The resources have been gathered for your convenience. Most countries in Africa have a documented guide on how to introduce new drugs to their respective markets. The guides get updated periodically due to policy changes and new requirements from time to time. Most countries in Africa will require that you use a local representative registered with the respective pharmaceutical board for your applications to be considered and that’s where we come in. With our coverage throughout Africa, you only need one consultant for the job.
Pharmaceutical Guides
Resources
We currated some key pharmaceutical compliance resources from all over Africa. The resources are divided by country to make navigation easier. In case you have any questions, please reach our via the contacts below.

Ethiopia 🇪🇹
Publication Date: 14/01/2024
Food, Medicine and Health Care Administration and Control Council of Ministers Regulation No. 299/2013
Namibia 🇳🇦
Mozambique 🇲🇿
Publication Date: 01/01/2021
Regulation of the National Pharmacovigilance System – Ministerial Diploma No./2021
Gambia 🇬🇲
Publication Date: 10/12/2021
Guideline for Reporting of Adverse Reactions to Medicines including Vaccines
Rwanda 🇷🇼
Kenya 🇰🇪
Publication Date: 01/12/2019
Guidelines on the Safety and Vigilance of Medical Products and Health Technologies
Nigeria 🇳🇬
Tanzania 🇹🇿
Uganda 🇺🇬
Publication Date: 09/02/2018
Guidelines for Introducing a Locally Manufactured New Pharmaceutical Product on the Ugandan Market
Sierra Leone 🇸🇱
Angola 🇦🇴
Zambia 🇿🇲
Publication Date: 17/03/2020
GUIDELINES FOR APPLICATION FOR GRANT OF MARKETING AUTHORISATION OF ANTISEPTICS AND DISINFECTANTS
Publication Date: 01/03/2020
Handbook for Reporting Adverse Drug Reactions, Medication Errors, and Product Quality Problems
Burkina Faso🇧🇫
Liberia🇱🇷
Malawi🇲🇼
Mauritius🇲🇺
Togo🇹🇬
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