翻译：julia 来源： Julia法规翻译

25.10.2017

Violation of GDPGuidelines and Counterfeiting of Medicines - a Current Case Demonstrates theDangers

药品 GDP 指南和防伪违规 — 一起案例显示出危险

The trade press has extensively covered the counterfeitcase of Harvoni, a medicinal product from Gilead. The background circumstancesas well as the consequences to be drawn from this incident are of interesthere.

商业类杂志中广泛报道了吉立德药品 Harvoni 的假药案。该事件的背景情况和后果颇令人感兴趣。

What happened? In short, it can be said that Harvonitablets which were not approved for the German market were discovered in Germanpharmacies. A patient had returned his tablets to a pharmacy in Dortmundbecause they were white instead of orange. A closer examination revealedthat the tablets contained the correct active ingredient content (see also thearticle in the German "Apotheker Zeitung" no. 28 dated 10. July2017). Apparently, these were tablets which had not been produced by Gilead forthe German or the European market. The packaging for the German market wasfake. This was detected among others because of spelling mistakes (such as"Deutchland" instead of "Deutschland"). At least, that'swhat DAZ.online (German only) learned from Gilead Germany. Thecreator of the fake packaging is unknown so far.

怎么回事？简而言之，就是在德国药房发现了在德国并未批准上市的 Harvoni 片剂。患者已经将其片剂退回给多特蒙德的药房，因为它们应该是橙色而实际上是白色的。进一步查检发现片剂中的原料药是对的（也参见德国“ ApothekerZeitung ”在 2017 年 7 月 10 日第 28 号文章）。显然，这些片剂并不是由吉立德为德国或欧洲市场生产的。德国上市的包装是假的，因为其中有一些拼写错误（例如，应该是“ Deutschland ”，却写成了“ Deutchland ”）。至少，这是 DAZ 在线（只有德语）从吉立德德国公司获得的消息。假包装的创建者截止目前尚不得而知。

The GDP impact of counterfeit medicinalproducts 假药的 GDP 影响

However, it is known how the fake (since not approved forGermany) medicinal products ended up in the pharmacy. And this is where the GDPrequirements (Good Distribution Practice) come into play. These demand thatgoods may only be obtained from a wholesaler if he has a valid authorisationfor the wholesale trade of pharmaceuticals. Apparently, this is exactly wherethe GDP requirements were not followed, since the Dutch wholesaler from whomthe goods were purchased had no wholesale authorisation from the competentauthority. It doesn't matter whether the purchaser of the goods had not askedfor the authorisation of the Dutch wholesaler or whether the wholesaler hadeven presented a falsified wholesale permit - according to GDP, the purchaseris always responsible. § 5.2. of the GDPGuideline demands: " Wheremedicinal products are obtained from another wholesale distributor, thereceiving wholesale distributor must verify that the supplier complies with theprinciples and guidelines of good distribution practices and that they hold anauthorisation for example by using the Union database. "

但是，我们知道假药（因为在德国未获批准）是如何在药房被发现处理的。这就是 GDP 要求起作用的地方。 GDP 要求只能从具有有效的药品批发贸易批发商处获取药品，显然，在此案中，没人遵守 GDP 要求，提供此药品的荷兰批发商并没有其当局的批发许可。药品采购方是否要求荷兰批发商提供许可证，或者是批发商提供了一份假的批发许可都不相干 --- 根据 GDP 的要求，购买方永远都要承担 GDP 指南第 5.2 条赋予的义务，该条款要求“如果药品是从另一个批发商处获得，接收方必须核查供应方是否符合 GDP