Skip to Content
HPRA logo
Menu Search
  • Gaeilge
  • Careers
  • Contact us
  • My Alerts
Or find a medicine
  • List of medicines for human use
  • List of medicines for animal use
  • Find a Medicine
    Back

    Find a Medicine

    Find a medicine

    Find information about authorised and withdrawn medicines for human and animal use, and notified medicine shortages.

    Find out more
    • Find out more
    • For human use
      • Overview
      • Authorised medicines
      • Withdrawn medicines
      • Interchangeable Medicines 
      • Medicine shortages 
      • Herbal and homeopathic medicines 
      • General sales and pharmacy-only sales
      • XML product lists
      • Using the medicines list
    • For animal use
      • Overview
      • Authorised medicines – HPRA
      • Authorised medicines – all EU/EEA
      • Withdrawn medicines
      • Suspended medicines
      • Medicines for animal use information 
      • Shortages of medicines for animal use
      • XML product list
      • Resources for vets and animal owners
  • Safety Information
    Back

    Safety Information

    Safety Information

    Find out how we monitor safety. See Safety Notices for important updates on products we regulate.

    Find out more
    • Find out more
    • Safety Notices
      • Overview
      • Sign up for alerts
    • How we monitor safety
      • Overview
      • Medicines for human use
      • Medicines for animal use
      • Medical devices
      • Cosmetics
      • Blood
      • Tissues and cells
      • Organs
  • Regulation
    Back

    Regulation

    Regulation

    Find out how we regulate and view resources to help you comply. View resources for sponsors, manufacturers, distributors, importers and retailers.

    Find out more
    • Find out more
    • Medicines for human use
      • Overview
      • Marketing authorisation holders
      • Manufacturers
      • Wholesalers and retailers
      • Clinical trial sponsors
      • Patients and healthcare professionals
    • Medicines for animal use
      • Overview
      • Regulation 2019/6
      • Medicines authorisation 
      • Labelling and distribution
      • Availability of medicines for animal use 
      • Clinical field trials 
      • Care in use 
      • Manufacturing
      • Active substance registration
      • Export certification
      • Market compliance and surveillance
      • Guidance documents
      • Fees – medicines for animal use
      • Legislation 
    • Scientific animal protection
      • Overview
      • The 3Rs
      • Guidance documents
      • Animal Welfare Body
      • Alternative approaches 
      • Authorisations 
      • Non-technical project summaries 
      • Statistical reporting 
      • Compliance monitoring
      • Training requirements and courses
      • Fees 
      • Useful links 
      • Legislation 
      • National Committee
    • Medical devices
      • Overview
      • Registration
      • Common aspects of the regulations
      • Medical Devices Regulation
      • In Vitro Diagnostics Regulation
      • Documents and guidance
      • Fees
      • Legislation
    • Cosmetics
      • Overview
      • Cosmetics regulation
      • Obligations of responsible persons
      • Labelling and claims
      • Guidance documents
      • Fees 
    • Blood
      • Overview
      • Our role
      • Legislation
      • Blood establishments
      • Hospital blood banks
      • Fees 
      • SoHO Regulation 
      • Guidance documents
    • Tissues and cells
      • Overview
      • Our role 
      • Legislation
      • Tissue establishments 
      • Fees 
      • SoHO Regulation
      • Human Tissues Act 
      • Guidance documents
    • Organs
      • Overview
      • Our role 
      • Authorisations 
      • Legislation 
      • Inspections 
      • Fees 
      • Organs establishment list
      • Human Tissues Act
      • Guidance documents
    • Controlled drugs
      • Overview
      • Our role
      • Legislation
      • Requirements
      • Medical cannabis access programme 
      • Guidance documents
    • Precursor chemicals
      • Overview
      • Our role
      • Legislation
      • Operators and end users 
      • Licensing and registration
      • Guidance documents
    • Classification and innovation services
      • Overview
      • Classification of human health products
      • Innovation Office
    • Guidance documents
  • News & Events
  • About Us
    Back

    About Us

    About Us

    Find out more about our organisation, the products we regulate and how we regulate them.

    Find out more
    • Find out more
    • Our role
      • Overview
      • What and how we regulate 
      • Mission, vision and values
      • Strategic plan
    • Our structure 
      • Overview
      • HPRA Leadership Team
      • HPRA Authority Members
      • Advisory Committees
    • Patient Forum
      • Overview
      • About the Patient Forum 
      • Terms of Reference
      • Conflicts of interest
      • Rolling Work Plan
      • Meeting reports
      • Resources
    • Our standards
      • Overview
      • Standards of service
      • Quality Management and Benchmarking
    • Consultations 
      • Overview
      • Previous consultations 
    • Corporate publications
  • Make a Submission
  • Report an Issue
  • Gaeilge
  • Careers
  • Contact us
  • My Alerts
  • Make a Submission
  • Report an Issue
  1. Home
  2. Regulation
  3. Organs
  4. Guidance documents
Regulation
  • Medicines for human use
  • Medicines for animal use
  • Scientific animal protection
  • Medical devices
  • Cosmetics
  • Blood
  • Tissues and cells
  • Organs
    • Our role 
    • Authorisations 
    • Legislation 
    • Inspections 
    • Fees 
    • Organs establishment list
    • Human Tissues Act
    • Guidance documents
  • Controlled drugs
  • Precursor chemicals
  • Classification and innovation services
  • Guidance documents

Guidance documents – organs

Guide to fees for human products

PDF : 365 KB | 02/01/2026 View tracked changes

Guide to Serious Adverse Reaction Events Reporting for Human Organs intended for Transplantation

PDF : 237 KB | 18/09/2025 View tracked changes

Homepage link

My Alerts

Get the latest HPRA safety and regulatory updates delivered directly to your inbox.

Sign up now

Explore

  • Clinical trial sponsors
  • Safety monitoring of medicines
  • Consumer advice for medical devices
  • Buying prescription medicines online

Regulated sectors

  • Innovation Office
  • Guidance documents
  • Fees – medicines for human use
  • Fees – medicines for animal use

Health professionals and public

  • Medicine shortages 
  • Safety Notices
  • Patient Forum
  • Dermal filler risks

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

Contact us
Follow
  • Linkedin Link
  • X Link
  • Instagram Link
  • Youtube Link
  • Privacy & Data Protection
  • Transparency
  • Accessibility
  • Terms of use
  • Cookie settings

© Health Products Regulatory Authority