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.




广西壮族自治区人民政府


广西壮族自治区著名商标认定和保护办法



广西壮族自治区人民政府令第1号


　　《广西壮族自治区著名商标认定和保护办法》已经2001年12月14日自治区人民政府第32次常务会议审议通过,现予公布,自2002年3月1日起施行。

自治区主席　李兆焯
二ОО二年一月八日

　　第一条　为规范广西壮族自治区著名商标认定工作,保护广西壮族自治区著名商标注册人和消费者的合法权益,促进经济发展,根据《中华人民共和国商标法》及其他有关法律、法规的规定,结合本自治区实际,制定本办法。
　　第二条　本办法所称广西壮族自治区著名商标(以下简称广西著名商标),是指在市场上享有较高声誉、为相关公众所熟知,并依照本办法认定的注册商标。
　　广西著名商标以被认定的注册商标及其核定使用的商品为限。
　　第三条　广西著名商标的认定和保护适用本办法。
　　第四条　自治区工商行政管理部门负责广西著名商标的认定和保护工作,各地区、市、县工商行政管理部门依照本办法履行职责。
　　各有关部门和社会团体应当在各自的职责范围内,协助和配合工商行政管理部门做好广西著名商标的认定和保护工作。
　　第五条　广西著名商标的资格由广西著名商标评审委员会评审确认、自治区工商行政管理部门认定并公布。
　　第六条　广西著名商标的认定应当遵循自愿申请和公平、公开、公正的原则,实行个案认定制度。
　　第七条　认定广西著名商标,应当符合下列条件:
　　(一)该商标注册人的住所在本自治区行政区域内;
　　(二)该商标自核准注册之日起连续使用时间在三年以上;
　　(三)使用该商标的商品质量优良、稳定,有良好的售后服务,消费者投诉率低;
　　(四)使用该商标的商品销售区域较广,近三年的销售量、利润和市场占有率等主要经济指标居本自治区同行业的前列;
　　(五)该商标为相关公众所熟知；
　　(六)出口商品的商标应当在主要出口国家(地区)注册,并且使用该商标的商品销售量较大或者销售区域广泛;
　　(七)该商标注册人有严格的商标使用、保护和管理措施;
　　(八)未发生过侵犯他人注册商标专用权及其他违反有关商标管理法律、法规、规章的行为。
　　第八条　商标所有人认为其注册商标符合本办法第七条规定条件的,可以向所在地的地区或者设区的市工商行政管理部门提交书面申请和本办法第七条所列条件的证明材料,并填写广西著名商标认定申请表。
　　第九条　地区或者设区的市工商行政管理部门应当在收到认定申请之日起30日内,根据认定条件对申请人提供的申请材料进行初审。对符合认定条件的,签署意见后报自治区工商行政管理部门;对不符合认定条件的,退回申请材料并书面说明理由。
　　第十条　申请人对地区或者设区的市工商行政管理部门的初审意见有异议的,可以向自治区工商行政管理部门请求复核。
　　自治区工商行政管理部门应当处收到复核申请之日起30日内,作出复核决定。异议成立的,由自治区工商行政管理部门直接受理;异议不成立的,退回申请材料并书面说明理由。
　　自治区工商行政管理部门的复核决定为最终决定。
　　第十一条　自治区工商行政管理部门应当在收到地区和设区的市工商行政管理部门推荐的广西著名商标认定申请或者直接受理广西著名商标认定申请之日起60日内,对申请材料进行调查、核实,提出审核意见。对符合认定条件的,提交广西著名商标评审委员会进行评审;对不符合条件的,退回申请材料并书面说明理由。
　　第十二条　广西著名商标评审委员会,由自治区工商行政管理部门会同自治区经济贸易、农业、质量技术监督、科学技术、物价、外经贸等有关部门组织设立,并聘请有关行业协会、消费者协会、教学科研等单位的代表和专家参加。
　　广西著名商标评审委员会委员的人数必须是单数,主任委员由自治区工商行政管理部门的代表担任。
　　广西著名商标评审委员会下设若干个专业组,负责对不同类别注册商标的申请材料进行技术审核并签署专业组意见。
　　广西著名商标评审委员会的办事机构设在自治区工商行政管理部门。
　　第十三条　广西著名商标评审委员会对申请材料、自治区工商行政管理部门审核意见和专业组意见的真实性、准确性进行评议审查,并根据广西著名商标认定条件的具体标准,对申请人的注册商标是否具备广西著名商标资格进行评审表决,表决以书面、署名形式进行。
　　评审确认具有广西著名商标资格,须经广西著名商标评审委员会三分之二以上委员表决同意。
　　第十四条　广西著名商标认定条件的具体标准、广西著名商标评审委员会委员和专业组成员的资格、任期和评审认定的程序、规则,由自治区工商行政管理部门会同有关部门共同制定,并报自治区人民政府批准后公布执行。
　　第十五条　自治区工商行政管理部门对经广西著名商标评审委员会评审确认具有广西著名商标资格的注册商标予以认定,发给广西著名商标证书,并向社会公告。
　　第十六条　广西著名商标自公告之日起三年内有效。
　　有效期满前90日内,广西著名商标注册人可以向自治区工商行政管理部门申请延续。对符合本办法第七条规定条件的,自治区工商行政管理部门应当予以核准;每次延续的有效期为三年。逾期不申请延续的,不再具有广西著名商标资格。
　　第十七条　广西著名商标注册人可以向自治区工商行政管理部门申请冠以“广西壮族自治区”或者“广西”字样的企业名称或者商号(包括字号,下同)。
　　第十八条　广西著名商标注册人可以在其核定使用的商品及其包装、装潢、说明书、广告上标明广西著名商标的字样或者标志,并同时标明认定有效期。
　　其他任何单位和个人不得在商品及其包装、装潢、说明书、广告上使用广西著名商标的字样或者标识。
　　第十九条　认定为广西著名商标的商品为知名商品。
　　被认定为广西著名商标的商品,为广西名牌产品。
　　任何单位和个人不得擅自使用被认定为广西著名商标的商品特有的或者近似的名称、包装、装潢。
　　第二十条　广西著名商标公告前两年内,他人已将与广西著名商标相同或者近似的文字作为同行业的企业名称或者商号使用,并引起公众误认的,广西著名商标注册人可以在广西著名商标公告之日起一年内,向自治区工商行政管理部门申请撤销该企业名称或者商号。是否予以撤销,由自治区工商行政管理部门决定。
　　第二十一条　广西著名商标自公告之日起,他人将与广西著名商标相同或者近似的文字作为企业名称的一部分或者商号使用,并可能引起公众误认的,工商行政管理部门不予核准登记。但有下列情形之一的除外:
　　(一)广西著名商标的文字为县级以上行政区划名称的;
　　(二)广西著名商标的文字为全国或者全自治区闻名的江河、湖泊、海域、山脉和名胜古迹等名称的;
　　(三)法律、法规规定的其他情形。
　　第二十二条　他人以广西著名商标相同或者近似的文字、图形在非同种、非类似的商品上作为商品名称、装潢使用或者作为未注册商标使用,使公众误认或者可能使公众误认该商品与广西著名商标注册人有某种联系,广西著名商标注册人认为该行为侵犯其合法权益的,可以在知道或者应当知道其权益受到损害之日起两年内,请求县级以上工商行政管理部门依法制止和处理。
　　在非同种、非类似商品上有相同或者近似的两个以上商标均被认定为广西著名商标的,互不适用前款规定。
　　第二十三条　广西著名商标注册人依法转让其注册商标的,该商标的广西著名商标资格自行丧失。受让方必须按照本办法的规定重新申请认定,方能取得广西著名商标资格。

　　第二十四条　工商行政管理部门应当加强对广西著名商标的管理,定期检查广西著名商标注册人的使用情况。
　　第二十五条　广西著名商标注册人有下列行为之一的,自治区工商行政管理部门可责令其限期改正或者撤销其广西著名商标资格:
　　(一)通过欺骗等不正当手段取得广西著名商标资格的;
　　(二)使用广西著名商标的商品已不符合本办法第七条规定条件的;
　　(三)超越商标注册核定,使用的商品范围使用广西著名商标字样、标志,经工商行政管理部门责令限期改正后仍不改正的;
　　(四)违反法律、法规、规章,严重影响广西著名商标声誉的其他行为。
　　被撤销广西著名商标资格的,自公告之日起三年内不得再申请认定广西著名商标。
　　第二十六条　对违反本办法,侵犯广西著名商标专用权的,县级以上工商行政管理部门可以依法采取措施制止侵权行为,并可处以非法经营额30%以上50%以下或者侵权所获利润3倍以上5倍以下的罚款;对侵犯广西著名商标专用权的单位的直接责任人,可处以5000元以上10000元以下的罚款;构成犯罪的,依法追究刑事责任。
　　第二十七条　违反本办法第十八条第二款规定的,由县级以上工商行政管理部门给予警告,并可处以2000元以上20000元以下的罚款。
　　第二十八条　违反本办法第十九条第三款规定的,依据《中华人民共和国反不正当竞争法》第二十一条第二款的规定处罚;其中,没有违法所得或者违法所得难以确定的,处以5000元以上50000元以下的罚款。
　　第二十九条　工商行政管理人员在认定和保护广西著名商标工作中玩忽职守、滥用职权、徇私舞弊的,依法给予行政处分;构成犯罪的,依法追究刑事责任。
　　第三十条　本办法适用于服务商标、集体商标和证明商标。
　　第三十一条　本办法自2002年3月1日起施行。