Introduction to the Regulations
Find out about Licensing under the Human Tissue (Quality and Safety for Human Application) Regulations, 2007 (as amended) (the Q&S Regulations).
Role of Designated Individual
Designated Individuals (DIs) have a key role to play in ensuring compliance with the requirements of the Q&S Regulations. You can find more information about DIs responsibilities under the Q&S Regulations here.
Reporting Serious Adverse Events and Reactions (SAEARs)
You are required to report serious adverse events (SAEs) or serious adverse reactions (SARs) to the HTA within 24 hours of discovery.
Find out more about SAEARs and how to report here.