This document summarizes an assessment of the Food, Medicine and Healthcare Administration and Control Authority of the Ethiopian Somali region conducted on April 5, 2016. The assessment aimed to identify gaps and weaknesses of the regulatory body. Key findings included a lack of endorsed regulations, directives, and job descriptions. Staffing, qualifications, budget, equipment and facilities were found to be inadequate. Inspection activities of medicines, food, and health facilities were being conducted but faced challenges due to capacity and resource constraints. Common noncompliances found included illegal medicines, expired foods, and poor sanitation.

1. Name addressof regulatorybodyassessed:EthiopianSomali regionFood,MedicineandHealthcare Administration
and Control Authority
Assessmentfocal person:UzerHassen,Abdi Farah
Tel : 251913009350,251922997730
Date of assessment:April 5/2016
Purpose of assessment:ToidentifygabsandWeaknessof the regulatorybody
Scope of the assessment:Functionsof the Food,Medicine andHealthcare AdministrationandControl authorityof
Ethiopian Somali region
AssessmentPerformedby:USP-PQMEthiopia
Legal instruments
Proclamation:Proclamationwasbeingdrafted
Regulation:there wasnoendorsedregulation
Directive:there wasnodirective
The authorityisaccountable to the president’soffice
Resources
Manager
inspection and
Here inspectionand
licensing werebing
done by the same
staff
Regulatory iformation
and dessimantion
Decision was being
made by this unit
based ontheresult of
the inspection
Finace
Human resource
Public relation

2. There wasadequate workspace for the staff at the time of assessment.However,Shelves,furniture,computers,
vehiclesandcommunication deviceswerenotadequatelyavailable to performthe dailyactivitiesof the authority.
There were noaccess forboth internetandfax services.
The numberof staff,typesof qualificationsandexperience were notadequatecomparedtothe workloadandthe
responsibilitygiventothe authority.
Staffswere notprovidedwiththe jobsdescriptionbecause the jobdescriptionforeachclassof jobhad not been
designed.
The dutiesandresponsibilityof keypersonnel wasnotestablished
Funds
Fundwas allocatedtothe authorityeveryyearbythe regional governmentof Somalia(Ethiopian):However,the
budgethadneverbeenadequate.Becauseof inadequate budgetthe authorityunabletoexecute itsdaily,monthly
and yearlyplan. Excludingthe staff salrythe total budgetallocatedtothe authoritytoexecute itsannual planwas
250,000 birronlyin2015/2016 fiscal year.
The budgetplanhad beenpreparedandsubmittedbythe authoritybutnevergotthe amountithad requested. It
had beenexplainedthatthe reasonforinadequate budgetallocationmightbe limitedawarenessof officialswho
allocatesthe budgetforthe authority.
The authorityhad nevergotfinical, technical ormaterial supportfromanyothersourcesalthoughrepeatedattempts
had beendone tosecure /getsupportfromdonors.
Medicine
Both licensingandinspectionwere beingdone bythe authoritytothe following typesof institution:
1. Community pharmacy
2. Drug store
3. Rural drug vendor
4. Clinics
5. Hospitals
6. Etc...
EthiopianMedicine retailoutletcompetencycertifyinglicensingandinspectionmodel directive issuedbyEFMHACA
was adoptedbythe authoritytolicense andinspectmedicine retail outlets. Forclinics,hospitals,specialtycenters
etc... The authoritywasusingthe standard issuedbynational standard authority.Renewalof licensewasbeingdone
annuallywhileinspectionswere beingplannedtobe done quarterly.However,due toinadequate budge,human
resource andvehicle quarterlyinspectionwerenotachievedmostof the time.

3. Update listof licensed healthfacilitieswere there andthe listof updatedfacilitieswereobtained.
Both announcedandannouncedinspectionswere done.Inspectionswere done usingapprovedcheckedlistdevelop
by EFMHAC as model.Mostof the inspectorshadnotbeentrainedin inspectiontechniques.
Mostlyencounteredandcritical inspectionfindingswere storinganddispensingillegal medicinesanddispensing
prescriptionmedicineswithoutprescription.Nohealthfacilitieshealthprofessionalshadbeentakentothe courtfor
theirmal practice because of absence of endorsedregulationstohandle suchcases.Insteadvariousadministrative
measureswere beingtakenbutnotproperlydocumented.
The authorityhad problemaccessingthe registeredmedicinesinEthiopiasoitmade itdifficultforinspectorsto
identifythe unregisteredandillegalmedicines(asthe regionsneartothe border).In addition,there werealso
problemof gettinginformation onproductsthatwere recalledorwithdrawnfromthe market ontime
Food
The authoritywas undertakingbothlicensingandinspectionof institutionswhichwere workinginthe foodsector.
However,in2008 no licensingandrenewalactivityhadbeendone due tolimitedcapacitythe authorityhad(Human
resource,vehicleandfinance).Inaddition,therewasnoupdatedlistof foodrelatedinstitutionslicensedbythe
authority.
Inspectionof foodrelatedinstitutionshadbeendone anditwasbeingdone quarterly.There wasnoupdated
checklistusedtoinspectthe foodrelatedinstitutions.The checklistthathadbeenusedduringthe time of this
assessmentwasoutdatedanditdidnotreflectthe sanitationandhygienicrequirementsof then.
None of the inspectorshadbeentrainedtoinspectthe foodrelatedinstitutions.The mostcritical andcommonest
problemsencounteredduringinspectionwere the followings:
1. Spoiledpackedfoodse.g.Mangojuice
2. Relabelingof the expirydate of the packedfood
3. Poortraceability –It was difficulttoidentifythe original importerordistributorof the foodbeing
sold.Pedigreeof the itemswere notmaintained
4. Illegal andcontrabandfood
No institutionshadbeentakentothe courttill the time of thisassessment.However, itwasexplainedthatmany
administrativemeasureshadbeentakenalthoughnoadministrative measureswere archivedatthe time inspection.
The inspectorsobservedthatshortage of potable waterinthe regionhadcontributedalotthe presencesof unsafe
and poorqualityof foodsespeciallyinthe hotelsandrestaurants.
It has beenexplainedthatthere wasincidence of recall of food itemsinthe regionbutthere were norecordsof the
recalls.
Health facilitiesandHealth Professionals
Licensingandinspectionof healthcare facilitieswere beingdone.Renewalof licenseswasbeingdone yearly.There
was updatedlistof healthcare facilitieslicensedin2008. Inspectionwasbeingconductedtooandthe frequencywas
quarterly.The inspectionchecklistused.The checklistwasadoptedfromEFMHACA inspectionchecklistfor
healthcare facilities.