Directive for Medicine Manufacturing Establishment 2013

WHEREAS, it is necessary to protect public health through regulation of medicine
manufacturer engaged in processing of active and inactive ingredient for further processing
and distribution of medicines manufactured within their premises;
WHEREAS, regulatory provisions regarding the layout, design, location, construction, and
maintenance of the premise; installation of equipments and utilities, personnel, and pre-
approval and post approval inspection of manufacturer are important factor in the resulting
safety, quality and efficacy of medicine to be produced;
WHEREAS, it is appropriate to suspend, revoke or take other administrative measures on the
manufacturing certificate of competence of any manufacturer that is found operating contrary
to 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.