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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.
The HTA would like to thank establishments in the HA sector for the prompt completion and return of the HA sector COVID-19 questionnaire at such a challenging time.
The HTA received a request for information on its inspections activities.
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