FDA response to illegal vaccines out of the case: identifying flow to quickly dispose of illegal vaccines out of the case _ | news

Original title: illegal vaccine into provincial food and drug administration requirements to identify flow to quickly dispose of

Xinhua Beijing March 18 Electric (reporter wangsi North) for Shandong Jinan recently cracked of involved amount over 500 million yuan of illegal business people with vaccine case, national food drug regulatory General spokesman 18th said, food drug prison General has obliges Shandong province food drug regulatory Council with police and health family planning sector, immediately identified vaccine, related products of source and flows, will first time to social public related information.

According to introduced, since 2011 yilai, crime suspects Pang XXX and its daughter Sun a in not gets any drug business license of situation Xia, in online contact China more than 10 more than province (City) of more than 100 more than medicine company salesman or vaccine illegal business personnel, purchased into control je, and crazy dog, and flu, virus of 25 species people with II class vaccine or biological products, increases sales to country more than 300 more than vaccine illegal business personnel or few disease control sector grass-roots site, involved value up more than 570 million more Yuan. Because the case major, proceeding subsequently by the Chinese Ministry of public security and the State food and drug administration as a supervising the case.

By the food and drug supervision departments to verify, although two suspects engaged in vaccines and biological products for the regular factory production, but not in accordance with the relevant national laws and regulations on transport, storage, out of 2-8 degrees Celsius temperature cold-chain has been difficult to ensure quality and effectiveness, even after the injection may cause side effects.

This reporter has learned, effective as of June 1, 2005 vaccine circulation and inoculation regulations explicitly require, pharmaceutical retail businesses may engage in the vaccine business. Only professionals who have engaged in vaccine management, cold storage facilities to ensure vaccine quality, equipment and refrigerated transportation, meet the vaccine stockpile, transport management and standardized management system of medicine wholesale enterprise may engage in vaccine approval and operational activities.

At present, the two suspects for allegedly illegal business Jinan municipal Public Security Bureau has been carrying out arrests, the case has been transferred to the procuratorial organs for examination and prosecution.

In this regard, the food and drug administration requirements, in connection with the products into food and drug supervision departments at the provincial level according to the public security organ to provide clues, immediately identifying flows of product purchased, used and inventory, unused immediately seized; on vaccination has been used for the human body, health and family planning departments to quickly identify specific situations, and to evaluate the effectiveness of vaccination in order to protect public health.

Food and Drug Administration spokesman, on suspect products for sale to illegal business vaccine production and operation of enterprises, and buy products from its operation, and use of, will immediately initiate an investigation by the provincial food and drug supervision departments, seriously dealt with according to law. Related work will be offered to the public in a timely manner. (End)

Responsible editor: Ni Zi Jiang

Article keywords:
Cases of illegal vaccines out of

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食药局回应非法疫苗流出案：查清流向迅速处置|非法疫苗流出案_新闻资讯

　　原标题：非法疫苗流入多省 食药监总局要求查清流向迅速处置

　　新华社北京3月18日电 (记者王思北)针对山东济南日前破获的涉案金额逾5亿元的非法经营人用疫苗案件，国家食品药品监管总局新闻发言人18日表示，食药监总局已责成山东省食品药品监管局会同公安和卫生计生部门，立即查清疫苗等相关产品的来源和流向，将第一时间向社会公开相关信息。

　　据介绍，自2011年以来，犯罪嫌疑人庞某某和其女儿孙某在未获取任何药品经营许可的情况下，在网上联系中国10余个省(市)的100余名医药公司业务员或疫苗非法经营人员，购入防治乙脑、狂犬、流感等病毒的25种人用二类疫苗或生物制品，加价销售给全国各地300余名疫苗非法经营人员或少量疾控部门基层站点，涉案价值达5.7亿多元。由于案情重大，此案随后分别被中国公安部、国家食药监总局列为督办案件。

　　经食药监管部门核查，两名犯罪嫌疑人经营的疫苗及生物制品虽为正规厂家生产，但由于未按照国家相关法律规定运输、保存，脱离了2－8摄氏度的恒温冷链，已难以保证品质和使用效果，注射后甚至可能产生副作用。

　　记者了解到，自2005年6月1日起施行的《疫苗流通和预防接种管理条例》明确要求，药品零售企业不得从事疫苗经营活动。只有具有从事疫苗管理 的专业技术人员，具有保证疫苗质量的冷藏设施、设备和冷藏运输工具，具有符合疫苗储存、运输管理规范的管理制度的药品批发企业经批准后方可从事疫苗经营活动。

　　目前，两名犯罪嫌疑人因涉嫌非法经营罪已被济南市公安局依法执行逮捕，案件已移送检察机关审查起诉。

　　对此，食药监总局要求，涉案产品流入地省级食品药品监管部门根据公安机关提供的线索，立即查明流入的疫苗产品购进、使用和库存情况，对尚未使用的立即查扣；对已用于人体接种的，会同卫生计生部门迅速查清具体情况，并对接种效果进行评估，切实保护公众健康。

　　食药监总局新闻发言人表示，对向非法经营疫苗嫌犯销售产品的生产经营企业，以及从其购入产品的经营、使用单位，将由所在地省级食品药品监管部门立即立案调查，依法严肃处理。相关工作进展将及时向社会公开。(完)

责任编辑：倪子牮

文章关键词：
非法疫苗流出案

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