Glossary

Marketing Authorisation (MA)

Also: MA

The approval that permits a medicinal product to be placed on the market in a jurisdiction, defining its approved conditions including storage.

A product's approved storage and transport conditions derive from its marketing authorisation and stability data.

Commercial import generally requires the product to be authorised, or to move under a defined exemption such as 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.