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Effective Date: 
5/2021

Documents

 

Instructions

Updated: 5/2021

 

Purpose

This form allows drug manufacturers or their representatives to create a free account for the VDP Electronic Certificate of Information (eCOI) portal. Manufacturers use this browser-based application to submit the required certificate of information forms.  Refer to 1 TAC section 354.1921 (Addition of Drugs to the Texas Drug Code Index) for more information.

Detailed Instructions:

  1. All sections of the form are required.
  2. If representing multiple labelers, you must list all labeler codes. Use “+” in section 5 to list additional labeler code information.
  3. The review process takes up to 90 days once the online form is submitted to HHSC and considered complete. The HHSC Drug Addition Process (PDF) explains the timeline of how drugs are added to the TDCI.
  4. FDA approval letter(s) are required with submission of COI.  The following are examples of FDA letters that are accepted: 
    1. FDA new drug application approval letter   
    2. FDA abbreviated new drug application approval letter 
    3. FDA over-the-counter monograph
    4. Other applicable documents
  5. The following are also required:
    1. Copy of package insert 
    2. Copy of Certificate of Liability Insurance
    3. Material for physicians or file card, if available

Send your form and questions by email to VDP-Formulary@hhsc.state.tx.us.

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