About

Advanced Therapy Investigational Medicinal Products (ATIMPs) are innovative investigational medicines which provide challenges in delivery.  Cell and tissue based ATIMPs often have specialist handling requirements and it may be necessary for the Trial Site Pharmacy to outsource Receipt, Storage, Preparation and Issue of these ATIMPs, 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).  There is a separate template related to outsourcing these services for marketed ATMPs, the template presented here is for investigational ATIMPs only.

Purpose

This template Technical Agreement is suitable for adaptation by NHS trial site Pharmacies, when there is a requirement to outsource any aspect of cell or tissue based ATIMP handling for investigational Advanced Therapy products.

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 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 ATIMPs.

Attachments

• TA Template for ATIMPs · PDF · 420 KB
• TA Template for ATIMPs · Word · 191 KB