Establishment of Interim National Medicines Regulatory Authority Ministry of Health & Human Services Federal Republic of Somalia
With reference to Law No. 9, and its article 4, dated 26 Jan 1989, about the regulation of Human Medicine and Medical Devices, and article 2 of the National Medicine policy endorsed by the Somali Council of Ministers in 2014, the Federal Minister of Health and Human Services HE Dr. Ali Haji Adam, hereby issues this ministerial decree to establish and revitalize the interim National medicines regulatory authority to implement the core regulatory functions.
The Interim National Medicines Regulatory Authority (INMRA) shall be under the Federal Ministry of Health and Human Services of the Federal Government of Somalia as an interim entity. The INMRA is responsible for regulating and controlling medicines, biologics, medical devices, herbal medicines, food Supplements, tobacco, and medicated cosmetics in a way that is in line with international norms and standards until the legal framework for regulating medical products is in place.
This interim regulatory body will provide and execute the core regulatory functions including registration, inspection, Pharmacovigilance, post-marketing surveillance, and quality control of medical products through the use of a reliance quality control policy and set procedures.
The objectives of INMRA
- To ensure the efficacy, safety, and quality of medical products imported and distributed in Somalia
- To be responsible for controlling/regulating medicines, biologics, medical devices, herbal medicines, food safety, cosmetics, and prevention of pharmaceutical crime in the country.
- To prepare standards and guidelines for the setup of a core regulatory system of the pharmaceutical sector.
- To safeguard the public by ensuring that quality medicines are available in the country through the registration of medical products.
- To grant/revoke registration/licenses for pharmaceutical services including retail and wholesale pharmacy outlets, import, and export of pharmaceutical products (medicines, biologics, medical devices, herbal medicines, and medicated cosmetics)
- To inspect the pharmaceutical products at the ports of entry and carry out post-marketing surveillance to ensure the quality of the products and compliance with the regulatory system.
- To confirm and ensure the quality of suspected pharmaceutical products by using a reliance Quality control model, and report the substandard and falsified medical products.
- To strengthen the capacity of the regulatory system of the country through training, development of standards, and development of the regulatory infrastructure (offices and equipment)
- To participate in the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce.
- To coordinate the finalization activities of the Somali Medicine and Food Safety Bill.
The Core Regulatory Functions of the INMRA
The INMRA shall be responsible for executing the following core regulatory functions
1. Inspection of manufacturing facilities, pharmacy outlets, and distribution channels
2. Product evaluation, registration, Licensing and Market Surveillance and control
3. Ensuring product safety (Pharmacovigilance and post-marketing surveillance)
4. Quality control of medical products
5. Narcotics and Psychotropic Control
6. Control of medical product promotion and advertising
7. Tobacco control and its products