Once licensed, importing tissue establishments cannot undertake any substantial changes to their import activities without our prior written approval.
Substantial changes include any changes to the:
- type of tissues and cells imported;
- activities undertaken in third countries which may have an impact on the quality and safety of imported tissues and cells;
- third country suppliers used.
You must also notify us before you stop carrying out any licensable activities. This includes stopping licensable activities all together, or no longer carrying a particular activity. For example, ceasing to process but continuing to procure and distribute tissues and cells.
You must notify us without delay, of:
- any revocation or suspension, in part or in full, of a third country supplier’s authorisation to export tissues and cells; and
- any other decision taken for reasons of non-compliance by the competent authority of the country in which the third country supplier is based, which may be relevant to the quality and safety of imported tissues and cells.
We may restrict activities by adding conditions, suspending or revoking activities on a licence of an importing tissue establishment. We may choose to do this if an establishment no longer meets the requirements of Directives 2004/23/EC and 2015/566/EC. This may be identified through inspection or other control measures.