European Medicines Agency (EMA) with the European Commission; national competent authorities in each member state
Is Orforglipron legal in European Union?
Under reviewUnder EMA evaluation for obesity and type 2 diabetes; no EU authorisation yet
A regulator is actively reviewing it.
EMA's list of applications under evaluation (data extracted 4 September 2026) shows orforglipron, EMEA/H/C/006632, for obesity and type 2 diabetes in adults, with evaluation started on 22 January 2026. It was not among the medicines given a positive opinion at the CHMP meeting of 14-17 September 2026. Until the European Commission issues a decision, it cannot lawfully be marketed in the EU.
Last verified 2026-09-29 · how we verify
Orforglipron elsewhere
Sources (3)
- 01Applications for new human medicines under evaluation by the CHMP (September 2026)European Medicines Agency · 2026-09-04 · accessed 2026-09-29
- 02Medicines under evaluation (human use)European Medicines Agency · 2026-09 · accessed 2026-09-29
- 03Meeting highlights from the CHMP 14-17 September 2026European Medicines Agency · 2026-09-18 · accessed 2026-09-29