Modification of the “Form DMF”

Encrypted e-mail delivery to DMF holder via IncaMail

01.11.2026

Swissmedic is introducing the possibility of sending questions on the Restricted Part of the application documentation directly to the Drug Master File (DMF) holder in encrypted form via IncaMail¹.

The authorisation holder and the DMF holder can now give their agreement to this delivery method in the “Form DMF”. Delivery by post, as previously, remains an option.

The revised “Form DMF” is valid with effect from 1 November 2026.

1IncaMail is an e-mail service provided by Swiss Post for encrypted transmission of confidential documents. Notification via an IncaMail may seem unusual for recipients outside of Switzerland in particular. The message is accessed via a link in the notification e-mail.