Publications

Title	Content	Date	Document Link	doc_category_hfilter
Guidelines for Medical Devices GMP Inspection	Guidelines for Medical Devices GMP Inspection	May 18, 2022	Guidelines for Medical Devices GMP Inspection	medical-device-guidelines
Ethiopia’s Medicine and Medicine Facility Inspection Process Achieved ISO/IEC 17020:2012 Accreditation	Ethiopia’s Medicine and Medicine Facility Inspection Process Achieved ISO/IEC 17020:2012 Accreditation. The Ethiopian Food and Drug Authority is granted accreditation by the Ethiopian National Accreditation Office (ENAO) to perform sampling and inspection in the field …	May 10, 2022	EFDA-ISO 17020 certificate	accreditations
Pharmaceutical Products Barcoding Guideline	Pharmaceutical Products Barcoding Guideline	May 6, 2022	Pharmaceutical Products Barcoding Guideline	ethiopian-traceability-system
Guidelines for Medical device Labeling	Guidelines for Medical device Labeling	April 28, 2022	Guidelines for Medical device Labeling	medical-device-guidelines
Hemlibra_Emicizumab_ Summary of product characteristics v1	Hemlibra_Emicizumab_ Summary of product characteristics v1	April 6, 2022	Hemlibra_Emicizumab_ Summary of product characteristics v1	public-assessment-report-for-registered-medicinal-products policies-legislation-and-regulation
Hemlibra_Emicizumab_ Public assessment summary reportv1	Hemlibra_Emicizumab_ Public assessment summary reportv1	April 6, 2022	Hemlibra_Emicizumab_ Public assessment summary reportv1	public-assessment-report-for-registered-medicinal-products policies-legislation-and-regulation
Lumerax DT 20120_ Artemether 20 mg & Lumefantrine 120 mg Dispersible_public assessment summary report	Lumerax DT 20120_ Artemether 20 mg & Lumefantrine 120 mg Dispersible_public assessment summary report	March 21, 2022	Lumerax DT 20120_ Artemether 20 mg & Lumefantrine 120 mg Dispersible_public assessment summary report	public-assessment-report-for-registered-medicinal-products policies-legislation-and-regulation
Lumerax DT 20120_ Artemether 20 mg & Lumefantrine 120 mg Dispersible_Summary of product characteristics	Lumerax DT 20120_ Artemether 20 mg & Lumefantrine 120 mg Dispersible_Summary of product characteristics	March 21, 2022	Lumerax DT 20120_ Artemether 20 mg & Lumefantrine 120 mg Dispersible_Summary of product characteristics	public-assessment-report-for-registered-medicinal-products policies-legislation-and-regulation
የኮቪድ 19 ወረርሽኝ ለመከላከልና ለመቆጣጣር ስለሚወሰዱ ክልከላዎች እና ስለሚጣሉ ግዴታዎች ለመወሰን የወጣ መመሪያ ቁጥር 803	803 የኮቪድ 19 ወረርሽኝ ለመከላከልና ለመቆጣጣር ስለሚወሰዱ ክልከላዎች እና ስለሚጣሉ ግዴታዎች ለመወሰን የወጣ መመሪያ ቁጥር 803	March 10, 2022	803_የኮቪድ_19_ወረርሽኝ_ለመከላከልና_ለመቆጣጣር_ስለሚወሰዱ_ክልከላዎች_እና_ስለሚጣሉ_ግዴታዎች_ለመወሰን የወጣ መመሪያ ቁጥር 803	medicine-directives
ፕሪከርሰር ኬሚካሎችን ለመቆጣጠር እና በአግባቡ ጥቅም ላይ ለማዋል የወጣ መመሪያ ቁጥር 393_2012	393 ፕሪከርሰር ኬሚካሎችን ለመቆጣጠር እና በአግባቡ ጥቅም ላይ ለማዋል የወጣ መመሪያ ቁጥር 393 2012	March 10, 2022	393_ፕሪከርሰር_ኬሚካሎችን_ለመቆጣጠር_እና_በአግባቡ_ጥቅም_ላይ_ለማዋል_የወጣ_መመሪያ_ቁጥር_393_2012	medicine-directives
ጉድለት የተገኘበት መድኃኒት እና የህክምና መሳሪያ አሰባሰብ መመሪያ ቁጥር_392_2013	392 ጉድለት የተገኘበት መድኃኒት እና የህክምና መሳሪያ አሰባሰብ መመሪያ ቁጥር 392 2013	March 10, 2022	392_ጉድለት_የተገኘበት_መድኃኒት_እና_የህክምና_መሳሪያ_አሰባሰብ_መመሪያ_ቁጥር_392_2013	medical-device-guidelines medicine-directives
በባለስልጣኑ ስር ለሚገኙ የቴክኒክ ኮሚቴዎች የአበል ክፍያ አፈጻጸም መመሪያ 377/2013	377 በባለስልጣኑ ስር ለሚገኙ የቴክኒክ ኮሚቴዎች የአበል ክፍያ አፈጻጸም መመሪያ 377_2013	March 10, 2022	377 በባለስልጣኑ ስር ለሚገኙ የቴክኒክ ኮሚቴዎች የአበል ክፍያ አፈጻጸም መመሪያ 377_2013
የምግብ መድሀኒትና የጤና ክብካቤ አስተዳደርና ቁጥጥር ባለስልጣን የአንድ ጊዜ የመድኃኒት ግዢ መመሪያ 374	374 የምግብ መድሀኒትና የጤና ክብካቤ አስተዳደርና ቁጥጥር ባለስልጣን የአንድ ጊዜ የመድኃኒት ግዢ መመሪያ	March 10, 2022	374_የምግብ_መድሀኒትና_የጤና_ክብካቤ_አስተዳደርና_ቁጥጥር_ባለስልጣን_የአንድ_ጊዜ_የመድኃኒት_ግዢ_መመሪያ	medicine-directives
የአልኮል ማስታወቂያና ሽያጭ መመሪያ_372_2013	372_የአልኮል_ማስታወቂያና_ሽያጭ_መመሪያ_372_2013	March 10, 2022	372_የአልኮል_ማስታወቂያና_ሽያጭ_መመሪያ_372_2013	food-directives
የናርኮቲክ መድኃኒቶችንና የሣይኮትሮፒክ ንጥረ ነገር ማዘዣ ወረቀት ለመቆጣጠር የወጣ መመሪያ ቁጥር 369	369 የናርኮቲክ መድኃኒቶችንና የሣይኮትሮፒክ ንጥረ ነገር ማዘዣ ወረቀት ለመቆጣጠር የወጣ መመሪያ ቁጥር 369	March 10, 2022	369_የናርኮቲክ_መድኃኒቶችንና_የሣይኮትሮፒክ_ንጥረ_ነገር_ማዘዣ_ወረቀት_ለመቆጣጠር_የወጣ_መመሪያ_ቁጥር 369	medicine-directives
የምግብ ጨው ቁጥጥር መመሪያ 361-2013	361 የምግብ ጨው ቁጥጥር መመሪያ 361-2013	March 10, 2022	361 የምግብ ጨው ቁጥጥር መመሪያ 361-2013	food-directives
የምግብ ላኪ፣ አስመጪና አከፋፋይ ቁጥጥር መመሪያ ቁጥር 357_2013	357 የምግብ ላኪ፣ አስመጪና አከፋፋይ ቁጥጥር መመሪያ ቁጥር 357 2013	March 10, 2022	357_የምግብ_ላኪ፣_አስመጪና_አከፋፋይ_ቁጥጥር_መመሪያ_ቁጥር_357_2013	food-directives
የመድኃኒትና የህክምና መሣሪያ ማስተዋወቅ መመሪያ ቁጥር 353_2013	353 የመድኃኒትና የህክምና መሣሪያ ማስተዋወቅ መመሪያ ቁጥር 353_2013	March 10, 2022	353 የመድኃኒትና የህክምና መሣሪያ ማስተዋወቅ መመሪያ ቁጥር 353_2013	medical-device-guidelines medicine-directives
የመድኃኒት፣ የህክምና መገልገያና መሳሪያ አስመጪ፣ ጅምላ አከፋፋይና ላኪ መመሪያ 350_2013	350 የመድኃኒት፣ የህክምና መገልገያና መሳሪያ አስመጪ፣ ጅምላ አከፋፋይና ላኪ መመሪያ 350 2013	March 10, 2022	350 የመድኃኒት፣ የህክምና መገልገያና መሳሪያ አስመጪ፣ ጅምላ አከፋፋይና ላኪ መመሪያ 350_2013	medical-device-guidelines medicine-directives
የመድኃኒት ችርቻሮ ድርጅቶች ቁጥጥር መመሪያ ቁጥር 349_2013	349 የመድኃኒት ችርቻሮ ድርጅቶች ቁጥጥር መመሪያ ቁጥር 349 2013	March 10, 2022	349_የመድኃኒት_ችርቻሮ_ድርጅቶች_ቁጥጥር_መመሪያ_ቁጥር_349_2013	medicine-directives
ከጨርቅ የተሰራ የፊት መሸፈኛ ጭንብል አምራች የብቃት ማረጋገጫ የምስክር ወረቀት እና የገበያ ፍቃድ 347	347 ከጨርቅ የተሰራ የፊት መሸፈኛ ጭንብል አምራች የብቃት ማረጋገጫ የምስክር ወረቀት እና የገበያ ፍቃድ	March 10, 2022	347_ከጨርቅ_የተሰራ_የፊት_መሸፈኛ_ጭንብል_አምራች_የብቃት_ማረጋገጫ_የምስክር_ወረቀት_እና_የገበያ_ፍቃድ	medicine-directives
አግባባዊ የመድኃኒት አጠቃቀም ቁጥጥር መመሪያ ቁጥር 346 2013	346 አግባባዊ የመድኃኒት አጠቃቀም ቁጥጥር መመሪያ ቁጥ 346 2013	March 10, 2022		medicine-directives
የመድኃኒት፣ የህክምና መገልገያና መሳሪያ አስመጪ፣ ጅምላ አከፋፋይና ላኪ መመሪያ_350_2013	350 የመድኃኒት፣ የህክምና መገልገያና መሳሪያ አስመጪ፣ ጅምላ አከፋፋይና ላኪ መመሪያ 350_2013	March 10, 2022	350 የመድኃኒት፣ የህክምና መገልገያና መሳሪያ አስመጪ፣ ጅምላ አከፋፋይና ላኪ መመሪያ 350_2013	medicine-directives
Administrative Measure Taking and Complaint Handling Directive No_345_2013	345 አስተዳደራዊ እርምጃ አወሳሰድና ቅሬታ አቀራረብ መመሪያ ቁጥር 345 2013	March 10, 2022	345_አስተዳደራዊ_እርምጃ_አወሳሰድና_ቅሬታ_አቀራረብ_መመሪያ_ቁጥር_345_2013
Pharmaceutical Manufacturer GMP Inspection Directive No 338	338 Pharmaceutical Manufacturer GMP Inspection Directive No 338	March 10, 2022	338_Pharmaceutical_Manufacturer_GMP_Inspection_Directive_No_338	medicine-directives
Medical Equipment Donation Directive No. 336-2020	336 Medical Equipment Donation Directive No. 336-2020	March 10, 2022	336 Medical Equipment Donation Directive No. 336-2020	food-directives
Infant Formula and Follow up Formula Directive No 335 2020	335 Infant Formula and Follow up Formula Directive No 335 2020	March 10, 2022	335_Infant_Formula_and_Follow_up_Formula_Directive_No_335_2020	food-directives
Graphic_Health_Warning_directive_No 334_2013		March 10, 2022
Food Supplement Directive No. 333-2020	333 Food Supplement Directive No. 333-2020	March 10, 2022	333 Food Supplement Directive No. 333-2020	food-directives
Guidelines for Medical Devices Good Clinical Practices	Guidelines for Medical Devices Good Clinical Practices	March 8, 2022	Guidelines for Medical Devices Good Clinical Practices	medical-device-guidelines
Medicine and Medical Device Import, Export and Wholesale Control Directive 872/2022	Medicine and Medical Device Import Export and Wholesale Control Directive 8722022	February 22, 2022	Medicine and Medical Device Import Export and Wholesale Control Directive 8722022	medical-device-guidelines medicine-directives
Master data Guideline _2nd Edition 2022	Master data Guideline _2nd Edition 2022	February 7, 2022	Master data Guideline _2nd Edition 2022	ethiopian-traceability-system
Ethiopian AMR PC_Strategic Plan 2021_2025	Ethiopian AMR PC_Strategic Plan 2021_2025	February 2, 2022	Ethiopian AMR PC_Strategic Plan 2021_2025	strategies
Risk Management Plan Guideline for COVID-19 Vaccines	Risk Management Plan Guideline for COVID-19 Vaccines	January 27, 2022	Risk Management Plan Guideline for COVID-19 Vaccines	medicine-guidelines
General Guidelines for Medical devices Marketing Authorization	General Guidelines for Medical devices Marketing Authorization	January 25, 2022	General Guidelines for Medical devices Marketing Authorization	medical-device-guidelines
Guideline on requirements of Medical Devices Clearance at ports of entry	Guideline on requirements of Medical Devices Clearance at ports of entry	January 24, 2022	Guideline on requirements of Medical Devices Clearance at ports of entry	medical-device-guidelines
Guidelines for Medical Device GDP and GSP	Guidelines for Medical Device GDP and GSP	January 20, 2022	Guidelines for Medical Device GDP and GSP	medical-device-guidelines
Global Trade Item Number (GTIN) Allocation Guideline	Global Trade Item Number (GTIN) Allocation Guideline	January 17, 2022	Global Trade Item Number (GTIN) Allocation Guideline	ethiopian-traceability-system
Global Location Number (GLN) Allocation Guideline	Global Location Number (GLN) Allocation Guideline	January 17, 2022	Global Location Number (GLN) Allocation Guideline	ethiopian-traceability-system
GMP Application form	GMP Application form	December 30, 2021	GMP Application form	medicine-guidelines