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Antivenom Permits

deadlyelapid Sep 10, 2004 03:44 AM

Hello, I am posting again in regards of a different situation in hopes that someone can provide me with proper information regarding filling out the Antivenom Permits. I was able to print out the permit applications for the investigational New Drug Application and the application entitled Statement of investigator. Are these the only applications that are needed for the acquisition of antivenom? I downloaded these applications from the venomousreptile.org website but was unable to download the instructions and other information. Every time I tried I was told that there was some type of error and no information was shown. My other question is does anyone know or can walk me threw on how to fill out these applications as some of the questions are very confusing and I want it to be done properly. Or at the very least does anyone know where I can get the proper instructions.

Replies (5)

BRYAN139 Sep 10, 2004 07:57 AM

I have never done it but I do have the instructions from that site downloaded. I can e-mail them to you if you'd like. That's about all the help I can offer though.

Matt Harris Sep 13, 2004 10:05 AM

....go to File library. In there are forms, and instructions(lay-man's instructions) on how to fill out the forms. They are very simple...and require no elaborate answers. The FDA understands you will only be importing in case of emergency, so its actually much simpler than the formal instructions make it seem.

The toughest part is getting your physician to sign as the investigator. You will be the sponsor. Aside from that, its simple.

Matt

DeadlyElapid Sep 14, 2004 12:08 AM

Hello Matt, This is where I am having problems. For some reason the instructions do not download and every time I try to download them it tells me that there is some type of error and it shows nothing. I really want to fill these applications out and get them on their way. Is there any other way of getting the instructions as I already have the applications which downloaded fine. Sincerely, Tony Baez.

BRYAN139 Sep 14, 2004 08:17 AM

NP

Matt Harris Sep 14, 2004 08:42 AM

I don't know. I was able to download it. I'll send you an email and have you reply, so I can email it as an attachment. You will need Adobe Acrobat to read it...it's a PDF file.

MH
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