Guideline for Post Marketing Surveillance.

The purpose of this guideline is to strengthen the system for effective Post Marketing Surveillance (PMS) of medicines, and regulated products including medical devices. It applies to all personnel involved in PMS activities and relevant partners involved in the sharing of resources including testing capacities, experiences and information that can enhance the effectiveness of the PMS program. It lays down the steps in PMS planning and provides guidance relating to training of personnel, surveillance study, sampling, storage and transport of samples and risk based approach to testing.