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       6. Current Page: Responsible for pharmacovigilance

    Qualified person responsible for pharmacovigilance

          Person responsible for pharmacovigilance (QPPV) and local contact person

            * The role and responsibilities of the person responsible for pharmacovigilance are detailed in GVP Module I.
            * The requirements for the local contact person are detailed in article 66 §2 in the royal decree of 14th December 2006 concerning medicines for human use.


          Administrative formalities in connection with the person responsible for pharmacovigilance

            * The holder of a marketing authorisation (MA) must be assisted permanently and continuously by a qualified person responsible for pharmacovigilance who resides in the EEA (European Economic Area)
            * The holder of a marketing authorisation (MA) must also be assisted by a local contact person.


          Circular 600 (and annex I and annex II) gives more information regarding the obligation for the MAH to notify the local contact person and current information regarding pharmacovigilance to the FAMHP.
          More explanation regarding the requirements for the local contact person and related legislation are described in a Q&A (version October 2013).


          Contact


          PhVInsp@fagg-afmps.be

                Last updated on 10/11/2023
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