The change must be implemented with the production of the next batch or the next reprinting of the packaging elements. If no production or reprinting has taken place in the meantime, the change must be implemented no later than one year after it has been approved. Excluded from this practice are safety-relevant changes, for which Swissmedic will, as a rule, continue to require immediate implementation. It should be noted that Swissmedic has recently included specific information on the implementation deadline into its approval letters, which may differ slightly from the general requirements.
Dr. Katharina Oehler
Scientific and Managing Director
Send email