Guidance documents – medicines for human use

Guide to advertising compliance

PDF : 446 KB | 28/03/2025 View tracked changes

Guide to batch-specific requests for human medicines

PDF : 106 KB | 25/03/2025 View tracked changes

Guide to THMP Registration Scheme

PDF : 203 KB | 25/03/2025 View tracked changes

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 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 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 submitting a request for a new national application (h)

PDF : 91 KB | 02/04/2024

Guide to submitting a request for Ireland to act as RMS in a DCP (h)

PDF : 93 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.

Medicines shortages framework

PDF : 337 KB | 01/08/2023 View tracked changes

Guide to clinical trials conducted under the CTR in Ireland

PDF : 394 KB | 27/06/2023 View tracked changes

Guide to Interchangeable Medicines

PDF : 188 KB | 23/01/2023

Updated following clarification received from the Department of Health that the demonstration of bioequivalence is not required by the Health (Pricing and Supply of Medical Goods) Act 2013.

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Guide to definition of a human medicine

PDF : 187 KB | 21/12/2022 View tracked changes

Guide to reclassification (switching) of legal supply status for human medicinal products

PDF : 222 KB | 15/12/2022 View tracked changes

HPRA note for non-pharmacy retail advertising of medicines

PDF : 76 KB | 28/07/2022

Guide to managing changes to registration for active substance manufacturers importers and distributors

PDF : 281 KB | 28/01/2022 View tracked changes

Guide to registration requirements for active substances manufacturers importers and distributors in Ireland

PDF : 2523 KB | 28/01/2022 View tracked changes