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食品药品监管总局关于进一步加强中药饮片生产经营监管的通知

发布时间:2015年02月10日    阅读量:717

各省、自治区、直辖市食品药品监督管理局:
  近日,广东省食品药品监管局针对中药饮片生产经营中存在的问题,积极主动开展检查,发现违法违规线索。总局根据上述线索开展飞行检查,发现多起中药饮片生产经营企业相互勾结、违法生产销售中药饮片的案件。总局已发布通告,并将飞行检查有关情况在总局政府网站“药品飞行检查”专栏予以通报。为进一步做好案件查处工作,切实加强中药饮片生产经营监管工作,现将有关要求通知如下:
Provinces, autonomous regions, municipalities directly under the central government, the food and drug administration:
Recently, the Guangdong provincial food and Drug Administration for Chinese herbal medicine production and management problems, and actively carry out inspection found illegal clues. According to the clue of flight inspection, found that the number of pieces of Chinese medicine production enterprises collusion, illegal production and sales of Chinese herbal medicine case. The administration has issued a circular, and the flight check the relevant information in the administration of the government website "drug inspection" columnto be informed. In order to further improve the case investigation work, strengthen thesupervision of Chinese herbal medicine production and management, the relevant requirements are hereby notified as follows:
  一、严厉查处违法违规行为
  总局要求立即停止销售和使用标识为广西玉林市祥生中药饮片有限责任公司、广西玉林市华安堂中药饮片有限责任公司、广西玉林市华济中药饮片有限责任公司、广西健一药业有限责任公司中药饮片加工厂、安徽亳州市国苑中药材饮片有限公司、安徽泰源中药饮片有限公司等6家企业的全部产品。广东、广西、安徽省(区)食品药品监管局已责令涉事的6家生产企业和4家批发企业暂停生产销售,督促企业彻底召回以其名义生产销售的全部中药饮片,并公开召回信息。广东、广西、安徽省(区)食品药品监管局要进一步加大案件查办力度,全面深入查清违法事实,坚决依法吊销涉事企业的《药品生产许可证》或《药品经营许可证》;对涉嫌犯罪的,及时移交公安机关追究刑事责任。其他相关省级食品药品监管部门要积极配合,协助做好召回工作。只有选择优质的产品生产设备,才能生产符合国家标准的药品,亚博足彩生产的不锈钢人孔不锈钢离心泵不锈钢人孔洁净设备完全满足行业标准。
A, and severely punish illegal behavior
General requirements to immediately stop the sale and use the logo for Guangxi Yulin Xiangsheng medicine limited liability company, Guangxi Yulin Huaan City Hall of Chinese herbal medicine limited liability company, Guangxi Yulin City Hua Ji all products of Chinese herbal medicine limited liability company and Guangxi health pharmaceutical limited liability company of Chinese herbal medicine processing plant in Bozhou City, Anhui Court Medicine Co. Ltd, Anhui Taiyuan Pharmaceutical Co. Ltd. and other 6 companies. Guangdong,Guangxi, Anhui province (area) 6 production enterprises of the food and drug administrationhas ordered the involved and 4 wholesale enterprises to suspend production and sales, and urge enterprises to recall in the name of the production and sales of all Chinese herbal medicine, and a public recall information. Guangdong, Guangxi, Anhui province (area) the food and drug administration to further increase the intensity of investigating the case,thoroughly to identify illegal facts, resolutely revoke the companies involved in the "drug production license" or "drug license"; suspected of a crime, criminal responsibility shall be investigated promptly transferred to public security organs. Other relevant provincial food and drug supervision departments should actively cooperate, assist to recall. Only choose the high quality production equipment, in order to meet the national standards for the production of pharmaceutical, Zhejiang Miller clean equipment Co. Ltd production of stainless steelmanhole, stainless steel centrifugal pump, stainless steel manhole cleaning equipment can meet the industry standard.
  二、进一步加强中药饮片监督管理
  违法生产经营中药饮片案件频发,反映出中药饮片的监管形势依然严峻,各级食品药品监管部门要引起高度警觉,举一反三,进一步加强对中药饮片生产经营的监督管理。要坚持问题导向,确定检查重点,对重点地区,尤其是对中药材专业市场周边的中药饮片生产经营企业要加大检查力度。对发现的线索要一追到底,对违法违规行为要依法严厉查处,坚决将非法生产经营的企业清退出市场。对中药饮片生产经营企业外购非法饮片出售的,药品生产经营企业出租出借证照或虚开票据为非法生产经营提供便利的,坚决吊销其《药品生产许可证》或《药品经营许可证》,并予以公开曝光;对涉事企业的饮片产品必须停止销售使用,责成企业召回产品,并公开召回信息;对涉嫌犯罪的,及时移送公安机关依法追究责任。
Two, to further strengthen the supervision and management of Chinese herbal medicine
The illegal production and operation of the frequent cases of Chinese herbal medicine,Chinese herbal medicine reflects the regulatory situation is still grim, food and drug supervision departments at all levels should be vigilant, by analogy, to further strengthen the supervision and management of Chinese herbal medicine production and management. To adhere to the problem oriented, focus on examination to determine, in key areas, especially for Chinese herbal medicine market surrounding the Chinese herbal medicine production enterprises to increase inspection efforts. To find clues to a catch in the end, the illegal activities severely punished according to law, and resolutely to the illegal production and operation of enterprises out of the market. The sale of Chinese herbal medicine production enterprises purchased illegal pieces, drug production enterprises lending licenses or false bills to provide convenience for the illegal production and operation, and resolutely revoke its"drug production license" or "drug license", and be exposed to the public; the enterprises involved pieces products must stop selling. To instruct the enterprise product recall, recall andpublic information; suspected of a crime, shall be investigated for responsibility according to law in a timely manner to the public security organ.
  三、切实落实监管责任
  各省级食品药品监管部门应当切实落实监管责任,严格依照药品生产经营质量管理规范及相关附录要求,严格执行中药饮片生产企业、药品经营企业的准入标准,不得以任何理由降低中药饮片生产企业、药品经营企业开办条件。对中药饮片生产经营企业集中且反复出现问题的地区,要切实加大监管力度,防止发生区域性风险。要切实加强日常监管,督促中药饮片生产企业依法依规生产经营,落实企业主体责任,严格执行法定药品标准和《药品生产质量管理规范(2010年修订)》有关要求,确保中药饮片质量。
Three, earnestly implement the regulatory responsibility
The provincial food and drug supervision departments should earnestly implement the regulatory responsibility, in strict accordance with the standards for quality control ofpharmaceutical production management and related appendix requirements, strict implementation of Chinese herbal medicine production enterprises, pharmaceutical trading enterprises access standards, shall not be any reason to reduce the pieces of Chinese medicine production enterprises, pharmaceutical trading enterprises run condition. TheChinese herbal medicine production enterprises concentrated and recurring problem areas, tostrengthen supervision, prevent the occurrence of the risk of regional. To strengthen the daily supervision, and urge Chinese herbal medicine production enterprises in accordance with the law and regulations of production and management, the implementation of corporate responsibility, strict implementation of the legal standard of drug and the "standards for quality control of pharmaceutical production (2010 Revision)" the relevant requirements, to ensure that the quality of Chinese herbal pieces.
  各地务必要提高认识,认真开展检查,坚决进行查处,做好信息报送和公开。对查实违法违规案件要主动公开,对制假售假、涉及面广、危害性大、情节严重的重大案件,要及时向总局报告。总局将继续开展飞行检查和督查工作,对监管不到位、监督责任不落实的,将通报批评,并依法依纪严肃追究责任。
All localities must enhance understanding, earnestly carry out the inspection, and resolutelyinvestigate and deal with, good information submitted and open. The verified violations of lawsto take the initiative to the public, to the production and sale of counterfeit goods, involving a wide range of major cases of great harm, the circumstances are serious, shall report to the State Administration of taxation. The administration will continue to carry out flight inspection and supervision work, not the implementation is not in place, the oversight responsibility, will be informed criticism, and in accordance with the law and discipline serious accountability.


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