Long time for NB to review to change the classification of one of our products!

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SteveK

I sent a request to our NB to change the classification of one of our products from IIa to Im with the appropriate justification and information – for what is classed as a significant change under NB-MED/2.5.2/Rec5 (and now NBOG BPG 2014-3). I just received today an invoice for their review time (one hour in November 2014 and two hours this March). However I submitted the request 14 months ago! Can anyone beat this?

Steve
 
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Charlotte Percy

Hi Steve,

Did you get the change approved? If so 3 hours would be considered a good price!
 

somashekar

Leader
Admin
Our NB auditor during the April 2015 MDD surveillance, checked upon our technical file updations, and more particularly the Label changes if any. We were informed that any changes / updations made in the technical file would go through a review man hours cost that will depend upon the extent of changes / updations made. Luckily there were none and we did not bother to ask the rate for review man hours. I am still awaiting the final report, 40 days through...
 
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SteveK

I've had no notification that the change has actually been approved - just assuming so due to the invoice. By the way we had our annual surveillance audit in November 2014 - still have not received the report (we have had the audit invoice though). Cannot remember if I mentioned this in another post, but the last TFs we were requested to submit; according to a NB issued schedule and post audit report request, was in 2013. According to this schedule two more TFs were due review in 2014. However, when I asked the NB when should I send these (since they need to have a reviewer booked in place) I was told I did not need to submit another TF until 2016! I thought it was a mandatory (MHRA?) requirement to submit annually. Anyway not complaining - cuts down on NB costs!

Steve
 
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