Regulatory Information

This section of the HPRA website includes information for the pharmaceutical sector including manufactures, wholesalers and distributors.

Explanatory information and relevant HPRA guides and forms are provided as appropriate under each topic as well as links to relevant external sources.

Classification of Medicines
Medicines Authorisation

Pharmacovigilance and Post Authorisation Safety
Clinical Trials

Generic and Interchangeable Medicines


Wholesalers and Distributors


Market Compliance and Surveillance
Human Products Fees

Export Certificates


Product Information Update (PIU)

National Scientific and Regulatory Advice

Information for Brokers


Active Substance Registrations