EU guideline on shipping and temp monitoring (536/2014)

Viewing 8 posts - 1 through 8 (of 8 total)
Back to topics
April 10, 2023

EU guideline on shipping and temp monitoring (536/2014)

Hi GCSG,

For the EU guideline that became effective 01-Jan-2023, the following statement is included: “Temperature monitoring of transport and storage conditions are necessary,…”.

Are you interpreting this text to mean that all IP shipments on clinical trials must be temperature monitored?

https://health.ec.europa.eu/system/files/2022-12/guideline_handling-shipping_investigational-mp_en.pdf

Thank you!

Viewing 8 posts - 1 through 8 (of 8 total)

You must be logged in to reply to this topic.