• 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
  • Medicines
  • Regulatory Information
My HPRA: Login Register
  • About Us
  • Medicines
    • Our Role
    • Medicines Information
    • Safety Information
    • Safety Notices
    • Regulatory Information
      • Classification of Medicines
      • Medicines Authorisation
      • Pharmacovigilance and Post Authorisation Safety
      • Clinical Trials
      • Generic and Interchangeable Medicines
      • Manufacturers
      • Wholesale Distribution
      • Retailers
      • Market Compliance and Surveillance
      • Medicine Fees
      • Export Certification
      • Consultations
      • Product Information Update (PIU)
      • National Scientific and Regulatory advice
      • Information for Brokers
      • Active Substance Registrations
    • News & Events
    • Special Topics
    • Emergency Medicines
  • Veterinary
  • Medical Devices
  • Blood, Tissues, Organs
  • Cosmetics
  • Controlled Substances

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
 
Medicines Fees


Export Certificates

Consultations

Product Information Update (PIU)


National Scientific and Regulatory Advice
 

Information for Brokers

 

Active Substance Registrations


About Us

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

Medicines

  • Our Role
  • Medicines Information
  • Safety Information
  • Safety Notices
  • Regulatory Information
  • News & Events
  • Special Topics
  • Emergency Medicines

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

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

Blood, Tissues, Organs

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

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

Important information regarding cookies and the HPRA

By using this website, you consent to the use of cookies in accordance with the HPRA Cookie Policy.
For more information on cookies, see our cookie policy.

Click here to accept the cookie policy and hide this message
Reset Cookie
Date Printed: 21/04/2018