#Pharmacovigilance Guidance Document for MAH

Pharmacovigilance Guidance Document for MAH

Pharmacovigilance Guidance Document for MAH 

Indian Pharmacopoeia Commision (IPC), Ghaziabad recently released Pharmacovigilance Guidance Document for Marketing Authorization Holders of Pharmaceutical Products in October 2017. Marketing Authorization Holder (MAH) refers to Pharma company or Sponsor. This document provides Pharmacovigilance guidance for Marketing Authorization Holders of Pharmaceutical Products.

This document is effective from 01Jan2018.

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The pharmacovigilance guidance document was developed by the National Coordination Centre of the Pharmacovigilance Programme of India (PvPI), Indian Pharmacopoeia Commission, in collaboration with the Central Drugs Standard Control Organization (CDSCO) and Ministry of Health & Family Welfare (MoHFW).

The objective of the guidance document is to ensure that a pharmacovigilance system is established at the Marketing Authorization Holder’s end in order mitigate risks associated with pharmaceutical products.

The guidance document also states that “it is required under rule to monitor adverse drug reactions/ complaints related to drugs marketed in the country by the MAH & submit it to the licensing authority / NCC PvPI” (Refer B.1.1)

Total 6 Modules are present.

 Module 1: Pharmacovigilance System Master File.

Module 2: Collection, Processing, Reporting of Individual Case Safety Report.

Module 3: Preparation submission of Periodic Safety Update Report.

Module 4: Quality Management System at MAH’s organization.

Module 5: Audits and Inspections of Pharmacovigilance systems at MAH’s organization.

Module 6: Risk Management Plan


To download document IPC Website: Click Here

The guidelines direct marketing authorisation holders (MAHs) of pharmaceutical products comprising importers and manufacturers to establish a pharmacovigilance (PV) system with a medical officer or a pharmacist who will act as a pharmacovigilance officer-in-charge (PvOI) for collection and analysis of adverse drug reaction reports related to pharmaceutical products marketed by them in India.

The PvOI is responsible for individual case safety report (ICSR) collection and collation, processing, assessment, reporting and follow-up, detection of signal (if any), corrective and/or preventive action(s) (CAPA), preparation & submission of periodic safety update report (PSUR) of new drugs, risk management system(s) including risk management plan for each pharmaceutical product.

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