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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