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  • Introduction and legal basis The present Guideline is a translation and adaptation in Romanian of the guideline CPMP/PhWP/175/95 regarding the procedure to be followed by Competent Authorities when undertaking the pharmacovigilance activities and it is in accordance with the Decision no. 12/24.03.2000 regarding the approval of ???Regulations on pharmacovigilance activity???, document approved by t
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