Late licence applications
This page provides information regarding late licence applications.
Licensing by the HTA of the storage of tissue for human application started in April 2006; licensing of all other activities within our remit under the Human Tissue Act 2004 started on 1 September 2006. The HTA communicated widely with the sectors to be regulated in advance of the licensing requirements of 1 September, and received approximately 400 licence applications by the 31 August deadline.
Late licence applications from 1 March 2007
Any establishment carrying out activities licensable under the HT Act who applied for a licence by midnight of 31 August 2006 was eligible for a deemed licence. This was a transitional provision which meant that establishments could continue their operations, pending full evaluation of their compliance report licence application prior to the HTA either granting or refusing a substantive licence.
The HTA adopted a pragmatic approach to any late applications that were received after 31 August 2006 and issued four month short-term licences to these establishments. These short term licences allowed the establishment to continue the activity whilst a full evaluation of the compliance report licence application was undertaken. The issue of short term licences ceased at the end of February 2007, six months since the HT Act was commenced. The HTA believed that the licensable sectors had had sufficient time to become familiar with the requirements of the HT Act and to submit licence applications, and therefore that it was a reasonable time for the transitional arrangement to end.
From 1 March 2007, any unlicensed establishment that requires a licence under the HT Act will not receive an immediate four month short-term licence.
Such establishments will need to allow four to six months from the date of submission of the compliance report licence application to enable a licensing evaluation and decision to be made. This period includes the statutory 28 days for the licence offer to be accepted or rejected by the Designated Individual and Licence Holder.
Licence requirements: The Human Tissue (Quality and Safety for Human Application) Regulations 2007
The Human Tissue (Quality and Safety for Human Application) Regulations 2007, which transpose the European Union Tissue and Cells Directive into UK law, make it a requirement that establishments storing tissues or cells for human application have an HTA licence to do so. Establishments procuring, processing, testing, distributing, importing or exporting tissues or cells for human application must either have an HTA licence or a third party agreement with an establishment which has an HTA licence under the Human Tissue (Quality and Safety for Human Application) Regulations 2007.
Establishments that are currently licensed by the HTA under the HT Act to store relevant material for transplantation will not need to apply for a licence. Establishments that are not currently licensed will be required to apply for a licence under the Regulations. An application form is available on the website. Establishments are expected to apply between 1-5 July 2007.
If you are applying after 5 July 2007, please contact the Head of Regulation for your geographical patch as a matter of urgency (contact details below).
What do you need to do now if you need a licence?
You must apply for a licence now. You cannot undertake licensable activities until you have been granted a licence by the HTA. In the interim you must suspend any activity you believe may be licensable and make alternative arrangements until you are granted a licence.
Does this mean unlicensed establishments need to dispose of any human tissue that they are storing?
The HTA encourages unlicensed establishments to make alternative arrangements until they are granted an HTA licence. This could include working with an HTA licensed establishment to store the tissue. A list of establishments which are licensed by the HTA and the names of Designated Individuals is provided in the licensing section.
Further information
If you have any questions about the process for late licence applications please contact the Head of Regulation for your area.
Scotland, East of England, North East of England and South East of England
Caroline.browne@hta.gov.uk
Northern Ireland, Central England, South West England and South East England
Imogen.swann@hta.gov.uk
Wales, North West England and South East England
Kristi.collins@hta.gov.uk