Human Tissue Authority Licences and Inspections

HTA Licences 

Organisations that store relevant material in England, Wales and Northern Ireland may require a Licence from the Human Tissue Authority. Organisations in Scotland are not licensed by the HTA for storage of human material under the Human Tissue Act 2004.

The HTA also licences storage of material for human application (under the EU Tissues and Cells Directive), their remit for this includes Scotland as well. Organisations should be aware that a licence for this activity is likely to be required from the HTA.

The HTA web pages on licensing help to clarify which activities are licensed.

It is worth highlighting that the storage of extracted DNA, where no whole cells remain, is not a licensable activity. For more information on the legislative requirements surrounding DNA analysis, please visit the Research Scenario. 

The MRC Regulatory Support Centre has produced a licensing summary for storage for research, outlining the requirements and exemptions.

Those organisations applying for a licence may find the guidance that the MRC Regulatory Support centre produced for MRC's research units useful. It outlines what to consider when applying for an HTA licence and completing the compliance report.

Also see HTA Licence station.

HTA Inspections

The HTA may inspect Licensed premises. An MRC research unit recently underwent such an inspection, and have helped the Regulatory Support centre produce a document outlining what to expect during an inspection and the role of the Designated Individual.

It is worth noting that HTA Inspections will be based on the information provided in the Compliance report and any conditions imposed on the licence.

Also see Audit and inspection station and the HTA Inspection web page.