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

Manufacturers

Wholesalers and Distributors

Retailers

Market Compliance and Surveillance
 
Human Products Fees

 
Export Certificates

Consultations

Product Information Update (PIU)


National Scientific and Regulatory Advice
 

Information for Brokers

 

Active Substance Registrations