Pakistan: DRAP Reminds Manufacturers & Importers to Appoint QPPV/LSO

ARQon
Sep 11, 2023
2 min read

On 16 August 2023, the Drug Regulatory Authority of Pakistan (DRAP) released a reminder to all Registration Holders, manufacturers, and importers to appoint a Qualified Person for Pharmacovigilance (QPPV) or Local Safety Officer (LSO) for their pharmacovigilance system. The guarantee of both consumer safety and quality requirements is provided by this designation.

As per Rule 11 (2) of Pharmacovigilance Rules, 2022, the appointment of QPPV or LSO is the legal responsibility of the registration holders and the nomination submission shall be done within 30 days together with the documents stated in Module 1 of the Good Pharmacovigilance Practices (GVP).

The appointment of LSO is accepted for the case of a multinational registration holder. In addition, it should be noted that each pharmacovigilance system should appoint only one QPPV or LSO. However, a QPPV/LSO may be employed by more than one registration holder, or, handling the task for more than one pharmacovigilance system for the same registration holder. Below are some responsibilities of a QPPV/LSO and can refer to Guidelines on Good Pharmacovigilance Practices for Registration Holders for more details:

Responsible for collecting, recording, and reporting the adverse events and safety data of the products related to the National Pharmacovigilance Centre (NPC) within the specific period
Conducting periodic safety update reports (PSURs) and risk-benefit assessments of the products and made submission to the NPC
Implementing the risk management plans (RMPs) and risk minimization measures (RMMs) for the products
Ensuring the products comply with the pharmacovigilance rules and guidelines
Maintaining the pharmacovigilance records and documentation for a minimum 10 years

This reminder is not only an action of the legal obligation but also a social responsibility to ensure the safety and quality standards of the drugs marketed in Pakistan. Besides, the advancement of the pharmacovigilance system shows that Pakistan is able to provide a competitive culture in the market.

Source: Drug Regulatory Authority of Pakistan (DRAP)