Guidance documents – medicines for human use
Guide to reporting and investigation of quality defects in human and veterinary medicinal products
PDF : 273 KB | 20/07/2025 View tracked changesGuide to Registration of Processes under Article 61(5) of the Clinical Trial Regulation
PDF : 190 KB | 19/05/2025 View tracked changesGuide to good distribution practice of medicinal products for human use
PDF : 378 KB | 07/04/2025 View tracked changesGuide to applications for a variation to a manufacturer's authorisation
PDF : 393 KB | 28/02/2025 View tracked changesGuide to applications for a new manufacturer's authorisation
PDF : 344 KB | 28/02/2025 View tracked changesGuide to the HPRA Emergency Medicines Portal
PDF : 258 KB | 08/11/2024Guide to Combining Multiple Presentations of a Parenteral Product in One Product Authorisation
PDF : 135 KB | 09/05/2024 View tracked changesGuide to attainment of Qualified Person status in Ireland
PDF : 110 KB | 10/04/2024 View tracked changesGuide to new applications and variations to wholesale distribution authorisations
PDF : 295 KB | 03/04/2024 View tracked changesGuide to submitting a request for Ireland to act as RMS in a DCP (h)
PDF : 77 KB | 02/04/2024 View tracked changesGuide to submitting a request for a new national application (h)
PDF : 74 KB | 02/04/2024Guide to renewal of marketing authorisations - human medicines
PDF : 120 KB | 14/03/2024This document has been extensively updated, therefore, a version of the document with changes tracked is not relevant.