For information on reproductive cells, please refer to the Human Embryology and Fertilisation Authority’s website.
The Directive allows us to exempt tissue establishments from the requirement to apply the SEC. The following guidance explains the relevant exemptions and how we expect these fit with the current regulatory framework in the UK.
Tissues and cells are already in storage on 29 October 2016 are exempt from the requirements to apply the SEC. This exemption applies if:
- the tissues and cells are released for circulation within 5 years – that is, by 29 October 2021; and
- full traceability is ensured using alternative means
For tissues and cells which are released after 29 October 2021, the SEC must be applied. If you cannot apply the SEC, you can unambiguously link the SEC to the tissues and cells, as set out in Article 10b paragraph 1(f). We expect this exemption will apply to tissues and cells stored under deep-freeze conditions.
Same centre exemption
This exemption can apply when tissues or cells remain within the same centre from either donation or import until application. This means all steps from procurement to human application are carried out at the same location:
- under the same responsible person (or DI);
- using the same quality management system and traceability system; and
- within a healthcare centre which includes:
- at least a licensed tissue establishment, and
- an organisation responsible for human application.
We are currently considering how this exemption may apply in the UK. If you think you may be affected by this exemption, please contact us.
Direct Authorisation and Emergencies
Tissue and cells which are distributed directly for immediate transplantation in the recipient may not need to have the SEC applied. The tissues and cells which may be exempt are referred to in Article 6(5) of the parent Directive 2004/23/EC.
We understand that in other EU countries this article has predominantly been used for imports of HSCT products. However in the UK, this exemption is not widely used. In addition in our current legislation, direct authorisation is only possible in an emergency.
We are currently reviewing arrangements in consultation with stakeholders and will provide a further update in due course.
If you work with HSCT and have any questions about how the Directives will affect you, please contact us.