Glossary

Marketing authorisation

In one lineRegulatory approval to sell a medicine.

Definition

The licence a regulator (the EMA, FDA, MHRA, TGA or Health Canada) grants for a specific product and indication after reviewing its trials and manufacturing. It attaches to the product, not the molecule: Wegovy is authorised; a vial of semaglutide powder from a website is not. Everything sold without one is an unapproved or unlicensed medicine.

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