We wrote to establishments in the Human Application and Organ Donation and Transplantation sectors on the with guidance on EU exit planning around the arrangements you should consider if the UK leaves the EU with ‘no deal’ by 29 March.
If the UK leaves the EU without a deal, it will become a third country for the purposes of the EU Tissues and Cells Directive and the EU Organ Donation Directives. The UK will also consider EU Member States to be third countries.
This will mean that tissues and cells from EU member states would need to be covered by the appropriate HTA import licence. If you already have an import licence, you can apply to vary this to include individual EU member states. If you do not have an import licence, you will need to apply for a new import licence
A requirement of import licences is that establishments have written agreements in place with suppliers in the third country, as set out in .
Additionally, if you send tissues and cells to any EU Member states you will require an export licence that covers this activity.
In the event of a no deal, there would be a six-month transitional period to allow establishments time to comply with any new requirements that result from the UK becoming a third country.
You can find information about the licence application and variation process on our .
Please note, you will not be able to apply to vary your licences, or to apply for new licences, for imports and exports to from the EU until the UK exits the EU.
If you wish to begin to prepare your application, please refer to the information on our website about
Possible disruptions to supply chains
By now, you should have conducted risk assessments on your supply chain of reagents and consumables relating to the handling of tissues and cells.
Please refer to our guidance on . If you have identified any potential risks, please .
NHS establishments should escalate any supply issues in line with established internal reporting mechanisms.
You can also refer to the Government Technical Notice on CE marking .
Finally, a reminder that the two draft statutory instruments for organs, tissues and cells have been made as part of preparations for a no deal scenario:
- The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019
- The Quality and Safety of Organs Intended for Transplantation EU Exit (Amendment) Regulations 2019
The two statutory instruments will be required if the UK leaves the EU on 29 March 2019 without a deal. Depending on the outcome of negotiations, they can be revoked or amended as required.
If you have any EU exit related questions or concerns, please contact us by or by telephone: 0207 269 1900