Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

My company was asked to provide a "commercial" drug for an investigator-initiated, multiple-center trial in the Europe in some English and non-English speaking countries. Our product is approved in the EU through centrally authorized process. However, it is only marketed in one English-speaking country in the EU. Therefore, product is only packaged with labels in English. With that in mind, I have the following questions:

Can we send the commercial product with English labels to the non-English speaking countries for use in the IITs?
OR
Do we need to have the product packaged in the clinical trial packaging with labels in local language and QP release per each country?

Your input will be much appreciated. 

This message was posted by a user wishing to remain anonymous

"Do we need to have the product packaged in the clinical trial packaging with labels in local language and QP release per each country?"

The above question should be posed to each of those non-english speaking countries.
Original Message:
Sent: 02-Sep-2020 15:06
From: Anonymous Member
Subject: Commercial product packaging for Investigator-initiated trials

This message was posted by a user wishing to remain anonymous

My company was asked to provide a "commercial" drug for an investigator-initiated, multiple-center trial in the Europe in some English and non-English speaking countries. Our product is approved in the EU through centrally authorized process. However, it is only marketed in one English-speaking country in the EU. Therefore, product is only packaged with labels in English. With that in mind, I have the following questions:

Can we send the commercial product with English labels to the non-English speaking countries for use in the IITs?
OR
Do we need to have the product packaged in the clinical trial packaging with labels in local language and QP release per each country?

Your input will be much appreciated.