Beijing food and Drug Administration investigation Shandong illegal vaccine clues
Legal evening news (reporters Zhang Xin) Beijing released food and drug administration, according to the State food and drug administration of deployment, combined with clues posted in Shandong province, were deployed to the city′s on-site inspection of vaccine production, circulation, and collaboration with the City Health Commission, public security organs, strengthening distribution channels, relevant persons and the use of the vaccine involved aspects of the investigation. In addition, the municipal food and drug supervision Bureau work closely with public security organs, is released to the media in Beijing 6 of the identity of persons, experiences such as verification, line up and down if found involved will be immediately traced, the offenders severely punished according to law.
Municipal food and Drug Administration said the vaccine production in the city, trading enterprises and other drug wholesaler has been requested by the food and Drug Administration to conduct self-examination, focus on the sale of customer intelligence and raw materials, including sales of units identity, authorization of consignees. About Enterprise head said, they has will 2013 yilai vaccine sales flows finishing finished, at any time reference; while also according to food drug Council requirements, on enterprise of sales customer units and sales personnel for troubleshooting, see whether has has column ming of involved Shang, and line personnel and whether and involved personnel has had directly or indirect of vaccine trading, as has will will immediately report food drug regulatory sector and police sector.
Municipal food and drug supervision Bureau said March 19-20th, municipal food and drug supervision Bureau sent out 34 inspection unit, 6, the vaccine manufacturer, 28 drug wholesale enterprises with vaccine industry conducted an on-site inspection. (Method micro-ID:fzwb_52165216 night)
In the vaccine production process, checking since 2013, all vaccine products in the production account, sales accounting, product issue, are checked one by one to confirm product outbound order, receipt confirmation document, cold chain transport document and yet discovered, I sell vaccine to individual offenders behavior, check and confirm that is still underway.
Reporter (method late micro-letter ID:fzwb_52165216) understand to, in vaccine circulation link, main check drug wholesale Enterprise 2013 yilai, vaccine of purchased into, and sales, and inventory number whether consistent, and notes whether match, and purchase and sale channel whether legal, and retained qualification whether meet requirements, content; business of vaccine whether are has registered approved proved file, whether batch batch has drug test report book, supply vaccine production enterprise whether has vaccine production range, and Whether to adopt good manufacturing practices (GMP) certification; superior vaccine delivery business unit has the vaccine business, whether through the new drug business quality management standard (GSP) certification to purchase units check that the vaccine industry, as well as through the new version of GSP certification, the existence of sales to individuals and no vaccination certificate for medical institution.
Food and drug administration official said, clues have been close contact with the City Department of health and family planning, to find medical and health institutions to buy into, use clues to vaccine and related personnel involved will be duly informed of health and family planning sectors. In addition, the municipal food and drug supervision Bureau work closely with public security organs, is released to the media in Beijing 6 of the identity of persons, experiences such as verification, line up and down if found involved will be immediately traced, the offenders severely punished according to law.
(Editors: Pan Yi burn UN657)
2016-03-20 18:23:17
Legal evening news
北京食药监局排查山东非法经营疫苗案件线索
法制晚报讯 (记者 张鑫)北京市食品药品监督管理局发布消息，根据国家食药监总局统一部署，结合山东省局网上公布的线索，部署了对全市疫苗生产、流通环节的现场检查工作，并与市卫生计生委、公安机关协作，加强对涉案疫苗的流通渠道、相关人员以及使用环节的排查。此外，市食药监局密切配合公安机关，正在对媒体公布的涉及北京的6名人员的身份、从业经历等进行核查，如有发现涉案的上下线人员，将立即追根溯源，对违法分子依法严惩。
市食药监局表示，全市疫苗生产、经营企业及其他药品批发企业已经根据食药监局的要求全面开展自查，重点检查本单位销售的下游客户资质，包括销售单位收货人员的身份信息、单位授权书。有关企业负责人表示，他们已经将2013年以来疫苗销售流向整理完毕，随时备查;同时也按照食药局要求，对企业的销售客户单位和销售人员进行排查，看是否有已经列明的涉案上、下线人员以及是否与涉案人员有过直接或间接的疫苗交易，如有将会立即报告食药监管部门和公安部门。
市食药监局称，3月19-20日，市食药监管局派出34个检查组对本市6家疫苗生产企业、28家具有疫苗经营范围的药品批发企业进行了现场检查。（法晚微信ID:fzwb_52165216）
在疫苗生产环节，检查了2013年以来，全部疫苗产品的生产台帐、销售台帐、制品批签发情况，正在逐笔核对确认疫苗产品出库单、收货确认单据、冷链运输单据等，暂未发现我市生产企业向个人违法销售疫苗行为，检查和确认仍在进行中。
记者（法晚微信ID:fzwb_52165216）了解到，在疫苗流通环节，主要检查药品批发企业2013年以来，疫苗的购进、销售、库存数量是否一致、票据是否相符、购销渠道是否合法、留存资质是否符合要求等内容;经营的疫苗是否都有注册批准证明文件，是否批批具有药品检验报告书，供货疫苗生产企业是否具有疫苗生产范围、是否通过药品生产质量管理规范(GMP)认证;上级供货疫苗经营单位是否具有疫苗经营范围、是否通过新版药品经营质量管理规范(GSP)认证;对购货单位则检查该单位的疫苗经营范围以及是否通过新版GSP认证，是否存在销售给个人和无疫苗接种资质的医疗机构。
食药监局有关负责人表示，已就相关案件线索与市卫生计生部门密切联系，对发现的医疗卫生机构购入、使用涉案疫苗以及相关人员的线索，将及时通报卫生计生部门。此外，市食药监局密切配合公安机关，正在对媒体公布的涉及北京的6名人员的身份、从业经历等进行核查，如有发现涉案的上下线人员，将立即追根溯源，对违法分子依法严惩。
(责任编辑：潘奕燃 UN657)
2016-03-20 18:23:17
法制晚报