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The Regulations that retain the existing quality and safety standards and provide legal and regulatory certainty after the end of the transition period can be found below:
As an establishment, you should risk assess your supply chain of reagents and consumables relating to the handling of tissues and cells.
Our shared focus should be on mitigating any potential disruption to supply including, but not limited to:
From 1 January 2021 there will be a six-month phase to allow Human Application sector establishments time to comply with any new UK import and export licensing requirements. Licence variations must be in place by 30 June 2021.
The UK has left the European Union (EU) single market and customs union which has resulted in regulatory changes within the UK.
Research establishments reported their involvement in a variety of different types of research (graph below).
NHS patients and healthy volunteers make up the majority of the types of donors with 31% and 32% respectively. Relevant material is also collected from establishment staff (22%) and private patients (15%) (graph below). This is comparable with data collected in 2017.
The graph provides information on the number of establishments that have different storage conditions ranging from room temperature storage to ultra-low frozen storage facilities. All establishments that store relevant material under critical conditions have temperature monitoring systems and...
The size of relevant material collections varies greatly between establishments; the establishment with the largest collection holds nearly one million samples, while some establishments hold fewer than 100 samples.
41% of establishments that hold a research licence either are a research tissue bank (RTB) or contain at least one RTB (70/171) (graph below). This is very similar to the previous 2017 data.