Last Updated on November 29, 2022

Following guidelines are intended to help the industry and other applicants to meet the regulatory requirements related to the Pharmacovigilance.

1. General Guidelines for Pharmacovigilance

Guidelines on National Pharmacovigilance System
English ( 3.3 MB – PDF)

Good Pharmacovigilance Practices for Registration Holder
English ( 1 MB – PDF)

Guidelines On Pharmacovigilance for Public Health Programmes
English ( 12.4 MB – PDF)

2. Guidelines to Report Adverse Events

Adverse Events Reporting Guidelines for Patients, Caretakers and Consumers
English ( 3 MB – PDF)

Adverse Event Reporting Guidelines for Healthcare Professionals
English ( 3 MB – PDF)

3. Medication Safety

Guidelines on Management of High Alert Medication
English ( 2.7 MB – PDF)