18 September 2026 MCA-GL-103, version 4 - 2026 MCA Technical Working Group Guideline for Import and Export of Medicines and Related Products Draft written and agreed by MCA Technical Working Group 19 June 2026 Release for and start of public consultation 23 June 2026 End of consultation (deadline for comments) 07 July 2026 Agreed by MCA Technical Working Group 15 September 2026 Approved by MCA Executive Director 18 September 2026 Date of coming into effect 21 September 2026 This version of the ‘MCA Guideline for Import and Export of Medicines and Related Products’ (MCA-GL-103) replaces version 3 - 10 July 2020. Version # Effective Date Reasons for Change: 1 25 July 2017 New document 2 15 February 2018 3 10 July 2020 4 21 September 2026 Editorial changes, harmonisation of format for MCA guidelines, ‘fast-track’ registration of medicines included and guideline for importer license separated. Editorial changes, change of Document Title; Export included. Format adapted to the current MCA template; editorial changes; listed products included; guidance for import of products from India included; submission of the valid GMP certificate and valid manufacturing licence of the manufacturer required for import clearance permit applications. Comments should be provided by using the template (MCA-F-021/03) for Submission of Comments and sent to info@mca.gm Off OIC Highway, Sukuta, West Coast Region, P.O. Box 3162, The Gambia Telephone +220 4380632 Send a question via our website www.MCA.gm or info@mca.gm An agency of The Gambia © MCA, 2026. Reproduction is authorised provided the source is acknowledged.
Guideline for Import and Export of Medicines and Related Products Keywords MCA The Gambia import, export, medicines, related products, permit Guideline for Import and Export of Medicines and Related Products Table of contents 1 Introduction (background) ..................................................................... 2 2 Legal basis .............................................................................................. 2 3 Scope ...................................................................................................... 3 4 General Requirements ............................................................................ 3 4.1 Import ................................................................................................ 3 4.2 Export ................................................................................................ 5 5 Application for Import Clearance Permit ................................................ 5 6 Application for Export Permit.................................................................. 6 7 Decision on Application .......................................................................... 7 8 Unauthorised Importation and Non-Compliant Products ........................ 8 Definitions ................................................................................................... 8 References .................................................................................................. 8 Annex .......................................................................................................... 9 1 Introduction (background) 1.1. In pursuance of the law this document provides guidance on the MCA requirements to persons who wish to import or export medicines and/or related products into or out of The Gambia. 1.2. The control of importation of medicines and related products by the Agency ensures that only products of acceptable standards with respect to quality, safety and efficacy are brought into the country. 1.3. The control of export of medicines and related products by the Agency ensures that only products of acceptable standards with respect to quality, safety and efficacy are shipped out of the country. 1.4. A person who wishes to import or export any medicine and related product is required to become familiar with this document including the documents needed for this guideline and the below stated law before applying for an import or export permit. 2 Legal basis 2.1. The regulation of medicines and related products in The Gambia is governed by the provisions and requirements of the Medicines and Related Products Act, MCA-GL-103, version 4 – 18 September 2026 Page 2 of 9
Guideline for Import and Export of Medicines and Related Products MCA The Gambia 2014 (“Act”), (by which the Medicines Control Agency (MCA) was established as the regulatory body for medicines and related products), the Medicines and Related Products (Amendment) Act, 2025, and the Medicines and Related Products Regulations, 2020. 2.2. Part VI of the Act, Registration of Medicines and Related Products, Sections 36 and 37 requires that the importer/exporter shall obtain import permit for importation or export permit for exportation of medicines or related products. 2.3. Part III of The Medicines and Related Products Regulations, 2020 (“Regulations”) details the legal requirements. 2.4. The Medicines and Related Products (Amendment) Act, 2025 amends Section 26 of the Act and states: “The Agency may adopt a mechanism other than registration permitting a person to import, distribute, sell, supply, or exhibit for sale any medicine or related product produced, manufactured, or sourced and approved for use and distribution in a country the Agency considers to have a competent and trusted regulatory authority or institution (In this Act referred to as “a Stringent Regulatory Authority”).” 3 Scope 3.1. This guideline applies to medicines and related products as defined in the Act and the Regulations including products to be used in a Public Health Emergency (PHE). 3.2. The guideline also applies to importation of products to be used as samples for marketing authorisation or registration, medical promotion, academic purpose, research use only and personal use in accordance with the Regulations. The guideline also applies to importation and exportation of products to be used in clinical trials and further information could also be obtained in the MCA Guideline for Clinical Trials in Humans. 3.3. It applies to licensed importers and other persons or entities who wish to import or export medicines and related products. 4 General Requirements The Agency charges non-refundable fees for import and export of medicines and related products as specified in the current Medicines and Related Products (Fees and Fines) Regulations published in the Gazette and MCA Website: www.mca.gm/policies. Evidence of payment should be submitted as part of the respective application. Note that any application without the requisite proof of completed payment will not be given consideration. 4.1 Import 4.1.1. Only entities or companies who are licensed by the Agency as importers are permitted to import medicines and/or related products. For requirements as an importer refer to MCA Guideline for Licensing as Importer of Medicines and Related Products. 4.1.2. Government hospitals, government health facilities and similar health-related institutions that provide healthcare services are authorised to import medicines and related products for use in patients undergoing treatment in their facilities. MCA-GL-103, version 4 – 18 September 2026 Page 3 of 9
Guideline for Import and Export of Medicines and Related Products MCA The Gambia 4.1.3. Non-governmental organisations (NGOs), private clinics or hospitals including veterinary clinics or hospitals that provide healthcare services may be permitted by the Agency to import reasonable quantities for use only in patients under their care in their facilities and only if the products are not locally available. 4.1.4. Registered medical doctors, dentists and veterinary surgeons may be permitted to import reasonable quantities on special request to the Agency for use only by patients under their care in their facilities and only if the products are not locally available. 4.1.5. Patients with specific prescriptions for specialist medicines may import such medicines for their personal use only. However, in such circumstances, patients should obtain import clearance permit prior and may apply to MCA to waive the import clearance permit fee. 4.1.6. A person who enters The Gambia whilst in possession of medicines or related products for personal medicinal use shall not require a permit from the Agency if: • the quantity of medicines or related products does not exceed the quantity required for use for a period of up to six months or a period determined by the Agency; or • the quantity of controlled medicines or related product does not exceed the quantity required for use for a period of 30 days or a period determined by the Agency. The person shall provide the Agency with the name, address and contact details of the licensed medical practitioner or dentist; and an original or a certified copy of the prescription for the medicine or related product. 4.1.7. Permits for importation of controlled drugs (e.g. psychotropics and narcotics) including precursors will be processed only after submission of returns on consumption. 4.1.8. Medicines and related products with the exception of investigational products are required to be authorised for marketing (registered) or listed with the Agency before being permitted to be imported. For marketing authorisation (registration) requirements of medicines in The Gambia refer to MCA Guideline for Marketing Authorisation (Registration) of Medicines, and for use in PHE refer to the MCA Guideline for Emergency Use Authorisation. Note: Prescribed medicines that are imported for a named patient do not need a registration with the Agency. 4.1.9. Each product imported is required to have at least 60% of its shelf-life remaining on arrival at the port unless a shorter time is justified for certain products and approved by the Agency. 4.1.10. Products containing active pharmaceutical ingredients such as steroids, hydroquinone (>2%), etc. are considered as medicines and shall not be permitted to be imported as cosmetics. 4.1.11. Except otherwise provided by this guideline, import clearance permits shall be granted before the importation of a product. 4.1.12. Products imported shall be inspected by authorised officials (inspectors) of the MCA at the port of entry and/or point of off-loading at the warehouse before they can be released for use. MCA-GL-103, version 4 – 18 September 2026 Page 4 of 9
Guideline for Import and Export of Medicines and Related Products 4.2 MCA The Gambia Export 4.2.1. Only licensed importers and local manufacturers are permitted to export medicines and related products, unless otherwise approved by the Agency for e.g. returning of products. 4.2.2. The exportation of medicines and related products should be carried out in accordance with the MCA requirements. 4.2.3. Products exported shall be inspected by authorised officials (inspectors) of the MCA at the point of loading at the warehouse and/or port of exit. 5 Application for Import Clearance Permit 5.1. For the permit to import • medicines or related products the application form Import Clearance Permit (MCA-F-113/01), • controlled drugs the Application Form for Import/Export of Controlled Medicines (MCA-F-113/03), and • products to be used as investigational products in clinical trials the Clinical Trial Import Application Form (MCA-F-501/06) must be completed by the applicant. The forms are available on the MCA website: www.mca.gm/forms. 5.2. All applications for import clearance permits shall bear the following information: • Full name, telephone number, email, postal address and premises physical address of the exporter and importer; • Name of port of shipment and port of entry into The Gambia and the dates; • Total CIF value; • Name (brand and generic names, compositions, strengths and dosage forms, where applicable), and description of products; • Total quantity of products and units of issue; • MCA Product Registration number, where applicable; • Name of manufacturer and country of origin; and • Batch numbers, Manufacturing and Expiry Dates. 5.3. For pharmaceutical companies and health facilities, the permit shall bear the full name, registration number with the Pharmacy Council of The Gambia and signature of the supervising pharmacist or duly authorised senior health official. 5.4. For other entities, the permit shall be signed by the owner/head of the business/organisation or an authorised person. 5.5. In applying for a permit, the following documents shall be submitted: • Three (3) copies of the supplier’s invoice(s); • Three (3) copies of the packing list; • Three (3) copies of the completed import clearance permit form; MCA-GL-103, version 4 – 18 September 2026 Page 5 of 9
Guideline for Import and Export of Medicines and Related Products MCA The Gambia • Three (3) copies of airway bill/bill of lading, where applicable; • One (1) copy of the stamped customs entry form; • 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; 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; • • For medicines, one (1) copy of the Certificates of Analysis (CoA) for each batch to be imported. • For related products, one (1) copy of the Certificates of Analysis (CoA)/Certificate of Compliance (CoC) for each batch to be imported, as applicable. • Evidence (Good Distribution Practice Certificate (GDP)) that the medicine or related product is sourced from an SRA country that approved the medicine or related product for use and distribution, if the medicine or related product is produced or manufactured in a non-SRA country. • A certificate of origin (CoO) is required for medicines and related products manufactured or produced in a country with SRA. 5.6. For import of medicines and/or related products from India, the Clean Report of Inspection and Analysis (CRIA) issued by Quntrol is required in addition. Refer to the MCA Guidance for Pre-shipment Inspection and Testing of Pharmaceutical Products Exported to The Gambia from India which is published on the MCA Website www.mca.gm/guidelines. 5.7. For the import of medicines and/or related products from non-SRA countries including China, Pakistan, Morrocco, Ghana, a Certificate of Analysis (CoA) from pre-shipment testing issued by MCA approved laboratories is required. 5.8. For the import of medicines and/or related products from countries without pre-shipment testing arrangements, MCA may take samples and send for post-shipment testing to MCA approved laboratories at the cost of the importer. 5.9. For related products, including medical devices and in vitro diagnostics, a certificate of compliance issued by an accredited or recognised conformity assessment body is required. 5.10. At the point of clearance, the importer should provide the approved import clearance permit and documents listed above to the Customs and MCA inspector for verification as applicable. 5.11. At the point of off-loading the importer should present the approved Import Clearance Permit form, supplier’s invoice(s) and packing list to the MCA inspector for verification. 5.12. Where goods are short-landed, a new import permit shall be obtained from the Agency. 6 Application for Export Permit 6.1. For the permit to export medicines or related products, the application form Export Permit for Medicines and Related Products (MCA-F-113/02) or (MCA- MCA-GL-103, version 4 – 18 September 2026 Page 6 of 9
Guideline for Import and Export of Medicines and Related Products MCA The Gambia F-113/03) for controlled medicines must be completed by the applicant. The form is available on the MCA website: www.mca.gm/forms. 6.2. 6.3. 6.4. All applications for export permit shall bear the following: • the name, address and contact details of the exporter and licence number of importer, where applicable; • the contact details of the recipient; • the name and registration number with the PCG of the supervising pharmacist, where applicable; • the name of the owner/head of the business/organisation or authorised person; • the source of the products; and • the purpose of the export. The applicant shall list the medicines or related products with: • a description of the products including the proprietary (brand) name and/or generic name, strength and dosage form; • the MCA Registration number, where applicable; • the name and address of manufacturer; • the country of origin, where applicable; and • the batch number, manufactured date, expiry date, unit of issue and total quantity of the medicines or related products. The applicant shall submit the following documents: • Three (3) copies of the Supplier’s Invoice; • Three (3) copies of the packing list (sea and air transport); and • Three (3) copies of the completed export permit form. • Three (3) copies of the import licence of the importer or its equivalent issued by the regulatory authority or relevant institution. 6.5. At the point of loading the exporter should present the approved Export Permit form, supplier’s invoice(s), packing list and the import licence of the importer or its equivalent issued by the regulatory authority or relevant institution to the MCA inspector for verification. 6.6. Where products are to be sent as different consignments, a new export permit shall be obtained from the Agency for each consignment. 7 Decision on Application 7.1. Vetting and approval of an application by the Agency for import or export permit may take up to five (5) working days. 7.2. Permits issued for import or export of products shall be valid for only one transaction. 7.3. Applications for import or export which do not conform to any of the requirements of the Agency shall not be approved. MCA-GL-103, version 4 – 18 September 2026 Page 7 of 9
Guideline for Import and Export of Medicines and Related Products 7.4. MCA The Gambia An application for import or export of a product or a certain quantity of a product may be rejected for several reasons. This may include, but not limited to: • Applicants not authorised by the Agency to import or export the proposed products; • A product with a potential for abuse; • For import, a controlled drug e.g. narcotic drugs and psychotropic substances, when the national quota for that particular medicine is exhausted; • A product found to be substandard and/or falsified. 8 Unauthorised Importation and Non-Compliant Products 8.1. Where a person or entity imports products without a valid import clearance permit as required or a non-compliant product, the imported products would be quarantined or seized and may be ordered to be re-exported or destroyed respectively. 8.2. The cost of re-export or destruction shall be borne by the importer, who may also be prosecuted accordingly. 8.3. The Agency may quarantine a non-compliant product if the non-compliance is not major and could be rectified by e.g. any sorting, processing, labelling/relabelling or analysis, which shall be supervised by the Agency at the expense of the importer. Definitions Interpretations and abbreviations contained in the MCA Glossary can be found on the MCA Website: www.mca.gm/policies. The definitions provided below apply to the terms used in this guideline. They may have different meanings in other contexts and documents. The interpretation of terms provided in the Act and Regulations apply, unless further defined in this guideline. References • Medicines and Related Products Act, 2014 • Medicines and Related Products (Amendment) Act, 2025 • Medicines and Related Products Regulations, 2020 • MCA Guidance for Pre-shipment Inspection and Testing of Pharmaceutical Products Exported to The Gambia from India (MCA-G-113/04) • Guideline for Listing of Medicines and Related Products (MCA-GL-117) • MCA Guideline for Licensing as Importer of Medicines and Related Products (MCA-GL-401) MCA-GL-103, version 4 – 18 September 2026 Page 8 of 9
Guideline for Import and Export of Medicines and Related Products MCA The Gambia Annex Annex 1: Import Clearance Permit (MCA-F-113/01) Annex 2: Export Permit for Medicines and Related Products (MCA-F-113/02) Annex 3: Import/ Export Permit of Controlled Medicines (MCA-F-113/03) [When this document will be published, delete the section below before converting to PDF file.] Prepared by: Name: Job Title: Signature: Date Executive Director: Signature MCA-GL-103, version 4 – 18 September 2026 Date Page 9 of 9