The Health Products Regulatory Authority (HPRA) is Ireland's national competent authority for medicinal products and pharmacovigilance.
Core official resources
- National pharmacovigilance requirements for MAHs — Irish legal basis and national implementation guidance.
- Reporting suspected side effects — national spontaneous-reporting routes.
- Safety monitoring of medicines — overview of the Irish and EU pharmacovigilance framework.
Practical use
The HPRA MAH page is especially useful because it gathers national implementation details that sit alongside EU GVP, including Irish DHPC requirements, additional-monitoring statements and submission expectations for certain non-interventional PASS protocols and reports conducted in Ireland.