20150408 ECA新闻：欧盟药品代理商注册指南

20150408 ECA新闻：欧盟药品代理商注册指南

GMP News
08/04/2015

Guideline to Register as a Broker of Medicinal Products

药品代理商注册指南

All Stakeholders dealing with Medicinal Products need to be registered and have to comply with GDP requirements. According to the definition a broker is involved in independently selling or buying medicinal products on behalf of another company. As per definition a broker does not buy or sell the products, does not own the products and does not physically handle the products.

所有处理药品的干系人均需要注册，并必须符合GDP要求。根据定义，代理商是指代表另一公司独立进行药品销售和采购的主体。根据定义，代理商并不采购或销售药品，并不会自己拥有药品，也不会实质性处理药品。

For some countries in Europe (Belgium, Spain, France, Croatia, The Netherlands, UK) the so called "Heads of Medicines Agency" provide a database to complete a Broker application. This application is the prerequisite to submit an application to the agency in the above mentioned countries. The UK for example does have a register of Brokers for Medicinal Products on their website. Currently 20 companies are listed there.

在有些欧洲国家（比利时、西班牙、法国、科罗地亚、荷兰、英国）被称为“药监的领导”提供一个数据库来完成代理商申报。该申报要求在上述国家提交申请。例如，英国在其网站上有一个药品代理商注册栏，目前已有20个公司列在上面。

The MHRA has defined very detailed requirements which brokers have to fulfil before they are registered. The MHRA will:

MHRA对代理商在注册前必须满足的要求做了详细说明，MHRA将

check the identities of the ‘responsible person’ and other named staff 检查“负责人”和其它提名员工的身份 will perform a GDP inspection at the site of the broker 将对代理商的场所实施GDP检查 interview the members of the staff of the broker
• 审核代理商的员工人数
  

If the inspection was successful a GDP certificate will be issued and transferred to the EudraGMDP Database. This comprehensive control of brokers is not established in each EU country yet but other agencies might follow the example of the MHRA.

如果检查顺利，就会签发一份GDP证书，数据会上传到欧盟GMDP数据库里。这种代理商综合控制并不是在每个欧盟国家都已建立，但其它药监局可能会跟随MHRA的脚步。

Source: MHRA Webpage for Brokers 摘自2015-04-12 23:45:35|  分类： ECA新闻

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