Guidelines

The Guidelines of the Egyptian Pharmaceutical Vigilance Center (EPVC)-Pharmacovigilance Department- have been developed to highlight the requirements, procedures, roles & activities of Pharmacovigilance and to provide a clear pathway for the MAHs & healthcare professionals.

1. Guidelines for Healthcare Professionals

This guidance is directed to healthcare professionals (HCPs) to complement and support the efforts of orienting them on the important concept of Pharmacovigilance. They also describe the reporting systems to the Egyptian Pharmacovigilance Center in the context of the Individual Case Safety Reports (ICSRs).

Egyptian Guidelines for Detecting & Reporting Adverse Drug Reactions for Healthcare professionals (HCPs)  (Click here)

 

2. Guidelines for Marketing Authorization Holders

This guidance describes the respective obligations of the MAH to set up a system for

Pharmacovigilance in order to collect, collate and evaluate information about suspected adverse reactions. All relevant information should be shared between medicines authority in Arab Countries and the MAH, in order to allow all parties involved in Pharmacovigilance activities to assume their obligations and responsibilities. The ultimate goal is to ensure that the MAHs are fulfilling their principal role in the safety monitoring of their medical products for human use, hence enhance efforts in ensuring that safe, efficacious, and quality medicines are made available for all patients in the Arab Countries.

It should be noted, as with all guidance documents in rapidly evolving technical areas, that this guidance below is intended to be regularly reviewed and updated.

 

The Good Pharmacovigilance Practices For Arab Countries -     Version 212/ 2014, Effective since July 2015 (Click here)