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Irelands HPRA's: Guide to Fees for Human Products

On 3rd January 2023, Irelands Health Products Regulatory Authority (HPRA) released an updated Guide related to "Fees for Human Products".

The Health Products Regulatory Authority is responsible for the regulation of medicines, medical devices, blood establishments, tissue establishments, transplant organs and cosmetics.


According to sections 13 and 32 of the Irish Medicines Board Acts 1995 and 2006, the Health Products Regulatory Authority (Fees) Regulations lay down fees for applications.


Applicants should use this guide,to identify the correct fee category to accompany applications for authorization.


This guide uses the number codes used on the 'Fee Application Form' to identify the fees and the fee application form should be completed and submitted with all applications.


Clcik this LINK to know the individual codes for each fee category and more importantly the List of Complex Variations.


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