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  1. pharma services oehler
21 November 2018

Temperature-Controlled Shipping

Q: Is non-temperature-controlled shipping of medicinal products still permissible in Switzerland at all?

A: Basically, there are no requirements that all transports must be carried out in a temperature-controlled manner. The only requirement from the good distribution practice (GDP) directive is that the permitted storage conditions must also be observed during transport.

Risk-based approaches can also be used for this by collecting data during transport in winter or summer with loggers.

Here, the maximum deviations are determined. If further stability data are available for the products, deviations from the storage conditions may also be justified. It should be noted, however, that a trend towards fully temperature-controlled transport is noticeable at Swissmedic.

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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