Guidance documents – medicines for human use

Guide to applications for a variation to a manufacturer's authorisation PDF : 393 KB | 28/02/2025 View tracked changes
Guide to applications for a new manufacturer's authorisation PDF : 344 KB | 28/02/2025 View tracked changes
Guide for national scientific and regulatory advice PDF : 142 KB | 24/02/2025 View tracked changes
Guide to labels and leaflets of human medicines PDF : 404 KB | 28/01/2025 View tracked changes
Guide to fees for human products PDF : 279 KB | 02/01/2025 View tracked changes
Guide to the HPRA Emergency Medicines Portal PDF : 187 KB | 08/11/2024
Guide to batch-specific requests for human medicines PDF : 106 KB | 16/10/2024 View tracked changes
Guide to advertising compliance PDF : 367 KB | 06/10/2024 View tracked changes
Guide to Combining Multiple Presentations of a Parenteral Product in One Product Authorisation PDF : 135 KB | 09/05/2024 View tracked changes
Guide to attainment of Qualified Person status in Ireland PDF : 110 KB | 10/04/2024 View tracked changes
Guide to new applications and variations to wholesale distribution authorisations PDF : 295 KB | 03/04/2024 View tracked changes
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 View tracked changes
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 View tracked changes
Guide to good distribution practice of medicinal products for human use PDF : 322 KB | 19/12/2023 View tracked changes
Medicines shortages framework PDF : 337 KB | 01/08/2023 View tracked changes
Guide to parallel imports of human medicines PDF : 302 KB | 11/07/2023 View tracked changes
Guide to refusals and appeals PDF : 141 KB | 03/07/2023 View tracked changes
Guide to clinical trials conducted under the CTR in Ireland PDF : 394 KB | 27/06/2023 View tracked changes