Guidance documents – medicines for human use

Guide to clinical trials conducted under the CTR in Ireland PDF : 394 KB | 27/06/2023 View tracked changes
Guide to reporting and investigation of quality defects in human and veterinary medicinal products PDF : 245 KB | 17/04/2023 View tracked changes
Guide to Registration of Processes Exempted under Article 61(5) of the Clinical Trial Regulation PDF : 123 KB | 02/02/2023
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 wholesaling and brokering of medicinal products for human use in Ireland PDF : 343 KB | 25/03/2022 View tracked changes
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
Guide for Marketing Authorisation Holders on Direct Healthcare Professional Communications PDF : 329 KB | 24/01/2022 View tracked changes
Guide to Notification of Marketing Status of Human Medicines PDF : 225 KB | 15/04/2021 View tracked changes
Guide to withdrawal of authorisations or certificates for human medicines PDF : 249 KB | 14/04/2021 View tracked changes
Guide to Transfers of MAs PPAs and DPRs for Human Medicines PDF : 273 KB | 22/03/2021 View tracked changes
Guide to the notification system for exempt medicinal products PDF : 508 KB | 04/12/2020 View tracked changes
Guide for suppliers of first aid kits containing medicinal products supplying solely to the end-user PDF : 421 KB | 01/10/2020 View tracked changes
Guide to control and monitoring of storage and transportation conditions PDF : 383 KB | 01/10/2020 View tracked changes
Guide to biosimilars for healthcare professionals PDF : 353 KB | 04/08/2020 View tracked changes
Guide to registration requirements for brokers of medicinal products in Ireland PDF : 329 KB | 30/04/2020 View tracked changes
Recall of medicinal products for human and veterinary use PDF : 307 KB | 22/11/2017 View tracked changes