FAQ - NMRC
The Namibia Medicines Regulatory Council (NMRC) is a statutory body established in terms of the Medicines and Related Substances Control Act, Act 13 of 2003, to regulate the use of medicines in Namibia.
TIPC is the Ministry of Health and Social Services Therapeutics Information and Pharmacovigilance Centre for the provision of unbiased and up-to-date therapeutics information for both the health care providers and the general public. The need for this medicine information centre in Namibia has long been established. The National Drug Policy (NDP) of 1998 actually recommends the establishment of a drug information center and an adverse reaction monitoring unit linked to the Medicines Control Council (MCC) to coordinate adverse reaction reporting and to manage data collection, analysis and dissemination.
Quality Surveillance Laboratory main functions of the QSL are to, Analyse medicines for Central Medical Stores to ascertain the level of quality and efficacy of medicines for batch release. Analyse samples for registration. Analyse samples for inspection. Carry out post-marketing surveillance activities and adhoc testing. Carry out proficiency testing with WHO and other regional bodies.Conduct training programs involving students/analysts from local institutions. Attend meetings and providing data and advice on the quality of medicines to policy makers involved in medicines safety issues.
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The inspectorate is concerned with compliance and enforcement as its core functions. This involves: Current Good Manufacturing Practices: Inspection regarding compliance with GMP in the following establishments: manufacturing, testing, distribution, wholesaling or importing medicines. Good Distribution Practice shall also be complied with. Good Distribution Practice is a quality system which ensures that medicinal products are stored and handled consistently under appropriate conditions as required by Council on registration as given in the specifications so that the quality of the product will be maintained during storage and distribution. Compliance verification: this involves compliance verification and investigation activities in the area of medicines as defined in the Medicines and Related Substances Control Act, 2003. This involves collection of samples from distribution outlets for examination to ensure that standards are maintained post registration.
Medicine application dossiers from pendingApps are received, screened for completeness and that application fees have been included. Data on the dossiers is entered into the registration data base; an application number is allocated and information communicated to the applicant. Dossier is scheduled for evaluation by staff of the registration section. A detailed evaluation report is generated. Deficiencies, missing information etc communicated to applicant and deadline to respond to queries outlined. Completed dossier reports and recommendation are forwarded to The Pharmaceutical and Analytical Committee of the NMRC. Recommendations from this committee to Council may define whether a product is to be registered or not. Products approved by NMRC based on the recommendations of the Pharmaceutical and Analytical Committee are allocated a registration number and gazetted. The product is then entered into the Medicines Register.