Late licence applications
This page provides information regarding the approach the HTA will take to the receipt of late licence applications if an establishment has been unlawfully undertaking licensable activities outside of the authority of a HTA licence.
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 2006, and received approximately 400 licence applications by the 31 August 2006 deadline.
Licensing by the HTA under The Human Tissue (Quality and Safety for Human Application) Regulations 2007 (Q&S Regulations) requires that
- tissues or cells intended for use for human application must only be stored on HTA-licensed premises; and
- the procurement, processing, testing, distributing, importing or exporting of tissues or cells for human application must either be undertaken on HTA-licensed premises or be undertaken under the authority of a third party agreement.
Establishments that undertake the licensable activities of processing, testing, distribution, importing and exporting were required to apply for a licence by 5 July 2007. Establishments that undertake the licensable activity of procurement were required to apply for a licence by 5 July 2008.
The page provides information regarding the approach the HTA will take to the receipt of late licence applications if an establishment has been unlawfully undertaking licensable activities not under the authority of a HTA licence.
Licence requirements
It is unlawful to undertake activities which are licensable under the Human Tissue Act 2004 or Q&S Regulations on premises which have not been licensed by the HTA. If the HTA becomes aware that an establishment has been undertaking licensable activities outside of the authority of a HTA licence, the HTA will take the matter very seriously. The HTA has a policy of asking such establishments to cease activity until a substantive licence offer has been acknowledged by both the Designated Individual and Licence Holder.
Such establishments will need to allow for four 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.
What should I do if I think that a licensed establishment is undertaking licensable activities unlawfully?
In the first instance, if you think licensable activities are taking place without the authority of a licence, please contact either a Head of Regulation of a Regulation Manager. This member of staff will be able to discuss the specific licensing requirements for you and your establishment.
The Quality & Safety Regulations exist to safeguard the quality and safety of any tissues and cells which are intended for use for human application and ensure that there is a European wide system which supports a framework for human health protection. Equally one of the aims of the Human Tissue Act 2004 is to ensure good practice in the post mortem, anatomy, research and public display sectors and the HTA ensures certain minimum standards are adhered.
It is therefore important that the legal and regulatory requirements are complied with. It is unlawful to undertake licensable activities until a licence has been granted by the HTA (or, in the tissue and cells for patient treatment (human application) sector, unless under the authority of a third party agreement). In the interim you must discuss the requirement to suspend any activity you believe may be licensable with a Head of Regulation or a Regulation Manager who will discuss the arrangements that you will need to have in place until you are granted a licence.
Does this mean unlicensed establishments need to dispose of material that is being stored?
The HTA encourages unlicensed establishments to make alternative arrangements until they are granted a HTA licence. This could include working with a HTA-licensed establishment to store the tissue. A list of HTA-licensed establishments and Designated Individuals is provided in the licensing section of the our website.
Further information
If you have any questions about how the HTA will deal with late licence applications, where licensable activities have been undertaken on unlicensed premises, please contact either a Head of Regulation or a Regulation Manager who will be able to discuss the specific licensing requirements required by you and your establishment.
Telephone: 020 7269 1900
Email: licensing.enquiries@hta.gov.uk
Updated August 2011