European Qualified Person Association - Publications/Question and Answer Documents
歐洲QP協會—出版物/問答文件
How to become a Qualified Person 如何成為QP
Q: I am a Chemist. How can I become a QP?
問：我是一個化學師，我怎樣才能成為一個QP呢？
A: 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 professional experience of a QP is defined. The EU requirements as defined in these Directives 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 State can implement the directives into national law with slight modifications.
答：指令2001/83的第49條（獸藥參見指令2001/82第53條）中對QP的資質和必要的專業經驗進行了界定。EU在這些指令裡的要求已經通過國家法律轉化為各成員國的要求。但是，由於各成員國實際情況有差異，因此可能會對指令具體實施要求略有不同。
Our recommendation is to discuss this matter with the respective authority in the Member State you plan to work as QP.
我們建議你與你準備作為QP工作的國家藥監當局討論此問題。
Q: Can companies outside the EU but with an MRA have a QP according the EU Directive. Can such a person be certified by the EU?
問：一個在歐盟領土之外的MRA持有人公司是否可以根據EU指令任命一位QP呢？該人員是否被EU認可？
A: Things that need to be considered are:
The QP is linked to a European Manufacturing authorisation.
If the "QP" is an employee of a company outside the EU, he/she is not employed by a company with an European manufacturing authorisation and therefore can not act as a QP.
There is no such thing as a certification to be a QP. A QP is registered by the authority of the respective EU member state.
答：要考慮以下問題：
1. QP是與歐洲生產許可相關的
2. 如果所謂的「QP」是一個歐盟以外公司的僱員，他/她並不由一個歐洲生產許可公司所僱傭，這種情況下是不能成為一個QP的
3. 並不存在什麼持有QP證書的說法，QP是要由相關的歐盟成員國註冊的
It is normal practice for a product manufacturer in a third country to have an EU-based importer who can provide the services of a QP? This EU-based QP would assess and certify a product/batch imported into the EU.
一般的做法是第三國藥品生產商有一個在歐盟的進口商，由進口商提供QP服務，該EU內的QP會評估和出具證明給進口至歐盟的藥品/批次。
Q: Does a QP from an EU Member State who is appointed by the Member State’s Main Pharmaceutical Inspectorate as a QP and is chemist and not a pharmacist can move to Germany and still carry out duties of QP?
問：如果一個歐盟成員國的QP被成員國的主要藥品檢查機構任命為QP，但是是化學師而不是藥師，他是否可以轉至德國仍擔當QP職責呢？
A: Although the educational background would not be considered sufficient by the various local authorities in Germany to be initially accepted as a QP, a Chemist would be accepted once he/she is registered as a QP in another Member State. So once a QP is eligible and registered by another Member State authority he/she could apply as a QP in Germany. However it needs to be decided by the local German authority (e.g. Regierungspr?sidium or local government). Many Member States require that a QP speaks the local language to be able to understand batch records, certificates and other GMP-related documents.
答：儘管在德國，各藥監當局會認為化學師的教育背景不足以被接受成為QP，但如果他/她在另一成員國註冊成為QP，則在德國也會被接受。因此，只要一個QP在另一個成員國藥監當局合法註冊成為QP，那麼在德國他也可以申請成為QP。但是，這還是要經過德國當地藥監機構來決定（例如，市政局或當地政府）。許多成員國要求QP可以講當地語言，可以讀懂批記錄、證書和其它GMP相關文件。
Q: If a company is based in Switzerland and produces pharmaceutical products, what are the possibilities to become a QP?
問：如果公司位於瑞士，生產藥品，其僱員是否可能成為QP呢？
A: As Switzerland is not an EU Member State, the applicable Directives apply via the MRA.
The QP in Switzerland is called the "Fachtechnisch verantwortliche Person".
To become a Fachtechnisch verantwortliche Person, an academic qualification is needed (for finished products and intermediates usually a pharmacist). Other academic qualification is acceptable in case of proven experience and for APIs and blood products. The Notification is handled by Swiss Medic and the "Fachtechnisch verantwortliche Person" will be named on the manufacturing license. We would recommend contacting Swiss Medic for further information.
答：由於瑞士不是歐盟成員國，相關指令是通過MRA實施的。
瑞士的QP被稱為「Fachtechnisch verantwortliche Person」（FvP）。
要成為FvP，需要具有學術教育背景（製劑和中間體一般要求是藥師）。如果有被證明的工作經驗，則其它學術背景也是可以接受的。對於原料藥和血液製品，瑞士藥監局有相關通知，FvP的姓名會被記載在生產執照上。我們建議與瑞士藥監局聯繫獲得更多信息。
Q: There are certain professional bodies in UK who can grant QP status and can advise people that they are eligible for QP status as per EU Directives. However, it appears that some Member States do not recognise the defined education and experience requirements for becoming a QP as per EU Directives. In France for example the 'Pharmacien Responsable' has to be a pharmacist qualified and registered in France. Is it possible to operate as a QP recognised by markets where our products are commercialised (all EU), while not being considered a QP by the country of manufacture?
問：在英國有一些專業團體，他們可以認證QP身份，可以告訴人們根據EU指令其具有法定的QP身份。但是，貌似有些成員國並不認可EU指令中所界定的QP所需教育背景和經驗。例如，在法國，「'Pharmacien Responsable」必須具備藥師資格並在法國註冊。是否有可能按我們的藥品銷售區域（全歐盟），由其認可的QP來操作，而不考慮使用生產國QP呢？
A: Directives are only binding as to the result to be achieved– and leave national authorities the choice of form and methods. The EU requirements as defined in the Directives 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 State can implement the directives into national law with slight modifications. This national law is the binding one. To operate as a QP one has to be named by the holder of the marketing authorisation in the EU and must be registered/ accepted by the EU member state where the company resides.
答：指令只是給出所要達到的結果，各國有自由選擇自己的形式和方法來實施。在指令中所述的歐盟要求必須轉化成為各歐盟成員國的國家法律才能實施，各成員國在實施時可以進行小的修訂。該國家法律是必須執行的。要成為QP，必須由歐盟內的上市許可持有人提名，必須在公司所在歐盟成員國註冊並被接受。
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