English — reviewed original text

MEDICINES CONTROL AGENCY MCA THE GAMBIA OBSERVATIONAL PHASE IV CLINICAL MCA-F-501/12 STUDY APPLICATION FORM 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 *Write NA if an item is not applicable Section 1: Study identification Study title Observation Plan, date, and version1 Study identification, where applicable Purpose of the study ☐ PASS ☐ PAES ☐ Other If other, specify: Status ☐ Commercial ☐ Non-commercial 1 Any translation of the observation plan should be assigned the same date and version as those in the original document Section 2: Identification of the Responsible Persons Name of the responsible person Qualification MDCG Registration number, if applicable Address Telephone number E-mail Website (if applicable) Persons the responsible person has delegated functions to2 Name of the organisation Address Name of the person Function Telephone number E-mail 2 Repeat as necessary MCA-F-501/12, version 2 – 24 January 2025 Page 1 of 3

Observational Phase IV Clinical Study Application Form MCA The Gambia Section 3: Details of location3 Name of location Physical address Contact person including telephone and email Website (if applicable) 3 Repeat as necessary Section 4: Information on the Products under observation4 Name of the product Marketing Authorisation Holder Manufacturer Marketing Authorisation Number ATC code(s) of medicine Pharmaceutical form of medicine Strength Dosage Regimen Route of administration/application Name of each active substance of medicine (INN) Is the medicine (if applicable)? • Immunological product (vaccine, allergen, immune serum) • Plasma derived product • Recombinant product • Radiopharmaceutical product • Herbal medicinal product • Other, specify Is the related product (if applicable)? • Medical device • Cosmetic • Homeopathic medicine Other, specify Date of publication of the product information 4 Present this information for each product to be under observation MCA-F-501/12, version 2 – 24 January 2025 Page 2 of 3

Observational Phase IV Clinical Study Application Form MCA The Gambia Section 5: Information on the patients5 Medical condition or disease5 the product is prescribed for Number of patients 5 Present this information for each product to be under observation Section 6: Study duration Total duration of the study Start date End date DECLARATION BY THE APPLICANT I, the undersigned have submitted all requested and required documentation, and have disclosed all information that may influence the approval of this application. I, hereby declare that all information contained therein, or referenced by, this application is complete and accurate and is not false or misleading. Signature of the Responsible Person Name Signature Date OFFICIAL USE Date received: MCA-number: Comments MCA-F-501/12, version 2 – 24 January 2025 Page 3 of 3