Guidance documents – medicines for human use

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

Guide to Interchangeable Medicines

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.

Guide to clinical trial applications

Guide to definition of a human medicine

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

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

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

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

Guide for Marketing Authorisation Holders on Direct Healthcare Professional Communications

Guide to Notification of Marketing Status of Human Medicines

Guide to withdrawal of authorisations or certificates for human medicines

Guide to Transfers of MAs PPAs and DPRs for Human Medicines

Guide to the notification system for exempt medicinal products

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

Guide to control and monitoring of storage and transportation conditions

Guide to biosimilars for healthcare professionals

Guide to registration requirements for brokers of medicinal products in Ireland

Guide to THMP Registration Scheme