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28 July 2017EMA/405655/2016Guideline on good pharmacovigilance practices (GAP) Module VI Addendum I Duplicate management of suspected adverse reaction reportsDraft finalized by the Agency in collaboration
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What is module vi addendum i?
Module VI Addendum I is a supplemental form that must be filed along with a specific module VI.
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Certain businesses or organizations as specified by the regulatory authority are required to file Module VI Addendum I.
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Module VI Addendum I should be filled out following the instructions provided by the regulatory authority.
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The purpose of Module VI Addendum I is to gather additional information or data that is not covered in the main module VI form.
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