Last updated on 11 May 2023

Human application sector - HTA standards

Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended) licensing standards.  

Licensed establishments are required to meet the criteria that are detailed in the HTA's licensing standards. You can find the standards below. 

Governance and Quality
Premises, Facilities and Equipment

Classification of the level of shortfall

Where the HTA determines that a licensing standard is not met, the improvements required will be stated and the level of the shortfall will be classified as ‘Critical’, ‘Major’ or ‘Minor’. Where the HTA is not presented with evidence that an establishment meets the requirements of an expected standard, it works on the premise that a lack of evidence indicates a shortfall.

The action an establishment will be required to make following the identification of a shortfall is based on the HTA's assessment of risk of harm and/or a breach of the HT Act or associated Directions.

Shortfall levels

Human Application Sector Licensing standards

A printable PDF version of this guidance can be downloaded below.