The Health Products Regulatory Authority (HPRA) proposes no general increase in its fees for 2027, across human medicines, compliance activities, blood, tissues, organs, medical devices and veterinary medicines. Two public consultations opened on 12 October 2026 and close on 31 October 2026, with two targeted changes for medical device companies.
The proposals are set out in two consultation papers on the HPRA consultations page: one covering human medicines, compliance activities, blood, tissue establishments, organs and medical devices, and a separate paper for veterinary medicinal products. If adopted, the fees would apply from 1 January 2027.
- No general increase: proposed for 2027 in both the human/devices paper and the veterinary paper.
- Deadline: comments by 31 October 2026, by email to feesconsultation@hpra.ie.
- Small device makers: Irish manufacturers with annual turnover under EUR 50,000 would pay no annual fee, down from 275.
- Certificates of free sale: the "four certificates per request" limit would go, with the fee unchanged at 200.
- Clinical trials: no change to the HPRA share of the Clinical Trials Regulation fee, and the National Office for Research Ethics Committees does not plan to raise its share either.
- Start date: new fees would apply from 1 January 2027.
What the HPRA is proposing for 2027
The headline is a freeze. "Following an internal review of the operating environment, the actual and proposed activity, income and cost levels, the HPRA proposes no general increase in its fees for 2027," the human medicines and devices paper states. The veterinary paper says the same for animal medicines: "no general increase in veterinary fees is proposed for 2027".
The regulator describes the freeze as a short-term measure. In its words, the approach "should provide stakeholders with short-term certainty whilst allowing the HPRA to assess more fully the financial impact of remit changes, implementation requirements and activity levels across multiple regulatory frameworks." Both papers say the position will be reviewed again in the 2028 fee-setting process.
The model behind the proposals is based on activity volumes from the first seven months of 2026.
The two changes for medical device companies
Within the overall freeze, the human medicines and devices paper proposes two targeted changes, both in the medical devices schedule.
| Fee line | Current fee and proposal |
|---|---|
| Fee code 418: digitally signed certificates of free sale, manufacturing location letters and export documents | 200 today; stays at 200. The "four certificates per request" wording is removed, because the documents are sent digitally with no limit on copies. |
| Annual fee for manufacturers, system and procedure pack producers and manufacturing facilities located in Ireland | 275 today in the small-entity row; proposed 0 where annual turnover is under EUR 50,000. |
For the annual fee exemption, eligibility would be checked at each annual registration renewal, and applicants would submit a declaration of turnover. One detail is worth checking with the HPRA: the body text sets a turnover test only (under EUR 50,000), while the fee table row describes the category as manufacturers "with fewer than 5 employees or with annual turnover of less than EUR 50,000". The paper also says the final arrangements still need to define the accounting period, whether turnover is measured for the legal entity or for the regulated activity, how connected entities are treated, and what happens if a declaration is inaccurate.
Why fees are being held despite rising costs
The freeze comes despite clear cost pressures, which the paper sets out. It cites the Central Bank headline inflation forecast of 3.1% for 2027, anticipated national pay awards, an expanded statutory remit whose funding source "has yet to be determined", and investment in the HPRA Strategic Plan 2026-2029. The HPRA says it "will endeavour to use the 2026 anticipated savings and efficiencies to absorb the incremental costs."
On 2026 finances, the paper says human medicines income and other income categories are "performing broadly in line with prior year albeit certain anticipated growth has yet failed to materialise." Variances were offset by savings, "particularly in relation to payroll, mainly due to delays in recruiting certain positions."
The workload named in the paper is substantial: medicine shortages, the sodium valproate inquiry, the codeine review, preparation for the EU regulation on substances of human origin (SoHO), which applies from 7 August 2027, the EU pharmaceutical package, cyber and resilience rules, the EU AI Act, and work linked to Ireland's EU Council Presidency, including the EU Biotech Act and revisions to the medical device and in vitro diagnostic regulations. For 2027 it also lists updates to the Clinical Trials Regulation and the Medical Device Regulation, and the Critical Medicines Act.
The paper also flags legal costs: "An ongoing area of concern is the prevalence of increased litigation, in the areas of both personal injury and judicial review. This unfortunately results in increased costs and resources dedicated solely to work which delivers nothing under our public health remit."
For medical devices, cosmetics, shortages, blood, tissues and cells, the HPRA notes that it receives a partial subvention from the Department of Health.
Veterinary medicines: no change to any fee
The separate veterinary paper, first reported by Agriland on 13 October, proposes no general increase and no changes to individual fee lines. The HPRA says veterinary income "remains strong" in 2026 and is forecast "to continue to remain strong for 2027".
The pressures it lists for animal medicines include implementing the EU Veterinary Medicines Regulation (EU) 2019/6, the Union Product Database, a decline in decentralised and mutual recognition procedure revenue that may reflect a shift towards the centralised procedure, more complex queries from applicants, availability initiatives such as joint UK and Northern Ireland or multilingual labelling, and rising compliance activity "particularly outside of Ireland".
How to respond before 31 October
Comments on either paper go by email to feesconsultation@hpra.ie by 31 October 2026. The HPRA encourages respondents to explain the likely impact on their organisation and to provide supporting evidence where available. It says it will publish an overview of the comments received and any changes to the proposals. Last year the outcome notice followed about a week after the consultation closed.
For most licence holders the practical message is budget certainty for 2027. The groups with most to gain from responding are very small Irish device manufacturers, who should check how the turnover test will be defined, and exporters who rely on certificates of free sale.
Frequently Asked Questions (FAQ)
Q: Will HPRA fees go up in 2027?
A: Not under these proposals. The HPRA proposes no general increase for 2027 for human medicines, compliance, blood, tissues, organs, medical devices or veterinary medicines.
Q: When does the consultation close?
A: On 31 October 2026. Comments go by email to feesconsultation@hpra.ie.
Q: Who would stop paying the medical device annual fee?
A: Manufacturers, system and procedure pack producers and manufacturing facilities located in Ireland with annual turnover under EUR 50,000, based on a declaration at each annual renewal. Some details, such as how turnover is measured, are still to be defined.
Q: Are clinical trial fees changing?
A: No. The HPRA component of the Clinical Trials Regulation fee is unchanged, and the National Office for Research Ethics Committees has said it does not intend to increase its component in 2027.
Q: When would the new fees apply?
A: From 1 January 2027, once the HPRA confirms them after the consultation.
Conclusion and Outlook
For 2027 the HPRA is choosing stability: no general fee rise, a small but useful waiver for the smallest Irish device makers, and simpler certificate rules for exporters. The consultation closes on 31 October 2026, and the HPRA will publish the outcome afterwards. With a 3.1% inflation forecast, a growing EU workload and an unfunded remit expansion, the 2028 fee review is likely to be the harder conversation.
Cover image: AI-generated illustration. It does not show any real person, organisation or location.
Sources
- HPRA, Consultations (accessed 16 October 2026)
- HPRA, Public consultation on proposed fees for 2027: human medicines, compliance activities, blood, tissue establishments, organs and medical devices (PDF, October 2026)
- HPRA, Public consultation on proposed fees for 2027: veterinary medicinal products (PDF, October 2026)
- Agriland, HPRA launches consultation on vet medicines fees, 13 October 2026
