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

SteveK

SteveK

Trusted Information Resource
#1
#1
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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somashekar

somashekar

Staff member
Super Moderator
#4
#4
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...
 
SteveK

SteveK

Trusted Information Resource
#5
#5
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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