• Follow @TheHPRA
  • Contact us
  • Glossary
  • As Gaeilge
The Health Products Regulatory Authority logo
My HPRA: Login Register
  • About Us
  • Medicines
  • Veterinary
  • Medical Devices
  • Blood, Tissues, Organs
  • Cosmetics
  • Controlled Substances
  • Veterinary
  • Regulatory Information
My HPRA: Login Register
  • About Us
  • Medicines
  • Veterinary
    • Our Role
    • Veterinary Medicines Information
    • Safety Information
    • Regulatory Information
      • Medicines Authorisation
      • Veterinary Clinical Field Trials
      • Packaging changes to authorised veterinary medicines
      • Additional Activities
      • Market Compliance and Surveillance
      • Manufacturers
      • Veterinary Medicines Fees
      • Export Certificates
      • Consultations
      • Implementation of the new veterinary regulation (Regulation 2019/6)
    • Veterinary News & Events
    • Special Topics
    • Contact details
    • Scientific Animal Protection
    • Availability of veterinary medicines in Ireland
  • Medical Devices
  • Blood, Tissues, Organs
  • Cosmetics
  • Controlled Substances

Regulatory Information

This section of the HPRA website includes information for the pharmaceutical sector.

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


Medicines Authorisation

Veterinary Clinical Field Trials

Packaging Changes to Authorised Veterinary Medicines

Additional Activities

Market Compliance and Surveillance

Manufacturers

Veterinary Medicines Fees

Export certificates
 

Consultations 

Implementation of the new veterinary regulation (Regulation 2019/6)

About Us

  • Our vision, mission and values
  • How We Regulate
  • Contact Us
  • Our Structure
  • Standards of Service
  • Privacy and Data Protection
  • Information and transparency
  • Consultations
  • Quality Management
  • Recruitment
  • Publications & Forms
  • Report an Issue
  • Legislation
  • Extranets
  • News and Events
  • Information Campaigns

Medicines

  • Medicines and Vaccines: COVID-19 Updates
  • Our Role
  • Medicines Information
  • Safety Information
  • Safety Notices
  • Quality Information
  • Regulatory Information
  • News & Events
  • Special Topics
  • Emergency Medicines
  • Emergency Contact Details

Veterinary

  • Our Role
  • Veterinary Medicines Information
  • Safety Information
  • Regulatory Information
  • Veterinary News & Events
  • Special Topics
  • Contact details
  • Scientific Animal Protection
  • Availability of veterinary medicines in Ireland

Medical Devices

  • COVID-19 Updates
  • Our Role
  • Safety Information
  • Regulatory Information
  • Medical Devices News & Events
  • Special Topics
  • Register Medical Devices Extranet
  • Medical Device Economic Operators in Ireland
  • Contact Medical Devices

Blood, Tissues, Organs

  • Our Role
  • Blood
  • Tissues and Cells
  • Organs
  • Blood and Tissues Establishments List
  • Inspection Process
  • Special Topics
  • News and Events
  • Safety Notices
  • Reporting Adverse Reactions / Events

Cosmetics

  • Our Role
  • Safety Information
  • Regulatory Information
  • News & Events
  • Special Topics

Controlled Substances

  • Our Role
  • Controlled Drugs
  • Precursor Chemicals

Website Information

  • Register for Alerts
  • Glossary
  • Terms of Use
  • Privacy and Cookie
  • Contacts
  • Links
  • FOI
  • Sitemap
 

© Health Products Regulatory Authority 2014

Contact Us

Kevin O'Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2, Ireland, D02 XP77

  • +353 (1) 676 4971
  • info@hpra.ie
  •  
  • Follow @TheHPRA
 
 

Developed by Engine Solutions

Date Printed: 25/01/2021