Regulatory Open Forum

  • 1.  QP(Qualified Person) Qualification

    Posted 16-Apr-2014 05:20
    Hello all,
    I am looking for some clarification on the qualifications of QP (Qualified Person)  in EU Member States.

    The Article 49 of the Directive 2001/83 (a link to the directive here) outlines the qualifications and necessary experience to become a QP. The part of the Article reads: 
    "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."

    After reviewing this Directive, I came up with the following question:
    1)  Is a "diploma or certificate of qualifications" received from Non-EU Member States, to say, in Republic of Korea (e.g. a registered pharmacist in Korea), acceptable/qualified?
    2)  Does each Member State have different Qualification process for QP? Is there an exam to complete to become a registed/qualified QP?

    I would appreciate any comments/directions.
    Thank you in advance for your help.

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    Dahuin Liz Lee
    Seoul
    Korea, Republic of
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