Guidance documents – medicines for human use

Guide to the HPRA Emergency Medicines Portal

PDF : 258 KB | 19/09/2025 View tracked changes

Guide to quality system for general sale wholesale distributors

PDF : 661 KB | 18/09/2025 View tracked changes

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

PDF : 239 KB | 18/09/2025 View tracked changes

Guide to new applications and variations to wholesale distribution authorisations

PDF : 295 KB | 18/09/2025 View tracked changes

Guide for Marketing Authorisation Holders on Direct Healthcare Professional Communications

PDF : 189 KB | 18/09/2025 View tracked changes

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

PDF : 199 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 : 171 KB | 18/09/2025 View tracked changes

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

PDF : 237 KB | 18/09/2025 View tracked changes

Guide to Registration of Homeopathic Medicinal Products

PDF : 318 KB | 18/09/2025 View tracked changes

Guide to Notification of Marketing Status of Human Medicines

PDF : 129 KB | 18/09/2025 View tracked changes

Guide to withdrawal of authorisations or certificates for human medicines

PDF : 107 KB | 18/09/2025 View tracked changes

Guide to the notification system for exempt medicinal products

PDF : 245 KB | 17/09/2025 View tracked changes

Guide to refusals and appeals

PDF : 199 KB | 17/09/2025 View tracked changes

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

PDF : 227 KB | 26/08/2025 View tracked changes

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

PDF : 273 KB | 20/07/2025 View tracked changes

Guide for national scientific and regulatory advice

PDF : 142 KB | 09/07/2025 View tracked changes

Guide to parallel imports of human medicines

PDF : 285 KB | 25/06/2025 View tracked changes

Guide to Registration of Processes under Article 61(5) of the Clinical Trial Regulation

PDF : 190 KB | 19/05/2025 View tracked changes

Guide to good distribution practice of medicinal products for human use

PDF : 378 KB | 07/04/2025 View tracked changes