Provisions for Supervision of Drug Distribution
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.
印发广东省2004年再就业工作目标责任制考评办法的通知
广东省人民政府办公厅
粤府办〔2004〕41号
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印发广东省2004年再就业工作目标责任制考评办法的通知
各地级以上市人民政府,各县(市、区)人民政府,省政府各部门、各直属机构:
《广东省2004年再就业工作目标责任制考评办法》已经省人民政府同意,现印发给你们,请按照执行。执行中遇到的问题,请迳向省劳动保障厅反映。
广东省人民政府办公厅
二○○四年四月二十八日
广东省2004年再就业工作目标责任制考评办法
为进一步推动就业再就业工作,确保完成省委、省政府确定的2004年就业工作各项目标任务,根据《中共广东省委、广东省人民政府关于贯彻〈中共中央、国务院关于进一步做好再就业工作的通知〉的意见》(粤发〔2002〕15号)、《中共广东省委、广东省人民政府关于实施〈十项民心工程〉的通知》(粤发〔2003〕13号)、《广东省人民政府关于建立再就业工作目标责任制的通知》(粤府〔2003〕80号)、《中共广东省委办公厅、省人民政府办公厅关于印发〈扩大与促进就业民心工程实施方案〉的通知》(粤办发〔2004〕6号)的精神,特制定本办法。
一、考评内容
(一)落实就业再就业工作目标责任制情况;
(二)落实就业再就业政策情况;
(三)推进城乡统筹就业情况;
(四)建立健全公共就业服务情况;
(五)强化技工教育和职业培训情况;
(六)加大再就业资金投入情况;
(七)帮助困难群体就业情况。
二、指标和分值
(一)落实责任制(15分)
1.各地级以上市政府、各县(市、区)政府制定“扩大与促进就业工程” 具体操作方案,并明确各级、各部门职责(3分);将2004年度再就业工作目标任务逐级下达到街道(乡镇)和有关部门(2分);开展年度考评工作(2分)。
2.完成省政府下达的年度净增就业岗位数(2分)、下岗失业人员再就业计划数(2分)、城镇登记失业率控制数(2分)、准确掌握下岗失业人员情况,并按时上报有关统计报表(2分)。
(二)落实就业再就业政策(12分)
1.各地级以上市政府,各县(市、区)政府、有关部门及时出台贯彻国家和省委、省政府、省有关部门各项就业和再就业政策的实施办法,且具有结合实际、切实可行、实际操作性强等特点(2分)。
2.各有关部门能及时兑现下岗失业人员、用人单位和有关服务机构按规定申请应享受的各项就业扶持政策和补贴资金(8分)。
3.开展再就业优惠政策宣传,及时处理群众有关就业再就业的来信来访和举报投诉事件(2分)。
(三)推进城乡统筹就业(20分)
1.把建立城乡统一的就业管理服务体系纳入当地社会经济发展规划以及各级党委、政府制订下发了有关推进城镇化、加快县域经济发展和增加农民收入的政策文件(2分)。结合实际制定具体的规划和政策,明确目标、实施步骤和保障措施(2分)。
2.把就业服务体系向农村延伸,在60%以上的乡镇建立劳动保障事务机构(2分),落实人员编制(2分),财政安排人员和工作经费(2分),落实场地(2分),做好农村劳动力资源调查工作(2分)。
3.各市、县依托综合性职业培训机构,开展农村富余劳动力职业技能培训(2分),当地财政安排培训经费给予补贴(2分),完成省下达的转移(输出、接收)农村富余劳动力任务(2分)。
(四)健全公共就业服务体系(18分)
1.完善街道劳动保障事务机构工作制度,开展工作人员培训,提高业务水平;100%的街道社区聘请工作人员并落实工作经费(3分)。
2.2004年底前,各市、县(市、区)按省下发的“劳动力市场信息网络硬件配置标准”完成网络硬件配置(3分);90%以上的县(市、区)劳动力市场实现与市信息联网(2分)。各市、县(市、区)均使用全省统一的“再就业管理系统”,开展再就业管理工作(2分)。
3.2004年底前,各市、县(市、区)政府建立公共就业服务机构,落实人员编制和财政经费(4分)。在劳动力市场开设下岗失业登记、职业介绍、职业指导、职业培训、劳动保障事务代理、受理享受再就业扶持政策资格认定申请等“一站式”服务(2分)。
4.对登记求职的城镇登记失业人员和国有企业下岗职工提供免费职业介绍,介绍成功率40%以上(2分)。
(五)强化技工教育和职业培训(15分)
1.抓好技工学校建设。各地级以上市政府在6月底前制定建设国家重点技工学校的建设方案(2分),落实建设资金和场所(2分),完成省下达的2004年技校招生计划(2分)。
2.各地级以上市、各县(市、区)政府在10月底前制定综合性职业培训基地建设方案(2分),明确建设资金来源、落实场地(3分)。
3.对有培训愿望的城镇登记就业转失业人员和国有企业下岗职工提供免费再就业培训,培训后再就业率60%以上(2分)。完成省下达的创业培训计划(2分)。
(六)加大再就业资金投入(12分)
各地级以上市、各县(市、区)均把再就业资金纳入财政预算(2分),安排农村劳动力职业技能培训经费(2分)。按本地下岗失业人员再就业人数所需资金安排落实各项补贴资金(4分),劳动力市场和信息网络建设资金(2分),街道、乡镇、社区劳动保障工作经费(2分)。
(七)帮助困难群体就业(8分)
1.建立公益性岗位空岗申报制度,落实公益性岗位安置下岗失业人员措施(4分)。
2.建立健全再就业援助制度,摸清就业困难人员底数,完成省下达的“4050”人员再就业数(4分)。
各项考评内容的评分计算标准和统计方法,见《2004年再就业工作目标责任制落实情况评分表》(附件1);各市2004年再就业工作目标任务,见《2004年各市再就业工作目标任务》(附件2)。
对在2003年度省考评中被扣分的工作项目,各市、县(市、区)必须在2004年6月底前整改完成原定目标任务,各地级以上市要在7月15日前向省政府作详细报告(送省再就业工作领导小组办公室),否则按被扣分数在2004年考评总分中加倍扣分。
三、考评步骤
(一)自评:2005年1月31日前,各地级以上市政府组织对本市2003年再就业工作目标责任制执行情况进行自评,填写《评分表》,连同2004年就业再就业工作总结和自评情况的书面报告报省再就业工作领导小组办公室(设在省劳动保障厅)。
(二)核对:省再就业工作领导小组办公室对各市自评情况进行核对。核对有疑问的,有关市应对该项考评内容进行核实,并补充相关材料。
(三)抽查:省再就业工作领导小组组成检查组,赴各市(县、区、街道、乡镇)进行实地抽查核实,抽查面不少于50%地级以上市。
(四)评定:省再就业工作领导小组办公室根据自查、核对和抽查的结果提出初评意见,提请省再就业工作领导小组全体成员单位会议评定。
四、奖惩办法
(一)考评分数在90分及以上的,为达标市,省政府给予通报表彰,颁发证书并奖励8万元。2003-2005年连续三年达标或2004年、2005年两年评分均在95分以上的,可参加再就业工作先进市评选。
(二)考评分数在70分以下的,省政府给予通报批评。对因工作不力造成严重后果的,追究政府主要领导责任。
(三)对在考评中或考评后核实有弄虚作假行为的市,一律取消其评选资格,省政府给予通报批评,并追究主要领导责任;已表彰奖励的,撤销奖励,收回奖金。
(四)对被通报批评或追究领导责任的市,取消其当年参加省政府综合性评优活动的资格。
五、其他事项
(一)省颁发的奖金由各市政府掌握,用于奖励再就业工作先进单位、个人和补贴再就业工作。
(二)省直有关部门再就业工作责任制考评办法另行制定。
(三)本办法由省再就业工作领导小组负责解释
附件:1.2004年再就业工作目标责任制落实情况评分表
2.2004年各市再就业工作目标任务