Human Products Fees
Fees are charged by the HPRA for authorisation applications as laid down in the Irish Medicines Board Acts 1995-2006.
Human medicines fees are charged for new applications, transfers and variations and for parallel-import applications. There is a yearly maintenance fee for each product but no fee is charged for renewal applications.
Medical device fees are charged for registrations, clinical investigations and classifications. There is a yearly maintenance fee for each manufacturer, authorised representative and distributor.
Each year we publish a guide to fees which is intended to assist applicants in identifying the correct category of fee to accompany applications for authorisation.
The fee application form must be completed and submitted with all applications.
The guide follows the order of the fees in the fee application form and uses the fee code numbers in that form.
Guide to Fees for Human Products
Fee Application form for Human Products
Payment of Fees Instructions
Veterinary Medicines Fees
Visit the Veterinary Medicines section of our website for information on veterinary fees