20140917 ECA新闻：药品存贮超过36小时的场所需要符合GDP要求（Julia翻译）

巴西木

GMP News
17/09/2014

If a Facility stores Medicinal Products for more than 36 Hours GDP will apply

药品存贮超过36小时的场所需要符合GDP要求

Since the EU Good Distribution Practice (GDP) Guide has been revised, a number of questions regarding its interpretation have been raised. One of these questions relates to storage facilities and so called distribution hubs. In the past, many facilities which have been involved in the supply chain were not managed under GDP and didn't posses a licence for their activities.

自从欧盟GDP指南修订后，关于其解释提出了很多问题。其中之一是关于存贮场所和所谓分销口的问题。过去，在供应链中涉及的存贮场所不在GDP管理范围内，也不需要持有实施其活动所需的许可证。

The British Medicines Authority MHRA published a press release on 18 August 2014 to explain what they consider to be a facility which must be licensed and which needs to implement the GDP requirements. According to the MHRA: "The GDP Inspectorate is raising awareness of the impact of the new regulations to those parties that are either directly or indirectly affected and any freight consolidator or freight forwarder either in the air, sea or road transport sector that is either holding ambient medicinal products on site for more than 36 hours or has cold room facilities will require a Wholesale Distribution Authorisation WDA(H) in order to comply with the Human Medicines Regulations 2012 [SI 2012/1916] (as amended) and with the Falsified Medicines Directive 2011/62/EU."

英国药监局MHRA在2014年8月18日公布了一份说明，解释其对必须持有执照，需要实施GDP的场所的想法。根据MHRA的说法，“GDP检查团对新法规的理解是，对那些直接或间接受影响的机构，以及负责空运、海运或陆路运输部分的承运人或货代，只有在其场所室温下保有药品超过36小时，或具有低温室设施，则需要持有批发分销许可WDA(H)，以符合人药法2012【SI2012/1916】（修订）及药品防伪指令2011/62/EU的要求”。

Source: MHRA Press Release: MHRA position on freight consolidation depots (freight forwarders)

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