20150722 ECA新闻：假药---目前案例显示中等规模公司也受到影响

20150722 ECA新闻：假药---目前案例显示中等规模公司也受到影响  

GMP News
22/07/2015

Counterfeit Medicines - A current Case shows that also medium-sized Companies are affected

假药---目前案例显示中等规模公司也受到影响

The issue of counterfeit medicines is often played down as it only affects the expensive blockbuster products anyway - mostly just products of the large pharmaceutical manufacturers. However, this is just as much a misconception as the belief that the products only show up in the internet trade and cannot be brought into the legal supply chain.

假药问题常常很低调，因为它只是影响比较贵的独占药品，受影响的大部分是大型制药生产商的产品。而认为假药只会出现在网上贸易，不会被带入合法供应链其实是一种错觉。

Another current case of counterfeit medicines now relates to products of the medium-sized company Desitin from Hamburg. According to a release from the German industry service provider Apotheke Adhoc (in German) Desitin reports about counterfeited Petnidan (Ethosuximide), 250 ml juice. The company therefore calls back the batch X514. The counterfeited product is equipped with German-speaking information and shows deviations from the original product. According to the report there is currently still no evidence that the fake products are also available in Germany.

现在有一个假药案例是与中等规模公司汉堡的DESITIN的产品相关的。根据德国行业服务供应商APOTHEKE ADHOC（德国）发布的新闻，DESITIN报告了假药PETNIDAN (ETHOSUXIMIDE)250ml 果汁。公司因此召回了批号X514。假药所配的是德语信息，显示与原装产品不同。根据报道，现在还没有证据表明假药也在德国出现。

The AMK News (Arzneimittelkommission der Deutschen Apotheker - Drug Commission of German Pharmacists) - (in German) further informs about a case in which 570 packs of Calcium Sandoz? D Osteo (Calcium Carbonate, Cholecalciferol), 120 chewable tablets (PZN 00490429) with the batch number FK7278 were stolen during transport. The batch was still not released at the time of transportation, and it cannot be excluded that the stolen products are introduced illegally into the distribution chain.

AMK新闻（德国）进一步通报了一起案例，其中有570包SANDOZ的碳酸钙维D3，120片装咀嚼片（PZN 00490429），批号FK7178在运输过程中被偷盗。该批号在运输时尚未被放行，因此不能排除被盗药品非法流入销售链。

We had recently reported about two more cases of counterfeiting in the legal supply chain. Due to the increased risk because of counterfeit medicines the EU Commission has legally enshrined the implementation of a Track&Trace system with a 2D Matrix Code in the so-called "Counterfeit Directive". Every company has to implement these requirements. The IT implementation necessary for track & trace was just ordered by the pharmaceutical associations in July.

最近我们报告过在合法供应链中2个假药案例。鉴于假药风险增加，欧盟委员会已立法实施跟踪追溯系统，在所谓的“防伪指令”中要求使用二维码。各企业必须实施这些要求。药品协会刚刚在7月订购了跟踪追溯系统所需的IT设施和服务。

多谢楼主分享，谢谢