Drug Control and Abuse Prevention Department
Drug Inspection & Competence Certifying Division  
Narcotic Drugs & Psychotropic Substances Control & Abuse Prevention Division

Drug Inspection and Competence Certifying Division

It is mainly responsible for:

•  Undertaking pre and post competence certification inspection on
   institutions involved in pharmaceutical manufacturing, import,
   distribution and dispensing in accordance with law and directives
   governing the sector

•  Is also responsible to undertake inspection on port of entry and
   exist and on such basis it issues port clearance permit and

•  Proper disposal pharmaceutical unfit for use

 Certificate of Competence

As per the Drug Administration and Control Proclamation No.176/99 of 1999, no one is allowed to establish Pharmaceutical Manufacturer, Importer, Whole Sale, Retail Outlet, Quality Control Laboratory, and Scientific Office as well as work as commission agent and to dispense Drug in Health Institution unless Certificate of competence is obtained  from the Authority, its Branch offices and Delegated Regional Health Bureau.

 Procedures for getting or renewing of Certificate of Competence

•  Applying to the certifying agencies using a format meant for it

•  Pre or post certification inspection is undertaken by inspectors
   from Inspection and Competency Certifying Division or Regional
   Health Bureaus as the case may be

•  Certificate of competence is issued or renewed by the department
   after reviewing the inspection report and pertinent documents as 
   well as collecting service fee

•  Certificate of competence for Drug Retail Outlets outside Addis
   Ababa is issued and renewed by the branch office of the Authority
   or Regional Health Bureaus  

•  The certificate of competence serves only for one fiscal budget year.
   It has to be renewed every year within first 4 months of the new
   fiscal budget year of the country 

Pre- import approval

Import or export of drugs, medical supplies and instrument, cosmetics and sanitary items as well as their raw and packaging materials requires pre order/import approval of purchase order/ requisition by the Authority.

Port Clearance Permit

Drugs, medical supplies and instrument, cosmetics and sanitary items as well as their raw and packaging materials are cleared from port of entry or exist only after getting port clearance permit from the Authority on the basis of inspection report.

The procedure for getting port clearance permits is as follows:

•  Applying for port clearance permit and the application has to be
   accompanied by transportation document, invoice, packing list,
   certificate of origin, batch analysis certificate, donation certificate
   (Donation), inspection report of the Authority etc

•  Port clearance permit is issued by Head of Drug Inspection and
   Competence certifying Division, on the basis of the inspection
   report

Safe disposal of pharmaceutical unfit for use

As per the law Pharmaceuticals unfit for use shall be disposed safely in the presence of inspectors from the Authority, its branch or delegated Regional health bureaus and certificate of disposal shall be issued.

Procedure for disposal

Institutions should apply for disposal of pharmaceutical using format meant for it, Prepare disposal facility by the applicant,

Disposal of the unfit for use pharmaceuticals in the presence of inspectors and then certificate of disposal is issued.