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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 Guideline for Emergency use Authorization of Medicines for Public Emergency Situations 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 338_Pharmaceutical_Manufacturer_GMP_Inspection_Directive_No_338 335_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 Medicine Good Manufacturing Practice (GMP) Inspection Procedure Directive 830 2021 Guideline for Classification of In Vitro Diagnostic Medical Devices_EFDA Guideline for Classification of 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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 AEFI-Surviellance & response of AEFI guideline-3rd edition AEFI-Surviellance & response of AEFI guideline-3rd edition October 21, 2022 pharmacovigilance AEFI-Surviellance & response of AEFI guideline-3rd edition AEFI-Surviellance & response of AEFI guideline-3rd edition October 19, 2022 pharmacovigilance-newsletter bulletin-and-newsletter 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 Guideline on variation applications to registered vaccines Guideline on variation applications to registered vaccines 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 Pharmaceutical Manufacturer GMP Inspection Directive No 338 338 Pharmaceutical Manufacturer GMP Inspection Directive No 338 March 10, 2022 medicine-directives 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 Guideline for Registration of Medicines 2020 Guideline for Registration of Medicines 2020 September 13, 2021 medicine-guidelines የመድኃኒት የመልካም አመራረት ስርዓት ቁጥጥር አሰራር መመሪያ 830 2013 የመድኃኒት የመልካም አመራረት ስርዓት ቁጥጥር አሰራር መመሪያ 830 2013 September 13, 2021 medicine-directives Medicine Good Manufacturing Practice (GMP) Inspection Procedure Directive 830 2021 Medicine Good Manufacturing Practice (GMP) Inspection Procedure Directive 830 2021 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 Guidance on waiver of in vivo bioequivalence requirements Guidance on waiver of in vivo bioequivalence requirements July 14, 2021 medicine-guidelines Guideline on variation applications to registered medicines Guideline on variation applications to registered medicines July 14, 2021 medicine-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 Guideline for Registration of Antiseptics and Disinfectants Guideline for Registration of Antiseptics and Disinfectants March 6, 2021 medicine-guidelines 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 Guideline for Conditional Approval of Medicines Guideline for Conditional Approval of Medicines January 29, 2021 medicine-guidelines ETHIOPIAN ESSENTIAL MEDICINES LIST SIXTH EDITION 2020 EML sixth edition December 9, 2020 drug-lists ETHIOPIAN ESSENTIAL MEDICINES LIST SIXTH EDITION 2020 EML sixth edition December 9, 2020 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 oral care skin care products with therapeutic claim Guideline for Registration of oral care skin care products with therapeutic claim October 9, 2020 medicine-guidelines Good Review Practices (GRevPs) Guideline Good Review Practices (GRevPs) Guideline October 1, 2020 medicine-guidelines Guideline for WHO Pre-qualified Medicines through Collaborative Registration Procedure Guideline for WHO Pre-qualified Medicines through Collaborative Registration Procedure October 1, 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: 690 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: 1824 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: 1553 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: 1368 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: 796 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: 577 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 on evaluation of similar bio-therapeutics The Ethiopian Food, Medicine and Healthcare Administration and Control Authority is mandated by the proclamation No . 661/2009 to ensure the safety, quality and efficacy of medicines. Biotherapeutics are pharmaceutical products that fall in this … March 6, 2019 non-categorized GUIDELINES FOR SUBMISSION OF POST-APPROVAL VARIATION MEDICINE APPLICATIONS 2015 The Food, Medicine and Health Care Administration and Control Authority (FMHACA) of Ethiopia was established to protect the public health from unsafe, inefficacious and poor quality medicines by insuring effective and efficient pre and post … 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 Guidelines for Registration of Bio-therapeutic Protein Products The Ethiopian Food, Medicine and Healthcare Administration and Control Authority is mandated by the proclamation No . 661/2009 to ensure the safety, quality and efficacy of medicines. Biotherapeutic protein products prepared by recombinant deoxyribonucleic acid … 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 GMP Guideliens This guideline is intended to help manufacturers implementing modern quality systems and risk management approaches to meet the requirements of quality products to ensure their intended purpose and to protect the public health. The requirement … March 4, 2019 non-categorized GCP Guideline Download GCP Guideline File size: 568 KB Downloads: 4586 March 4, 2019 clinical-trials Finalized_Promotion_Control_guideline_2nd_Edition Download Finalized_Promotion_Control_guideline_2nd_Edition File size: 286 KB Downloads: 1022 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 Ethiopian Pharma co-vigilance Guideline 2014 Medicines are one of the most essential components in the health care system. This indisputable fact makes rational selection, procurement, distribution, and use of medicines of paramount importance in health care. Worldwide, numerous numbers of … 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 Medicines Market Authorization Strategy 2017 Ethiopia has been putting tremendous efforts in implementing the National Medicine Policy (1993) and Health Sector Development Programme (HSDP) since the last two decades. During this period, our country has made huge strides to improve … February 26, 2019 strategies Rate of service fees regulation no 370 2015 Download Rate of service fees regulation no 370 2015 File size: 23 MB Downloads: 8617 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: 11429 February 26, 2019 regulations policies-legislation-and-regulation FCTC Ratification proclamation Download FCTC Ratification proclamation File size: 1 MB Downloads: 3032 February 26, 2019 proclamations policies-legislation-and-regulation Guideline for Registration of Vaccine The Ethiopian Food, Medicine and Healthcare Administration and Control Authority is mandated by the proclamation N o . 661/2009 to ensure the safety, quality and efficacy of medicines. Vaccines are pharmaceutical products that fall in … February 26, 2019 medicine-guidelines 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: 5515 January 8, 2019 non-categorized National Drug Policy National drug Policy of Ethiopia TGE 1993 January 8, 2019 policies policies-legislation-and-regulation
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