Pharmacovigilance Guidance Document for Market Authorization Holders of Pharmaceutical Products

Hello Readers,

We are back with one more interesting article—this time with Pharmacovigilance Guidance Document for Market Authorization Holders of Pharmaceutical Products.

NCC-PvPI released Pharmacovigilance Guidance Document for Market Authorization Holders (MAHs) of Pharmaceutical Products (Version 2.0) on the inaugural of 4th National Pharmacovigilance Week, 17th September 2024.

What’s New!

This guidance document is updated in the light of New Drugs and Clinical Trials Rules, 2019 and revised Schedule M of Drugs and Cosmetics Rules, 1945.

• The terminology for PVOI is replaced with PVOIC.

• The “Module” is replaced with “Chapter”.

• Definition of New Drug is updated in accordance with NDCT Rules, 2019.

• The Marketing Authorization Holders should maintain records in Excel/Electronic sheets.

• All Non-Serious Adverse Events should be reported by MAHs within 90 calendar days.

• The International Classification of Diseases (ICD) is replaced with MedDRA dictionary for coding of “Indication” during entry of Individual Case Safety Reports (ICSRs).