CannTrust shipped unlicensed medical cannabis overseas 

CannTrust 将未获许可的医用大麻运往海外

2019-07-10 10:41:36 mjbizdaily

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Beleaguered cannabis grower CannTrust shipped some unlicensed medical cannabis overseas, the Ontario company told Marijuana Business Daily, adding an international dimension to the Canadian company’s regulatory woes. The overseas shipments of unlicensed product raise questions about CannTrust’s own quality controls and Health Canada’s overall capability to monitor medical cannabis exports, according to experts. Those issues, in turn, could result in further scrutiny from the International Narcotic Control Board, which has said Canada is in violation of the 1961 Single Convention on Narcotic Drugs. On Monday, Health Canada sanctioned CannTrust for conducting unlicensed cultivation for six months at its facility in Pelham, Ontario. As a result, the company is holding back from the market 12,500 kilograms (27,500 pounds) of marijuana. The company’s greenhouse facility in Pelham, Ontario, received a “noncompliant” rating from Health Canada for operating five unlicensed rooms between last October and March 2019. Depending on the outcome of Health Canada’s review and product testing, CannDelta CEO Sherry Boodram said Canadian cannabis companies operating oversees may receive some backlash. “However Canada does have very high standards for cannabis production and foreign countries and companies should not be overly concerned,” she said. “It’s definitely a learning lesson for other cannabis companies.” if (!window.AdButler){(function(){var s = document.createElement("script"); s.async = true; s.type = "text/javascript";s.src = 'https://servedbyadbutler.com/app.js';var n = document.getElementsByTagName("script")[0]; n.parentNode.insertBefore(s, n);}());} var AdButler = AdButler || {}; AdButler.ads = AdButler.ads || []; var abkw = window.abkw || ''; var plc299585 = window.plc299585 || 0; document.write('<'+'div id="placement_299585_'+plc299585+'">'); AdButler.ads.push({handler: function(opt){ AdButler.register(172085, 299585, [300,250], 'placement_299585_'+opt.place, opt); }, opt: { place: plc299585++, keywords: abkw, domain: 'servedbyadbutler.com', click:'CLICK_MACRO_PLACEHOLDER' }}); International shipments Health Canada would not verify whether any of the unsanctioned medical marijuana had been shipped overseas. But in an email to MJBizDaily, CannTurst said some had. “CannTrust has international supply agreements with partners in Australia and Denmark. A portion of the cannabis cultivated in the five rooms pending licensing would have been shipped to these markets after passing quality testing at Health Canada certified labs,” CannTrust said in a statement. CannTrust’s partner in Denmark, STENOCARE, confirmed in a press release that a small amount of the cannabis had been shipped to the country. It has been set aside and is not expected to have any negative impact on patients, the company said. “STENOCARE has been in contact with the Danish Medicines Agency, and the single, noncompliant small batch has been put in quarantine for potential destruction, pending the outcome of the ongoing investigation by Health Canada,” the Dutch company noted in its statement. Deepak Anand, CEO of Toronto cannabis firm Materia Ventures, said the news will be concerning for international medical cannabis regulators and raises some doubts on the quality controls of both Health Canada and CannTrust. “I imagine (the regulators) will be forced to at a minimum write to Health Canada to inquire as to receiving some assurances that the products are safe for consumption and equally as important for them will be to ensure that none of them as regulators and governments are off side on their international obligations – as far as international conventions go,” he said. “(Health Canada) might have inadvertently issued an export permit for unlicensed product which could make both governments – the one issuing the import permit and the other the export permits – in violation of the conventions – albeit inadvertently.” ‘Noncompliant’  In an email to Marijuana Business Daily, Health Canada said CannTrust has 10 business days – until July 18 – to respond to the noncompliant inspection report. The regulator will determine the appropriate compliance and enforcement action after reviewing any additional information the company provides. Health Canada conducted an unannounced inspection at CannTrust’s facility in Pelham on June 17, which resulted in “critical observations” and an overall noncompliant rating for the inspection. Critical observations are made for a deficiency that will increase diversion and/or will cause health risks. Critical observations are rare. The regulator only noted two such instances in the recently-released compliance report for fiscal-2017-2018 out of 257 inspections. Health Canada said the critical observations were for conducting unauthorized activities – namely, producing cannabis in unlicensed rooms before obtaining regulator approval – providing false and misleading information to inspectors during the inspection, and inadequate record keeping. The inspectors returned to the facility on July 3 and July 4 to hand deliver the inspection report and seized 4,327 kilograms (9,539 pounds) of implicated product, and obtained samples for further testing. CannTrust had previously stated that Health Canada put “a hold” on 5,200 kilograms of dried cannabis inventory and the company voluntarily held back another 7,500 kilograms of dried cannabis equivalent. ‘Root cause’ In emailed responses to queries from MJBizDaily, CannTrust said it will submit a report to Health Canada with “a root cause analysis” and steps the company is taking to address the findings. “We have bolstered our quality and compliance department and improved our processes along the way. We want to reassure our patients and consumers that all CannTrust products are safe and have passed quality testing at Health Canada certified labs as well as CannTrust’s own quality control processes and safety reviews,” the company said. CannTrust said it does not know exactly how much product from the unlicensed rooms was sold into the regulated adult-use market or to medical patients. “We don’t have the exact numbers yet while we complete our full investigation,” the company said, noting that all product sold from the unsanctioned rooms had passed quality control testing at Health Canada-certified labs as well as the company’s quality control processes and safety reviews. “We are in contact with all of our provincial retail partners to ensure that they have the information they need and understand any potential impact on supply for consumers.” CannTrust shares trade as CTST on the New York Stock Exchange and as TRST on the Toronto Stock Exchange.
加拿大安大略省的大麻种植公司 CannTrust 告诉《马里亚纳商业日报》( Marijuana Business Daily ),陷入困境的大麻种植者 CannTrust 将一些未获许可的医用大麻运往海外,这为这家加拿大公司的监管困境增添了一个国际层面。 专家表示,无证产品的海外发货令人质疑 CannTrust 自身的质量控制以及加拿大卫生部监控医用大麻出口的整体能力。 反过来,这些问题可能会导致国际麻醉品管制局的进一步审查,该委员会曾说,加拿大违反了1961年《单一麻醉药品公约》。 周一,加拿大卫生部批准了 CannTrust 在其位于安大略省佩勒姆的工厂进行为期六个月的无证种植。 因此,该公司正从市场上撤出12500公斤(27500磅)大麻。 该公司位于安大略省佩勒姆( Pelham )的温室设施因在去年10月至2019年3月间经营五间无证客房而获得加拿大卫生部( Health Canada )的“违规”评级。 根据加拿大卫生部的审查结果和产品测试结果, CannDelta 首席执行官 SherryBoodram 表示,加拿大大麻公司在监管下运营可能会受到一些反弹。 “然而,加拿大在大麻生产方面的确有很高的标准,外国和企业不应过分担心,”她说。 “对其他大麻公司来说,这绝对是一个教训。” 如果(! windows.AdButler ){( function (){ vars = document 。createElement (" script "); s .async = true ; s 。type =" text / javascript "; s 。src =' https://servebyadbutler 。com / app 。js '; var n = document 。getElements ByTagName (" script ")[0]; n 。父母。插入( s , n );();} 变量 AdButler = AdButler |{}; AdButler 。广告= AdButler 。广告[]; varabkw = wind 。abkw |; var plc299585= window 。plc299585||||0; 文件。写入(<'+' div id =" place _299585_+ plc299585+"); 阿德巴特勒。广告。push ({ handler : function ( opt ){ AdButler 。register (172085,299585,[300,250],' place _299585_+ opt.place , opt );}, opt :{ place : plc299585++,关键字: abkw , domain :' served by ad管家。com ',单击:' CLICK _ MACRO _ PLCEHOLDER '}"; 国际货运 加拿大卫生部不会核实任何未经批准的医用大麻是否已运往海外。 但 CannTurst 在给 MJBizDaily 的一封电子邮件中说,有些人已经收到了。 “ CannTrust 与澳大利亚和丹麦的合作伙伴签订了国际供应协议。CannTrust 在一份声明中表示:“在等待许可的五个房间里种植的大麻中,有一部分将在通过加拿大卫生部认证实验室的质量检测后运往这些市场。” CannTrust 在丹麦的合作伙伴 STENOCARE 在一份新闻稿中证实,少量大麻已经运往该国。该公司表示,它已被搁置,预计不会对患者产生任何负面影响。 这家荷兰公司在声明中指出:“ STENOCARE 一直与丹麦药品管理局保持联系,在加拿大卫生部正在进行的调查结果出来之前,一批不合格的小批药品已被隔离,以备潜在销毁。” 多伦多大麻公司 Materia Ventures 的首席执行官 Deepak Anand 表示,这一消息将引起国际大麻监管机构的关注,并对加拿大卫生部和 CannTrust 的质量控制提出了一些质疑。 “我认为(监管机构)将被迫至少致函加拿大卫生部,询问是否收到一些保证,即这些产品对消费是安全的,对它们同样重要的是,确保它们中没有一个像监管机构和政府那样不履行国际义务——就国际公约而言,他说。 “(加拿大卫生部)可能无意中发布了无证产品出口许可证,这可能使两国政府(签发进口许可证的政府和签发出口许可证的政府)违反公约,尽管是无意中的。” “不合规” 加拿大卫生部在给《大麻商业日报》的一封电子邮件中表示, CannTrust 有10个工作日(直到7月18日)来回应不符合规定的检查报告。 监管机构将在审查公司提供的任何其他信息后,确定适当的合规和执法行动。 6月17日,加拿大卫生部在位于 Pelham 的 CannTrust 工厂进行了一次未宣布的检查,结果导致“关键观察”和检查的总体不符合评级。 对将增加转用和/或将造成健康风险的不足提出了批评意见。 重要的观察是罕见的。在最近发布的2017-2018财政年度合规报告中,监管机构仅注意到了257次检查中的两次。 加拿大卫生部表示,关键观察是在未经授权的情况下进行活动——即在未获得监管机构批准前在无许可的房间生产大麻——在检查期间向检查人员提供虚假和误导性信息,以及记录保存不当。 视察员于7月3日和7月4日返回该设施,递交了视察报告,并查获了4327公斤涉入产品,并获得样品进行进一步测试。 CannTrust 此前曾表示,加拿大卫生部对5200公斤的干大麻库存实施了“冻结”,该公司自愿将另外7500公斤的干大麻等同物予以扣留。 “根本原因” CannTrust 在通过电子邮件回复 MJBizDaily 的询问时表示,它将向加拿大卫生部提交一份报告,提供“根本原因分析”,并采取措施解决调查结果。 “我们加强了质量和合规部门,并在此过程中改进了流程。我们希望向患者和消费者保证, CannTrust 的所有产品都是安全的,并通过了加拿大卫生部认证实验室的质量测试,以及 CannTrust 自己的质量控制流程和安全审查。” 佳能信托表示,它不知道有多少产品从无证客房销售到规范的成人使用市场或医疗患者。 “在我们完成全面调查的同时,我们还没有确切的数据,”该公司表示。该公司指出,从未获批准的房间销售的所有产品都通过了加拿大卫生部认证的实验室的质量控制测试,以及该公司的质量控制流程和安全审查。 “我们正与所有省级零售合作伙伴联系,以确保他们掌握所需信息,并了解对消费者供应的任何潜在影响。” CannTrust 的股票在纽约证券交易所交易为 CTST ,在多伦多证券交易所交易为 TRST 。

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