Pharmacovigilance (PV) has been defined by the World health Organization (WHO) as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine related problem.

This guideline has been developed to bring guidance on the requirements, procedures, roles and activities in the field of PV, for Marketing Authorization Holders (MAH) of medicinal products for human use in Oman. Pharmacovigilance obligations apply to all products available in Oman, including the registered and non-registered products.

All pharmaceutical companies/ Marketing Authorization Holder (MAH) whose products are registered and marketed in Oman have to have a system in place for documenting the objectives laid down in the GVP modules viz.,

1. Pharmacovigilance systems and their quality systems

2. Pharmacovigilance System Master File (PSMF)

3. Pharmacovigilance Inspections

4. Pharmacovigilance audits

5. Risk management systems

6. Management and reporting adverse reactions to medicinal products

7. Periodic safety update reports (PSURs)/ Periodic Benefit Risk Evaluation Report (PBRER)

8. Post authorization safety studies

9. Signal management

10. Safety communication

11. Risk minimization measures.