Glossary

Manufacturing and Import Authorisation (MIA)

Also: MIA, MIA(IMP)

A licence authorising the manufacture or import of medicinal products, including the import of investigational product under an MIA(IMP), with QP oversight.

An MIA is required to import medicinal products from third countries into the EU or UK, distinct from a wholesale authorisation.

For investigational product, the MIA(IMP) plus QP certification governs import for a clinical trial.

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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.