Glossary

Investigational Medicinal Product (IMP)

Also: IMP

A pharmaceutical form of an active substance or placebo being tested, or used as a reference, in a clinical trial.

IMP moves under the clinical trial authorisation rather than a marketing authorisation, and its movement must be accountable from receipt through dispensing to return or destruction.

IMP import into the EU or UK requires an MIA(IMP) and QP certification.

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Eight guided flows: compliance review, DPS screening, Part 11 e-signature, custody chain, breach prediction, GDPR erasure and the validation report. Then a 90-day pilot on your own programme, fully creditable.