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鸿茅药酒 公司从未宣称 鸿茅药酒可 包治百病_www.forex21.cn

时间:2018/4/26 21:19:50 点击:

  核心提示: Today (April 26th) afternoon, Hong Mao pharmaceutical liquor in its official account issued by the ...
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Today (April 26th) afternoon, Hong Mao pharmaceutical liquor in its official account issued by the enterprise self-examination and rectification report, which said that at present, all advertisements have been suspended, and expressed the recognition that Hong Mao pharmaceutical liquor in the last five years of advertising has a large amount of advertising, downstream dealers and retail drugstores advertising violations and other issues. For the security of social concern, the source of the leopard and the quality of production, Hong Mao liquor indicates that the purchase and use of the "leopard bone" is in conformity with the laws and regulations, and that "the use of Hong Kong medicinal liquor in accordance with the usage and dosage of pharmaceutical instructions is safe". (Zhang Xiaomei, a journalist from the North Qing newspaper)

The full text of the self-examination report is as follows:

Inner Mongolia Hong Mao country drug Limited by Share Ltd (hereinafter referred to as "Hong Mao national medicine"), as the main responsibility of the market and security of Hong Mao drug wine, according to the requirements of the former State Administration of food and drug administration, the State Administration of drug administration and the food and drug Administration of the Inner Mongolia Autonomous Region, conscientiously look up their own problems and strengthen their quality. Safety, strengthen risk control, standardize production and operation, and resolutely be responsible for consumers.

After the recent public opinion of Hong Mao drug wine event, our company did not seriously judge the risk, actively voice, take the initiative, respond actively to social concerns, leading to further expansion of public opinion. As a result, the company has attached great importance to the problems and impacts brought by the various sectors of the society, and sincerely apologized to the public for its understanding.

This incident is a profound lesson for Hong Mao's medicine. Our company is soberly aware that as a pharmaceutical production enterprise, we must bear the responsibility of the main responsibility, take full responsibility for the safety and effectiveness of the whole life cycle of the product; undertake the task of direct reporting of adverse reactions and the continuous improvement of the quality of the drug, and ensure the safety and health of the consumers with higher quality products and services.

Our company is conscientiously organizing self-examination, and actively cooperating with the inspection of relevant state functional departments, and now inform all walks of life by the current self-examination and rectification to all walks of life as follows:

I. explanation of the safety, leopard bone origin and production quality of Hong Kong medicinal liquor, which is highly regarded by the society.

1. the "preparation of aconite, the Pinellia ternata and the making of the Southern Star" are all processed products. According to the daily dosage required by the pharmaceutical instructions, the dosage of the medicinal herbs is converted into the medicinal dosage. The daily dosage of the medicinal materials is within the scope of the safe dosage stipulated in the Pharmacopoeia. Therefore, it is safe to use Hong Kong medicinal liquor according to the usage and dosage of drug instructions.

The rhizoma Aconiti Lateralis Preparata and Rhizoma Pinelliae Preparata are commonly used in Chinese patent medicine.

2. in view of the safety of Hong Mao drug wine, our company has carried out toxicity test, major pharmacodynamic research and clinical trial, and the research and experimental conclusions are safe and effective. According to the data of the adverse reaction center, 137 cases of adverse reaction were reported from 2004 to the end of February 2018. The main adverse reactions were dizziness, pruritus, rash, vomiting and abdominal pain.

3. the purchase and use of "leopard bone" in Hong Mao medicinal liquor comply with laws and regulations. In the process of production, the material balance meets the requirements. In 2007, we started the research work of leopard bone in Hong Mao medicinal liquor and completed the pharmacodynamic comparative experiment.

4. our company has been carrying out comprehensive management in strict accordance with the requirements of the "standards for drug production quality management". In the process of production quality management, we constantly improve the production quality management assurance system to ensure product quality stability. In the previous sampling inspection of products, no product failed. In the future, our company will continue to organize production according to the requirements of GMP standards, and undertake the main responsibility for continuous reporting of adverse reactions and continuous improvement of product quality.

In the future, our company will further strengthen the risk assessment of drug safety, actively monitor the risk of drug, and continue to study the safety and effectiveness of Hong Mao drug wine, keep the "quality" and "drug safety", and better responsible for the consumer.

Two, about the public and media attention to Hong Kong drug liquor advertising problem description

Through strict self-examination and profound introspection, our company has realized that the advertising of Hong Mao drug liquor in the last five years has a large amount of advertising, the downstream dealers and retail drugstores, such as advertising violation, and so on; enterprise management is overly dependent on advertising.

 

今天(4月26日)下午,鸿茅药酒在其官方账号发布企业自查整改报告,其中表示,目前已停播全部广告,并表示认识到鸿茅药酒在近五年的广告投放中存在广告投放量大、下游经销商和零售药店广告违规等问题。对于社会关注的安全性、豹骨来源及生产质量等问题,鸿茅药酒表示"豹骨"的购买及使用符合法律法规,并称"按照药品说明书的用法用量使用鸿茅药酒是安全"。(北青报记者张小妹)

自查报告全文如下:

内蒙古鸿茅国药股份有限公司(以下简称"鸿茅国药"),作为鸿茅药酒市场与安全的责任主体,按照原国家食品药品监督管理总局、国家药品监督管理局和内蒙古自治区食品药品监督管理局的要求,认真查找自身问题,强化质量安全,加强风险控制,规范生产经营,坚决做到对消费者负责。

在近期鸿茅药酒事件的舆情发生后,我公司没有认真研判风险,主动发声,主动处置,主动回应社会关切,导致舆情进一步扩大。由此,给社会各界带来的问题和影响,我公司高度重视并向社会真诚道歉,恳请公众谅解。

本次事件,对于鸿茅国药是一次深刻教训。我公司清醒地认识到,作为一家药品生产企业,必须承担主体责任,对产品全生命周期的安全性和有效性负全部责任;承担不良反应直报和对药品质量持续提升的任务,以更高质量的产品和服务保障消费者的安全和健康。

我公司正在认真组织自查,并积极配合国家相关职能部门的检查,现将截至目前的自查及整改情况向社会各界通报如下:

一、对于社会高度关注的鸿茅药酒安全性、豹骨来源及生产质量等问题的说明

1.鸿茅药酒组方中的"制附子、制半夏、制天南星"都是炮制品,按照药品说明书要求的日服用量,折算成药材剂量,上述药材日用量均在药典规定的安全用量范围之内。因此,按照药品说明书的用法用量使用鸿茅药酒是安全的。

鸿茅药酒组方中制附子和制半夏同用在中成药制剂中具有普遍性。

2.针对鸿茅药酒的安全性,我公司主动开展过毒性试验、主要药效学研究和临床试验,研究和试验结论是安全有效的。根据不良反应中心数据,2004年至2018年2月底,鸿茅药酒共有不良反应报告137例,不良反应主要表现为头晕、瘙痒、皮疹、呕吐、腹痛等。

3.鸿茅药酒中"豹骨"的购买及使用符合法律法规。生产过程中,物料平衡符合要求。并在2007年启动了鸿茅药酒中去豹骨研究工作并完成了药效学对比研究实验。

4.我公司始终严格按照《药品生产质量管理规范》的要求进行全面管理。在生产质量管理过程中,不断完善生产质量管理保证体系,保证产品质量稳定。在历次产品监督抽检中,未出现产品不合格情况。今后,我公司会持续按照GMP标准要求组织生产,承担不良反应直报和产品质量持续提升的主体责任。

今后,我公司将进一步加强药品安全性的风险评估,主动监测药品风险,并对鸿茅药酒持续进行安全性和有效性研究,守好"品质关"和"用药安全关",更好地对消费者负责。

二、关于社会公众及媒体关注的鸿茅药酒广告问题的情况说明

我公司经过严格自查及深刻反省,认识到鸿茅药酒在近五年的广告投放中存在广告投放量大、下游经销商和零售药店广告违规等问题;企业经营管理过度依赖广告、广告发布管理存在漏洞等问题。我公司对由此引发的媒体争议、社会批评,负有不可推卸的主体责任。

1.近五年来,我公司作为广告投放主体,发布的广告平台为中央电视台、中央人民广播电台、各卫视及地方媒体。经认真自查,广告发布过程均依法合规。但鸿茅药酒的全国各地经销商和零售药店存在违规发布广告的问题。通过查询近五年的《违法药品医疗器械保健食品广告公告》,涉及鸿茅药酒的公告共计17个,其中2015年9月1日新《广告法》颁布之后的公告有4个。

2.关于"鸿茅药酒祝您:每天两口健康长寿"广告语的创意,是因为鸿茅药酒产品说明书中的用法用量为:口服一次15毫升,一日2次。因药酒剂型特殊,有酒的特性,容易出现消费者超过规定用量服用的情况,所以广告语表述为"每天两口",是特意提醒消费者每天服用量不要超过"两口",以保证用药安全;"祝您健康长寿",则是一句祝福语。为避免歧义,2017年12月,内蒙古自治区食品药品监督管理局按照原国家食品药品监督管理总局有关部门的要求,及时与我公司约谈,要求企业对凡是含有有可能引起误解、歧义、争议广告用语的广告全部改版、尽快停播。我公司已按要求停播有关广告,并交回了相关广告批文。

2018年改版后播出的广告内容特意增加"鸿茅药酒提示您,购买药品前请阅读说明书"的安全用药公益性宣传,同时也明确了鸿茅药酒是药品的属性。

3.近年来,鸿茅药酒饱受侵权产品、假冒产品的侵害,我公司从未发布过"喝鸿茅百病消"、"鸿茅药酒包治百病"等广告内容,也从来没有宣称过"鸿茅药酒能够治疗高血压、糖尿病",对此我公司将进一步调查其发布主体及来源,并进行追责。

目前,为了消除不良影响,承担企业主体责任,我公司采取了一系列从严整改措施。现已停播中央电视台、中央人民广播电台、各卫视及地方媒体的全部广告;同时派出检查小组,深入全国31个省市自治区开展自查自纠工作;从速建立了从企业到零售终端的完整、严格、可控的广告宣传管理链条;对假冒鸿茅商标或商号的违法经营行为进行维权;积极宣传药品用药安全;承担社会责任、关爱患者健康、大力参与和推动社会公益活动。

最后,鸿茅国药感谢近日来媒体和舆论的关注和批评,向各界人士及消费者真诚道歉。同时也欢迎社会各界在我公司今后的发展中继续发挥监督作用。
其实,前一段时间上述消息在圈内已经有传言了,终于得到了主流媒体的报道。

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