QP Oversight for Importation from Approved Countries

MODEPHARMA provides a full range of QP oversight services in compliance with MHRA guidelines.

Background

Following Brexit from 1st Jan 2022 it is mandatory for sponsors of UK clinical trials to have a UK MIA(IMP) holder provide an assurance system that IMPs imported from an ‘approved country’ have been certified by a Qualified Person in a listed country, before release to the trial. The assurance system must be overseen by a QP, however, the IMPs do not require re-certification.

Approved countries for import currently include all EU and EEA countries.

What Our Services Include

  • Assurance system overseen by a QP named on a UK MIA(IMP)
  • Technical agreement between the Sponsor and UK MIA(IMP) holder
  • All required set up and ongoing documentation compliance checks
  • Efficient set up process using a ‘QP oversight’ checklist
  • Fast turnaround times
  • Simple and competitive pricing structure
  • Optional storage and distribution services for cold-chain (2-8°C) and controlled ambient (15-25°C) investigational medicinal products
  • Optional QP certification for Northern Ireland clinical trial sites

Optional Storage and Distribution Hub Services

For IMPs imported from a listed country, these can be sent directly to GB clinical trial sites or first routed via a local storage and distribution hub. In the case of the latter, MODEPHARMA can provide local storage and distribution services to safely store and distribute these to GB clinical trial sites. Based in Liverpool, the hub is MIA(IMP) authorised and has extensive temperature-controlled storage for products with 2-8°C and 15-25°C storage conditions.

We can support sponsor-arranged courier collections or arrange shipments using GDP-compliant courier services. Temperature control and monitoring options are available.

RPi Oversight for Non-Investigational Medicinal Products and Unmodified Comparators

MODEPHARMA also provides Responsible Person for Import (RPi) oversight for the importation of non-investigational medicinal products and unmodified comparators.

Importer of Record Services

Please contact us or call us on 0207 0432 442 to discuss this requirement.

Fees

Our QP oversight fees are competitive and simple to ensure budgeting clarity as well as project flexibility.

For further information on any of the above services please contact us or call us on 0207 0432 442.