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HPRA

Health Products Regulatory Authority

Use of Animals for Scientific and Educational Purposes

Animals may only be used for scientific purposes under strict conditions:

  • No alternative non-animal methods are available.
  • The minimum number of animals is used.
  • Only the minimum necessary pain, suffering, or distress is caused.

Role

The Health Products Regulatory Authority (HPRA) is responsible for regulating and enforcing EU and national legislation on the protection of animals used for scientific purposes in Ireland. They achieve this by:

  • Authorising each animal study, premises, researcher, and operator in accordance with strict legal and regulatory conditions.
  • Monitoring and enforcing compliance with these conditions by authorisation holders.
  • Providing advice and guidance to the regulated community.
  • Fulfilling reporting obligations to the EU Commission.

Commitment

The HPRA are dedicated to ensuring that the care and use of animals for scientific purposes align with the 3R principles:

  • Replacement: Avoiding the use of animals where alternative methods exist.
  • Reduction: Using the minimum number of animals necessary.
  • Refinement: Minimising pain, suffering, and distress.

Primary Functions

  1. Inspections and Authorisations:
    • Inspect and authorise establishments that keep, breed, or use animals for scientific purposes.
    • Review and approve projects and individuals conducting animal research.
  2. Compliance:
    • Monitor compliance with legal requirements and 3R principles through regular inspections.
  3. Record Monitoring and Reporting:
    • Ensure establishments maintain accurate records.
    • Report key statistical parameters to the EU Commission.
  4. Collaboration and Best Practices:
    • Work with competent authorities across EU Member States to exchange information and share best practices related to the 3Rs.

Relationship with the National Committee

The National Committee, appointed by the Minister for Health, serves as an independent advisory body to meet specific requirements under EU legislation.

    • The National Committee provides advice to the HPRA on scientific animal protection matters.
    • The HPRA, in agreement with the Department of Health, offers secretarial and logistical support to the National Committee to facilitate its role.

Biological Services Unit

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