Background: The problem posed by the substandard and falsified (SF) medicines is a rising global challenge. WHO estimates that sales of SF medical products in low- and middle-income countries is around US$ 30 billion whereby 1 in 10 medical is substandard or falsified. Objectives: The purpose of this article was to enlighten the actions by the Somali NRA to tackle the scourge of SF medicines in Somalia. Methods: The literature was reviewed on the topic and evidence from other sources were incorporated including reports of post-marketing surveillance surveys, assessments at national and regional levels, as well as author’s experiences. Findings: The medicines regulatory capacity is weak in Somaliland and Somalia, where only 16% of total indicators for the regulatory system was in place as per WHO/IGAD rapid benchmarking of the National Regulatory Authority (NRA) in 2017, increasing the risk of circulation of SF medicines in the local private sector dominated and exclusively import relied pharmaceutical supply chain. Key actions by the NRA to address this problem include: regulatory reliance mechanisms such as using the WHO PQ/EUL for emergency authorization of vaccines, i.e. COVID-19 vaccines, enhanced licensing procedures, information exchange with NRAs in the region as well as technical collaboration with WHO. Conclusion & Recommendation: However, a lot has to be done and considering the weak laboratory capacity and the porous national borders, the risk of local circulation of SF medicines is high and swift actions are needed to ensure access to safe and quality medicines and health technologies in Somaliland and Somalia.