法庭判决：脱离了合法供应链的药品不能再销售

julia朱玉姣

GMP News
31/03/2016

CourtJudgement: A Medical Product can not be Marketed Anymore if it has Left theLegal Supply Chain

法庭判决：脱离了合法供应链的药品不能再销售

Thedistribution and the storage of medicinal products have been strictly regulatedsince the introduction of the new EU Good Distribution Practice Guideline (EU GDP Guideline).Basically, the reason for the revision in 2013 was the so-called EU Counterfeit Directive. It should be ensured that nocounterfeits can enter the legal supply chain. The so-called Track&Trace regulations - according to which a 2D MatrixCode must be applied to the packaging of certain medicinal products - have alsobeen established to fight against counterfeit medicines.

自从引入新的EU GDP指南后，药品的销售和存贮受到了严格管理。基本上来说，2013年修订的理由是所谓的防伪法案。要确保没有假药可以进入合法供应链。所谓的追踪&追溯法规---据此要求，必须在特定的药品包装上印制二维码----也已建立来与假药斗争。

Now, theHigher Regional Court for the Land of North Rhine Westphalia inGermany (Oberverwaltungsgericht Nordrhein-Westfalen) has decided a case inwhich a medicinal product had seemingly the quality required but had left thelegal supply chain temporarily. The court stated that an abstract risk maybe sufficient for the competent monitoring authorities to take a medicinalproduct out of the market. The branch service Apotheke Adhoc (in German language) has written a reportabout the case. According to Apotheke Adhoc, the case in question concerns thecompany Orifarm: "The re-importer from Leverkusen bought medicinalproducts from Romania which were brought back to the supply chain by pharmacieswithout wholesale authorisation. This is forbidden in Romania. The case leakedout because from the same background three situations of visible falsifiedmedicines had been discovered."

现在，德国一个高等地区法庭判定了一个案件，案件中一个药品看起来具备所需的质量，但适时脱离了合法供应链。法庭宣布理论上的风险已足以让药监局将该药品拒于市场之外。APTHEKE ADHOC分支服务机构已书写了一份关于案子的报告。根据APOTHEKEADHOC，该案件关系到一家名为ORIFARM的公司。“在LEVEKUSEN的再进口商将药品从罗马尼亚带入，由没有批发执照的药房带回到供应链。这在罗马尼亚是被禁止的。该案被发现是因为在3个场合下相同背景下发现了目视可识别的假药。

The companyOrifarm placed the medicinal products in quarantine after the competentauthority in Romania had issued a product recall. Although Orifarm checked theproducts again, the District Government (Bezirksregierung) inCologne rejected the release of these products onto the market. TheDistrict Government justified the rejection of the release indicating that themedicinal products had been handed on by pharmacies in Romania. Yet, the courtclarified that pharmacies do not comply with the Good Distribution Practice inprinciple. For this, a wholesale authorisation is required which can only beissued when the EU GDP requirements are established within an internal QMsystem. Therefore, the company Orifarm couldn't consistently demonstratewhether the quality of the medicinal products hadn't been reduced - for examplethrough inappropriate storage. According to the court, as illegal medicines hadalready entered the supply chain in the past, it can't be fully ensured thatthe medicinal products have the quality required and that falsifications ormodifications can be excluded to 100%.

公司ORIFARM在罗马尼亚签发了药品召回令后，将药品隔离。虽然ORIFARM重新检查了药品，区政府还是拒绝将这些药品放行至市场。区政府认为拒绝放行表示药品已在罗马尼亚由药房经手。法庭声明药房并不符合GDP要求。批发商要具备内部QM体系，符合EUGDP要求，然后药监才发放批发执照。因此，ORIFARM公司并不能持续地证明是否药品质量已经降低----例如，由于不恰当的存贮。根据法庭说法，由于过去已有非法药品进入过供应链，除非有100%的保证，否则就不能确保药品具备所需的质量，不能保证没有假药。

The decisionof the Higher Regional Court stresses the importance of the EU GDP Guideline inthe course of medicines safety. It is not possible to argue that quality isguaranteed when the legal distribution channel can't be maintained to 100%.This principle has been common practice in the GMP environment for many years.Only the compliance with all necessary measures laid down in the EU GMP Guidecan ensure the quality of the medicinal product. Comprehensive release testingcan't remedy the fact that certain QA/GMP requirements have not been met inproduction. This principle also applies to the GDP compliant storage andtransport within the legal supply chain.

高等地区法庭的判决强调了EU GDP指南在药品安全方面的重要性。如果销售渠道不能保证100%合规，就不可能去辩解说药品质量得到保证。这个原则在GMP环境已经成为常识很多年了。只有符合EU GMP指南下所有必须的要求，才可以确保药品的质量。综合放行测试不能补救生产中不符合特定的QA/GMP要求的事实。此原则也适用于合法供应链中GDP符合性存贮和运输。

红茶.

坚决抵制西方价值观。西方帝国主义在此时时刻做出该判决，居心叵测。

lzjxqt

"如果销售渠道不能保证100%合规，就不可能去辩解说药品质量得到保证。"?

北重楼

好严格呀

过河的小马

对中国的冷链运输，我只能呵呵

wentao-han

“如果销售渠道不能保证100%合规，就不可能去辩解说药品质量得到保证。这个原则在GMP环境已经成为常识很多年了。”
“只有符合EU GMP指南下所有必须的要求，才可以确保药品的质量。综合放行测试不能补救生产中不符合特定的QA/GMP要求的事实。此原则也适用于合法供应链中GDP符合性存贮和运输。”
回顾我们国家最近的疫苗事件，官方只一味强调没有毒性，安抚老百姓等等。说穿了，是态度问题，头疼医头，脚痛医脚，只顾眼前，非长久之计

月奴

过河的小马 发表于 2016-4-1 10:26
对中国的冷链运输，我只能呵呵

呵呵

marktiger

那我延伸一下，运输过程中被人偷了，然后警方追回来了。这样的情况，是不是也只能销毁不能出售了？因为脱离了合法的供应链，不能保证质量。
那这个损失谁付？
那以后药企恶性竞争是不是就可以找人去破坏对方的运输过程啊？整批整批的就毁了。

syhorchid

冷链运输环节值得重视

lumang

药品供应链管理面临巨大的挑战，一方面是符合GDP的要求，另一方面是如何防止假药进入合法供应链中，可惜电子监管码被叫暂停。