18 September 2026 MCA-GL-401, version 4 - 2026 MCA Technical Working Group Guideline for Licensing as Importer of Medicines and Related Products Reviewed 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 guideline (MCA-GL-401) replaces version 3 - 10 July 2020. Version # Effective Date Reasons for Change: 1.0 25 July 2017 New document 2 12 February 2018 Editorial changes; harmonisation of format for MCA guidelines; separate guideline for importation. 3 10 July 2020 Editorial changes; change of Document Identification and Title. 4 21 September 2026 Format changed to the current template; editorial changes; roles of importers more detailed Keywords licence, importer, medicine, related product 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 Licensing as Importer of Medicines and Related Products MCA The Gambia Guideline for Licensing as Importer of Medicines and Related Products Table of contents 1 Introduction (background) ..................................................................... 2 2 Legal basis .............................................................................................. 2 3 Purpose and Scope.................................................................................. 3 4 Responsibilities of the Importer.............................................................. 3 5 New Licence as Importer and Renewals.................................................. 3 5.1 Application for a licence ......................................................................... 3 5.2 Issuance of a licence ............................................................................. 4 5.3 Renewal of a licence .............................................................................. 5 Definitions ................................................................................................... 6 References .................................................................................................. 6 Annex .......................................................................................................... 6 1 Introduction (background) 1.1. Importers are obliged to have adequate personnel and premises for the activities in question, appropriate arrangements for management of complaints and recalls, and procedures in place to control their supply chains. 1.2. Only importers licensed by the Medicines Control Agency (MCA) are entitled to import medicines and related products unless they are exempt by the MCA in accordance with the Act and Regulations. 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, 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, requires that a person has to be issued with a licence by the Agency to import medicines and/or related products. 2.3. The Medicines and Related Products Regulations, 2020 (“Regulations”) details the legal requirements. 2.4. Applicants are required to familiarise themselves with this document and the above stated law before applying for licensing as an importer. MCA-GL-401, version 4 – 18 September 2026 Page 2 of 6
Guideline for Licensing as Importer of Medicines and Related Products MCA The Gambia 3 Purpose and Scope 3.1. This document provides guidance to applicants on the procedures for licensing as an importer to import medicines and related products into The Gambia and for the renewal of a licence in accordance with MCA requirements. 3.2. It applies to companies or other legal entities in The Gambia that are or will be licensed as importers of medicines and related products. 3.3. This guideline applies to medicines and related products as defined in the Act and the Regulations. 4 Responsibilities of the Importer 4.1. Licensed importers are acting as or on behalf of the marketing authorisation holder (MAH) with the expectation that products have a marketing authorisation (registration) or listed by the MCA prior to importation. Registered products that have a marketing authorisation by the MCA are published on the MCA website. 4.2. MAHs shall have a person who is responsible for Pharmacovigilance, referred to as Qualified Person for Pharmacovigilance (QPPV). 4.3. MAHs not resident in The Gambia must have a local representative and a QPPV residing in The Gambia. Where no local representative is identified, the importer fulfils these obligations. For details on representatives of MAHs refer to the MCA Guideline for Marketing Authorisation (Registration) of Medicines (MCA-GL-102) and for the QPPV refer to MCA Guideline for Safety Monitoring of Medicines (Pharmacovigilance) including Vaccines (MCA-GL-307). 4.4. An importer of medicines and/or related products must be a corporate body or an entity duly registered as a pharmaceutical company or business or related products businesses by the Registrar of Companies in The Gambia to be eligible to be licensed as an importer. 4.5. The pharmaceutical company/business shall have a supervising pharmacist and related products businesses shall have qualified professional as a supervisor. 4.6. The supervising pharmacist shall be duly registered with the Pharmacy Council of The Gambia (PCG) and be responsible to confirm for imported medicines and related products that they are in conformity with regulatory requirements. 4.7. The supervisor for related products shall have academic and professional registration certificate from the relevant statutory body as applicable. 5 New Licence as Importer and Renewals 5.1 Application for a licence 5.1.1. The Agency charges non-refundable application fees for the importer licence 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 application. Note that any application without the requisite proof of completed payment will not be given consideration. MCA-GL-401, version 4 – 18 September 2026 Page 3 of 6
Guideline for Licensing as Importer of Medicines and Related Products MCA The Gambia 5.1.2. The application forms: Application for Licensing as Importer of Medicines and Related Products (MCA-F-411/01) and Application for Licensing as Importer of Related Products (MCA-F-411/02) are available from the MCA website: www.mca.gm/forms. 5.1.3. The application for a licence as importer of medicines and related products shall include the completed application form and the following documents: • Proof of payment of application fee (MCA receipt); • a copy of a valid identification document (e.g. Gambian identification document or passport); • a copy of the registration of the pharmaceutical company or business by the Registrar of Companies in The Gambia; • a copy of the annual return certificate from the Registrar of Companies in The Gambia; • a copy of the wholesale licence by the Pharmacy Council of The Gambia; • a copy of the certificate of registration of the supervising pharmacist with the Pharmacy Council of The Gambia; and • any other information as may be requested by the Agency. 5.1.4. The application for a licence as importer of related products shall include the completed application form for licensing as importer and the following documents: • • Proof of payment of application fee (MCA receipt); a copy of a valid identification document (e.g. Gambian identification document or passport); • a copy of the registration of the business by the Registrar of Companies in The Gambia; • a copy of the annual return certificate from the Registrar of Companies in The Gambia; • a copy of the academic and professional registration certificate of the supervisor from the relevant statutory body; • any other information as may be requested by the Agency. 5.1.5. The application form shall be signed and dated by the head/owner of the entity and by the supervising pharmacist or supervisor. 5.1.6. The form and documents can be submitted electronically by email to info@mca.gm and hardcopies delivered by hand to the MCA office, Off OIC Highway, Sukuta, West Coast Region, The Gambia, 97XW+8HH. 5.2 Issuance of a licence 5.2.1. The timeline for the issuance of a new licence is fifteen (15) working days by the Agency. 5.2.2. An importer licence would be valid until the end of one (1) calendar year (31st December of each year). MCA-GL-401, version 4 – 18 September 2026 Page 4 of 6
Guideline for Licensing as Importer of Medicines and Related Products 5.3 MCA The Gambia Renewal of a licence 5.3.1. Importers are required to renew their licence with the Agency annually. The importer shall apply for renewal in January of each year. 5.3.2. The fee for renewal of a licence in accordance with the fee schedule is due at the time of submission of the application. The application will only be processed when the fee payment is completed. 5.3.3. The application forms (MCA-F-411/01 for medicines and related products, and MCA-F-411/02 for related products) are available from the MCA website: www.mca.gm/forms. 5.3.4. The application for a renewed licence as importer of medicines and related products shall include the completed application form and the following documents: • a copy of an identification document (e.g. Gambian identification document, valid driver's licence, passport); • a copy of the registration of the business by the Registrar of Companies in The Gambia; • a copy of the premise licence by the Pharmacy Council of The Gambia; • a copy of the certificate of registration of the supervising pharmacist with the Pharmacy Council of The Gambia; • any changes in the names and addresses of the importer and/or supervising pharmacist; and • any other information as may be requested by the Agency. 5.3.5. The application for a renewed licence as importer of related products shall include the completed application form and the following documents: • a copy of an identification document (e.g. Gambian identification document, valid driver's licence, passport); • a copy of the updated registration of the business by the Registrar of Companies in The Gambia; • a copy of the academic and professional registration certificate of the supervisor from the relevant statutory body; • any changes in the names and addresses of the importer and/or supervisor; and • any other information as may be requested by the Agency. 5.3.6. The previous licence number shall be entered in the application form and the completed form shall be signed and dated by the head/owner of the entity and the supervising pharmacist or supervisor. 5.3.7. The application form and documents can be submitted as described in 5.1.6. 5.3.8. The timeline for the issuance of the renewed licence by the Agency is fifteen (15) working days. MCA-GL-401, version 4 – 18 September 2026 Page 5 of 6
Guideline for Licensing as Importer of Medicines and Related Products MCA The Gambia 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. Marketing Authorisation Holder (MAH) The company or other legal entity that has the authorisation to market a medicine or related product and who is responsible for its quality, efficacy and safety and for compliance with conditions of registration References • Medicines and Related Products Act, 2014 • Medicines and Related Products Regulations, 2020 • Medicines and Related Products (Amendment) Act, 2025 • Pharmacy Council Act, 2014 • MCA Guideline for Import and Export of Medicines and Related Products (MCA-GL103) Annex Annex 1: Application for Licensing as Importer of Medicines and Related Products (MCA-F-411/01) Annex 2: Application for Licensing as Importer of Related Products (MCA-F-411/02) [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-401, version 4 – 18 September 2026 Date Page 6 of 6