Classification of changes: questions and answers

27 March 2026

Changing the labelling and package leaflet (Article 61(3) notifications)

27 March 2026

Quarterly System Demo - Q1 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 26 March 2026, 09:00 (CET) to 26 March 2026, 12:45 (CET)

27 March 2026

Timetable: Initial (full) marketing authorisation application assessment

27 March 2026

EnprEMA & ACT EU workshop on paediatric clinical trials, Online, European Medicines Agency, Amsterdam, the Netherlands, from 12 May 2026, 10:00 (CEST) to 12 May 2026, 17:00 (CEST)

27 March 2026

PCWP/HCPWP joint meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, from 30 June 2026, 09:15 (CEST) to 1 July 2026, 12:00 (CEST)

27 March 2026

Orphan designation: N-[[(2S)-4-[(4-Methyl-1H-imidazol-5-yl)methyl]-3-oxo-2-(phenylmethyl)-1-piperazinyl]carbonyl]-L-leucine trihydrate Treatment of cutaneous T-cell lymphoma, 09/12/2025 Positive

27 March 2026

Orphan designation: domvanalimab Treatment of gastric cancer, 09/12/2025 Positive

27 March 2026

Orphan designation: [4-(6-aminopyridazin-3-yl)piperidin-1-yl][5-(4-fluorophenoxy)-4-methoxypyridin-2-yl]methanone Treatment of focal segmental glomerulosclerosis, 09/12/2025 Positive

27 March 2026

Orphan designation: amsulostat Treatment of myelofibrosis, 09/12/2025 Positive

27 March 2026