Human Tissue Authority

The regulator for human tissue and organs

External guidance

Guidance from the European Commission

The Commission have published guidance, alongside FAQs, which provide advice on applying the SEC. Please note, this guidance is based on the general requirements set out in the Directive and there may be differences in the way these requirements are implemented in the UK.

In particular, there are references to haematopoietic stem cells being exempt from application of the SEC. This exemption would apply when the direct distribution or import is authorised by the competent authority. We are currently working with DH and stakeholders to consider this issue.  We recommend you read our guidance on exemptions.

Please feel free to contact us if you think that you will be affected.
 

Guidance for ISBT 128 users

ICCBBA have published guidance on how the SEC should be formulated and printed on tissue and cell products labelled with ISBT 128. Please read the guidance to help you prepare for the new coding Directives.

Last updated on: 22 Dec 2016