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FAQs on HTA licensing requirements for human tissues and cells used in clinical trials and medicines
Do I need a licence to import/export starting material for an ATMP from/to the EU?
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.
The UK is leaving the European Union (EU) single market and customs union when the transition period ends on the 31 December 2020.
At the end of the transition period, there will be 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.