Prior notification of new applications with new active substances (NA NAS) for human medicinal products enables Swissmedic to plan resources early on and subsequently supports efficient processing of applications. Prior notification is an advantage in all NA NAS procedures, including accelerated, simplified and international procedures.
Prior notification should be given once the approximate submission date (+/-2 weeks) is known, ideally 4-6 months before submission. If the submission date changes, Swissmedic should be informed accordingly.
Prior notification can be sent via the eGov portal (see short instructions Prior notification of NA NAS via eGov portal on the Swissmedic website > Services & lists > eGov services > eSubmissions), by letter or via e-mail to eSubmissions@swissmedic.ch, and must include at least the following information:
- Subject: “Prior notification of NA NAS”
- Active substance(s)
- Product name (if known)
- Month of planned application submission
- ATC code (if known)
- Indication
- Indication wording applied for (if known)
- Pharmaceutical form
Following the notification, Swissmedic will undertake preliminary resource planning, enter a dummy application in the internal planning system and assign this an application identifier (application ID). When it has been entered in the planning system, the assigned application ID becomes visible for the applicant in the eGov portal. The application ID must be given as a reference in the subsequent submission of the NA NAS application so that Swissmedic can allocate the NA NAS to the planned application.
Prior notification is possible with immediate effect.