QP Oversight of IMPs Imported from a Country on a List

With the QP Oversight process if you are the Sponsor of a UK clinical trial using IMPs imported from countries on an ‘approved country for import’ list, you can leverage the certification performed by a QP in the EU. The approved country for import list is currently all countries in the EU and EEA. This removes the requirement for a duplicate full review of the batch records and speeds up the time for release of the product to the patient.

The QP Oversight must be performed by a party that holds a UK MIA (IMP). In this scenario, MIAS Pharma is perfectly positioned as we hold a MIA (IMP) in Ireland and in the UK.  Utilising the same PQS and with all necessary agreements in place between both our Irish and UK sites, this allows us to meet the needs of our clients with trials on both sides of the English Channel with reduced time to patient.

The Oversight process does require that the UK QP has the following (non exhaustive) documentation available to them:

• details of the manufacturing and distribution supply chain.
• the UK Clinical Trial Application form, plus amendments. This should be used to confirm the site responsible for final certification of the finished IMP.
• the UK Clinical Trial Application and any amendment approval records (including any post approval commitment requirements).
• evidence that the certifying site in the listed country is appropriately licensed and holds a current GMP certificate for the IMP dosage form(s) and associated activities (e.g. manufacture, packaging, testing and / or import from a third country).
• details of the approved Great Britain trial sites from the ethics application, plus any updates or amendments.
• details of each shipment of IMP to Great Britain including the addressees’ information. This should be verified against the ethics approvals.
• details of any excursions from the stated storage conditions during shipment, along with any decisions taken by the Sponsor and certifying QP, and the rationale for those decisions.
• details of the responsibilities described in the written agreement between the Sponsor and the listed country MIA(IMP) holder.

Evidence of batch certification by the EU QP should also be available in the form of either:

• Batch certificate confirming QP certification in accordance with Article 13.3 of Directive 2001/20/EC
• Statement of certification (ad-hoc, confirming certification in accordance with Article 13.3 of Directive 2001/20/EC)
• Access to the certifying MIA(IMP) holder’s internal systems (e.g. global Enterprise Resource Planning system) that confirms batch certification

In conclusion, the QP oversight process allows for a smoother certification of clinical trial products in the UK. MIAS Pharma is perfectly positioned to be your trusted partner in both the UK and EU for the QP certification of your clinical trial product.