The Namibian Regulatory Council is the statutory authority established to regulate medicines and its use in Namibia. The council is controlled by the Medicines and Related Substances Act (2003) which outlines the various guidelines for each aspect of the council. The various subdivisions in the council include medicine registration, inspection and licensing, Quality Assurance surveillance laboratory, therapeutic information and pharmacovigilance centre. The council has a website where comprehensive information on their processes can be found. They also have forms, guidelines available for download by various stakeholders.

With medicine registration, applicants are required to download a form from the website. Applications involve registration of medicines, related substances and medical devices. Once medicine applications dossiers are submitted, they are reviewed for completeness and to verify if application fee have also been paid. Data on the application is then entered into the registration database. An application number is then assigned to the dossier which is then communicated to the applicant. The registration section of the NMRC evaluates the dossier and generates a report regarding the submitted dossier.
All missing information is communicated with the applicant along with the expected deadline. After the evaluation has been completed, the registration section forwards the completed dossier report along with recommendations to the pharmaceutical and Analytical Committee. With the committee’s approval, the product is gazette and a registration number is then assigned to the product. The details of the product are then entered into the medicines register, a list of all approved medicines in the countries.

Manufacturing companies in and outside of Namibia need to be inspected and licensed for their products to be distributed and sold in the country. All aspects of the supply chain before reaching the final consumer are inspected to ensure that each aspect is in compliance with the Good Manufacturing Practices outlined by the World Health Organization (WHO) and also follows the processes outlined in the Medicines and related Substances Act (2003). Once approved by the licensing and inspection section of the council, details of the manufacturer are added to the approved manufacturer register on the website. This is the list of all approved manufacturers inside and outside of Namibia. It is also available on the website. The licenses given to the manufacturers are to be renewed in the first month of every year.

The Quality Surveillance Laboratory was built to test the quality and efficacy of drugs at the Central Medical Stores for batch release. The lab also tests samples for registration and inspection, among others.
Therapeutic Information and Pharmacovigilance Centre
The Therapeutics Information and Pharmacovigilance Centre (TIPC) was established to improve the rational and safe use of medicines in Namibia. This covers two aspects: therapeutic information and pharmacovigilance. The therapeutic information section was established for the provision of unbiased and up-to-date therapeutics information for both the health care providers and the general public (NMRC,2020). The Pharmacovigilance section of TIPC is the monitors adverse drug reactions. Adverse Drug Reactions (ADR) reports are sent to the centre for investigation and evaluation. A reporter can obtain an ADR form from a pharmacy, nurse office, therapeutic committee and the various departments of health institutions. The form can also be downloaded from the NMRC website. It can be sent to TIPC via mail or fax. Information regarding the reporter and the patient is kept confidential.