Post-Notice of Compliance (NOC) Changes: Level III

Contact: eReview

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This form must be completed using Adobe Reader or Adobe Acrobat version 8.2 or higher.

1. Product Information
   • 1. Product (Brand) Name*
   • 2 .Drug Identification Number (DIN)*
   • 3. Submission File Number*
   • 4. Electronic Common Technical Document (e CTD) identifier (if applicable)
   • 5. Type of Drug*
2. Level III Change
   • 6. Type of Change*
   • 7. Category of Change*
   • 8. Change*
   • 9. Implementation Date* (yyyy-mm-dd)
3. Declaration (Select all boxes to confirm agreement)
   
   I, the undersigned, certify that:
   • 10. All of the products listed above are new drugs;*
   • 11. No changes have been made to the above products other than those Level III changes described herein;*
   • 12. The information provided herewith is complete and accurate;*
   • 13. Complete supporting data (as recommended in the Post-Notice of Compliance Changes guidances) for the above changes is available upon request and has not been provided at this time; and*
   • 14. The conditions/criteria in the Post-Notice of Compliance Changes guidances have been met.*
4. Information for the Authorized Signing Official and the Company to which they Belong
   • 15. Manufacturer/Sponsor Name (for example Drug Identification Number/Notice of Compliance (DIN/NOC) Owner; full name, no abbreviations)*
   • 16. Address of Manufacturer/Sponsor - Street/Suite/Post Office Box*
   • 17. City/Town*
   • 18. Province/State*
   • 19. Country*
   • 20. Postal/Zip Code*
   • 21. Name of Authorized Signing Official*
   • 22. Title*
   • 23. Email address
   • 24. Telephone Number*
   • 25. Fax Number
   • 26. Signature
   • 27. Date* (yyyy-mm-dd)

* denotes mandatory