Get Appendix 11a Dmf Submission Form - Hsa.gov.sg

Filling out the Appendix 11A DMF Submission Form online is a straightforward process that requires careful attention to detail. This guide offers clear, step-by-step instructions to help you complete the form accurately and efficiently.

Follow the steps to successfully complete the submission form online.

1. Click ‘Get Form’ button to obtain the form and open it in your editor.
2. Begin by filling out the submission type. Indicate whether you are submitting an initial or an update to an existing Drug Master File.
3. Enter the active pharmaceutical ingredient name, including its International Nonproprietary Name (INN) and any relevant salts or counter ions.
4. If available, input the DMF manufacturer's internal API code.
5. Complete the details of the Drug Master File holder, including the name and address.
6. Fill in the DMF applicant's part, ensuring to indicate the version and date of the submission.
7. Indicate the quality standard claimed for the active pharmaceutical ingredient.
8. Enter the API manufacturer's name and address, including block or unit and GPS coordinates if available.
9. State the status of this DMF with other regulatory agencies.
10. Provide consent from the DMF holder by selecting yes or no for sharing information with international regulatory partners.
11. Once all required fields are completed, save your changes.

Start filling out your Appendix 11A DMF Submission Form online today!