HPRA Announces Review of Proposed Fee Increases After Public Consultation

The Health Products Regulatory Authority (HPRA) Ireland has unveiled revisions to its proposed fee structure following a public consultation on fees for 2025 in the areas of Human Medicines, Compliance, Medical Devices, and Veterinary Medicine. Despite receiving only two responses to the consultation, HPRA has taken the time to carefully review and incorporate the feedback provided, refining the initial proposal to better align with stakeholder concerns and operational needs.

Among the key elements of the updated fee structure are several adjustments that aim to address specific concerns raised during the consultation process.

HPRA Fee Increases: How Does the Revised Structure Address Stakeholder Concerns?

• • A general fee increase of 5% will still be implemented across all categories, reflecting the HPRA’s need to maintain effective regulatory oversight and continue funding essential activities within its remit.
  • In response to calls for fairness from stakeholders, dormant authorizations — which pertain to licenses for entities that are not currently active — will be exempt from the annual fee increase. This decision comes after feedback highlighting the financial burden that inactive businesses might face when attempting to maintain their regulatory status without active operations.
  • Clinical trial fees, which were initially proposed to rise by 15%, have now been adjusted to a more modest 10% increase. This change aims to provide some relief to organizations conducting clinical research, ensuring that the cost of regulatory oversight does not unduly impact vital medical studies and innovation.

Following these revisions, the HPRA is set to submit the updated fee structure to the Minister for Health for final approval. If approved, the new fees will take effect in 2025, with the HPRA committed to continuing its work to ensure that the regulatory environment supports both public health and industry needs.

For further details and to read the full report, please refer to Outcome of the Process – Public Consultation on Proposed Fees for 2025.

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If you’re affected by the HPRA fee increases, review the updated structure to understand the impact on your organization. The new fees are set to take effect in 2025, with final approval pending. For more information or any inquiries, please contact us directly.

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