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murocman

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murocman

Re: badslinke post# 367

Saturday, 12/22/2012 4:20:32 PM

Saturday, December 22, 2012 4:20:32 PM

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From what I can gather, the technical file filing is stage 5 of a 6-stage process, with the final stage be labeling. The PR make it sound like they have already done stage 6 and included it so it may be possible to meet the timeline. It was also discussed on the website I got this from that this whole process is essentially a self-certification and the actual "approval" is more or less getting the EU FDA equivalent agency to agree that you have completed the process.

Hope that helps. GLTU,

Murocman
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