The Regulations that retain the existing quality and safety standards and provide legal and regulatory certainty after the end of the UK Transition Period can be found below:
The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019
The Quality and Safety of Organs Intended for Transplantation (Amendment) (EU Exit) Regulations 2019
Since 1 January 2021, the United Kingdom (UK) has operated a full border with the European Economic Area (EEA). This means that there are changes to the checks and controls on goods (including blood, organs, tissues and cells) as they move between the UK and the EEA.
The regulatory changes introduced at the end of the UK Transition Period differ for Great Britain (GB) and Northern Ireland (NI) as the Government ensures it meets its obligation of implementing the Northern Ireland Protocol.
The HTA continues as the ‘Competent Authority’ in Northern Ireland for the regulation of tissues and cells for human application.
Establishments in NI need to treat tissue and cell suppliers in GB as third country suppliers (3CSs). This requirement came into force on 1 January 2021.
If you are an establishment based in Great Britain (GB) that imports or exports human tissues or cells for human application between GB and a country in the European Economic Area (EEA), you may need an HTA licence that covers these activities.
This requirement came into force on 1 July 2021.
Human application means using human tissues or cells on or in a human recipient. This includes use in extracorporeal applications. It excludes the use of an autologous graft within the same surgical procedure.
We license more than 800 establishments that store and use human tissue for purposes such as patient treatment, organ transplantation, post mortem examination, research, teaching, and public exhibitions. The information below covers the frequently asked question in relation to the UK transition.
If you are an establishment based in GB that imports or exports human tissues or cells between GB and a country in the European Economic Area (EEA), you may need a licence that covers these activities.
The United Kingdom (UK) has left the European Economic Area (EEA) single market and customs union. This has resulted in regulatory changes in the UK, including some that apply to the movement of human tissues and cells between Great Britain (GB), Northern Ireland (NI), and the EEA.
Establishments importing or exporting human tissues and cells intended for human application (patient treatment) may require a HTA licence covering these activities.
New EU regulations for medical devices (MDR) and in-vitro medical devices (IVDR) have been introduced. These regulations entered into force on 25 May 2017 across EU Member States. However, most requirements will not fully apply until 26 May 2020 for the MDR, and 26 May 2022 for the IVDR.
Importing tissue establishments must ensure that imports from third countries meet standards of quality and safety equivalent to those in the UK. The majority of imports originate in the US and we have identified a number of key differences in regulatory requirements.
Guidance for establishments on meeting HTA licensing requirements for the procurement of tumour samples to be used as a starting material in the manufacture of an Advanced Therapy Medicinal Product (ATMP).
Faecal microbiota transplantation (FMT) is recognised as an emerging treatment for recurrent Clostridium difficile infections in patients where antibiotic and other lines of treatment have failed.
FMT is outside the scope of the Human Tissue (Quality and Safety for Human Application) Regulations, 2007 (as amended) and is not regulated by the HTA.
Establishments seeking to perform FMT should contact the MHRA Medicines Borderline Section for further advice.
