卫生部、铁道部关于规定铁道食品卫生监督职责的通知

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卫生部、铁道部关于规定铁道食品卫生监督职责的通知

卫生部 铁道部


卫生部、铁道部关于规定铁道食品卫生监督职责的通知
1996年2月29日,卫生部、铁道部

根据《中华人民共和国食品卫生法》(以下简称《食品卫生法》)第三十二条第二款“铁道、交通行政主管部门设立的食品卫生监督机构,行使国务院卫生行政部门会同国务院有关部门规定的食品卫生监督职责”的规定,现就铁道行政主管部门食品卫生监督机构的监督职责作如下规定,请遵照执行。
一、铁道食品卫生监督机构职责范围的界定原则:
(一)必须符合食品卫生法的立法精神和基本原则,适应建立社会主义市场经济体制的要求,有利于加速我国法制化建设的进程。
(二)有利于提高卫生行政执法力度,避免食品卫生监督中的交叉重复和管理上的真空,责权一致,树立良好的政府执法形象。
(三)符合我国卫生行政体制改革方向,有利于贯彻国家有关卫生工作方针、政策,树立大卫生观,体现卫生全行业管理和区域卫生规划等宏观管理的指导思想。
(四)食品卫生监督以地域管辖为基础,同时充分考虑铁路食品卫生工作的特殊性,体现铁路食品卫生监督的特点,确保铁路运输、生产的正常进行。
(五)符合我国国情,体现积极发展各类卫生保健事业的思想,充分发挥铁路现有卫生资源的作用,以利于提高我国食品卫生监督的整体水平。
二、铁道食品卫生监督机构的职责、管辖范围:
(一)旅客列车、承运食品的列车及食品运输过程中的卫生监督,铁路车站内食品生产经营活动的卫生监督。
(二)铁路局(集团公司)、分局(总公司)、工程局(处)、段(队)和铁路招待所、乘务员公寓和铁路工厂、院、校内的食品生产经营活动的卫生监督。
(三)铁路家属集中区内的食品生产经营活动的卫生监督管理,根据住宅区的集中程度和地理位置不同,需要界定管辖范围的,由当地省级卫生行政部门会同所在地铁道行政主管部门作出规定。
(四)界定由铁道食品卫生监督机构管辖范围以外的铁路办食品生产经营者,由地方政府卫生行政部门统一监督管理。
(五)铁道食品卫生监督机构对管辖范围内的食品生产经营者进行卫生许可证审发,行使《食品卫生法》第三十三条规定的食品卫生监督职责。
三、卫生部通过铁道部卫生行政主管部门领导铁道食品卫生监督机构。各地政府卫生行政部门、铁道卫生主管部门,要严格按照本规定执行,从大局出发,从有利于保障食品的营养和卫生质量,预防和控制食源性疾病,保护人民群众和旅客的健康出发,相互支持,严肃执法。对执法中出现的具体问题,要协商解决,在各级政府的领导下共同做好食品卫生监督工作。


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为隐瞒贪污公款而实施爆炸行为的定性

20030102 广西河池市金城江区人民检察院 欧流献



案情:2002年4月份,某高等职业学院远程教学部干部兼出纳的覃某某,在对账中被发现有短款行为,而受到远程教学部副主任潘某某的批评,加上平时在工作中与潘某某有矛盾,更为达到隐瞒短款的目的,覃某某决定对潘某某采用爆炸的行为。 8月中旬,覃某某找来1992年通过非法渠道获取的销铵炸药3千克、电雷管1枚,并于8月15日以80元的价格购得摩托车用蓄电池1个。得知潘某某于20日到25日负责假期办公室值班的情况后,21日中午,覃某某在家里自制爆炸装置,用“AD钙奶”的纸箱装好,在纸箱上用园珠笔书写“电大远程办 潘某某老师亲起 内详”的字样。17时许,覃某某将爆炸装置放在摩托车后箱,从河池民族高等职业学院宿舍驾驶摩托车来到公路宾馆停车场内存放(两处相距3公里,是该城区最主要的交通、政治、经济地段)。19时许,覃某某拿出爆炸装置,雇佣一部“的士”来到河池民族高等职业学院远程教学部,用钥匙打开办公室大门,将爆炸装置放在韦某某的办公桌上,由于心慌,未锁好门即离开现场。当坐车来到河池市中级人民法院附近时,覃某某觉得不妥,就转坐一部“三马车”回到河池民族高等职业学院,进入远程教学部办公室内,感觉装有爆炸装置的纸箱放在办公桌上太显眼,就把爆炸装置放到韦某某办公桌下的地面上,用一张椅子挡在桌子前面,仍然没有锁好门就离开现场。次日7时30分,潘某某按时来到远程教学部办公室,打开虚掩的拉扎门进入室内,搞卫生时,发现写有自己收的纸箱,就拿到桌面上打开,发现是一自制的爆炸装置后,立即报警。
爆炸案发生后,检察院组成专案组,对覃某某的经济问题进行侦查,发现覃自2000年11月至2002年7月在远教部工作期间,利用手上掌握公款的便利及远教部对财务收费管理上的混乱,采取收入不记帐、支出虚报等手段,贪污公款139445.7元,并嫁祸于潘某某的事实。
本案对贪污罪的定性没有异议,对爆炸行为的定性主要有三种不同的意见:
第一种意见认为构成故意杀人罪(未遂),理由:
行为人覃某某主观上明知自制爆炸装置安放在办公室引爆的话会炸死被害人的后果发生,而希望这种结果发生,有故意杀人、夺取他人生命健康权的故意;犯罪侵犯的客体是特定人的生命权利和健康权利;客观方面表现为对特定人身实施爆炸行为。
第二种意见认为构成爆炸罪(未遂),理由:
根据《刑法》第二十三的规定,已经着手实行犯罪,由于犯罪分子意志以外的原因而未得逞的,是犯罪未遂。本案中,覃某某已经安放爆炸装置,着手实行犯罪,由于潘小心打开,未发生爆炸的后果,是覃某某意志以外的原因而未得逞的,所以覃的行为构成爆炸罪(未遂)。
第三种意见认为构成爆炸罪,理由:
认定行为人是否构成危害公共安全不应只看行为人的主观犯意,还应看行为人对危害公共安全持有何种心理态度,更主要的是行为人的犯罪行为是否足以危害到了公共安全。本案中,覃某某为了隐瞒贪污公款和报复的目的,,自制爆炸物途经繁华公共场所拿到被害人的办公室,表面上看侵犯的对象为特定的人,但不能保证潘某某某打开纸箱时无旁人在场,认定行为人是否构成危害公共安全不应只看行为人的主观犯意,还应看行为人对危害公共安全持有何种心理态度,更主要的是行为人的犯罪行为是否足以危害到了公共安全。本案中,被告人覃某某为了隐瞒贪污公款和报复的目的,竟然自制爆炸物并邮寄到被害人的办公室,从表面上看侵犯的对象为特定的人,但不能保证滕某拆开邮件时无旁人在场,实际情况是当潘某拆纸箱时,确有多人在办公室前的公共场所活动,这说明覃某某主观上具有危害公共安全的间接故意,客观上也危及到公共安全,使不特定的多数人的生命、健康或重大公私财产受到严重威胁。因此,其行为应认定为爆炸罪。
笔者同意第三种意见,即覃某某的行为构成爆炸罪。理由:
一是覃某某主观上具有危害公共安全的间接故意。覃某某明知当时虽然是假期,但办公室除潘某某值班外,还可能有其他老师来办公,并接待报名的学生,办公室前是师生和家属活动的公共场所,附近还有很多建筑物。覃某某为隐瞒贪污公款和报复的目的而自制爆炸物辗转途经繁华公共场所拿到被害人的办公室,虽然表面上看其侵害目标是特定的对象,但是,如果爆炸可能会伤及无辜,包括在运输途中。这一点,覃某某应当有所预见,因而应当认定覃某某具有危害公共安全的间接故意的心理态度。
二是客观上覃某某的行为足以造成对公共安全的危害。覃某某选择作案的地点是人口密集的办公大楼,作为领导的覃某某在办公室既有可能个人在工作,也有可能与他人在一起工作,还有可能接等学生报名,还有可能将纸箱带到其他公共场所打开;另一方面,由于自制炸弹的安全系数相对较小,如果在运输等过程中,由于其他不确定原因引起爆炸,所造成的危害结果显然并非特定对象。由于其侵害的对象带有不确定性,所以覃的行为属于危害公共安全,使不特定多数人的生命、健康和财产的安全受到威胁。
从《刑法》第114条和第115条来看,只要行为人实施爆炸,危害公共安全,尚未造成严重后果,就具备爆炸罪的全部构成要件,即为既遂。如果致人重伤、死亡或者使公私财产遭受重大损失,应按第115条作为爆炸罪的结果加重犯处罚。从立法精神看,不存在实行终了的未遂,因为爆炸行为已经实行终了,在一定条件下就足以危害不特定多数人的命、健康和财产的安全,无论是否引起严重后果,都是既遂。爆炸罪未遂,只能发生在爆炸行为尚未实行终了的阶段,比如刚着手引爆或者在引爆过程中,被人发现夺下炸药,使爆炸未能得逞,这种行为属于未实行终了的爆炸未遂。
该案经提起公诉,法院开庭审理查明,认为覃某某身为国家工作人员,为了达到隐瞒贪污公款的目的,不计后果地采用爆炸手段,企图夺取他人生命,该行为在社会上造成严重的影响,以覃某某犯贪污罪判处有期徒刑十一年,剥夺政治权利三年,犯爆炸罪判处有期徒刑五年,决定执行刑期十六年,剥夺政治权利三年。

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.