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  1. pharma services oehler
5 November 2018

Implementation of Packaging Material Changes

Q: When are packaging material changes to be implemented? For how long may a product still be released in the old packaging or according to the old manufacturing process?

A: 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 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.

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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