European Medicines Agency procedural advice for users of the centralised procedure for generic / hybrid applications (track changes)
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes
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