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Stricter Requirements for the Transport of Medicinal Products at Room Temperature

Just as in other European states, new, tightened requirements are in force for the transport of medicinal products in Austria through the AMBO (the austrain drug regulation). Critical factors, like temperature, must be measured and documented. 34 defines for example: " (7) when accepting a delivery, the goods have to be tested for observance of the validated transportation duration and transportation temperature ()"
and "(10) medicinal products that must be stored at controlled temperature are to be transported under suitable validated precautions."

The special storage conditions are also applicable to products that must be stored at room temperature. Since the storage conditions are defined in the marketing authorisation and different limits can be indicated at room temperature, manufacturers must observe these temperatures during transport. This requirement is in place since 1 January 2005 and strictly monitored in Austria since 1 January 2008. This means that all producing companies, logistics companies and pharmaceutical wholesalers introducing medicinal products to Austria must exactly fulfil these requirements and also control and monitor the transport of goods to be stored at room temperature. It is just a question of time until transports to be conducted at room temperature will be questioned in so much detail also by the authorities of the other Member States of the European Union.

For this reason, 15 - 20 storage and transport are among the topics of the ECA event Efficient Supply Chain and Cold Chain Management in Prague on 14 and 15 October 2008. Here the requirements for transport to or through Austria are explained and pssible solutions are discussed.
Additionally, authority representatives from the USA (FDA) and Europe (MHRA) and further experts from industry and service providers inform about further current developments and implementation possibilities.

Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)


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