Tunisia: Publication of the Regulatory Compliance, Reliance, and Pharmacovigilance Guide

In June 2025, Tunisia’s National Agency for Medicines and Health Products (ANMPS) released a new official guide titled:  Regulatory Compliance, Reliance, and Pharmacovigilance Guide.

The guide outlines the regulatory requirements applicable to Marketing Authorization Holders (MAHs), with a specific focus on:

• the structuring of registration dossiers,
• obligations related to pharmacovigilance throughout the product lifecycle,
• and the use of regulatory reliance mechanisms, particularly through decisions issued by reference authorities (WHO, EMA, etc.).

The guide also details the roles and responsibilities of the Qualified Person Responsible for Pharmacovigilance (QPPV), requirements for risk management, and procedures for reporting adverse events.

This initiative is part of a broader effort to align Tunisia’s pharmaceutical regulations with international standards and to strengthen the national medicine safety monitoring system.

You can read consolidated version via this link : http://www.dpm.tn/images/pdf/procedure/t-op3-001-fr-000-guide-comf-regl-reliance-pharmacovigilance.pdf