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clock Created with Sketch. 08/09/14
10:35
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Originally posted by Revreboot
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This is my understanding:IF the responses to the last list of questions was lodged on or before the 25th of July then Vitrogro will be discussed at the CHMP meeting in 2 weeks (the only reason I raise this as a potential issue is that the timing of the announcement of the lodgement gave little room for error about getting it in on time for the lodgement cut off date). At that meeting the CHMP will either adopt a list of outstanding issues which they will send to TIS/BSI to address OR they will give a positive opinion regarding Vitrogro. If they give a positive opinion they will convey that to the notified body (BSI) who then will issue a CE Mark. Given the workings of BSI in the past there is the potential for a delay before the issue of the CE Mark but hopefully no longer than a couple of weeks. If the CE Mark is issued then sales will start very soon afterwards, so potentially by the end of October.IF a list of outstanding issues is adopted (rather than a positive opinion) then the clock will stop again and it could be months before TIS responds to that list of issues. Given past behaviour I would expect that to be about 6 months but it could be less or it could be more depending on the issues.IF the responses to the last list of questions was lodged after the 25th of July then the above procedure will take place at the October CHMP meeting.
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Thanks Rev
