WHEREAS, it is necessary to protect public health through regulation of small scale medicine manufacturers to operate in accordance with the required safety, quality and efficacy requirements of medicine products;

WHEREAS, regulatory provisions regarding the layout, design, location, construction, and maintenance of the premise; installation of equipments and utilities, personnel of small scale manufacturer are important factor in the resulting safety, quality and efficacy of products;

WHEREAS, it is found appropriate to take the necessary administrative measures on noncomplying small scale manufacturers operating against the provision of this directive and other applicable laws;

NOW, THEREFORE, this directive is issued by the Ethiopian Food, Medicine and Healthcare Administration and Control Authority in accordance with article 55(3) of the Food, Medicine and Healthcare Administration and Control Proclamation No. 661/2009.