European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
European Medicines Agency procedural advice for users of the centralised procedure for generic / hybrid applications
Renewal and annual re-assessment of marketing authorisation
Type-IA variations: questions and answers
ICH S7B Non-clinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation) by human pharmaceuticals - Scientific guideline
EMA business hours over holiday period
Co-ordinating good manufacturing practice (GMP) inspections for centrally authorised products
CTIS newsflash - 17 December 2024
Q&A Clinic on post-authorisation procedure management in IRIS - 17 Jan 2025, Online, from 17 January 2025, 10:00 (CET) to 17 January 2025, 11:00 (CET)
Q&A Clinic on post-authorisation procedure management in IRIS, Online, from 8 January 2025, 14:00 (CET) to 8 January 2025, 15:00 (CET)