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The Implementation of Electronic Submissions in eCTD Format at Swissmedic - Step 2
Swissmedic Follow-up Information Meeting
"The Implementation of Electronic Submissions in eCTD Format at Swissmedic - Step 2"
Tuesday, 31st August 2010
Kursaal/Hotel Allegro, Bern
09.00 - 16.30 hrs.
Since January 2010 Swissmedic accepts Marketing Authorisation Applications in eCTD format for defined application types (big applications like New Active Substances or Generics). As of July 2010 Swissmedic will start step 2 of the introduction: the solution will be expanded to variations and master files (DMF, PMF, VAMF). Applicants will be able to switch their existing products with baselines submissions from paper to electronic. Furthermore Swissmedic will start a pilot phase for the submission of applications according to paragraph 13 of the Therapeutic Product Act (TPA; SR 812.21).
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