19 June 2026 MCA-GL-117, version 1 - 2026 MCA Technical Working Group Guideline for Listing of Medicines and Related Products Draft written by MCA Technical Working Group 03 February 2026 Release for and start of public consultation 11 February 2026 End of consultation (deadline for comments) 25 February 2026 Agreed by MCA Technical Working Group 18 June 2026 Approved by MCA Executive Director 19 June 2026 Date of coming into effect 19 June 2026 This is a new guideline which replaces the ‘MCA Guidance to Manufacturers, Marketing Authorization Holders and Importers for Listing of Medicines and Related Products’. Comments should be provided by using the template (MCA-F-021/03) for Submission of Comments and sent to info@mca.gm Keywords listing, listed products, registration, stringent regulatory authority, SRA, sameness 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 Listing of Medicines and Related Products MCA The Gambia Guideline for Listing of Medicines and Related Products Table of contents 1 Introduction (background) and Legal basis ............................................ 2 2 Purpose and Scope ................................................................................. 3 3 Application for Listing ............................................................................. 3 3.1 General requirements ............................................................................ 3 3.2 Application process ............................................................................... 4 References .................................................................................................. 5 Annexes ...................................................................................................... 6 Appendix 1: List of Countries Considered to Have Stringent Regulatory Authorities .................................................................................................. 7 1 Introduction (background) and Legal basis 1.1. The regulation of medicines 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. 1.2. The Act requires in Section 24 and 25 that MCA keeps registers for medicines and related products, if it is satisfied that the medicine or related product complies with the prescribed standards. 1.3. Part VI, Section 26 (1) of the Act states that a person shall not manufacture, prepare, import, export, distribute, sell, supply or exhibit for sale a medicine or related product unless the article has been registered by the Agency. 1.4. 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”).” • “In adopting a mechanism other than registration, the Agency shall: o Ensure that the medicine or related product is approved by a Stringent Regulatory Authority recognised in accordance with this section; and o Conduct an independent risk-benefit assessment of the medicine or related product before it is used in The Gambia, including laboratory verification where practicable.” MCA-GL-117, version 1 – 19 June 2026 Page 2/7
Guideline for Listing of Medicines and Related Products 1.5. 1.6. MCA The Gambia In line with the MCA Guideline for Reliance on decisions, reports, or information from other national regulatory authorities (NRAs) or regional and international bodies, MCA accepts regulatory decision of another regulator or other trusted institution. The countries that the Agency considers as having a stringent regulatory authority are provided in Appendix 1 of this guideline. Applicants are required to familiarise themselves with this document and the law before applying for a listing. 2 Purpose and Scope 2.1. This document serves as a guidance to assist a person or entity submitting an application for listing of medicines and related products to MCA. 2.2. It applies to medicines and related products as defined in the Act’. 2.3. The MCA Guideline for Import and Export of Medicines and Related Products and other relevant MCA guidelines apply in the importation of the listed products. 2.4. The marketing authorisation of medicines and related products as described in the MCA Guideline for Marketing Authorisation (Registration) of Medicines does not apply to listed products. 3 Application for Listing 3.1 General requirements 3.1.1. Products that are intended to be imported shall be listed or registered prior to importation. Note: MCA would not be responsible and/or liable for any losses incurred due to failure to follow the procedures of getting the products listed or registered before importation. 3.1.2. The same product is permitted to be listed by multiple applicants if the product has not been granted a marketing authorisation right. 3.1.3. A product that is registered and issued a marketing authorisation is not eligible for listing. 3.1.4. Medicines that differ in active pharmaceutical ingredient(s), strength, dosage forms, flavour, proprietary names though containing the same ingredients or from different manufacturers, package size and presentation are considered to be different products and hence required to be listed individually and separate listing fee per product. 3.1.5. Related Products that differ in presentation (including flavour), size, package size or manufacturer(s) are considered to be different products and hence required to be listed individually and separate application for listing fee per product. 3.1.6. The Agency charges non-refundable application fee for listing as specified in the Medicines and Related Products (Fees and Fines) Regulations, 2022 published in the Gazette and MCA website www.mca.gm/policies. The fee shall be paid at the time of submission of an application prior to importation of a medicine or related product. Evidence of payment as MCA official receipt should be submitted alongside the application. Note that any application not MCA-GL-117, version 1 – 19 June 2026 Page 3/7
Guideline for Listing of Medicines and Related Products MCA The Gambia accompanied by the requisite proof of completed payment will not be given consideration. 3.1.7. The listing of a medicine or related product is based on calendar year (from 1st January to 31st December) and expires at the end of every year. 3.1.8. A new application is required for listing of products for each year. 3.1.9. An applicant can apply for listing of a medicine or related product any time of the year but the listing expires on 31st December of each year. 3.1.10. All submitted documents shall be in English, must be legibly printed and not handwritten. Documents that are in any language other than English must be accompanied by a notarised English translation. 3.1.11. The labelling requirements for medicines for human use must be fulfilled as detailed in the MCA Guideline for Labelling of Medicines for Human Use (MCA GL-101). The requirements for medicines for animal use and related products apply accordingly as far as they correspond. 3.2 Application process 3.2.1. An applicant must submit an application for each medicine or related product to the Agency. 3.2.2. The application consists of: • A duly signed cover letter addressed to Executive Director, Medicines Control Agency, Off OIC Highway, Sukuta, West Coast Region, P.O. BOX 3162, The Gambia; • Two hard copies of the completed application form: Medicines and Related Products Listing Form (Annex 1, MCA-F-117/01) excluding medical devices or Medical Devices Listing Form (Annex 2, MCA-F-117/02) available from the MCA website www.mca.gm/forms. • Samples or Pictures (in PDF format) of packaging or artwork (including primary and secondary packaging) and Patient Information Leaflet (PIL). • Evidence of approval (including name & address of Marketing Authorisation Holder and Marketing Authorisation/Registration number) for use and distribution in a country with SRA, if the medicine or related product is produced or manufactured in a non-SRA country. • Evidence 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. • Certificate of Conformance/Compliance (CoC) for medical devices and other concerned related products. • Certificate of Origin (COO) for medicines and related products produced or manufactured in a country with SRA • Certificate of Analysis (COA) for medicines, cosmetics and other concerned related products. Note: In addition to the above, MCA shall conduct a quality control testing of the medicine or related product where practicable, before it is approved for use in the Gambia at the cost to the applicant. MCA-GL-117, version 1 – 19 June 2026 Page 4/7
Guideline for Listing of Medicines and Related Products MCA The Gambia 3.2.3. The application documentation should be provided electronically via email for review and once accepted hard copies of the complete application should be submitted, where practicable. 3.2.4. The following information are required to be submitted: In the Medicines and Related Products (excluding medical devices) Listing Form: • Name and description of the product including: o Dosage form o Route of administration o Strength • Generic name • Composition of product (name and quantity of active pharmaceutical ingredients) • Indication/Claim • Package size & presentation • Dispensing category (OTC/PM/POM/POM-CD) • Name & full address of manufacturer (manufacturing site address) • SRA country product approved/registered • Name & address of source In the Medical Devices Listing Form: • Name and description of the product • Indication/Use • Package size & presentation • Name & full address of manufacturer (manufacturing site address) • SRA country product approved/registered • Name & address of source 3.2.5. Evidence of verification of the “sameness” of the approved medicine or related product in SRA country with the one applied for listing. 3.2.6. The processing of listing application by the MCA takes ten (10) working days. References • • • • • Medicines and Related Product Act, 2014 Medicines and Related Product (Amendment) Act, 2023 MCA Guideline for Marketing Authorisation (Registration) of Medicines MCA Guideline for Import and Export of Medicines and Related Products MCA Guideline for Labelling of Medicines for Human Use MCA-GL-117, version 1 – 19 June 2026 Page 5/7
Guideline for Listing of Medicines and Related Products MCA The Gambia Annexes Annex 1: Medicines and Related Products (excluding medical devices) Listing Form (MCA-F-117/01) Annex 2: Medical Devices Listing Form (MCA-F-117/02) MCA-GL-117, version 1 - 19 June 2026 Page 6/7
Guideline for Listing of Medicines and Related Products MCA The Gambia Appendix 1: List of Countries Considered to Have Stringent Regulatory Authorities 1 Australia 25 Netherlands 2 Austria 26 Norway 3 Belgium 27 Poland 4 Bulgaria 28 Portugal 5 Canada 29 Republic of Korea 6 Croatia 30 Romania 7 Cyprus 31 Russia 8 Czech Republic 32 Singapore 9 Denmark 33 Slovakia 10 Estonia 34 Slovenia 11 Finland 35 Spain 12 France 36 Sweden 13 Germany 37 Switzerland 14 Greece 38 Turkey 15 Hungary 39 16 Iceland 40 United Kingdom of Great Britain and Northern Ireland United States of America 17 Ireland 18 Italy 19 Japan 20 Kingdom of Saudi Arabia 21 Liechtenstein 22 Lithuania 23 Luxembourg 24 Malta MCA-GL-117, version 1 – 19 June 2026 Page 7/7