Guidance documents – medicines for human use

Guide to quality system for general sale wholesale distributors

PDF : 757 KB | 24/02/2026 View tracked changes

Guide for national scientific and regulatory advice

PDF : 210 KB | 18/02/2026 View tracked changes

Guide to fees for human products

PDF : 375 KB | 16/01/2026 View tracked changes

Guide to registration requirements for brokers of medicinal products in Ireland

PDF : 152 KB | 03/11/2025 View tracked changes

Guide to the HPRA Emergency Medicines Portal

PDF : 262 KB | 19/09/2025 View tracked changes

Guide to new applications and variations to wholesale distribution authorisations

PDF : 299 KB | 18/09/2025 View tracked changes

Guide for suppliers of first aid kits containing medicinal products supplying solely to the end-user

PDF : 244 KB | 18/09/2025 View tracked changes

Guide for Marketing Authorisation Holders on Direct Healthcare Professional Communications

PDF : 194 KB | 18/09/2025 View tracked changes

Guide to additional monitoring requirements and statements encouraging reporting of adverse reactions

PDF : 204 KB | 18/09/2025 View tracked changes

Guide to biosimilars for healthcare professionals

PDF : 196 KB | 18/09/2025 View tracked changes

Guide to electronic submissions - human medicines

PDF : 175 KB | 18/09/2025 View tracked changes

Guide to National Rules Scheme for Homeopathic Medicinal Products for human use

PDF : 242 KB | 18/09/2025 View tracked changes

Guide to Registration of Homeopathic Medicinal Products

PDF : 322 KB | 18/09/2025 View tracked changes

Guide to Notification of Marketing Status of Human Medicines

PDF : 134 KB | 18/09/2025 View tracked changes

Guide to withdrawal of authorisations or certificates for human medicines

PDF : 112 KB | 18/09/2025 View tracked changes

Guide to the notification system for exempt medicinal products

PDF : 250 KB | 17/09/2025 View tracked changes

Guide to refusals and appeals

PDF : 204 KB | 17/09/2025 View tracked changes

Guide to wholesaling and brokering of medicinal products for human use in Ireland

PDF : 232 KB | 26/08/2025 View tracked changes

Guide to reporting and investigation of quality defects in human and veterinary medicinal products

PDF : 277 KB | 20/07/2025 View tracked changes

Guide to parallel imports of human medicines

PDF : 289 KB | 25/06/2025 View tracked changes