PV Guidance Documents

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  1. Notice regarding implementation of Pharmacovigilance Guidance Document for Marketing Authorization Holders (MAHs) of Pharmaceutical Products, Version 2.0  
  2. Pharmacovigilance Guidance Document for Marketing Authorization Holders of Pharmaceutical Products (Version: 2.0)  

  3. Draft of Pharmacovigilance Guidance Document for the Marketing Authorization Holders (MAHs) of Pharmaceutical Products for seeking comments from stakeholders (Version 2.0) The comments on this draft should be reached with valid justification within 30 days from the date of uploading by 22/02/2024 to This email address is being protected from spambots. You need JavaScript enabled to view it.

  4. Pharmacovigilance Guidance Document for Marketing Authorization Holders of Pharmaceutical Products (Version 1.0)

  5. Guidance Document for spontaneous Adverse Drug Reaction Reporting 
  6. Implementation Guide for Electronic Transmission of Individual Case Safety Reports (ICSRs)