| Forms
In
this section you will be able to view the different Forms
required by the FDA. It is important to understand that
these Forms are proposed by the FDA and will not be official
until October 12th, 2003. GTH is constantly monitoring for
any changes and immediately these Forms will be modified.
The FDA requires that all Forms needs to be submitted in
English. GTH can provide translation services from most
languages into English and have the Forms transmitted automatically
to the FDA.
The following Forms are for information
only, so you can view the data required in each one. If
you would like to Officially Register, click on any of the
"register buttons" located on top, on the right
side and bottom of the page.
To
view a Form, press the Form name that you want to access.
1.
Registration Form
This
Form needs to be submitted to the FDA between October 12th
and December 12th, 2003 as stipulated by the Bioterrorism
Act in order to be in compliance.
2.
Registration Cancellation Form
This
Form is used when you want to cancel a Registration that
is active.
3.
Prior Notice Form
This
Form has to be submitted every time you ship products to
the USA. Although the Bioterrorism Act specifies that the
US Buyer is the entity that needs to submit it, it is important
to recognize that the majority of the information is known
and should be supplied by the exporter / distributor.
By
trading your products through the GTH Trading Systems we
can assure you that all the information required on the
Prior Notice Forms and by the FDA can be provided automatically
and electronically submitted at the time stipulated to avoid
problems at the port of entry.
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