Electronic Submission - DMF (Drug Master Files) Type III

SGquality

Quite Involved in Discussions
Has anyone submitted Drug Master Files Type III (for Packaging Materials) electronically instead of physical hard copies ?

Pls help me how to di it electronically as my Customer wants me to submit electronically to FDA.

PS - can a non US citizen be an US Agent for DMFs ?

:thanx:
 
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AnaMariaVR2

Trusted Information Resource
Re: Electronic Submission - DMF Type III

It is my understanding that currently you are not obligated to submit electronically...if you go to the DMF site they say:
ELECTRONIC DMFs (Category 3), you see this statement:
There is no requirement to file DMFs in electronic format. Paper DMFs will continue to be accepted. If this policy changes there will be advance notification.

But if you want to submit electronically...
(broken link removed)

 
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SGquality

Quite Involved in Discussions
Re: Electronic Submission - DMF Type III

Thanks for all the info.

One fundamental question - why and when is a Drug Master File, Type III required ? Typically, we create when our customers ask us to but I wanted to know when has it to be initiated ?
 
N

nadavreu

Re: Electronic Submission - DMF Type III

Hello everyone:bigwave:
we manufactur cell culture media (type II)
i will be happy if anyone can refer me to a templet of format for submission of a DMF
thanks
nadav
 

Highground

Involved In Discussions
Re: Electronic Submission - DMF Type III

Thanks for all the info.

One fundamental question - why and when is a Drug Master File, Type III required ? Typically, we create when our customers ask us to but I wanted to know when has it to be initiated ?

It should be initiated during the beginning of the manufacturing processes. Then all you have to do is issue an LOA to the FDA and a copy to any customer that buys your product and is making a Drug submission. This will give the FDA access to your DMF.

All DMFs II, III, VI, V will be required to submitt eCTD after 5 May 2017.

But you don't need to resubmit the orginial DMF in eCTD if submitted before May 2017, but it would probably benefit the company if they did.
Any new DMF after 5 May 2017 it will have to be in eCTD.
Amendments and Annual reports will have to be in eCTD as well to existing DMF.

Goto the FDA Website and type in: Electronic Submissions Presentations
 
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