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Published Date: April 15, 2014 CHAPTER ONEPurpose, Scope, Basis and DefinitionsARTICLE 1 – (Amended:OG-21/7/2022-31899)(1) The purpose of this Regulation is to determine the procedures and principles regarding thesystematic monitoring of adverse reactions and

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                                  Guideline on Good Pharmacovigilance Practices (GVP)   Module III- Periodic benefit-risk evaluation report (PBRER)