English — reviewed original text

MEDICINES CONTROL AGENCY MCA THE GAMBIA NOTIFICATION OF THE END MCA-F-501/15 OF A CLINICAL TRIAL MEDICINES CONTROL AGENCY Off Bertil Harding Highway, Kotu East, Kanifing Municipality, P.O. Box 3162, Serekunda, The Gambia Website: www.mca.gm; E-mail: info@mca.gm; Tel. No.: +2204380632 A TRIAL IDENTIFICATION PACTR Number: Protocol Number: Full Title of Clinical Trial: B APPLICANT IDENTIFICATION (please tick the appropriate box) Sponsor ☐ Legal representative of the sponsor ☐ Person or organisation authorised by the sponsor to make the application ☐ Complete below: Organisation Name of person to contact Address Telephone number Email C END OF TRIAL Is this the end of the trial in The Gambia ☐ Yes ☐ No only1 If yes, give date (DD/MM/YYYY): Is this the end of the complete trial in all countries concerned by the trial1 ☐ Yes ☐ No If yes, give date (DD/MM/YYYY): Is it an early termination? ☐ Yes ☐ No If yes, give date (DD/MM/YYYY): Briefly describe in an annex (free text): • The justification for early termination of the trial MCA-F-501/15, version 1 – 24 February 2025 Page 1 of 2

Clinical Trial Progress Report MCA The Gambia • Number of participant still receiving treatment at time of early termination in The Gambia and their proposed management; • The consequences of early termination for the evaluation of the results and for overall risk benefit assessment of the investigational medicinal product 1 In case of a multi-country trial, if the national and global end of trial dates are different submit this form two times: 1) At the end of the trial in The Gambia 2) At the global end of the trial Declaration by the Applicant I hereby confirm that/confirm on behalf of the sponsor that (delete which is not applicable): • The above information given on this declaration is correct; and • That the clinical trial summary report will be submitted within the applicable deadlines in accordance with the MCA Guideline for Clinical Trials in Humans Name: Signature Date For official use Date of receipt MCA registration number Ethics committee registration number MCA-F-501/15, version 1 – 24 February 2025 Page 2 of 2