Guidance documents – medicines for human use
Guide to labels and leaflets of human medicines
PDF : 404 KB | 28/01/2025
Guide to the HPRA Emergency Medicines Portal
PDF : 187 KB | 08/11/2024
Guide to applications for a variation to a manufacturer's authorisation
PDF : 395 KB | 15/05/2024
Guide to applications for a new manufacturer's authorisation
PDF : 344 KB | 15/05/2024
Information on applications for a variation to a manufacturer's authorisation is contained in AUT-G0182 Guide to applications for a variation to a manufacturer's authorisation v1
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Guide to Combining Multiple Presentations of a Parenteral Product in One Product Authorisation
PDF : 135 KB | 09/05/2024
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Guide to attainment of Qualified Person status in Ireland
PDF : 110 KB | 10/04/2024
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Guide to new applications and variations to wholesale distribution authorisations
PDF : 295 KB | 03/04/2024
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Guide to submitting a request for a new national application (h)
PDF : 74 KB | 02/04/2024
Guide to submitting a request for Ireland to act as RMS in a DCP (h)
PDF : 77 KB | 02/04/2024
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Guide to renewal of marketing authorisations - human medicines
PDF : 120 KB | 14/03/2024
This document has been extensively updated, therefore, a version of the document with changes tracked is not relevant.
Guide to quality system for general sale wholesale distributors
PDF : 739 KB | 15/01/2024
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Guide to good distribution practice of medicinal products for human use
PDF : 322 KB | 19/12/2023
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Guide for national scientific and regulatory advice
PDF : 133 KB | 19/09/2023