Human Tissue Authority

The regulator for human tissue and organs

Compliance updates required for licensed establishments

All establishments licensed under the Human Tissue Act 2004 and the Quality and Safety of Organs for Transplantation Regulations 2012 must complete and submit the compliance update questionnaire on the HTA portal.

General Directions

The HTA has issued new General Directions for the following sectors regarding the 2017 compliance updates:

Submitting your compliance update

All establishments in the sectors listed above must submit the compliance update questionnaire on the HTA portal.

You can access the compliance update questionnaires by clicking on the relevant sector below:

Submissions will be open from 31 August to 12pm 2 October 2017. After this date, the portal will close for submissions and your risk rating may be affected if you have not submitted your return.

For further instructions, please refer to the Guide to submitting Compliance Updates using the HTA Portal.

Please let us know as soon as possible if you will be unable to provide the information requested by the deadline date.

Why are we asking you to complete a self-assessment?

In April 2009, the HTA moved to a system of continuous, rather than fixed-term, licensing. To support this system, as well as to maintain oversight of the sectors we regulate, guide our regulatory approach to each sector, and inform the scheduling of site-visit inspections, all establishments are required to provide us with an update of licensing information and to complete a questionnaire.

What should you do if you have been inspected recently or are due to be inspected in the near future?

All establishments are required to complete the exercise, regardless of whether they have just been inspected by the HTA or are due to be inspected. This is to ensure we have the most up to date, consistent information from all establishments.

Is completion of the self-assessment compulsory?

Yes. Not submitting the questionnaire would constitute a breach of the General Directions, which might in turn lead to consideration of regulatory action.

We understand that staff at our licensed establishments are very busy and may have limited resources. However, completing the self-assessment is essential so that we can maintain oversight of the sectors we regulate and ensure public confidence in the safe and ethical use of human tissue.  We have tried to minimise the time required to complete the self-assessment wherever possible.

Please note that the information gathered may be subject to Freedom of Information requests. Further information regarding the HTA’s responsibilities, under both the Freedom of Information Act 2000 and Data Protection Act 1998, can be found at https://www.hta.gov.uk/freedom-information-requests.

Contact us

Please contact us if you have any questions

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