English — reviewed original text

MEDICINES CONTROL AGENCY Off OIC Highway, Sukuta, West Coast Region, P.O. Box 3162, The Gambia, 97XW+8HH Website: www.mca.gm; E-mail: info@mca.gm; Tel. No.: +2204380632 IMPORT CLEARANCE PERMIT Name of Importer Name of Exporter Postal and Premises Physical Address Postal and Premises Physical Address Tel: Tel: Email: Email: Port of Shipment: Expected Date of Shipment: Port of Entry: Expected Date of Arrival: Size of container or pallets Total CIF Value MCA-F-113/01, version 6 – 18 September 2026 Page 1 of 4

Import Clearance Permit MCA The Gambia Name* and MCA Product Name and address of Batch Manufacturing Expiry Unit of Total description of Registration Manufacturer number: Date Date: Issue Quantity product No: (or indicate if listed) * Brand and generic name, strength & dosage form, where applicable MCA-F-113/01, version 6 – 18 September 2026 Page 2 of 4

Import Clearance Permit MCA The Gambia Importer Licence Number (where applicable) Name of Supervising Registration Number of Pharmacy Pharmacist/Supervisor Council/Relevant Statutory Body OFFICIAL STAMP Signature Date Name of business owner or duly authorised person Signature Date CONDITIONS OF PERMIT 1. Products imported shall be inspected by authorised officials (inspector) of the Agency at the port of entry and/or point of off-loading before their release. 2. Three (3) copies of the permit together with three (3) copies of the Supplier’s Invoice packing list, and Airway Bill/Bill of Lading (if applicable). 3. One (1) copy of the stamped Customs Entry Form. 4. For medicines, one (1) copy of the certificate of Analysis (COA) for each batch. 5. For related products, one (1) copy of the Certificate of Analysis and/or Certificate of Compliance (CoC) for each batch. 6. One (1) copy of the current Good Manufacturing Practice (cGMP) Certificate of the manufacturer of the medicine, issued by the competent authority of the country of manufacture, shall be submitted. 7. One (1) copy of the valid Manufacturing Licence of the manufacturer of the medicine or related product, issued by the competent authority of the country of manufacture, shall be submitted. 8. For medicines or related products manufactured in a non-Stringent Regulatory Authority (SRA) country but authorised by an SRA, evidence that the products are sourced from the SRA country that approved them for use and distribution (e.g. Good Distribution Practice (GDP) Certificate) 9. For medicines and related products manufactured or produced in an SRA country, a Certificate of Origin (CoO). 10. For import of medicines and/or related products from India, the Clean Report of Inspection and Analysis (CRIA) issued by Quntrol. 11. For import of medicines and/or related products from non-SRA countries with pre- shipment testing arrangements, including China, Pakistan, Morocco and Ghana, a CoA issued by an MCA approved laboratory. 12. For imports from countries without pre-shipment testing arrangements, the MCA may take samples for post-shipment testing at an MCA-approved laboratory at the importer's expense. 13. For related products, including medical devices and in vitro diagnostics, a CoC issued by an accredited or recognised conformity assessment body MCA-F-113/01, version 6 – 18 September 2026 Page 3 of 4

Import Clearance Permit MCA The Gambia 14. Permits issued for importation of products shall be valid for only one transaction. 15. Where goods are short-landed, a new import clearance permit shall be obtained from the Agency. 16. At the point of clearance, the importer shall present the approved Import Clearance Permit together with the applicable supporting documents to the Customs and present the copies to MCA inspector for verification and clearance of goods. 17. At the point of off-loading, the importer shall present the approved Import Clearance Permit, supplier's invoice(s) and packing list to the MCA Inspector for verification. FOR OFFICIAL USE ONLY Vetted by (Name) Signature and Date Designation Approved by Signature and Date OFFICIAL STAMP Director of Operations MCA-F-113/01, version 6 – 18 September 2026 Page 4 of 4