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RegisterShipment of Investigational Medicinal products [Regulatives / Guidelines]
Hello experts,
RLD (from EMA) label claims "This medicinal product does not require any special storage conditions". Winter is going on in Europe and maximum temperature is below 20°C at both locations (shipper and consignee).
Can we ship RLD via DHL (without temperature controlled shipment) from supplier to sponsor by just keeping the datalogger during the transportation considering that temperature excursion above 40°C (accelerated stability condition) will not occur. RLD will be used in BE study. Same question for the shipment of IMPs from sponsor to CRO.
Regards,
QA
RLD (from EMA) label claims "This medicinal product does not require any special storage conditions". Winter is going on in Europe and maximum temperature is below 20°C at both locations (shipper and consignee).
Can we ship RLD via DHL (without temperature controlled shipment) from supplier to sponsor by just keeping the datalogger during the transportation considering that temperature excursion above 40°C (accelerated stability condition) will not occur. RLD will be used in BE study. Same question for the shipment of IMPs from sponsor to CRO.
Regards,
QA
Complete thread:
- Shipment of Investigational Medicinal productsqualityassurance 2024-10-30 13:47 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Shipment of Investigational Medicinal products Ohlbe 2024-11-05 22:11
- Shipment of Investigational Medicinal products qualityassurance 2024-11-06 14:15
- Shipment of Investigational Medicinal products Ohlbe 2024-11-05 22:11
Ing. Helmut Schütz