About

Advanced Therapy Medicinal Products (ATMPs) are innovative medicines which provide challenges in delivery.  Cell and tissue based ATMPs have specialist handling requirements and it may be necessary for the Pharmacy to outsource Receipt, Storage, Preparation and Issue of these ATMPs, when the delivery centre does not have access to the specialist facilities required.  Similar to outsourcing preparation of any medicine, it is necessary for a Technical Agreement to be set up by the NHS pharmacy provider (Contract Giver) with the outsourcing partner (Contract Acceptor), which is often a blood and transfusion service.

Purpose

Initially set up to facilitate the onboarding of Wave 3 CAR-T centres in England, this template Technical Agreement is suitable for adaptation by NHS Pharmacies, when there is a requirement to outsource any aspect of cell or tissue based ATMP handling for ATMPs which hold a marketing authorisation.

Instructions for Use

An editable ‘word’ version has been included.  The exact detail of the agreement will depend on a host pharmacy site’s capability, and outsourcing requirements.  For all agreements, the areas highlighted in yellow on the template need to be modified to tailor the agreement and make it applicable to each site.  Where more complex activity such as labelling or reconstitution is required, the suggested text is highlighted in blue and should be tailored accordingly.

The template has been designed to be implemented with any third party service provider and it can be adapted to cover a range of ATMPs.

Attachments

• TA for Outsourced Storage for Marketed ATMPs v2 · PDF · 1 MB
• Technical Agreement Template (editable) · Word · 156 KB