EU Directives are being put in place for the coding and import of tissues and cells for human application (HA). These will be transposed into UK law during 2016 and the process of writing the UK Regulations is underway.
Copies of these Directives and an overview from the Department of Health (DH) are available:
- Donated Tissues and Cells for Human Application DH communication (PDF)
- Commission Directive amending Directive 200686EC (PDF)
- Commission Directive implementing Directive 200423EC (PDF)
These Directives are due to come into force throughout the EU on or before 29 April 2017. When implemented, all HA licensed establishments will be required to meet the requirements laid out in these Directives. We were part of the European Working Groups for the drafting of both Directives. Through this, we have worked towards ensuring that they are robust while remaining proportionate.
Transposing the Directives
We are currently working closely with the Department of Health and stakeholders to transpose the Directives into UK legislation. This includes determining how the exemptions will apply in the UK.
DH will be consulting on the new legislation and we will also consult on our draft Directions and guidance. We will continue to share information with you as it becomes available through our newsletter and on our website.