All establishments licensed for patient treatment under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 must submit data relating to the activities they undertook and the tissue types they worked with in 2017.
Submission of this data is a requirement under the standard conditions of a human application sector licence. Failure to submit data before the deadline may result in regulatory action by the HTA.
The information collected will be used:
- to calculate licence fees;
- to collect information on the volume of import and export activity between the UK and EEA countries;
- to inform the HTA’s ongoing assessment of licensable activities being carried out by satellite licenses and/or under the terms of third party agreements (TPAs);
- in our reconciliation of information listed on the EU Coding System tissue establishment compendium; and
- to guide our regulatory approach and inform our risk profiling.
You will be able to complete and submit your data via our online portal from 8 January – 23 February 2018.
To help you prepare, we strongly recommend that you read the guidance document on annual activity data 2017 in full before you begin collecting your data. This is to ensure consistency in the way data is reported across all establishments.
You should also check that you have access to the HTA portal. If you do not have a portal account or need to register a new person designate, please follow the instructions in the HTA web portal guidance document.
If you have any questions now, or during the submission period, please contact HTA on 020 7269 1900 or firstname.lastname@example.org