Establishments licensed under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended) may need to update their licence following the end of the BREXIT transition period. This only applies to establishments in the human sector who import tissues or cells from the EU, or who export tissues or cells to countries in the EU. This includes starting material for the manufacture of an Advanced Therapy Medicinal Product (ATMP).
There will be a six-month phase to allow time for complying with any new licensing requirements, though all licence variations must be in place by 30 June 2021.