Guidance for time and temperature sensitive pharmaceutical product Update List of Authorized Clinical Trials In Ethiopia_Oct 2_2024 2023.09.06 Guideline-for-WHO-Pre-qualified-Medicines-through-Collaborative-Registration-Procedure- 2023.11.02 Guideline on Variation Application to Registered Medicines 2023.12.22 Guidelines on Reliance for Regulatory Decision Making 2023.12.21 Guideline on Medical Products Special import permit 2024.01.11 Guideline for control of advertising and promotion 2024.01.19 Guidance for Registration of Radiopharmaceuticals 2024.01.20 Guideline for preparation and publication of public assessment reports 2024.01.29 Guideline on Variation Applications to Registered Vaccines 2024.01.31.Guideline-for-Registration-of-Antiseptics-and-Disinfectants 2024.01.31.Guideline-for-Registration-of-oral-care-skin-care-products-with-therapeutic-claim 2024.02.27 Guidance-on-waiver-of-in-vivo-bioequivalence-requirements 2024.01.13 Guideline for describing the role and responsibilities of MA 2024.01.30 Guidelines for Registration of Biotherapeutic Proteint Products 2024.01.30 Guidelines on evaluation of similar biotherapeutics 1003- ማብራሪያ – የትንባሆ ምርት አወጋገድ መመሪያ ቁጥር 1003-2016 TOBACCO PRODUCTS DISPOSAL DIRECTIVE 1003-2016 Ethiopian National Tobacco Control Strategic Plan From 2023 – 2031 1000 – የመድኃኒት ማምረቻ ተቋማት የብቃት ማረጋገጫ አሰጣጥ እና ቁጥጥር መመሪያ ቁጥር 1000-2016 Artemether 20 mg and Lumefantrine 120 mg tablet_Comether_KPC Pharmaceuticals, Inc A blueprint for strengthening pharmacovigilance systems in resource limited countries Comparative Assessment of the National Pharmacovigilance Systems Definition of Powers and Duties of the Executive Organs Proclamation No. 1263-2021 Medicine and Medical Device Import, Export and Wholesale Control Directive 872-2022 PV Training for Healthcare Professionals Participant’s Manual 2022 Guidelines for Consumer Reporting of Side effects of medicines EFDA GMP Guideline for pharmaceutical products second edition Brochure Results on ADR Reports on DTG containing ARV regimens OCTANATE 500 and OCTANATE 1000 _SUMMARY OF PRODUCT CHARACTERISTICS OCTANATE 500 and OCTANATE 1000 _ Public assessment summary report Utrogestan Vaginal 100 mg and 200 mg Soft capsules _ Public assessment summary report_Package label Utrogestan Vaginal 100 mg and 200 mg Soft capsules_SUMMARY OF PRODUCT CHARACTERISTICS Minox 5, 50 mg ml, cutaneous solution_SUMMARY OF PRODUCT CHARACTERISTICS Minox 5, 50 mg ml, cutaneous solution_ Public assessment summary report_Package label Delstrigo 100 mg 300 mg 245 mg film-coated tablets_ Public assessment summary report_Package label-1 CELMANTIN 10 mg and 20 mg film-coated tablets_public assessment summary report_Package label- Delstrigo100 mg 300 mg 245 mg film-coated tablets_SUMMARY OF PRODUCT CHARACTERISTICS CELMANTIN 10 mg and 20 mg film-coated tablets_SUMMARY OF PRODUCT CHARACTERISTICS Verquvo 2.5 mg, 5 mg 10 mg film-coated tablets Summary of product Characteristics Medicine Marketing Authorization Directive No. 963-2023 የመድኃኒት የገበያ ፈቃድ አሰጣጥ መመሪያ ቁጥር 963-2015 CLINICAL TRIAL DIRECTIVE No. 964 2023 የህክምና ሙከራ መመሪያ ቁጥር 964-2015 Brochure-COVID-19 (Covishield-astrazeneca) vaccine active safety monitoring report Medicine Donation Control Directive 958-2023 የእርዳታ መድኃኒት ቁጥጥር መመሪያ 958-2015 Summary of product characteristics for Ritonavir Tablets USP 100 mg Summary of product characteristics for Pyrazinamide 150mg Tablets Summary of product characteristics for DOVPRELA (Pretomanid Tablets 200 mg) Public assessment summary report for DOVPRELA (Pretomanid Tablets 200 mg) Summary of product characteristics for Isoniazid 100mg and 300mg tablets Public assessment summary report for Isoniazid 100 and 300 mg tablets Guidelines for Medical devices Clinical Investigation Authorization 803_የኮቪድ_19_ወረርሽኝ_ለመከላከልና_ለመቆጣጣር_ስለሚወሰዱ_ክልከላዎች_እና_ስለሚጣሉ_ግዴታዎች_ለመወሰን የወጣ መመሪያ ቁጥር 803 393_ፕሪከርሰር_ኬሚካሎችን_ለመቆጣጠር_እና_በአግባቡ_ጥቅም_ላይ_ለማዋል_የወጣ_መመሪያ_ቁጥር_393_2012 377 በባለስልጣኑ ስር ለሚገኙ የቴክኒክ ኮሚቴዎች የአበል ክፍያ አፈጻጸም መመሪያ 377_2013 374_የምግብ_መድሀኒትና_የጤና_ክብካቤ_አስተዳደርና_ቁጥጥር_ባለስልጣን_የአንድ_ጊዜ_የመድኃኒት_ግዢ_መመሪያ 369_የናርኮቲክ_መድኃኒቶችንና_የሣይኮትሮፒክ_ንጥረ_ነገር_ማዘዣ_ወረቀት_ለመቆጣጠር_የወጣ_መመሪያ_ቁጥር 369 347_ከጨርቅ_የተሰራ_የፊት_መሸፈኛ_ጭንብል_አምራች_የብቃት_ማረጋገጫ_የምስክር_ወረቀት_እና_የገበያ_ፍቃድ 335_Infant_Formula_and_Follow_up_Formula_Directive_No_335_2020 General Guidelines for Medical devices Marketing Authorization Guideline on requirements of Medical Devices Clearance at ports of entry Regulatory Preparedness and Mitigation Strategy for Emergency Health Threats Guideline for Classification of In Vitro Diagnostic Medical Devices_EFDA Guideline for Classification of Medical devices other than IVD Medical devices_EFDA Guideline for Application of Accessories and Spare parts_EFDA Guidance on criteria for bundling or grouping of medical devices Guideline for Medical device Post-approval Change Notification_EFDA Guideline for Marketing Authorization of Low risk Medical devices_EFDA Covid-19 vaccine AEFI Reporting Form word document Guidance for Emergency Use Authorization of COVID-19 Vaccine Supplementary guideline for Clinical trial Authorization 2020 Annexes to cosmetic product manufacturing Directive No. 49 2020 Temporary COVID-19 Medical Product Approval and Import Permit Authorization Directive 331_Cosmetics,_Import,_Export_and_Whole_sale_Control_Directive_No 331-2020 Strategy for the Prevention and Containment of AMR in Ethiopia Oct 2015 Standard operating procedures for pharmaceuticals good distribution and storage practices National Medical Instruments List with minimum specification 2013 Food Medicine and Healthcare Administration and Control Councils of Ministers Regulation No 299 2013Title Content Date Document Link doc_category_hfilter EFDA VOICE for October 2024 EFDA VOICE for October 2024 October 21, 2024 efda-newsletter bulletin-and-newsletter GDPGSP and Re-call Guideline Revised Second edition GDPGSP and Re-call Guideline Revised Second edition October 21, 2024 medicine-guidelines Guidance for time and temperature sensitive pharmaceutical product Guidance for time and temperature sensitive pharmaceutical product October 21, 2024 medicine-guidelines Guideline for prevention, detection and response to SF Guideline for prevention, detection and response to SF October 18, 2024 medicine-guidelines Rational Drug Use of Malaria medicine-2 Rational Drug Use of Malaria medicine-2 October 18, 2024 articles bulletin-and-newsletter Rational Drug Use of Malaria medicine-1 Rational Drug Use of Malaria medicine-1 October 18, 2024 articles bulletin-and-newsletter Medicine safety regulation Medicine safety regulation October 18, 2024 articles bulletin-and-newsletter Food Adulteration Food Adulteration October 18, 2024 articles bulletin-and-newsletter wheat flour and edible oil fortification wheat flour and edible oil fortification October 18, 2024 articles bulletin-and-newsletter Medicine Good Manufacturing Practice (MGMP) Medicine Good Manufacturing Practice (MGMP) October 18, 2024 articles bulletin-and-newsletter Clinical trial protocol writing Template Versions 001 Clinical trial protocol writing Template Versions 001 October 16, 2024 clinical-trials Good Clinical Practice(GCP) Guideline_3rd Version Good Clinical Practice(GCP) Guideline_3rd Version October 9, 2024 clinical-trials medicine-guidelines Pharmacovigilance newsletter Q 3 Issue Pharmacovigilance newsletter Q 3 Issue October 7, 2024 pharmacovigilance-newsletter bulletin-and-newsletter Risk Based -Post Marketing Surveillance Guidline Risk Based -Post Marketing Surveillance Guidline October 7, 2024 medicine-guidelines pharmacovigilance Pharmacovigilance Guideline Pharmacovigilance Guideline October 7, 2024 medicine-guidelines pharmacovigilance Guideline for Consumer Reporting of ADEs -English Version Guideline for Consumer Reporting of ADEs -English Version October 7, 2024 medicine-guidelines pharmacovigilance Guideline for Consumer Reporting of ADE -l Amharic Version Guideline for Consumer Reporting of ADE -l Amharic Version October 7, 2024 medicine-guidelines pharmacovigilance Adverse Event Following Immunization Guideline Adverse Event Following Immunization Guideline October 7, 2024 medicine-guidelines pharmacovigilance Update List of Authorized Clinical Trials In Ethiopia Update List of Authorized Clinical Trials In Ethiopia_Oct 2_2024 October 3, 2024 clinical-trials Non_routine Procedure for Radiopharmaceutical products 2024 Non_routine_Procedure_for_Radiopharmaceutical_products 2024 October 2, 2024 medicine-guidelines guideline for temporary MA of Medicinal Gasses guideline for temporary MA of Medicinal Gasses October 2, 2024 medicine-guidelines Good Laboratory Practice Guideline Good Laboratory Practice Guideline September 17, 2024 clinical-trials medicine-guidelines Bioequivalence Studies Guideline Bioequivalence Studies Guideline September 17, 2024 clinical-trials medicine-guidelines Low-Risk Medical device Manufacturers Control Directive 1010/2024 Low-Risk Medical device Manufacturers Control Directive 1010-2024 የስጋት ደረጃቸው ዝቅተኛ የሆኑ የህክምና መሳሪያ አምራቾች ቁጥጥር መመሪያ ቁጥር 1010-2016 August 21, 2024 medical-device-directives Medicine Information Bulletin 2024 Medicine Information Bulletin 2024 August 21, 2024 drug-bulletin bulletin-and-newsletter 1020/2024 Food Additives Control Directive Food Additives Control Directive 1020-2024 የምግብ ጭማሪ ቁጥጥር መመሪያ ቁጥር 1020-2016 August 21, 2024 food-directives Guideline on Reliance for GMP inspection Guideline on Reliance for GMP inspection scan pdf July 22, 2024 medicine-guidelines EFDA Voice Newsletter July 2024 EFDA Voice Newsletter July 2024 July 22, 2024 efda-newsletter bulletin-and-newsletter Medical Devices Adverse Event Reporting (MDAER) form Ethiopian Food and Drug Authority (EFDA) Medical Devices Adverse Event Reporting (MDAER) form for Healthcare professionals and Users MDAER form July 18, 2024 medical-device-guidelines 2024.03.01 Guideline for Registration of Medicine 2024.03.01 Guideline for Registration of Medicine June 14, 2024 medicine-guidelines 2023.09.06 Guideline-for-WHO-Pre-qualified-Medicines-through-Collaborative-Registration-Procedure- 2023.09.06 Guideline-for-WHO-Pre-qualified-Medicines-through-Collaborative-Registration-Procedure- June 14, 2024 medicine-guidelines 2023.12.20 GUIDELINE FOR NON-ROUTINE REGISTRATION 2023.12.20 GUIDELINE FOR NON-ROUTINE REGISTRATION June 14, 2024 medicine-guidelines 2023.11.02 Guideline on Variation Application to Registered Medicines 2023.11.02 Guideline on Variation Application to Registered Medicines June 14, 2024 medicine-guidelines 2023.12.22 Guidelines on Reliance for Regulatory Decision Making 2023.12.22 Guidelines on Reliance for Regulatory Decision Making June 14, 2024 medicine-guidelines 2023.12.21 Guideline on Medical Products Special import permit 2023.12.21 Guideline on Medical Products Special import permit June 14, 2024 medicine-guidelines 2024.01.11 Guideline for control of advertising and promotion 2024.01.11 Guideline for control of advertising and promotion June 14, 2024 medicine-guidelines 2024.01.19 Guidance for Registration of Radiopharmaceuticals 2024.01.19 Guidance for Registration of Radiopharmaceuticals June 14, 2024 medicine-guidelines 2024.01.19 Guideline of Medicinal Gases Registration 2024.01.19 Guideline of Medicinal Gases Registration June 14, 2024 medicine-guidelines 2024.01.20 Guideline for Medicinal product information 2024.01.20 Guideline for Medicinal product information June 14, 2024 medicine-guidelines 2024.01.20 Guideline for preparation and publication of public assessment reports 2024.01.20 Guideline for preparation and publication of public assessment reports June 12, 2024 medicine-guidelines 2024.01.20 Guideline for Renewal of MA 2024.01.20 Guideline for Renewal of MA June 12, 2024 medicine-guidelines 2024.01.29 Guideline on Variation Applications to Registered Vaccines 2024.01.29 Guideline on Variation Applications to Registered Vaccines June 12, 2024 medicine-guidelines 2024.01.31 Guidelines for Conditional Approval 2024.01.31 Guidelines for Conditional Approval June 12, 2024 medicine-guidelines 2024.01.31.Guideline-for-Registration-of-Antiseptics-and-Disinfectants 2024.01.31.Guideline-for-Registration-of-Antiseptics-and-Disinfectants June 12, 2024 medicine-guidelines 2024.01.31.Guideline-for-Registration-of-oral-care-skin-care-products-with-therapeutic-claim 2024.01.31.Guideline-for-Registration-of-oral-care-skin-care-products-with-therapeutic-claim June 12, 2024 medicine-guidelines 2024.02.27 Guidance-on-waiver-of-in-vivo-bioequivalence-requirements 2024.02.27 Guidance-on-waiver-of-in-vivo-bioequivalence-requirements June 12, 2024 medicine-guidelines 2024.04.16 Good RevPractice Guideline 2024.04.16 Good RevPractice Guideline June 12, 2024 medicine-guidelines 2024.01.13 Guideline for describing the role and responsibilities of MA 2024.01.13 Guideline for describing the role and responsibilities of MA June 12, 2024 medicine-guidelines 2024.01.30 Guidelines for Registration of Biotherapeutic Proteint Products 2024.01.30 Guidelines for Registration of Biotherapeutic Proteint Products June 12, 2024 medicine-guidelines 2024.01.29 Guideline-for-Registration-of-Vaccine 2024.01.29 Guideline-for-Registration-of-Vaccine June 12, 2024 medicine-guidelines 2024.01.30 Guidelines on evaluation of similar biotherapeutics 2024.01.30 Guidelines on evaluation of similar biotherapeutics June 12, 2024 medicine-guidelines 1003- ማብራሪያ – የትንባሆ ምርት አወጋገድ መመሪያ ቁጥር 1003-2016 Description TOBACCO PRODUCTS DISPOSAL DIRECTIVE 1003-2016 1003- ማብራሪያ – የትንባሆ ምርት አወጋገድ መመሪያ ቁጥር 1003-2016 Description TOBACCO PRODUCTS DISPOSAL DIRECTIVE 1003-2016 May 31, 2024 tobacco TOBACCO PRODUCTS DISPOSAL DIRECTIVE 1003-2016 1003- ማብራሪያ – የትንባሆ ምርት አወጋገድ መመሪያ ቁጥር 1003-2016 TOBACCO PRODUCTS DISPOSAL DIRECTIVE 1003-2016 May 31, 2024 tobacco tobaco Pharmacovigilance newsletter Q 3 Issue 1_Final__2024 Pharmacovigilance newsletter Q 3 Issue 1_Final__2024 May 31, 2024 pharmacovigilance-newsletter bulletin-and-newsletter Ethiopian National Tobacco Control Strategic Plan From 2023 – 2031 Ethiopian National Tobacco Control Strategic Plan From 2023 – 2031 May 27, 2024 strategies Sinopharm Covid 19 vaccine active surveillance report Sinopharm Covid 19 vaccine active surveillance report April 16, 2024 pharmacovigilance EFDA Voice Newsletter April 2024 EFDA Voice Newsletter April 2024 April 11, 2024 efda-newsletter bulletin-and-newsletter 1000 – የመድኃኒት ማምረቻ ተቋማት የብቃት ማረጋገጫ አሰጣጥ እና ቁጥጥር መመሪያ ቁጥር 1000-2016 1000 – የመድኃኒት ማምረቻ ተቋማት የብቃት ማረጋገጫ አሰጣጥ እና ቁጥጥር መመሪያ ቁጥር 1000-2016 April 3, 2024 medicine-directives 999 – የመድኃኒት የመልካም አመራረት ሥርዓት ቁጥጥር መመሪያ ቁጥር 999-2016 999 – የመድኃኒት የመልካም አመራረት ሥርዓት ቁጥጥር መመሪያ ቁጥር 999-2016 April 3, 2024 medicine-directives Rational Drug Use of insulin Rational Drug Use of insulin April 3, 2024 articles bulletin-and-newsletter Rational Drug Use 2 Rational Drug Use 2 April 3, 2024 articles bulletin-and-newsletter Product Registration Product Registration April 3, 2024 articles bulletin-and-newsletter Jimma Branch Jimma Branch April 3, 2024 articles bulletin-and-newsletter Counterfeit Drugs Counterfeit Drugs April 3, 2024 articles bulletin-and-newsletter Pharmacovigilance newsletter Q 2 Issue 1 Pharmacovigilance newsletter Q 2 Issue 1 March 29, 2024 pharmacovigilance-newsletter bulletin-and-newsletter Guideline for Medicinal product information Guideline for Medicinal product information March 26, 2024 medicine-guidelines Guidance on waiver of in vivo bioequivalence requirements Guidance on waiver of in vivo bioequivalence requirements March 26, 2024 medicine-guidelines EFDA Voice Newsletter December 2023 EFDA Voice Newsletter December 2023 January 16, 2024 efda-newsletter bulletin-and-newsletter Traditional medicine Traditional medicine January 15, 2024 articles bulletin-and-newsletter Tobacco Tobacco January 15, 2024 articles bulletin-and-newsletter Tobacco control Addis Ababa 3 Tobacco control Addis Ababa 3 January 15, 2024 articles bulletin-and-newsletter Tobacco control Addis Ababa 2 Tobacco control Addis Ababa 2 January 15, 2024 articles bulletin-and-newsletter Tobacco control Addis Ababa 1 Tobacco control Addis Ababa 1 January 15, 2024 articles bulletin-and-newsletter Self medication Self medication January 15, 2024 articles bulletin-and-newsletter Seeding trees Seeding trees January 15, 2024 articles bulletin-and-newsletter Press conference Press conference January 15, 2024 articles bulletin-and-newsletter Prescription and non- prescription drug Prescription and non- prescription drug January 15, 2024 articles bulletin-and-newsletter Pharmacovigilance Pharmacovigilance January 15, 2024 articles bulletin-and-newsletter Milk safety Milk safety January 15, 2024 articles bulletin-and-newsletter Iodized salt Iodized salt January 15, 2024 articles bulletin-and-newsletter Good Dispensing practice Good Dispensing practice January 15, 2024 articles bulletin-and-newsletter Food Adulteration Food Adulteration January 15, 2024 articles bulletin-and-newsletter ERIS ERIS January 15, 2024 articles bulletin-and-newsletter Anti-microbial resistance Anti-microbial resistance January 15, 2024 articles bulletin-and-newsletter Clinical Trial Application Form Clinical Trial Application Form November 30, 2023 clinical-trials Routine Clinical Trial Application screening form Routine Clinical Trial Application screening form November 30, 2023 clinical-trials Non routine clinical trial application screening form Non routine clinical trial application screening form November 30, 2023 clinical-trials Clinical Trial Authorization Guideline (4th edition) Clinical Trial Authorization Guideline (4th edition) October 31, 2023 clinical-trials EFDA Voice Newsletter September 2023 EFDA Voice Newsletter September 2023 October 3, 2023 efda-newsletter bulletin-and-newsletter Overview of barcode use for pharmaceutical products in Ethiopia Overview of barcode use for pharmaceutical products in Ethiopia July 25, 2023 ethiopian-traceability-system Identification and Labeling of Pharmaceutical Products with barcode Identification and Labeling July 25, 2023 ethiopian-traceability-system Tenofovir alafenamide fumarate 25 mg _Vemlidy_Gilead Sciences, Inc Tenofovir alafenamide fumarate 25 mg _Vemlidy_Gilead Sciences, Inc July 12, 2023 summary-of-product-characteristics Sofosbuvir 400 mg and Velpatasvir 100 mg_Epclusa_Gilead Sciences, Inc Sofosbuvir 400 mg and Velpatasvir 100 mg_Epclusa_Gilead Sciences, Inc July 12, 2023 summary-of-product-characteristics Emtricitabine and Tenofovir alafenamide fumarate_Descovy 200 mg-25 mg _Gilead Sciences, Inc Emtricitabine and Tenofovir alafenamide fumarate_Descovy 200 mg-25 mg _Gilead Sciences, Inc July 12, 2023 summary-of-product-characteristics Emtricitabine and Tenofovir alafenamide fumarate_Descovy 200 mg-10 mg _Gilead Sciences, Inc Emtricitabine and Tenofovir alafenamide fumarate_Descovy 200 mg-10 mg _Gilead Sciences, Inc July 12, 2023 summary-of-product-characteristics Artemether injection 80 mg_KPC Pharmaceuticals, Inc_SmPC Artemether injection 80 mg_KPC Pharmaceuticals, Inc_SmPC July 12, 2023 summary-of-product-characteristics Artemether injection 40 mg_KPC Pharmaceuticals, Inc_SmPC Artemether injection 40 mg_KPC Pharmaceuticals, Inc_SmPC July 12, 2023 summary-of-product-characteristics Artemether 20 mg and Lumefantrine 120 mg tablet_Comether_KPC Pharmaceuticals, Inc Artemether 20 mg and Lumefantrine 120 mg tablet_Comether_KPC Pharmaceuticals, Inc July 12, 2023 summary-of-product-characteristics Amphotericin B 50mg _AmBisome_Gilead Sciences, Inc. Amphotericin B 50mg _AmBisome_Gilead Sciences, Inc. July 12, 2023 summary-of-product-characteristics List of Medicines for Community Pharmacy List of Medicines for Community Pharmacy June 9, 2023 drug-lists List of Medicines for Drug Shop List of Medicines for Drug Shop June 9, 2023 drug-lists CEM-ART drugs-2016-2021 CEM-ART drugs-2016-2021 June 8, 2023 pharmacovigilance A blueprint for strengthening pharmacovigilance systems in resource limited countries A blueprint for strengthening pharmacovigilance systems in resource limited countries June 8, 2023 pharmacovigilance Prevalence, Intensity, and Correlates of Schistosomiasis and Soil-Transmitted Helminth Infections after Five Rounds of Preventive Chemotherapy among School Children in Southern Ethiopia Prevalence, Intensity, and Correlates June 8, 2023 pharmacovigilance Clinical Trial Authorization Guideline CTA Guideline 3rd edition June 8, 2023 clinical-trials Health Policy Health Policy June 7, 2023 policies policies-legislation-and-regulation Clinical Trial application processing flow diagram Clinical Trial application processing flow diagram June 7, 2023 clinical-trials List of recalled medicines and medical devices List of recalled medicines and medical devices June 7, 2023 public-information Medicines Waste Management Disposal Directive Medicines Waste Management Disposal Directive June 7, 2023 medicine-directives Report of Pfizer vaccine AEFI in July 2022 Report of Pfizer vaccine AEFI in July 2022 June 6, 2023 pharmacovigilance Janssen AEFI Active surveillance Janssen AEFI Active surveillance June 6, 2023 pharmacovigilance Efficacy and safety of praziquantel preventive chemotherapy in Schistosoma mansoni infected school children in Southern Ethiopia A prospective cohort study Efficacy and safety of praziquantel preventive chemotherapy in Schistosoma mansoni infected school children in Southern Ethiopia A prospective cohort study June 6, 2023 pharmacovigilance COVISHIELD vaccine report COVISHIELD vaccine report June 6, 2023 pharmacovigilance Comparative Assessment of the National Pharmacovigilance Systems Comparative Assessment of the National Pharmacovigilance Systems June 6, 2023 pharmacovigilance Baseline assessment of pharmacovigilance Baseline assessment of pharmacovigilance June 6, 2023 pharmacovigilance Adverse Drug Events Reported on DTG Adverse Drug Events Reported on DTG June 6, 2023 pharmacovigilance ADE-aDSM-Preliminary EFDA ADE-aDSM-Preliminary EFDA June 6, 2023 pharmacovigilance MQCD ISO/IEC 17025:2017 MQCD ISO IEC 17025-2017 EFDA’S Medicine Quality Assessment Directorate was accredited by the ANSI National Accreditation Board (ANAB) for seven physicochemical parameters in 2011 G.C. In 2014 G.C, the condom laboratory was accredited for five … June 6, 2023 accreditations Definition of Powers and Duties of the Executive Organs Proclamation No. 1263-2021 Definition of Powers and Duties of the Executive Organs Proclamation No. 1263-2021 June 5, 2023 proclamations policies-legislation-and-regulation Medicine and Medical Device Import, Export and Wholesale Control Directive 872-2022 Medicine and Medical Device Import, Export and Wholesale Control Directive 872-2022 June 5, 2023 medicine-directives SUMMARY OF PRODUCT CHARACTERISTICS TEMPLATE FOR Applicants SUMMARY OF PRODUCT CHARACTERISTICS TEMPLATE FOR Applicants June 5, 2023 public-assessment-report-for-registered-medicinal-products policies-legislation-and-regulation PATIENT INFORMATION LEAFLET (PIL)TEMPLATE FOR Applicants PATIENT INFORMATION LEAFLET (PIL)TEMPLATE FOR Applicants June 5, 2023 public-assessment-report-for-registered-medicinal-products policies-legislation-and-regulation AEFI SURVEILLANCE COURSE FOR HEALTH PROFESSIONALS AEFI SURVEILLANCE COURSE FOR HEALTH PROFESSIONALS June 5, 2023 pharmacovigilance PV Trainer Guide May 2022 PV Trainer Guide May 2022 June 5, 2023 pharmacovigilance AEFI Training Manual for HCP-EFDA AEFI Training Manual for HCP-EFDA June 5, 2023 pharmacovigilance PV Training for Healthcare Professionals Participant’s Manual 2022 PV Training for Healthcare Professionals Participant’s Manual 2022 June 5, 2023 pharmacovigilance list of GCP Inspectors list of GCP Inspectors June 4, 2023 List of GMP inspectors List of GMP inspectors June 4, 2023 List of pharmaceutical Importer and Wholesaler inspector List of pharmaceutical Importer and Wholesaler inspector June 4, 2023 Guidelines for Consumer Reporting of Side effects of medicines Guidelines for Consumer Reporting of Side effects of medicines June 4, 2023 pharmacovigilance TB PV guideline TB PV guideline June 2, 2023 pharmacovigilance HIV PV guideline HIV PV guideline June 2, 2023 pharmacovigilance Antimalarial PV guideline Antimalarial PV guideline June 2, 2023 pharmacovigilance NTD PV guideline NTD PV guideline June 2, 2023 pharmacovigilance NCD PV guideline NCD PV guideline June 2, 2023 pharmacovigilance EFDA Vaccine Safety Risk and Crisis Communication Guideline EFDA Vaccine Safety Risk and Crisis Communication Guideline June 2, 2023 pharmacovigilance EFDA GMP Guideline for pharmaceutical products second edition EFDA GMP Guideline for pharmaceutical products second edition June 2, 2023 medicine-guidelines EFDA Voice Newsletter May 2023 EFDA Voice Newsletter May 2023 May 24, 2023 efda-newsletter bulletin-and-newsletter EFDA Voice Newsletter December 2022 EFDA Voice Newsletter December 2022 May 24, 2023 efda-newsletter bulletin-and-newsletter EFDA Voice Newsletter August 2022 EFDA Voice Newsletter August 2022 May 24, 2023 efda-newsletter bulletin-and-newsletter EFDA Voice Newsletter April 2022 EFDA Voice Newsletter April 2022 May 24, 2023 efda-newsletter bulletin-and-newsletter Brochure Results on ADR Reports on DTG containing ARV regimens Brochure Results on ADR Reports on DTG containing ARV regimens May 23, 2023 pharmacovigilance-newsletter bulletin-and-newsletter Magnesium sulfate-Kalceks 500 mg per ml solution for injection_ Public assessment summary report_Package label Magnesium sulfate-Kalceks 500 mg per ml solution for injection_ Public assessment summary report_Package label May 17, 2023 public-assessment-report-for-registered-medicinal-products policies-legislation-and-regulation OCTANATE 500 and OCTANATE 1000 _SUMMARY OF PRODUCT CHARACTERISTICS OCTANATE 500 and OCTANATE 1000 _SUMMARY OF PRODUCT CHARACTERISTICS May 17, 2023 public-assessment-report-for-registered-medicinal-products policies-legislation-and-regulation OCTANATE 500 and OCTANATE 1000 _ Public assessment summary report OCTANATE 500 and OCTANATE 1000 _ Public assessment summary report May 17, 2023 public-assessment-report-for-registered-medicinal-products policies-legislation-and-regulation Utrogestan Vaginal 100 mg and 200 mg Soft capsules _ Public assessment summary report_Package label Utrogestan Vaginal 100 mg and 200 mg Soft capsules _ Public assessment summary report_Package label May 17, 2023 public-assessment-report-for-registered-medicinal-products policies-legislation-and-regulation Utrogestan Vaginal 100 mg and 200 mg Soft capsules_SUMMARY OF PRODUCT CHARACTERISTICS Utrogestan Vaginal 100 mg and 200 mg Soft capsules_SUMMARY OF PRODUCT CHARACTERISTICS May 17, 2023 public-assessment-report-for-registered-medicinal-products policies-legislation-and-regulation Minox 5, 50 mg ml, cutaneous solution_SUMMARY OF PRODUCT CHARACTERISTICS Minox 5, 50 mg ml, cutaneous solution_SUMMARY OF PRODUCT CHARACTERISTICS May 16, 2023 public-assessment-report-for-registered-medicinal-products policies-legislation-and-regulation Minox 5, 50 mg ml, cutaneous solution_ Public assessment summary report_Package label Minox 5, 50 mg ml, cutaneous solution_ Public assessment summary report_Package label May 16, 2023 public-assessment-report-for-registered-medicinal-products policies-legislation-and-regulation Delstrigo 100 mg 300 mg 245 mg film-coated tablets_ Public assessment summary report_Package label-1 Delstrigo 100 mg 300 mg 245 mg film-coated tablets_ Public assessment summary report_Package label-1 May 16, 2023 public-assessment-report-for-registered-medicinal-products policies-legislation-and-regulation CELMANTIN 10 mg and 20 mg film-coated tablets_public assessment summary report_Package label CELMANTIN 10 mg and 20 mg film-coated tablets_public assessment summary report_Package label- May 16, 2023 public-assessment-report-for-registered-medicinal-products policies-legislation-and-regulation Delstrigo100 mg 300 mg 245 mg film-coated tablets_SUMMARY OF PRODUCT CHARACTERISTICS Delstrigo100 mg 300 mg 245 mg film-coated tablets_SUMMARY OF PRODUCT CHARACTERISTICS May 16, 2023 public-assessment-report-for-registered-medicinal-products policies-legislation-and-regulation CELMANTIN 10 mg and 20 mg film-coated tablets_SUMMARY OF PRODUCT CHARACTERISTICS CELMANTIN 10 mg and 20 mg film-coated tablets_SUMMARY OF PRODUCT CHARACTERISTICS May 16, 2023 public-assessment-report-for-registered-medicinal-products policies-legislation-and-regulation Verquvo 2.5 mg, 5 mg 10 mg film-coated tablets Summary of product Characteristics Verquvo 2.5 mg, 5 mg 10 mg film-coated tablets Summary of product Characteristics May 15, 2023 public-assessment-report-for-registered-medicinal-products policies-legislation-and-regulation Verquvo 2.5 mg, 5 mg 10 mg film-coated tablets_Public assessment summary report and packaging material Verquvo 2.5 mg, 5 mg 10 mg film-coated tablets_Public assessment summary report and packaging material May 15, 2023 public-assessment-report-for-registered-medicinal-products policies-legislation-and-regulation J&J Vaccine Brochure J&J Vaccine Brochure May 9, 2023 pharmacovigilance-newsletter bulletin-and-newsletter Medicine Marketing Authorization Directive No. 963-2023 የመድኃኒት የገበያ ፈቃድ አሰጣጥ መመሪያ ቁጥር 963-2015 Medicine Marketing Authorization Directive No. 963-2023 የመድኃኒት የገበያ ፈቃድ አሰጣጥ መመሪያ ቁጥር 963-2015 May 4, 2023 medicine-directives CLINICAL TRIAL DIRECTIVE No. 964 2023 የህክምና ሙከራ መመሪያ ቁጥር 964-2015 CLINICAL TRIAL DIRECTIVE No. 964 2023 የህክምና ሙከራ መመሪያ ቁጥር 964-2015 May 4, 2023 clinical-trials Brochure-MDR medicines aDSM-TICs analysis report Brochure-MDR medicines aDSM-TICs analysis report April 27, 2023 pharmacovigilance-newsletter bulletin-and-newsletter Brochure-COVID-19 (Covishield-astrazeneca) vaccine active safety monitoring report Brochure-COVID-19 (Covishield-astrazeneca) vaccine active safety monitoring report April 27, 2023 pharmacovigilance-newsletter bulletin-and-newsletter Brochure-Medsafety mobile app for ADR reporting user guide Brochure-Medsafety mobile app for ADR reporting user guide April 27, 2023 pharmacovigilance-newsletter bulletin-and-newsletter Pfizer Vaccine Brochure Pfizer Vaccine Brochure April 27, 2023 pharmacovigilance-newsletter bulletin-and-newsletter Pharmacovigilance newsletter 2015 Q3 March Pharmacovigilance newsletter 2015 Q3 March April 24, 2023 pharmacovigilance-newsletter bulletin-and-newsletter Pharmacovigilance newsletter 2015 Q2 December Pharmacovigilance newsletter 2015 Q2 December April 24, 2023 pharmacovigilance-newsletter bulletin-and-newsletter Pharmacovigilance newsletter 2015 1st quarter Pharmacovigilance newsletter 2015 1st quarter April 24, 2023 pharmacovigilance-newsletter bulletin-and-newsletter List of Authorized Clinical Trial Applications V1, 2015 E.C List of Authorized Clinical Trial Applications V1, 2015 E.C March 10, 2023 clinical-trials Definition of Organization, Powers and Duties of the Ethiopian Food and Drug Authority Council of Ministers Regulation No. 531/2023 Definition of Organization Powers and Duties of the Ethiopian Food and Drug Authority Council of Ministers Regulation No 531 2023 March 8, 2023 regulations policies-legislation-and-regulation 957 Traditional medicinal products Manufacturing Certificate of Competence and Market Authorization Directive 957 Traditional medicinal products Manufacturing Certificate of Competence and Market Authorization Directive የባህል መድኃኒት ምርት የብቃት ማረጋገጫ የምስክር ወረቀት እና የገበያ ፈቃድ አሰጣጥ መመሪያ February 1, 2023 medicine-guidelines Medicine Donation Control Directive No. 958/2023 Medicine Donation Control Directive 958-2023 የእርዳታ መድኃኒት ቁጥጥር መመሪያ 958-2015 February 1, 2023 medicine-directives Summary of product Characteristics of Sildenafil Citrate 50 Summary of product Characteristics of Sildenafil Citrate 50 January 3, 2023 public-assessment-report-for-registered-medicinal-products policies-legislation-and-regulation Public assessment summary report of sildenafil Public assessment summary report of sildenafil January 3, 2023 public-assessment-report-for-registered-medicinal-products policies-legislation-and-regulation Pharmacovigilance newsletter Quarter 1 ,Issue 1 Sep, 2022 Pharmacovigilance newsletter Quarter 1 ,Issue 1 Sep, 2022 December 21, 2022 pharmacovigilance-newsletter bulletin-and-newsletter Pharmacovigilance newsletter Volume 1, Issue 1, 2022 Pharmacovigilance newsletter Volume 1, Issue 1, 2022 December 21, 2022 pharmacovigilance-newsletter bulletin-and-newsletter Droxiderm SmPC Droxiderm SmPC November 24, 2022 public-assessment-report-for-registered-medicinal-products policies-legislation-and-regulation Droxiderm PAsRv1 Droxiderm PAsRv1 November 24, 2022 public-assessment-report-for-registered-medicinal-products policies-legislation-and-regulation Diclofenac Sodium Injection 75 mg/2 ml Public assessment summary report Diclofenac inj. PAsRv1 November 2, 2022 public-assessment-report-for-registered-medicinal-products policies-legislation-and-regulation SUMMARY OF PRODUCT CHARACTERISTICS DICLOFENAC SODIUM INJECTION 75MG/2ML Diclofenac inj. SmPC V1 November 2, 2022 public-assessment-report-for-registered-medicinal-products policies-legislation-and-regulation AEFI standard reporting form Ethiopia AEFI standard reporting form Ethiopia October 21, 2022 pharmacovigilance Addendum to AEFI Surveillance Guideline 2022 Addendum to AEFI Surveillance Guideline 2022 October 21, 2022 pharmacovigilance ADE-ADR-ME-reporting form-EFDA ADE-ADR-ME-reporting form-EFDA October 21, 2022 pharmacovigilance ADE-ADR-ME-reporting form-EFDA ADE-ADR-ME-reporting form-EFDA October 19, 2022 pharmacovigilance-newsletter bulletin-and-newsletter Addendum to AEFI Surveillance Guideline 2022 Addendum to AEFI Surveillance Guideline 2022 October 19, 2022 pharmacovigilance-newsletter bulletin-and-newsletter AEFI standard reporting form Ethiopia AEFI standard reporting form Ethiopia October 19, 2022 pharmacovigilance-newsletter bulletin-and-newsletter Pharmacovigilance Directive No. 932/2022 932 የመድኃኒት ጎጂ ባህሪያት ክትትል ሥርዓት መመሪያ ቁጥር 932-2015 932 የመድኃኒት ጎጂ ባህሪያት ክትትል ሥርዓት መመሪያ ቁጥር 932-2015 October 17, 2022 medicine-directives pharmacovigilance-newsletter bulletin-and-newsletter Summary of product characteristics for Ritonavir Tablets USP 100 mg Summary of product characteristics for Ritonavir Tablets USP 100 mg October 17, 2022 public-assessment-report-for-registered-medicinal-products policies-legislation-and-regulation Summary of product characteristics for Pyrazinamide 150mg Tablets Summary of product characteristics for Pyrazinamide 150mg Tablets October 14, 2022 public-assessment-report-for-registered-medicinal-products policies-legislation-and-regulation Summary of product characteristics for DOVPRELA (Pretomanid Tablets 200 mg) Summary of product characteristics for DOVPRELA (Pretomanid Tablets 200 mg) October 14, 2022 public-assessment-report-for-registered-medicinal-products policies-legislation-and-regulation Public assessment summary report for DOVPRELA (Pretomanid Tablets 200 mg) Public assessment summary report for DOVPRELA (Pretomanid Tablets 200 mg) October 14, 2022 public-assessment-report-for-registered-medicinal-products policies-legislation-and-regulation Summary of product characteristics for Isoniazid 100mg and 300mg tablets Summary of product characteristics for Isoniazid 100mg and 300mg tablets October 10, 2022 public-assessment-report-for-registered-medicinal-products policies-legislation-and-regulation Public assessment summary report for Isoniazid 100 and 300 mg tablets Public assessment summary report for Isoniazid 100 and 300 mg tablets October 10, 2022 public-assessment-report-for-registered-medicinal-products policies-legislation-and-regulation PRIVACY POLICY PRIVACY POLICY Last updated March 30, 2022 This privacy notice for Ethiopian Food and Drug Authority (doing business as EFDA) (“EFDA,” “we,” “us,” or “our”), describes how and why we might collect, store, use, and/or … October 8, 2022 policies policies-legislation-and-regulation Guidelines for Software as Medical Devices Guidelines for Software as Medical Devices September 28, 2022 medical-device-guidelines Guidelines for Medical Device Refurbishment Guidelines for Medical Device Refurbishment September 28, 2022 medical-device-guidelines Guidelines for Medical Device Donations 2022 08 29_Guidelines for Medical Device Donations September 16, 2022 medical-device-guidelines Emergency medicines list Emergency medicines list September 2, 2022 drug-lists OTC medicines list OTC medicines list September 2, 2022 drug-lists Guidelines for Medical devices Clinical Investigation Authorization Guidelines for Medical devices Clinical Investigation Authorization July 26, 2022 medical-device-guidelines Medical devices Decommissioning and Disposal Guideline Medical devices Decommissioning and Disposal Guideline July 18, 2022 medical-device-guidelines Medical Devices Recall Guideline Medical Devices Recall Guideline July 18, 2022 medical-device-guidelines Medical devices Post Marketing Surveillance Guideline Medical devices Post Marketing Surveillance Guideline July 18, 2022 medical-device-guidelines Guidelines for Medical Devices GMP Inspection Guidelines for Medical Devices GMP Inspection May 18, 2022 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 accreditations Pharmaceutical Products Barcoding Guideline Pharmaceutical Products Barcoding Guideline May 6, 2022 ethiopian-traceability-system Guidelines for Medical device Labeling Guidelines for Medical device Labeling April 28, 2022 medical-device-guidelines Hemlibra_Emicizumab_ Summary of product characteristics v1 Hemlibra_Emicizumab_ Summary of product characteristics v1 April 6, 2022 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 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 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 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 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 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 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 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 medicine-directives የአልኮል ማስታወቂያና ሽያጭ መመሪያ_372_2013 372_የአልኮል_ማስታወቂያና_ሽያጭ_መመሪያ_372_2013 March 10, 2022 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 medicine-directives የምግብ ጨው ቁጥጥር መመሪያ 361-2013 361 የምግብ ጨው ቁጥጥር መመሪያ 361-2013 March 10, 2022 food-directives የምግብ ላኪ፣ አስመጪና አከፋፋይ ቁጥጥር መመሪያ ቁጥር 357_2013 357 የምግብ ላኪ፣ አስመጪና አከፋፋይ ቁጥጥር መመሪያ ቁጥር 357 2013 March 10, 2022 food-directives የመድኃኒትና የህክምና መሣሪያ ማስተዋወቅ መመሪያ ቁጥር 353_2013 353 የመድኃኒትና የህክምና መሣሪያ ማስተዋወቅ መመሪያ ቁጥር 353_2013 March 10, 2022 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 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 medicine-directives አግባባዊ የመድኃኒት አጠቃቀም ቁጥጥር መመሪያ ቁጥር 346 2013 346 አግባባዊ የመድኃኒት አጠቃቀም ቁጥጥር መመሪያ ቁጥ 346 2013 March 10, 2022 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 Medical Equipment Donation Directive No. 336-2020 336 Medical Equipment Donation Directive No. 336-2020 March 10, 2022 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 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 food-directives Guidelines for Medical Devices Good Clinical Practices Guidelines for Medical Devices Good Clinical Practices March 8, 2022 medical-device-guidelines Master data Guideline _2nd Edition 2022 Master data Guideline _2nd Edition 2022 February 7, 2022 ethiopian-traceability-system Ethiopian AMR PC_Strategic Plan 2021_2025 Ethiopian AMR PC_Strategic Plan 2021_2025 February 2, 2022 strategies Risk Management Plan Guideline for COVID-19 Vaccines Risk Management Plan Guideline for COVID-19 Vaccines January 27, 2022 medicine-guidelines General Guidelines for Medical devices Marketing Authorization General Guidelines for Medical devices Marketing Authorization January 25, 2022 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 medical-device-guidelines Guidelines for Medical Device GDP and GSP Guidelines for Medical Device GDP and GSP January 20, 2022 medical-device-guidelines Global Trade Item Number (GTIN) Allocation Guideline Global Trade Item Number (GTIN) Allocation Guideline January 17, 2022 ethiopian-traceability-system Global Location Number (GLN) Allocation Guideline Global Location Number (GLN) Allocation Guideline January 17, 2022 ethiopian-traceability-system GMP Application form GMP Application form December 30, 2021 medicine-guidelines INIGAST 40 Public assessment summary report v1 INIGAST 40 Public assessment summary report v1 December 15, 2021 public-assessment-report-for-registered-medicinal-products policies-legislation-and-regulation INIGAST 40 Summary of product characteristics v1 INIGAST 40 Summary of product characteristics v1 December 15, 2021 public-assessment-report-for-registered-medicinal-products policies-legislation-and-regulation ALLTERA 50 Summary of product characteristics v1 ALLTERA 50 Summary of product characteristics v1 December 15, 2021 public-assessment-report-for-registered-medicinal-products policies-legislation-and-regulation ALLTERA 50 Public assessment summary report v1 ALLTERA 50 Public assessment summary report v1 December 15, 2021 public-assessment-report-for-registered-medicinal-products policies-legislation-and-regulation ALLTERA 50 Public assessment summary report v1 ALLTERA 50 Public assessment summary report v1 December 14, 2021 Baby food control directive 840-2021 Baby food control directive 840-2021 November 25, 2021 food-directives Guideline for Medical Devices Good Manufacturing Practice Guideline for Medical Devices Good Manufacturing Practice November 1, 2021 medical-device-guidelines Regulatory Preparedness and Mitigation Strategy for Emergency Health Threats Regulatory Preparedness and Mitigation Strategy for Emergency Health Threats October 11, 2021 strategies Guidelines for Borderline Medical devices_EFDA Guidelines for Borderline Medical devices_EFDA October 8, 2021 medical-device-guidelines የመድኃኒት የመልካም አመራረት ስርዓት ቁጥጥር አሰራር መመሪያ 830 2013 የመድኃኒት የመልካም አመራረት ስርዓት ቁጥጥር አሰራር መመሪያ 830 2013 September 13, 2021 medicine-directives Guideline for Registration of Insecticide Treated Net 2021 Guideline for Registration of Insecticide Treated Net 2021 August 4, 2021 medicine-guidelines Guideline for Classification of In Vitro Diagnostic Medical Devices_EFDA Guideline for Classification of In Vitro Diagnostic Medical Devices_EFDA July 21, 2021 medical-device-guidelines Guideline for Classification of Medical devices other than IVD Medical devices_EFDA Guideline for Classification of Medical devices other than IVD Medical devices_EFDA July 21, 2021 medical-device-guidelines Guideline for Application of Accessories and Spare parts_EFDA Guideline for Application of Accessories and Spare parts_EFDA July 12, 2021 medical-device-guidelines Guideline for Medical Devices Bundling for Marketing authorization application Guidance on criteria for bundling or grouping of medical devices May 6, 2021 medical-device-guidelines Tobacco Control Directive Number 771/2021 Tobacco Control Directive Number 771 2021 April 20, 2021 tobacco-amh Tobacco Control Directive Number 771/2021 Tobacco Control Directive Number 771 2021 April 20, 2021 tobacco National-pharmacovigilance-Roadmap-2020 National-pharmacovigilance-Roadmap-2020 April 13, 2021 pharmacovigilance-newsletter bulletin-and-newsletter Guideline for Medical device Post-approval Change Notification EFDA Guideline for Medical device Post-approval Change Notification_EFDA April 5, 2021 medical-device-guidelines Guideline for Marketing Authorization of Low risk Medical devices_EFDA Guideline for Marketing Authorization of Low risk Medical devices_EFDA April 5, 2021 medical-device-guidelines Covid-19 vaccine AEFI Reporting Form Covid-19 vaccine AEFI Reporting Form word document March 12, 2021 pharmacovigilance-newsletter bulletin-and-newsletter Covid-19 vaccine AEFI Reporting Form Covid-19 vaccine AEFI Reporting Form March 12, 2021 pharmacovigilance-newsletter bulletin-and-newsletter EFDA_Guidelines for IVD Registration Requirements EFDA_Guidelines for IVD Registration Requirements February 19, 2021 medical-device-guidelines EFDA_Guidelines for Non-IVD Registration Requirements EFDA_Guidelines for Non-IVD Registration Requirements February 19, 2021 medical-device-guidelines Guideline for COVID-19 Vaccine donation Guideline for COVID-19 Vaccine donation February 15, 2021 medicine-guidelines Guidance for Emergency Use Authorization of COVID-19 Vaccine Guidance for Emergency Use Authorization of COVID-19 Vaccine January 29, 2021 medicine-guidelines Traditional Medicine Clinical Trial guidance 2020 Traditional Medicine Clinical Trial guidance 2020 November 9, 2020 medicine-guidelines Supplementary guideline for Clinical trial Authorization 2020 Supplementary guideline for Clinical trial Authorization 2020 November 9, 2020 medicine-guidelines Guideline for Registration of Low-risk Medicines Guideline for Registration of Low-risk Medicines October 1, 2020 medicine-guidelines Risk-based Guideline for Post-Marketing Quality Surveillance PMS Guideline 2020 September 25, 2020 medicine-guidelines Food Consignment Technical guideline Food Consignment Technical guideline September 22, 2020 food-guidelines PV Newsletter V7 ISSUE 2 Feb 2020 Pharmacovigilance newsletter No 2 2012 July 8, 2020 pharmacovigilance-newsletter bulletin-and-newsletter PV Newsletter V7 Issue 1 Oct 2019 Pharmacovigilance newsletter No 2 2012 July 8, 2020 pharmacovigilance-newsletter bulletin-and-newsletter Annexes to cosmetic product manufacturing Directive No. 49/2020 Annexes to cosmetic product manufacturing Directive No. 49 2020 June 17, 2020 cosmetic-directive Food and Medicine Administration Proclamation No.1112/2019 Food and Medicine Administration Proclamation 1112 June 10, 2020 proclamations policies-legislation-and-regulation Internal quality Food import export Internal quality Food import export June 5, 2020 food-directives Traditional Medicine Guidance Traditional Medicine Guidance May 26, 2020 medicine-guidelines የኮሮና ቫይረስ ግብአት አምራች፣ አስመጪና አከፋፋይ ድርጅት የብቃት ማረጋገጫ የምስክር ወረቀት አሰጣጥ ጊዜያዊ መመርያ Temporary Licensing Procedures April 13, 2020 Temporary COVID-19 Medical Product Approval and Import Permit Authorization Directive Temporary COVID-19 Medical Product Approval and Import Permit Authorization Directive April 10, 2020 Annexes to Cosmetics Import, Export and Wholesale Control Directive No. 48/2020 AnnexeAnnexes to Cosmetics Import Export and Wholesale Control Directive No 482020s to Cosmetics Import Export and Wholesale Control Directive No 482020 April 1, 2020 cosmetic-directive Cosmetics Import, Export and Wholesale Control Directive No 331-2020 331_Cosmetics,_Import,_Export_and_Whole_sale_Control_Directive_No 331-2020 April 1, 2020 cosmetic-directive የኮሮና ቫይረስ ወረርሺኝን ለመከላከል ኅብረተሰቡ የሚጠቀምባቸው የመከላከያ ምርቶች አምራች፣ አስመጪ እና አከፋፋይ የብቃት ማረጋገጫ የምስክር አሰጣጥ ጊዜያዊ የአሠራር መመሪያ፡፡ 2012 የኮሮና ቫይረስ ወረርሺኝን ለመከላከል ኅብረተሰቡ የሚጠቀምባቸው የመከላከያ ምርቶች አምራች፣ አስመጪ እና አከፋፋይ የብቃት ማረጋገጫ የምስክር አሰጣጥ ጊዜያዊ የአሠራር መመሪያ፡፡ 2012 March 25, 2020 medicine-directives Strategy for the Prevention and Containment of AMR in Ethiopia Oct 2015 During the past seven decades, antimicrobial medicines have saved millions of lives, substantially reduced the burden of diseases that were previously widespread, improved the quality of life, and helped increase life expectancy. However, in the … March 7, 2019 non-categorized Strategic plan For Traceability Implementation Ethiopia has one of the fastest growing economies in the world. However, production capacity, technological developments, creation of employment opportunities and investments in the healthcare sector are behind on other sectors (HSTP, 2015), while at … March 7, 2019 ethiopian-traceability-system STG -Primary Hospital Irrational use of drugs has been one of the major problems in the Ethiopian health care system for a long time. Among the strategies devised to improve the situation, Medicine, Food and Healthcare Administration and … March 7, 2019 non-categorized STG -Health Center Irrational use of drugs has been one of the major problems in the Ethiopian health care system for a long time. Among the strategies devised to improve the situation, Medicine, Food and Healthcare Administration and … March 7, 2019 non-categorized STG-General Hospital. Irrational use of drugs has been one of the major problems in the Ethiopian health care system for a long time. Among the strategies devised to improve the situation, Medicine, Food and Healthcare Administration and … March 7, 2019 non-categorized Standard operating procedures for pharmaceuticals good distribution and storage practices Distribution of pharmaceutical products is an important activity in the integrated supply-chain management. Feeble points in the distribution processes of pharmaceutical products provide viable ground for counterfeit, illegally imported, stolen and substandard medicines to enter … March 7, 2019 non-categorized RDV Formulary Proper medicines use including rational prescribing, rational despensing and proper administration of medicines by the patient’s is important in the health of the public. Defining the patient’s problems, setting therapuetic objectives and proper comuniction with … March 6, 2019 non-categorized PV NL 8 Medications are given to treat a specific disease and as they do so they can result in unwanted effects, one of which is adverse drug reaction. These reactions manifest in different forms. It is the … March 6, 2019 non-categorized PV Newsletter VI ISSUE I Nov 2010 The only thing that remains between an adverse drug reaction observed in a drug treatment and the help that the user of the drug gets as a result is the will and commitment of the … March 6, 2019 non-categorized PV_Newsletter_V5_ISSUE 3_Dec_2015 Awareness creation trainings were provided to 123 health care providers of 4 health centers of Yeka sub city ,Addis Ababa on pharmacovigilance .The trainings were provided to the participants of Aware Health Center (HC), Ankorcha … March 6, 2019 non-categorized PV Newsletter V2 ISSUE 1 Sept 2012 Face to a Face discussion on Pharmacovigilance was carried out at 5 Health Centers in Addis Ababa by the Ethiopian Food, Medicine and Healthcare Administration and Control Authority (FMHACA) with the technical support from MSH/SIAPS. … March 6, 2019 non-categorized PV Newsletter V2 issue 2 Medication error is one of the main causes of drug related injury or Adverse drug event. It is any preventable event that may cause or lead to inappropriate medication use or patient harm while the … March 6, 2019 non-categorized PV Newsletter V1 ISSUE 3 Nov 2011 The day I was called to participate in the launching of the establishment of drug safety monitoring center of the Ethiopia Food, Medicine and Health Care Administration and Control Authority, I started to understand and … March 6, 2019 non-categorized PV Newsletter V1 ISSUE 2 June 2011 According to a recent survey carried out by the Food Medicine and Health Care Authority (FMHACA) and MSH/SPS, health providers practice with Adverse drug Reaction (ADR) showed that ( 225, 56.25%) of the participants had … March 6, 2019 non-categorized PV Newsletter V5 ISSUE 2 Sep 2015 Use of medicines is associated with risks that include occurrence of adverse drug reactions, treatment failure and /or, medication error. Adverse drug events may be seen in clinical trials, but this effect becomes clearly seen … March 6, 2019 non-categorized PV newsletter V3 Issue 4 Download PV_newsletter_V3_Issue_4 File size: 1 MB Downloads: 1008 March 6, 2019 non-categorized PV newsletter V3 Issue 1 He also described that, even though post marketing surveillance is vital and untouched area in developing world, especially in Ethiopia, most health providers participation is very far from what could have been done in practice … March 6, 2019 non-categorized Proclamation 661 Download Proclamation_661 File size: 878 KB Downloads: 2471 March 6, 2019 Pharmacovigilance newsletter No 15 An Adverse Event Following Immunization (AEFI) is any untoward medical occurrence which follows immunization and which does not necessarily have a causal relationship with the usage of the vaccine. The adverse event may be any … March 6, 2019 non-categorized Pharmacovigilance newsletter No 10 The importance of Adverse Drug Event Reporting (ADE) system lies in its objective which is ,the provision of drug safety data to FMHACA pharmacovigilance center .This initial information enriched by further investigation will finally enable … March 6, 2019 non-categorized pharmacovigilance newsletter No 11 After I participated in the workshop on Pharmacovigilance which was organized by SIAPS/ USAID in collaboration with PFSA at Jimma some eight months back, I started to understand and visualize the magnitude of the problem … March 6, 2019 non-categorized pharmacovigilance newsletter no 7 Nigst Eleni Mohammed Memorial Hospital is situated in Hadiya zone at Hosanna town in the South Nations Nationalities and Peoples Republic. It is a known fact that drugs are important for disease prevention as well … March 6, 2019 non-categorized Pharmacovigilance newsletter 16 Importance of Active surveillance and Cohort Event monitoring on ARV medicines in Ethiopia The cornerstone of any pharmacovigilance system is Spontaneous reporting system which is a passive surveillance system that uses voluntary reporting of an … March 6, 2019 non-categorized Pharmacovigilance newsletter 14 Training was given to six health centers of yeka sub city on pharmacovigilance from January 22 to the end of March 2016. Wereda 8/Chefe Health center (HC), Wereda 12 HC, Entoto no 2 HC, and … March 6, 2019 non-categorized Pharmaceutical Assessment 2016 “Ensuring healthy lives and promoting well-being for all at all ages” is one of the Sustainable Development Goals (SDGs) and founding concept of the World Health Organization and the Universal Deceleration of Human Rights (WHO, … March 6, 2019 non-categorized OVER THE COUNTER MEDICINES LIST FOR ETHIOPIA 2nd edition Ethiopian drug policy ensures that medicines which are required for prevention, diagnosis, treatment, mitigation and rehabilitation of diseases affecting the majority of Ethiopian people have to be identified and classified to respective levels of health … March 6, 2019 non-categorized NPS List and report format The history of drug abuse is as old as the history of mankind. Since ancient times,. human beings have been using the different parts of plants (roots, leaves, stems, etc…) as medicine for relieving different … March 6, 2019 non-categorized NPS FORMULARY The history of human race has also been the history of drug use. Since earliest times, herbs, roots, bark leaves and plants have been used to relieve pain and help control disease. In and of … March 6, 2019 non-categorized National Medical Instruments List with minimum specification 2013 As the dynamicity of the healthcare continuous to expand, an increasing number of sophisticated medical instruments will be introduced into the healthcare delivery system. As a result, a system capable of supporting the utilization of … March 6, 2019 non-categorized Narcotic Manual final Download Narcotic_Manual_fainal File size: 55 MB Downloads: 1839 March 6, 2019 non-categorized Medicines Market Authorization Strategy 2017 In the last two decades, the government of Ethiopia has been putting tremendous efforts in implementing policies and strategies including the National Medicine Policy (1993) and the 20-year Health Sector Development Programme (HSDP). The political … March 6, 2019 non-categorized Medicines Good Dispensing Manual second edition 2012 Good medicine dispensing practice refers to the delivery of the correct medicine to the right patient, in the required dosage and quantities, in the package that maintains acceptable potency and quality for the specified period, … March 6, 2019 non-categorized Medicine Retail outlet model 2013 Download Medicine Retail outlet model 2013 File size: 262 KB Downloads: 1941 March 6, 2019 non-categorized Medicine For Ethiopia NDL The Food, Medicine and Health Care Administration and Control Authority (FMHACA) of Ethiopia would like to extend its gratitude to the World Health Organization (WHO) for its technical assistance, meeting all financial expenses associated with … March 6, 2019 non-categorized Medicines Good Prescribing Manual second edition 2012 Medicines are an essential component of health care delivery. When used rationally, they produce the desired effect of improving patients’ ailments. Their irrational use on the other hand leads to prolongation of the illness, development … March 6, 2019 non-categorized LIST OF ORPHAN MEDICINES FOR ETHIOPIA 2014 A pharmaceutical product is called “orphan drug” when, although promising or clearly valid from a Scientific and therapeutic point of view, but it is not profit – bearing and therefore, not interesting for the pharmaceutical … March 6, 2019 non-categorized LIST OF MEDICINES FOR RURAL DRUG VENDOR 2011 Download LIST_OF_MEDICINES_FOR_RURAL_DRUG_VENDOR_2011 File size: 1 MB Downloads: 1101 March 6, 2019 non-categorized List of Medicine for Health Centers It is by far known that medicines are integral components of a health care system. Although there are immense active pharmaceutical entities in the global market, limiting medicines that shall be used within a given … March 6, 2019 non-categorized LIST OF ESSENTIAL MEDICINES FOR ETHIOPIA Provision of promotive, preventive, curative and rehabilitative health services require regular availability of relevant medicines of proven safety, efficacy and quality at an affordable price and their proper use; including proper diagnosis of health problems, … March 6, 2019 non-categorized LDHC Download LDHC File size: 275 B Downloads: 749 March 6, 2019 non-categorized Inspection Manual for Inspectors The government of Ethiopia has been working to strengthen the regulatory system at national level. Providing comprehensive regulation of all matters related to safety and quality of pharmaceutical products is crucial. The regulation of medicines … March 6, 2019 non-categorized Health Institution Promotion እያደገ ከመጣው የጤና ተቋም አገልግሎት ጋር በተያያዘ የማስተዋወቅ ተግባር በማናቸውም መንገድ የሚተላለፍበት ሁኔታ ደረጃውን ባልጠበቀ የጤና አገልግሎት እንዲሁም ሙያዊ ስነ ምግባርን ባላከበረ ማስተዋወቅ ምክንያት ሊደርስ የሚችለውን የጤና ችግር መግታት አስፈላጊ በመሆኑ፤ የጤና ተቋም አገልግሎት ማስታወቂያ … March 6, 2019 non-categorized Handbook on Substance Abuse For Trainers March 6, 2019 non-categorized Guidelines For Registration Of Medical Devices or Supplies Medical supplies such as surgical dressings, surgical ligatures and sutures are standardized in many pharmacopeias and other monographs. The provisions of the medical supplies acts of many countries stipulate that this category of products comply … March 6, 2019 non-categorized Guideline For Drug Information Center Rational use of drugs requires access to objective drug information. Health professionals need a good understanding of the therapeutic action, the possible hazards and the cost of drugs they prescribe; the publics need to know … March 6, 2019 non-categorized Good prescribing manual for Ethiopia new 2 Drugs are an essential component of health care delivery. When used rationally, they produce the desired effect of improving patients ailments. Their irrational use on the hand leads to prolongation of the illness, development of … March 6, 2019 non-categorized Good Dispensing manual new 2 Good dispensing of drugs and medical supplies is an important component of rational drug therapy in order to maximize the benefit and minimize the risk to recipients. However, the prevailing dispensing practices in Ethiopia are … March 4, 2019 non-categorized GCP Guideline Download GCP Guideline File size: 568 KB Downloads: 5349 March 4, 2019 clinical-trials Finalized_Promotion_Control_guideline_2nd_Edition Download Finalized_Promotion_Control_guideline_2nd_Edition File size: 286 KB Downloads: 1551 March 4, 2019 non-categorized EXECUTIVE SUMMARY GATS Ethiopia Oct 20 2017 Tobacco use is a major preventable cause of premature death and disease worldwide (1). Globally, more than 7 million people die each year from tobacco-related illnesses (more than 6 million from direct tobacco use and … March 4, 2019 non-categorized Ethiopia Tobacco Control Strategic Plan The Ethiopian Food, Medicine and Health Care Administration and Control Authority (FMHACA) would like to acknowledge Ethiopia’s National Tobacco Control Coordinating Committee for developing this multi-sectoral strategic plan on tobacco control. The Authority also acknowledges … March 4, 2019 non-categorized Ethiopia_National Drug Control Master Plan 2017 Ethiopia has ratified the international drug control conventions, namely the Single Convention on Narcotic Drugs of 1961, as amended by the 197 Protocol; The Convention on Psychotropic Substances of 1971; and the Convention against illicit … March 4, 2019 non-categorized Ethiopia GATS FactSheet Aug 2017 The Global Adult Tobacco Survey (GATS) is a global standard for systematically monitoring adult tobacco use (smoking and smokeless) and tracking key tobacco control indicators. GATS is a nationally representative survey, using a consistent … March 4, 2019 non-categorized DIB_V5_issue2_new The rapid increase in the number of drugs used to treat HIV requires that physicians keep up-to date with the latest developments and the potential interactions these drugs may have with drugs used to treat … March 4, 2019 non-categorized Citizen Charter ይህ የዜጎች ቻርተር ሰነድ ባለስልጣን መስሪያቤታችን በአዋጅ ቁጥር 661/2002 በተሰጠው ስልጣንና ተግባር መሰረት ለተገልጋዮቻችንና ለህብረተሰቡ የምንሰጣቸው አገልግሎቶች ዝርዝር፣ የአገልግሎት መስጫ ቦታዎች፣ አገልግሎቱ ለመስጠት ተገልጋዮቻችን ማJላት ያለባቸው መስፈርቶችና አገልግሎቱ ለመስጠት የሚፈጀው ጊዜ እንዲሁምበገባነው ቃል መሰረት ለተገልጋዮቻችንአገልግሎቱ … March 4, 2019 non-categorized Bulletin_2007_Issue_1 In our effort to get abreast with the latest information and knowledge on drugs and diseases of concern, the first issue of volume 5 has paid much attention on: HIV and the chronic hepatitis viruses … March 4, 2019 non-categorized Bulletin_2006_Issue_3 In our effort to get abreast with the latest information and knowledge on drugs and diseases of concern, the third issue of 2006 has paid much attention on: Malaria and HIV interaction Coartemether-the new highly … March 4, 2019 non-categorized Bulletin_2006_Issue_2 This is the second issue of the bulletin for the year 2006. Several topical issues that are of current relevance and importance are hereby brought to our readers attention .We certainly hoped that the information … March 4, 2019 non-categorized ART Study In collaboration with national AIDS control programs and other relevant programs, groups from the International Network for Rational Use of Drugs (INRUD) conducted a survey in five East African countries— Ethiopia, Kenya, Rwanda, Tanzania, and … March 4, 2019 non-categorized AMR Baseline Survey Emergence of antimicrobial resistance is a result of the use, overuse and misuse of antibiotics both in humans and animals. In Ethiopia, there are indications on the misuse of antibiotics by health care providers’, unskilled … March 4, 2019 non-categorized Allergy_card_scan March 4, 2019 non-categorized Adverse Drug Event Reporting Form Food, Medicine and Health Care Administration and Control Authority of Ethiopia (FMHACA) Adverse Drug Event reporting form Patient Name (abbreviation) ———————— Card No —————— Age, Date of birth —————– Sex ———- Weight ————– Height ——————— … March 4, 2019 non-categorized ADR_Study Spontaneous reporting is the voluntary reporting of an adverse reaction by a physician, pharmacist and other health professionals or a patient with the main objective being able to provide signals about potentially serious, previously unknown … March 4, 2019 non-categorized 4th_LMDS_List_for_Drug_Shop Pharmacotherapy has always been an integral part of healthcare system and will remain so in the future. This relies on the availability of safe, effective and affordable medicines with the required quality, in reasonable amount. … March 4, 2019 non-categorized Rate of service fees regulation no 370 2015 Download Rate of service fees regulation no 370 2015 File size: 23 MB Downloads: 10891 February 26, 2019 regulations policies-legislation-and-regulation Food Medicine and Healthcare Administration and Control Councils of Ministers Regulation No 299 2013 Download Food Medicine and Healthcare Administration and Control Councils of Ministers Regulation No 299 2013 File size: 5 MB Downloads: 13142 February 26, 2019 regulations policies-legislation-and-regulation FCTC Ratification proclamation Download FCTC Ratification proclamation File size: 1 MB Downloads: 3638 February 26, 2019 proclamations policies-legislation-and-regulation Guideline for Registration of Medical devices 2014 The Food, Medicine and Health Care Administration and Control Authority (FMHACA) of Ethiopia was established to safeguard the health and safety of patients, users, and other persons by ensuring that manufacturers of medical devices follow … February 26, 2019 medical-device-guidelines Ethiopian Medicines Formulary 2013 This second edition of Ethiopian Medicines Formulary (EMF) has passed intensive works starting from preparation of the draft document by arranging monographs for each medicine to preparing detailed document. It was commented by a national … February 26, 2019 drug-formulary Drug Administration And Control Proclamation No. 176/99 Download et012en File size: 274 KB Downloads: 5909 January 8, 2019 non-categorized National Drug Policy National drug Policy of Ethiopia TGE 1993 January 8, 2019 policies policies-legislation-and-regulation
EFDA
Ethiopian Food and Drug Administration
- Home
- About Us
- News and Events
- Services
- Publications
- Directorates
- Director General
- Medicine Sector Deputy Director General
- Food Sector Deputy Director General
- Medical Device Sector Deputy Director General
- Chief Executive Officer
- Basic Service Executive Officer
- Competence & Human Resource Management Executive Officer
- Information & Technology Executive Officer
- Organizational Change Management Executive Officer
- Procurement & Finance Executive Officer
- Strategic Affair Executive Officer
- Women & Inclusive Social Affair Executive Officer
- Branch Office Head
- COVID19
- Public Information
- Announcement
- Contact
Publications
You are here:
- Home
- Publications