What is a TPA
In the Human Application sector, a Third Party Agreement (TPA) may be used to provide an unlicensed third party with the authority to undertake licensable activities on behalf of an appropriately licensed establishment.
The Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended) define a TPA as:
“An agreement in writing between a licence holder (or the Designated Individual on behalf of the licence holder) and another person, which is made in accordance with any directions given by the Authority under section 23(1) of the 2004 Act for the purpose of securing compliance with the requirements of Article 24 of the first Directive (relations between tissue establishments and third parties), and under which the other person:
(a) carries out licensed activity (other than import or storage) on behalf of the licence holder; or
(b) supplies to the licence holder any goods or services which may affect the quality or safety of tissue or cells.”
Notification and authorisation of TPAs
Establishments must inform the HTA of all third parties intending to carry out licensable activities on their behalf under TPAs; the proposed arrangements must be authorised by the HTA prior to the commencement of activities.
Establishments can notify the HTA of third parties at the time they apply for a licence or using the following TPA form if adding a new third party to an existing licence.
Inspections and oversight
The HTA inspects establishments licensed in the HA sector at least once every two years. We also have powers to enter and inspect third party premises and regularly inspect such sites as part of inspections.
As part of our routine inspections, licensed establishments will be asked to provide information about their TPAs using the following spreadsheet form.
FAQs and other information
Additional information about TPAs can be found on our FAQ pages and in the HTA’s Guide to Quality and Safety Assurance for Human Tissues and Cells for Patient Treatment