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There are specific circumstances when you can carry out procurement under a third party agreement rather than a licence. In order to carry out procurement under a third party agreement you must:
The following licensable activities can take place under a third party agreement: procurement, testing, processing, distribution and export. The activities of import and storage cannot take place under a third party agreement.
The Human Tissue Authority (HTA) has been responsible for regulating living organ donation since 1 September 2006. This is when the Human Tissue Act 2004 came into force.
If you or someone within your organisation is carrying out procurement of tissues and / or cells for patient treatment, a HTA licence will normally be required, unless the procurement is being carried out under a third party agreement. In these circumstances:
Any serious adverse reaction in a living donor which may influence the quality and / or safety of tissues and cells should be reported to the HTA.
There are no time limits for which signed consent forms remain valid and there are no legal requirements for the format of consent forms. There is no need to ask for new forms to be signed if consent was written down by the donor several years before he or she died.
A serious adverse event (SAE) can occur at any stage from donation to transplantation. A suspected SAE should be reported to the HTA when one or more of the following applies:
The DI must notify the HTA of any suspected SAE and / or SAR as soon as possible after the incident has been discovered or after notification by a third party or end user.
A follow-up report should be submitted using the online system within 24 hours following completion of the internal investigation.
New licence applications for processing of tissue or cells for human application must include a PPD to describe the process validation. Processing of the tissues and cells cannot commence until the processes proposed under a new licence have been authorised. We also require new or modified...