Guidance documents – medicines for human use

Guide to the HPRA Emergency Medicines Portal

PDF : 187 KB | 08/11/2024

Information about how to use the HPRA's online system allowing organisations to register their intention to procure, store and use an emergency medicine.

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 fees for human products

PDF : 254 KB | 02/07/2024

Fees for human medicines and medical devices

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Guide to labels and leaflets of human medicines

PDF : 333 KB | 20/06/2024

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 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 : 178 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

Guide for national scientific and regulatory advice

PDF : 133 KB | 19/09/2023

This document has been substantially updated so no track changed document has been provided as it would not be helpful.

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

You can write a description here

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Guide to clinical trials conducted under the CTR in Ireland

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