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Legislation
The core of what the HTA does is laid down in four pieces of legislation. These are:
King's College Hospital
Establishment page with licensing information and inspection reports
HTA Legislation: Powers, Consent and Licensing
This page provides a summary of the key pieces of legislation, licensing frameworks, and a brief overview of responsibilities for Designated Individuals (D...
BBI Solutions OEM Ltd (Crumlin site)
Establishment page with licensing information and inspection reports
Model consent forms for anatomy schools
The Human Tissue Act 2004 permits, with consent, the donation of whole bodies for anatomical examination.
Annual horizon scanning report
Horizon scanning activities identify and monitor developments within and adjace
Advance Therapy Medicinal Products (ATMP) definitions
Advance Therapy Medicinal Products (ATMPs) are medicinal products which are prepared industrially or manufactured by a method involving an industrial proce...
Regulation of dendritic cells and white blood cells other than granulocytes
The Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended) (the Q&S Regulations) and the Blood Safety and Quality Regula...
The Regulatory Advice Service for Regenerative Medicine (RASRM)
RASRM is a ‘one stop shop’ for research and development professionals across academia, industry, and the NHS.
Regulation of blood as a starting material for ATMP manufacture
The HTA and MHRA have agreed to extend their existing policy relating to dendritic cells to allow collection of blood as a starting material for an ATMP to...
Guidance for transplant centres considering using different premises
In preparation for ODT establishments considering or planning, for transplantation services to resume, we have created this guidance.