Pre-submission request form

German is available via eTranslation, the European Commission's machine translation service.

Request for a European Medicines Agency procedure prior to the submission of a marketing authorisation application or Article 58 Application.

Current effective version

Pre-submission request form for a EMA procedure prior to the submission of a marketing authorisation application or Article 58 Application

English (EN) (5.19 MB - PDF)

Erstmals veröffentlicht: 05/02/2010 Zuletzt aktualisiert: 08/09/2025