Know how the new rules for importing finished investigational medicinal products (IMPs) into Great Britain from approved countries affect a clinical trial supply? 

As of January 1st, 2022, IMPs imported into Great Britain from approved countries (EU) will require a UK Manufacturing and Import Authorisation (MIA(IMP)) holder to have in place an assurance system to check that these IMPs have been certified by QP before releasing to the trial.

This webinar will describe:

  • The importation routes available — direct to site or through a UK Distribution Hub
  • The authorizations required by the UK MIA(IMP) holder and the clinical trial sponsor
  • The assurance system required of the UK MIA(IMP) holder
  • The trial documentation required by the UK (IMP) holder
  • How Sharp provides the UK QP oversight of these imports

Importer of Record (IOR) — Know what importer record means and its responsibilities? How will a supply chain be affected by the new QP oversight regulations introduced? What changes has Brexit brought when importing to the UK?

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