ECA新闻20150506：合法供应链又增2例假药案例

ECA新闻20150506：合法供应链又增2例假药案例 2015-05-08 12:44:13|  分类： ECA新闻

GMP News
06/05/2015

Two more Cases of Counterfeiting in the legal Supply Chain

合法供应链又增2例假药案例

Just recently we reported about the counterfeited HIV drug Viread (Tenofovir) from Gilead and how the counterfeited Viread packs had penetrated into the legal supply chain. At that time a parallel importer had detected the deviations and could therefore stop their further distribution. Now, promptly, another two cases came up which shows that counterfeiters increasingly want their products to infiltrate into the distribution of wholesale and pharmacies. So far, the problem was primarily relevant in the online trade. Once again, a parallel importer has detected the counterfeit through his controls.

最近我们刚报道过吉列德的艾滋病药维瑞德假药的新闻，以及假药包装如何渗透入合法供应链。那时，一个进口商已经发现问题，因此停止了其进一步销售行为。现在，又出现另2例，显示造假者非常希望将其产品打入批发和药房销售渠道。到目前为止，问题基本是在线贸易中发现的。这次也是平行进口商通过其控制发现了假药。

As the online portal pharmacy ad hoc reports now, 23 packs of the batch 4249XD18, Humira 40 mg / 0,8 ml solution for injection in pre-filled syringes, durable until May 2016, were identified as counterfeits. The batch number is not used by the company AbbVie. The portal pharmacy ad hoc refers to a release from the German Paul Ehrlich Institute (Federal Institute for Vaccines and Biomedicines): "According to PEI the blisters have two labels, under the top label another label can be found with Turkish inscription and a total of six different batch names. In one case batch number and expiry date on the top label were missing." The origin of the products is, according to PEI, in Poland and Turkey. AbbVie identified the supplied certificates as counterfeits.

在线终端药房组织报道，有23个包装批号为4249XD18的HUMIRA 40mg/0.8ml预装注射液，有效期为2016年5月被鉴定为假药。该批号并不是ABBVIE公司所生产的。终端药房组织引用了德国PAUL EHRILICH研究所（联邦疫苗和生物制品研究所，PEI）的话，“根据PEI，泡罩有2个标签，在顶部标签的下面可以发现一个土耳其语标注的标签，总共有6个不同的批名称。在另一起案例中，顶部的标签中没有批号和有效期”。原装的药品，根据PEI，在波兰和土耳其，ABBVIE发现所提供的证书是伪造的。

The German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte - BfArM) also informs about a possible counterfeit of Pulmozyme 2,500 E./2,5 ml (Dornase alfa) in the legal distribution chain in Germany. Two batches of N0070B03 and N0066B05 which were destined for the market in Poland were discovered by the parallel importer Axicorp Pharma GmbH in Germany. A release of the AMK News states: "According to information of the company Roche the Pulmozyme ampoules were replaced with saline solution ampoules within the original boxes. The text on the ampoules refers to sodium chloride 0,9% solution (Gilbert NaCl 0,9%)."

德国联邦药品和医疗器械研究所（BfArM）也通告了在德国的合法供应链中发现疑似假药PULMOZYME2500E/2.5ml（DOMASE ALFA）。德国平行进口商AXICORP PHARMA发现销售的2个批号N0070B03和N006B05，其发往地为波兰。AMK新闻称，“根据罗氏公司的信息，PULMOZYME安瓿被沙林溶液安瓿所替代，放在原装盒中。安瓿上的文字显示为氯化钠0.9%溶液（GILBERT NaCl0.9%）。

These two new cases show once again how important the controls in the legal supply chain are. The introduction of the 2D matrix codes as well as the GDP requirements and their monitoring are therefore important steps that will increase in importance and relevance.

这2起新的案例再次显示对合法供应链的控制有多重要。引入二维码和GDP要求并进行监管成为重要的措施，这将增加其重要性和相关性。

Sources (in German language):
Online Portal Apotheke Adhoc
Paul Ehrlich Institute
AMK Nachrichten
BfArM Risk Information on Medicinal Products

什么是平行进口？

平行进口（PARALLEL IMPORTS）是指本国的商标权人将自己生产的商品出售给国外经销商或者将自己的商标许可给国外生产企业后，这些国外的经销商或者生产企业将其与商标权人在国内生产的相同的商品，重新进口到国内的做法。

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