Irelan HPRA Guide: Fees for Human Products: Key Regulatory Fees for Medicines, Clinical Trials and Manufacturing Activities

Regulatory submissions for medicines and other human health products involve a range of application, assessment, maintenance, inspection, and administrative fees. The Health Products Regulatory Authority (HPRA) Guide to Fees for Human Products provides applicants with a structured framework for identifying the appropriate fee category and fee code to accompany applications submitted to the Authority.

The guide covers fees associated with medicines, clinical trial authorisations, manufacturers and importers, wholesale distributors, inspections, blood and tissue establishments, exempt medicinal products, precursor chemicals, medical devices, and various technical and administrative services.

Why This Guide Is Important

The guide helps applicants identify the correct fee category for regulatory applications and explains how different fee codes apply depending on the type of application, regulatory procedure, product, or service involved. The fee application form should be completed and submitted with applications, with the applicable fee code selected according to the relevant activity. The guide follows the order of fees in the Fee Application Form and uses the corresponding fee code numbers.

Medicinal Product Authorisations and Registrations

The guide covers fees for new medicinal product applications, including products containing new active substances and applications submitted through national, mutual recognition, and decentralised procedures.

Different fee codes apply depending on whether Ireland acts as the Reference Member State (RMS) or Concerned Member State (CMS). Additional fees may apply for certain procedures, additional master files, or specific regulatory activities. The guide also addresses applications for homeopathic products, variations, registrations, and other authorisation-related activities.

For medicinal products, fees also apply during the maintenance phase of the product lifecycle. Annual maintenance fees cover routine dossier management and maintenance activities, including work associated with ongoing pharmacovigilance. Different fee categories apply depending on the number and status of marketing authorisations, including dormant authorisations.

Clinical Trial Authorisations

Clinical trial applications under the Clinical Trials Regulation are subject to a single fee covering the HPRA scientific assessment and, where applicable, the National Office for Research Ethics Committee ethical assessment.

The guide also specifies that there are no clinical trial application fees in Ireland for qualifying non-commercial clinical trials. A non-commercial sponsor is defined based on the absence of commercial or financial interest in the outcome, with ownership and control of the investigation data and trial conduct remaining with the non-commercial sponsor.

Different fee codes apply depending on the type of clinical trial application, including mono-national applications, applications where Ireland is the reporting Member State, applications where Ireland is a concerned Member State, applications with or without an investigational medicinal product dossier, and substantial modifications. Fees are also specified for appeals of clinical trial decisions.

Manufacturers, Importers and Wholesale Distributors

The guide also establishes fees for manufacturers' and importers' authorisations and wholesale distributor authorisations.

Annual maintenance fees for manufacturers and importers are linked to facility size and the number of relevant employees involved in activities such as production, processing, quality control or assurance, and engineering. Separate provisions apply to investigational medicinal product manufacturing authorisations.

Variations to manufacturing authorisations are also subject to different fee categories depending on whether the change is administrative or requires technical assessment, inspection, or review of supplementary data. Incorrect or incomplete applications may also incur an additional fee.

Inspections and Regulatory Certificates

Inspection fees apply to a range of activities, including inspections associated with manufacturing and wholesale authorisations, Good Clinical Practice inspections, pharmacovigilance activities, contract laboratories, active substance manufacturers, third-country sites, and inspections related to suspected non-compliance.

Inspection fees are charged based on the inspection time and the number of members of the inspection team. Additional travel and expense costs may apply for certain inspections, including inspections outside the EEA.

The guide also provides fees for certificates such as certificates of pharmaceutical products, free sale certificates, GMP certificates, certificates of analysis, and TSE declarations. Urgent requests for certain certificates are subject to separate fees.

Scientific Advice and Regulatory Services

Applicants can request national scientific advice during product development in quality, clinical, non-clinical, and regulatory areas. Different fee codes apply depending on whether advice is requested in one, two, three, or all four areas. A separate fee applies for swift national scientific advice provided through a written procedure.

The guide also covers classification requests for determining whether a product falls within the definition of a medicinal product. Fees differ between simple and complex classification assessments, with a separate fee applying where a determination is appealed.

Other Regulatory and Administrative Fees

Additional fees apply to technical and administrative services, requests for information, and formal appeals. Technical staff charge-out rates may apply for assessments outside the authorisation process and other services, while administrative charges may apply for non-routine work and certain application-related activities.

The guide also includes fees for batch-specific requests, enforcement activities, and other regulatory services. Annual enforcement fees apply to marketing authorisation and parallel import licence holders, while specific fees apply to requests relating to individual batches of medicinal products.

As regulatory activities span the complete product lifecycle—from initial authorisation and clinical development through manufacturing, inspection, maintenance, variations, and post-authorisation activities—understanding the applicable HPRA fee category is an important part of submission planning. The guide provides applicants with the relevant fee codes and categories needed to support the appropriate regulatory application and associated processes.

References

• Health Products Regulatory Authority (HPRA): Guide to Fees for Human Products, FIN-G0002-38.