drug classification regulations set forth by the State Food and Drug Administration, sell prescription drugs in the presence of prescriptions.

Any drug retailer selling prescription drugs or Class A non-prescription drugs shall, in the absence of its licensed pharmacists and other qualified pharmaceutical professionals, put up a public notice and stop selling prescription drugs and Class A non-prescription drugs.

Article 19 For drugs that need low-temperature or cold storage as specified in drug insert sheets, the drug manufacturer or distributor shall transport and store the drugs with low-temperature or cold storage facilities in accordance with the relevant provisions.

When finding any drug manufacturer or distributor violates the requirements in the previous paragraph of this article, the drug regulatory department shall seal up or seize the drugs concerned immediately and deal with the matter in accordance with law.

Article 20 A drug manufacturer or distributor shall not provide the public with prescription drug or Class A non-prescription drug by means of tie-in sale, offering free drugs in association with sales of drug or commodity sale, etc.

Article 21 A drug manufacturer or distributor shall not sell prescription drugs directly to the public by post or over internet.

Article 22 Any illegal purchase of drugs is prohibited.


Chapter III Supervision on Drug Purchase and Storage by Medical Institutions

Article 23 The pharmacy established by a medical institution shall have the premise, equipment, storage facilities, hygienic environment, and pharmaceutical professionals required for drug dispensing. It shall also have the drug quality control units or personnel, and establish a system for drug storage.

Article 24 Where a medical insititution purchases drugs, it shall request, examine and retain the relevant certificates, documents and notes of the supplier in accordance with the requirements set forth in Article 12 of the Provisions.

Article 25 Where a medical institution purchases drugs, it shall establish and apply an examination and acceptance system, and keep authentic and complete purchase records. Purchase records shall indicate the adopted name of the drug in China, manufacturer (for Chinese crude drug, the origin should be noted), dosage form, date of expiry, drug approval number, supplier, quantity, price and date of purchase.

Drug purchase records shall be kept till one year after the date of expiry, but not less than three years.

Article 26 A medical institution shall establish and apply a system for drug storage and maintenance, and take necessary measures to ensure drug quality, such as cold storage, protection against freeze and humidity, ventilation, moisture proof, protection from direct light and fire, and avoidance of insects and rodents.

A medical institution shall store drugs and non-drug products separately; Chinese crude drugs, prepared slices of Chinese crude drugs, pharmaceuticals, and traditional Chinese medicine preparations shall be stored separately by category.

Article 27 A medical institution or family planning technical service institution shall not directly provide drugs for patients without diagnosis or treatment.

Article 28 A medical institution shall not sell prescription drugs directly to the public by post or over internet.

Article 29 Where a medical institution purchases drugs via a centralized tendering, it shall comply with the relevant requirements of the Drug Administration Law, Regulations for Implementation of the Drug Administration Law and the Provisions.


Chapter IV Legal Liabilities

Article 30 In any of the following circumstances, the drug manufacturer or distributor shall be instructed to rectify within a time limit and given a disciplinary warning; and if the drug manufacturer or distributor fails to do so, it shall be fined not less than RMB 5,000 yuan but not more than RMB 20,000 yuan:
(1) any drug manufacturer or distributor in violation of Article 6 of the Provisions;
(2) any drug manufacturer or wholesaler in violation of the first paragraph of Article 11 of the Provisions;
(3) any drug manufacturer or distributor, in violation of Article 12 of the Provisions, failing to keep the relevant documents as required.

Article 31 Any drug manufacturer or distributor in violation of Article 7 of the Provisions shall be given a disciplinary warning and instructed to rectify within a time limit.

Article 32 In accordance with the provisions in Article 73 of the Drug Administration Law, in any of the following circumstances, the drugs illegally sold and the illegal gains therefrom shall be confiscated, and the drug manufacturer or distributor shall be fined not less than two times but not more than five times the value of the drugs illegally sold:
(1) any drug manufacturer or distributor, in violation of Article 8 of the Provisions, spot trading drugs on the premises not approved by the drug regulatory departments.
(2) any drug manufacturer in violation of Article 9 of the Provisions;
(3) any drug manufacturer or distributor in violation of Article 15 of the Provisions;
(4) any drug distributor in violation of Article 17 of the Provisions.

Article 33 Any drug manufacturer or distributor, in violation of Article 8 of the Provisions, storing drugs on the premises not approved by the drug regulatory departments，shall be punished pursuant to the provisions in Article 74 of the Regulations for Implementation of the Drug Administration Law.

Article 34 Any drug retailer in violation of the provisions in the second paragraph of Article 11 of the Provisions shall be instructed to rectify and given a disciplinary warning; and if the drug retailer fails to do so within a time limit, it shall be fined not more than RMB 500 yuan.

Article 35 Where a drug manufacturer or distributor, in violation of Article 13 of the Provisions, knows or should know that any person without certificates produces or distributes drugs, but still provide the person with drugs, they shall be given a disciplinary warning, instructed to rectify and fined not more than RMB 10,000 yuan. If the circumstances are serious, they shall be fined not less than RMB 10,000 yuan but not more than RMB 30,000 yuan.

Article 36 Drug manufacturers and distributors in violation of Article 14 of the Provisions shall be punished pursuant to the provisions in Article 82 of the Drug Administration Law.

Article 37 Where a drug distributor, in violation of Article 16 of the Provisions, purchases or sells pharmaceutical preparations dispensed by medical institutions, it shall be punished pursuant to the provisions in Article 80 of the Drug Administration Law.

Article 38 Any drug retailer in violation of the first paragraph of Article 18 of the Provisions shall be instructed to rectify within a time limit and given a disciplinary warning; if it fails to do so or the circumstances are serious, it shall be fined not more than RMB 1,000 yuan.

Where a drug retailer, in violation of the second paragraph of Article 18 of the Provisions, sells prescription drugs or Class A non-prescription drugs in absence of licensed pharmacists or other qualified pharmaceutical professionals, it shall be instructed to rectify within a time limit and given a disciplinary warning; if it fails to do so, it shall be fined not more than RMB 1,000 yuan.

Article 39 Where a drug manufacturer or wholesaler, in violation of Article 19 of the Provisions, fails to transport drugs under low-temperature or cold storage conditions as specified in insert sheets, it shall be given a disciplinary warning and instructed to rectify within a time limit; if it fails to do as instructed, it shall be fined not less than RMB 5,000 yuan but not more than RMB 20,000 yuan. Where the drugs concerned are legally proved to be counterfeit or substandard drugs, the drug manufacturer or wholesaler shall be punished in accordance with the relevant provisions of the Drug Administration Law.

Where a drug manufacturer or wholesaler, in violation of Article 19 of the Provisions, fails to store drugs under low-temperature or cold storage conditions as specified in insert sheets, it shall be punished pursuant to the provisions in Article 79 of the Drug Administration Law. Where the drugs concerned are legally proved to be counterfeit or substandard drugs, the drug manufacturer or wholesaler shall be punished in accordance with the relevant provisions of the Drug Administration Law.

Article 40 Any drug manufacturer or distributor in violation of Article 20 of the Provisions shall be instructed to rectify within a time limit and given a disciplinary warning; if the drug manufacturer or distributor fails to do so or the circumstances are serious, they shall be fined not more than two times the value of the free drugs offered, but not more than RMB 30,000 yuan.

Article 41 Any institution, in violation of Article 23 to Article 27 of the Provisions, shall be instructed to rectify within a time limit; if the circumstances are serious, it shall be announced.

Article 42 Where a drug manufacturer or distributor in violation of Article 21 of the Provisions or a medical institution in violation of Article 28 of the Provisions sells prescription drugs directly to the public by post, over internet, etc., they shall be instructed to rectify, given a disciplinary warning, and fined not more than two times the value of the drugs sold, but not more than RMB 30,000 yuan.

Article 43 Any illegal purchase of drugs, in violation of Article 22 of the Provisions, shall be punished pursuant to the provisions in Article 73 of the Drug Administration Law.

Article 44 Where a drug regulatory department or its staff that neglects its duty fails to stop or punish illegal activities that should be stopped or punished, administrative sanctions shall be imposed to the person directly in charge and other persons directly responsible. If a crime is constituted, criminal liabilities shall be investigated in accordance with law.


Chapter V Supplementary Provisions

Article 45 Spot trading of drugs in the Provisions refers to the activity that drug manufacturers, distributors or their appointed sales staff carry and sell drugs to unspecified objects on spot other than the premises approved by the drug regulatory departments.

Article 46 With respect to the supervision on the distribution of specially controlled drugs, vaccines, and military medicines, if otherwise provided by the relevant laws, regulations and provisions, they shall prevail.

Article 47 The Provisions shall come into force as of May 1, 2007. As of the date when the Provisions goes into effect, the Provisions for Supervision of Drug Distribution (Interim) (SFDA Decree No.7) implemented on August 1, 1999 shall be annulled therefrom.




广东省珠海市人民政府


关于修改《珠海市烟花爆竹安全管理规定》有关条款的决定

珠海市人民政府令第33号
　　

《珠海市人民政府关于修改<珠海市烟花爆竹安全管理规定>有关条款的决定》已经2003年1月23日市人民政府第2次常务会议审议通过，现予发布，自公布之日起施行。


市长 王顺生
二OO三年一月二十七日

　　　　　　　　　　　　　　　　　　

　 关于修改《珠海市烟花爆竹安全管理规定》有关条款的决定

　　珠海市人民政府决定对《珠海市烟花爆竹安全管理规定》作如下修改：
　　一、第四条修改为：公安行政主管部门(以下简称公安部门)主管烟花爆竹的安全管理工作。
　　城市管理行政执法部门负责烟花爆竹禁放管理的行政处罚工作。
　　建设、交通、工商等有关职能部门，应当按照各自职责，共同做好烟花爆竹的管理工作。
　　二、第七条修改为：运输、储存、销售烟花爆竹，依法实行许可证制度。
　　《爆炸物品销售许可证》根据本市实际，实行招、投标，具体办法由辖区政府会同市公安、贸易和产权交易中心制定并实施。
　　三、第十条修改为：市区烟花爆竹燃放区域为情侣路沿海一侧的人行道的指定地段。指定的具体地段由辖区政府会同市公安局等有关部门商定，并由辖区城市管理部门竖牌明示。
　　四、第十一条修改为：在规定的燃放区域可以在下列节假日燃放烟花爆竹：
　　(一)中秋节；
　　(二)春节(农历除夕至初三、农历十五)。
　　在上述节日时间内，每天具体燃放时间为：除夕之夜晚上十九时至次日凌晨一时，其余节日为晚上十九时至晚上二十四时。
　　五、第十二条修改为：除规定的燃放区域外，市区范围内的香洲(华前村以北农村除外，不包括华前村)、吉大、拱北、前山(上冲边防检查站以外的农村除外)和斗门区城区、金湾区城区禁止燃放烟花爆竹。
　　六、第十六条修改为：全市性庆祝、庆典活动或者其他需要燃放烟花爆竹的，必须报经辖区政府批准。
　　本决定自公布之日起施行。
　　《珠海市烟花爆竹安全管理规定》根据本决定作相应的修改，重新公布。

　　珠海市烟花爆竹安全管理规定
　　(2000年1月6日珠海市人民政府第1次常务会议通过。根据2003年1月23日珠海市人民政府第2次常务会议《关于修改<珠海市烟花爆竹安全管理规定>有关条款的决定》修正)
　　第一章 总 则
　　第一条 为加强烟花爆竹安全管理。预防爆炸、火灾和人身伤害事故，保障人民群众生命财产安全，根据法律、法规的有关规定，结合本市实际，制定本规定。
　　第二条 在本市行政区域内运输、储存、销售和燃放烟花爆竹的，均应遵守本规定。
　　第三条 对烟花爆竹实行限定燃放、严格执法、综合治理的原则。
　　第四条 公安行政主管部门(以下简称公安部门)主管烟花爆竹的安全管理工作。
　　城市管理行政执法部门负责烟花爆竹禁放管理的行政处罚工作。
　　建设、交通、工商等有关职能部门，应当按照各自职责，共同做好烟花爆竹的管理工作。
　　第五条 各级人民政府、街道办事处和居民委员会、村民委员会以及机关、团体、企业事业单位，应当在干部、职工、居民、村民和学生中开展燃放烟花爆竹的安全教育。
　　未成年人、限制行为能力人或无行为能力人的监护人对其负有教育和管束的责任。
　　第二章 烟花爆竹的运输、储存与销售
　　第六条 禁止在本市行政区域内生产烟花爆竹。
　　第七条 运输、储存、销售烟花爆竹，依法实行许可证制度。
　　《爆炸物品销售许可证》根据本市实际，实行招、投标，具体办法由辖区政府会同市公安、贸易和产权交易中心制定并实施：
　　第八条 储存烟花爆竹的仓库应当远离商业(工业)区、居民住宅区和其他公共设施，并符合安全、消防条件。
　　第九条 持有《爆炸物品销售许可证》的单位和个人所经营的烟花爆竹的品种、规格、数量应当事先报经市、区公安部门同意，在指定地点销售。
　　第三章燃放烟花爆竹的管理
　　第十条 市区烟花爆竹燃放区域为情侣路沿海一侧的人行道的指定地段。指定的具体地段由辖区政府会同市公安局等有关部门商定，并由辖区城市管理部门竖牌明示。
　　第十一条 在规定的燃放区域可以在下列节假日燃放烟花爆竹：
　　(一)中秋节。
　　(二)春节(农历除夕至初三、农历十五)。
　　在上述节日时间内，每天具体燃放时间为：除夕之夜晚上十九时至次日凌晨一时，其余节日为晚上十九时至晚上二十四时。
　　第十二条 除规定的燃放区域外，市区范围内的香洲(华前村以北农村除外，不包括华前村)、吉大、拱北、前山(上冲边防检查站以外的农村除外)和斗门区城区、金湾区城区禁止燃放烟花爆竹。
　　第十三条 在未禁止燃放烟花爆竹的地区，不得在下列地点燃放烟花爆竹：
　　(一)机关办公场所和车站、码头、机场、医院、学校、幼儿园、集贸市场、文化娱乐等公共场所。
　　(二)建筑物的房顶、楼道、阳台、窗口、室内。
　　(三)存放易燃易爆物品场所及变电站、煤气站、加油站及其周围100米内。
　　(四)公墓和坟场。
　　(五)群众集体活动场所。
　　(六)明令禁止燃放烟花爆竹的其它区域。
　　第十四条 燃放烟花爆竹应当按照燃放说明，正确、安全燃放，禁止向行人、车辆、道路、建筑物投掷烟花爆竹。
　　第十五条 禁止携带烟花爆竹乘坐车、船等公共交通工具或者在托运的行李包裹和邮件中夹带烟花爆竹。
　　第十六条 全市性庆祝、庆典活动或者其他需要燃放烟花爆竹的，必须报经辖区政府批准。
　　第四章法律责任
　　第十七条 对违反本规定燃放烟花爆竹的单位或个人，任何人均有权劝阻或者及时向城市管理行政执法部门举报。
　　第十八条 违反本规定运输、储存烟花爆竹的，由公安机关没收其烟花爆竹，并处5000元以上10000元以下罚款。
　　第十九条 未取得《爆炸物品销售许可证》而销售烟花爆竹的，由城市管理行政执法部门没收其烟花爆竹及其非法所得，并处2000天以上5000元以下罚款。
　　第二十条 携带烟花爆竹乘坐车、船等公共交通工具或者托运的行李包裹和邮件中夹带烟花爆竹的，由公安机关没收其烟花爆竹，并处500元以上1000元以下罚款。
　　第二十一条 违反本规定燃放烟花爆竹的，由城市管理行政执法部厂没收烟花爆竹并予以处罚：
　　(一)单位燃放烟花爆竹的，处1000元以上3000元以下罚款，并对直接责任人处200元以上1000元以下罚款。
　　(二)个人燃放烟花爆竹的，处200元以上1000元以下罚款．
　　(三)未成年人、限制行为能力人或无行为能力人违反本规定燃放烟花爆竹的，对其监护人给予警告或按照本条第二项处以罚款。
　　第二十二条 拒绝、阻碍执法人员依法执行公务的，由公安部门按照《中华人民共和国治安管理处罚条例》予以处罚。
　　第二十三条 罚款应上缴同级财政，没收的烟花爆竹应按规定统一处理。
　　第二十四条 执法人员不得滥用职权、玩忽职守、徇私舞弊，违者，由其所在单位或其上级主管部门给予行政处分，构成犯罪的，由司法机关依法追究刑事责任。
　　第五章附则
　　第二十五条 本规定自2000年2月1日起执行。