20150902 ECA新闻：如何成为欧洲授权人（QP）？

20150902 ECA新闻：如何成为欧洲授权人（QP）？

GMP News
02/09/2015

How to become a QP for Europe

如何成为欧洲授权人（QP）？

Both the ECA Academy and the European Qualified Person Association (EQPA) are often contacted by people who would like to become a Qualified Person (QP according the EU Directives) in a Member State of the European Union or outside the EU to release products for the EU market. Questions are for example:

ECA学会和欧洲质量授权人协会（EQPA）经常收到来自欧盟成员国或欧盟以外地区放行产品至EU市场想要成为授权人（根据欧盟指令定义的QP）的人们的问题。例如：

• "Can I become a QP and live and work outside the EU?"
• 我能成为一个QP，但在EU以外生活和工作吗？
• "I work for an American company that would like to export medicinal product to the EU. How can we hire a QP here in the U.S.?"
• 我为一个美国公司工作，我们想要出口药品到欧盟。我要如何在美国雇佣一个QP呢？
• "I am an Irish Citizen living and working in Australia. I am thinking of studying a course by distance learning, which also meets the requirement for persons seeking to become a QP. Is that possible?"
• 我是爱尔兰市民，生活和居住在澳大利亚。我想要进一步学习，希望这个课程也符合成为QP所需的要求。这可能么？
• "I'm a Spanish pharmacist working in Switzerland. I'm wondering how to proceed to become a Qualified Person. Which is the training that I have to follow to become QP in Europe?"
• 我是一个西班牙的药师，在瑞士工作。我想要知道如何能成为一个QP。在欧洲想要成为QP是否必须参加某种培训呢?
  

Unfortunately this is not as easy as one would think. To become a QP there are a few things that need to be considered:

不幸的是这并不如大家所想的那么简单。想要成为QP，有一些问题是需要考虑的：

1. The European Qualified Person is linked to a European Manufacturing authorization and licence (EU/ECC).

欧洲QP是与欧洲生产许可相关联的（EU/ECC）。

2. A QP is registered by the authority of the respective EU member state (or MRA-State). The requirements might differ from member state to member state.

一个QP要由相应的EU成员国（或MRA国）药监机构进行登记，而各国的要求可能有差异。

In Article 49 of Directive 2001/83 (for veterinary medicinal products, please read Article 53 of Directive 2001/82), the qualification level as well as the necessary experience of a QP is defined:

指令2001/83第49款（兽药请参见指令2001/82第53款）中说明了一个QP所需必须的资质水平和经验。

(2) "A qualified person shall be in possession of a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course of study, or a course recognized as equivalent by the Member State concerned, extending over a period of at least four years of theoretical and practical study in one of the following scientific disciplines: pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, biology (…). The course shall include theoretical and practical study bearing upon at least the following basic subjects:

“一个授权人应完成大学学习并被授予正式的学历、证书或有其它证据，或者参加了由相关成员国组织的相等同的认可的学习课程，时长达到或超过四年，在以下科学学科之一具备有理论和实践学习：药学、医学、兽药、化学、药物化学和技术、生物学（……）。课程应包括理论和实践学习，至少包括以下基本科目：

• Applied physics
• 应用物理
• General and inorganic chemistry
• 化学和无机化学
• Organic chemistry
• 有机化学
• Analytical chemistry
• 分析化学
• Pharmaceutical chemistry including analysis of medicinal products
• 药物化学，包括药物分析
• General and applied biochemistry (medical)
• 通用和应用生物化学（医学）
• Physiology
• 生理学
• Microbiology
• 微生物学
• Pharmacology
• 药理学
• Pharmaceutical technology
• 药物技术
• Toxicology
• 毒理学
• Pharmacognosy (study of the composition and effects of the natural active substances of plant and animal origin).
• 生药学（研究动植物来源的自然活性物质的组分和效用）
  

In so far as certain diplomas, certificates or other evidence of formal qualifications mentioned in the first subparagraph do not fulfil the criteria laid down in this paragraph, the competent authority of the Member State shall ensure that the person concerned provides evidence of adequate knowledge of the subjects involved."

目前第一段中提到的正式资质的学历、证书或其它证据并不满足法规中所定的标准，成员国的药监机构要确保相关人员提供证据证明其具备所涉及学科的充分的知识。

So, to act as a QP as defined in the EU Directives, you have to work in an EU Member State and fulfil the requirements of the directives. These requirements have to be transferred to national law in each EU Member State. However, there are a number of differences in the EU Member States due to the fact that each Member can implement the directives into national law with slight modifications.

因此，要成为如EU指令所定义的QP，你必须在EU成员国工作，并符合指令中所列出的要求。这些要求在各欧盟成员国会细化为国家法律。但是，由于不同成员国可以在其国家法律中对欧盟指令进行细微的修改，因此，不同欧盟成员国对此有很大差异。

More information can also be found on the website of the European QP Association.

更多信息请参见欧洲

QP

协会官网。

谢谢分享！！