Registration holders are stakeholders of pharmacovigilance who have valid registration of therapeutic goods. There are also legal obligations on registration holders to monitor the safety of therapeutic goods. Therefore, there is a need that they should have basic knowledge and understanding of pharmacovigilance activities to fulfil their legal obligations. The purpose of this guidance document is to provide a basic framework for the implementation of the pharmacovigilance programme of Pakistan and to ensure that registration holders are better equipped to monitor the safety of therapeutic goods and to detect, assess, understand, prevent and investigate ADRs/ AE and AEFI reports.
This guidelines intended to assist registration holders:
a. To develop a pharmacovigilance system and monitor the safety of therapeutic goods registered in their name;
b. Collect pharmacovigilance data, perform its assessment and accordingly submit to National Pharmacovigilance Centre (NPC), DRAP;
c. Cooperate with NPC in the performance of pharmacovigilance inspection;
d. Preparation and submission of periodic safety reports and risk management plan;
e. Design and conduct post-authorization safety studies; and
f. Detect, validate and assess signals and accordingly communicate to NPC and other stakeholders and considers options for risk minimization.
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