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  1. pharma services oehler
24 September 2018

Commonly Asked Question: Completion of Formal Control by Swissmedic

Question: When is a letter issued by Swissmedic and when is it not?

Answer: A letter is only generated if there was a formal deficiency for the respective application previously, and may be sent by Swissmedic or downloaded from the Inbox of the eGoV portal as a letter.

If an application has passed formal control without deficiency, this is indicated only on the application tracking of the portal by putting a checkmark under ‘Task Status Formal Control’ of the concerned application.

This means that formal control has been completed without deficiency and the application is forwarded for scientific review.

This white paper highlights what it takes to bring a drug to the Swiss market, including the marketing authorisation application MAA), preapproval and launch preparation...
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