chmp meeting minutes, page-23

Getting back to Deltafive's original post of the minutes of the CHMP meeting in Feb. it states the committee adopted the BWP report.
Can anybody clarify what this report would be?
The committee discussed the issues identified in this application mainly regarding the benefit/ risk of this product as we'll as quality control.
I was under the impression that all we needed to gain the CE mark was a review of the manufacturing process.