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solution_ Public assessment summary report_Package label Delstrigo 100 mg 300 mg 245 mg film-coated tablets_ Public assessment summary report_Package label-1 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 369 350 የመድኃኒት፣ የህክምና መገልገያና መሳሪያ አስመጪ፣ ጅምላ አከፋፋይና ላኪ መመሪያ 350 2013 347_ከጨርቅ_የተሰራ_የፊት_መሸፈኛ_ጭንብል_አምራች_የብቃት_ማረጋገጫ_የምስክር_ወረቀት_እና_የገበያ_ፍቃድ 350_የመድኃኒት፣_የህክምና_መገልገያና_መሳሪያ_አስመጪ፣_ጅምላ_አከፋፋይና_ላኪ_መመሪያ_350_2013 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 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Voice Newsletter April 2024 EFDA Voice Newsletter April 2024 April 11, 2024 efda-newsletter-amh 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 %e1%8b%a8%e1%88%98%e1%8b%b5%e1%8a%83%e1%8a%92%e1%89%b5-%e1%88%98%e1%88%98%e1%88%aa%e1%8b%ab%e1%8b%8e%e1%89%bd 999 – የመድኃኒት የመልካም አመራረት ሥርዓት ቁጥጥር መመሪያ ቁጥር 999-2016 999 – የመድኃኒት የመልካም አመራረት ሥርዓት ቁጥጥር መመሪያ ቁጥር 999-2016 April 3, 2024 %e1%8b%a8%e1%88%98%e1%8b%b5%e1%8a%83%e1%8a%92%e1%89%b5-%e1%88%98%e1%88%98%e1%88%aa%e1%8b%ab%e1%8b%8e%e1%89%bd Rational Drug Use of insulin Rational Drug Use of insulin April 3, 2024 articles-amh Product Registration Product Registration April 3, 2024 articles-amh Counterfeit Drugs Counterfeit Drugs April 3, 2024 articles-amh Pharmacovigilance newsletter Q 2 Issue 1 Pharmacovigilance newsletter Q 2 Issue 1 March 29, 2024 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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 %e1%8d%96%e1%88%8a%e1%88%b2%e1%8b%8e%e1%89%bd %e1%8d%96%e1%88%8a%e1%88%b2%e1%8b%8e%e1%89%bd%e1%8d%a3-%e1%88%95%e1%8c%8e%e1%89%bd-%e1%8a%a5%e1%8a%93-%e1%8b%b0%e1%8a%95%e1%89%a6%e1%89%bd Guidelines for Software as Medical Devices Guidelines for Software as Medical Devices September 28, 2022 %e1%8b%a8%e1%88%85%e1%8a%ad%e1%88%9d%e1%8a%93-%e1%88%98%e1%88%a3%e1%88%aa%e1%8b%ab%e1%8b%8e%e1%89%bd-%e1%88%98%e1%88%98%e1%88%aa%e1%8b%ab Guidelines for Medical Device Refurbishment Guidelines for Medical Device Refurbishment September 28, 2022 %e1%8b%a8%e1%88%85%e1%8a%ad%e1%88%9d%e1%8a%93-%e1%88%98%e1%88%a3%e1%88%aa%e1%8b%ab%e1%8b%8e%e1%89%bd-%e1%88%98%e1%88%98%e1%88%aa%e1%8b%ab Guidelines for Medical Device Donations 2022 08 29_Guidelines for Medical Device Donations September 16, 2022 %e1%8b%a8%e1%88%85%e1%8a%ad%e1%88%9d%e1%8a%93-%e1%88%98%e1%88%a3%e1%88%aa%e1%8b%ab%e1%8b%8e%e1%89%bd-%e1%88%98%e1%88%98%e1%88%aa%e1%8b%ab Guideline on variation applications to registered vaccines Guideline on variation applications to registered vaccines September 16, 2022 %e1%8b%a8%e1%88%85%e1%8a%ad%e1%88%9d%e1%8a%93-%e1%88%98%e1%88%a3%e1%88%aa%e1%8b%ab%e1%8b%8e%e1%89%bd-%e1%88%98%e1%88%98%e1%88%aa%e1%8b%ab Guideline on variation applications to registered vaccine GUIDELINE ON VARIATION APPLICATIONS TO REGISTERED VACCINES September 6, 2022 %e1%8b%a8%e1%88%98%e1%8b%b5%e1%8a%83%e1%8a%92%e1%89%b5-%e1%8c%8b%e1%8b%ad%e1%8b%b5%e1%88%8b%e1%8b%ad%e1%8a%95 Emergency medicines list Emergency medicines list September 2, 2022 %e1%8b%a8%e1%88%98%e1%8b%b5%e1%8a%83%e1%8a%92%e1%89%b5-%e1%8b%9d%e1%88%ad%e1%8b%9d%e1%88%ad OTC medicines list OTC medicines list September 2, 2022 %e1%8b%a8%e1%88%98%e1%8b%b5%e1%8a%83%e1%8a%92%e1%89%b5-%e1%8b%9d%e1%88%ad%e1%8b%9d%e1%88%ad Guidelines for Medical devices Clinical Investigation Authorization Guidelines for Medical devices Clinical Investigation Authorization July 26, 2022 %e1%8b%a8%e1%88%85%e1%8a%ad%e1%88%9d%e1%8a%93-%e1%88%98%e1%88%a3%e1%88%aa%e1%8b%ab%e1%8b%8e%e1%89%bd-%e1%88%98%e1%88%98%e1%88%aa%e1%8b%ab Medical devices Decommissioning and Disposal Guideline Medical devices Decommissioning and Disposal Guideline July 18, 2022 %e1%8b%a8%e1%88%85%e1%8a%ad%e1%88%9d%e1%8a%93-%e1%88%98%e1%88%a3%e1%88%aa%e1%8b%ab%e1%8b%8e%e1%89%bd-%e1%88%98%e1%88%98%e1%88%aa%e1%8b%ab Medical Devices Recall Guideline Medical Devices Recall Guideline July 18, 2022 %e1%8b%a8%e1%88%85%e1%8a%ad%e1%88%9d%e1%8a%93-%e1%88%98%e1%88%a3%e1%88%aa%e1%8b%ab%e1%8b%8e%e1%89%bd-%e1%88%98%e1%88%98%e1%88%aa%e1%8b%ab Guidelines for Medical Devices GMP Inspection Guidelines for Medical Devices GMP Inspection May 18, 2022 %e1%8b%a8%e1%88%85%e1%8a%ad%e1%88%9d%e1%8a%93-%e1%88%98%e1%88%a3%e1%88%aa%e1%8b%ab%e1%8b%8e%e1%89%bd-%e1%88%98%e1%88%98%e1%88%aa%e1%8b%ab 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-amh Pharmaceutical Products Barcoding Guideline Pharmaceutical Products Barcoding Guideline May 6, 2022 traceability-amh Guidelines for Medical device Labeling Guidelines for Medical device Labeling April 28, 2022 %e1%8b%a8%e1%88%85%e1%8a%ad%e1%88%9d%e1%8a%93-%e1%88%98%e1%88%a3%e1%88%aa%e1%8b%ab%e1%8b%8e%e1%89%bd-%e1%88%98%e1%88%98%e1%88%aa%e1%8b%ab Hemlibra_Emicizumab_ Summary of product characteristics v1 Hemlibra_Emicizumab_ Summary of product characteristics v1 April 6, 2022 public-assessment-report-for-registered-medicinal-products-amh-2 Hemlibra_Emicizumab_ Public assessment summary reportv1 Hemlibra_Emicizumab_ Public assessment summary reportv1 April 6, 2022 public-assessment-report-for-registered-medicinal-products-amh-2 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-amh-2 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-amh-2 የኮቪድ 19 ወረርሽኝ ለመከላከልና ለመቆጣጣር ስለሚወሰዱ ክልከላዎች እና ስለሚጣሉ ግዴታዎች ለመወሰን የወጣ መመሪያ ቁጥር 803 803 የኮቪድ19 ወረርሽኝ ለመከላከልና ለመቆጣጣር ስለሚወሰዱ ክልከላዎች እና ስለሚጣሉ ግዴታዎች ለመወሰን የወጣ መመሪያ ቁጥር 803 March 10, 2022 %e1%8b%a8%e1%88%98%e1%8b%b5%e1%8a%83%e1%8a%92%e1%89%b5-%e1%88%98%e1%88%98%e1%88%aa%e1%8b%ab%e1%8b%8e%e1%89%bd 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 %e1%8b%a8%e1%88%98%e1%8b%b5%e1%8a%83%e1%8a%92%e1%89%b5-%e1%88%98%e1%88%98%e1%88%aa%e1%8b%ab%e1%8b%8e%e1%89%bd 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 %e1%8b%a8%e1%88%85%e1%8a%ad%e1%88%9d%e1%8a%93-%e1%88%98%e1%88%a3%e1%88%aa%e1%8b%ab%e1%8b%8e%e1%89%bd-%e1%88%98%e1%88%98%e1%88%aa%e1%8b%ab %e1%8b%a8%e1%88%98%e1%8b%b5%e1%8a%83%e1%8a%92%e1%89%b5-%e1%88%98%e1%88%98%e1%88%aa%e1%8b%ab%e1%8b%8e%e1%89%bd 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 %e1%8b%a8%e1%88%98%e1%8b%b5%e1%8a%83%e1%8a%92%e1%89%b5-%e1%88%98%e1%88%98%e1%88%aa%e1%8b%ab%e1%8b%8e%e1%89%bd የአልኮል ማስታወቂያና ሽያጭ መመሪያ_372_2013 372_የአልኮል_ማስታወቂያና_ሽያጭ_መመሪያ_372_2013 March 10, 2022 %e1%8b%a8%e1%88%9d%e1%8c%8d%e1%89%a5-%e1%88%98%e1%88%98%e1%88%aa%e1%8b%ab%e1%8b%8e%e1%89%bd 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 %e1%8b%a8%e1%88%98%e1%8b%b5%e1%8a%83%e1%8a%92%e1%89%b5-%e1%88%98%e1%88%98%e1%88%aa%e1%8b%ab%e1%8b%8e%e1%89%bd የምግብ ጨው ቁጥጥር መመሪያ 361-2013 361 የምግብ ጨው ቁጥጥር መመሪያ 361-2013 March 10, 2022 %e1%8b%a8%e1%88%9d%e1%8c%8d%e1%89%a5-%e1%88%98%e1%88%98%e1%88%aa%e1%8b%ab%e1%8b%8e%e1%89%bd የምግብ ላኪ፣ አስመጪና አከፋፋይ ቁጥጥር መመሪያ ቁጥር 357_2013 357 የምግብ ላኪ፣ አስመጪና አከፋፋይ ቁጥጥር መመሪያ ቁጥር 357 2013 March 10, 2022 %e1%8b%a8%e1%88%9d%e1%8c%8d%e1%89%a5-%e1%88%98%e1%88%98%e1%88%aa%e1%8b%ab%e1%8b%8e%e1%89%bd የመድኃኒትና የህክምና መሣሪያ ማስተዋወቅ መመሪያ ቁጥር 253_2013 353 የመድኃኒትና የህክምና መሣሪያ ማስተዋወቅ መመሪያ ቁጥር 253 2013 March 10, 2022 %e1%8b%a8%e1%88%85%e1%8a%ad%e1%88%9d%e1%8a%93-%e1%88%98%e1%88%a3%e1%88%aa%e1%8b%ab%e1%8b%8e%e1%89%bd-%e1%88%98%e1%88%98%e1%88%aa%e1%8b%ab %e1%8b%a8%e1%88%98%e1%8b%b5%e1%8a%83%e1%8a%92%e1%89%b5-%e1%88%98%e1%88%98%e1%88%aa%e1%8b%ab%e1%8b%8e%e1%89%bd የመድኃኒት፣ የህክምና መገልገያና መሳሪያ አስመጪ፣ ጅምላ አከፋፋይና ላኪ መመሪያ 350_2013 350 የመድኃኒት፣ የህክምና መገልገያና መሳሪያ አስመጪ፣ ጅምላ አከፋፋይና ላኪ መመሪያ 350 2013 March 10, 2022 %e1%8b%a8%e1%88%85%e1%8a%ad%e1%88%9d%e1%8a%93-%e1%88%98%e1%88%a3%e1%88%aa%e1%8b%ab%e1%8b%8e%e1%89%bd-%e1%88%98%e1%88%98%e1%88%aa%e1%8b%ab %e1%8b%a8%e1%88%98%e1%8b%b5%e1%8a%83%e1%8a%92%e1%89%b5-%e1%88%98%e1%88%98%e1%88%aa%e1%8b%ab%e1%8b%8e%e1%89%bd የመድኃኒት ችርቻሮ ድርጅቶች ቁጥጥር መመሪያ ቁጥር 349_2013 349 የመድኃኒት ችርቻሮ ድርጅቶች ቁጥጥር መመሪያ ቁጥር 349 2013 March 10, 2022 %e1%8b%a8%e1%88%98%e1%8b%b5%e1%8a%83%e1%8a%92%e1%89%b5-%e1%88%98%e1%88%98%e1%88%aa%e1%8b%ab%e1%8b%8e%e1%89%bd 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 %e1%8b%a8%e1%88%98%e1%8b%b5%e1%8a%83%e1%8a%92%e1%89%b5-%e1%88%98%e1%88%98%e1%88%aa%e1%8b%ab%e1%8b%8e%e1%89%bd አግባባዊ የመድኃኒት አጠቃቀም ቁጥጥር መመሪያ ቁጥር 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12, 2021 %e1%8b%a8%e1%8d%8b%e1%88%ad%e1%88%9b%e1%8a%ae%e1%89%aa%e1%8c%82%e1%88%8b%e1%8a%95%e1%88%b5-%e1%88%98%e1%8d%85%e1%88%84%e1%89%b5 %e1%88%98%e1%8c%bd%e1%88%94%e1%89%b6%e1%89%bd%e1%8a%93-%e1%8a%a5%e1%8a%93-%e1%89%a0%e1%88%ab%e1%88%a8-%e1%8c%bd%e1%88%91%e1%8d%8e%e1%89%bd Covid-19 vaccine AEFI Reporting Form Covid-19 vaccine AEFI Reporting Form March 12, 2021 %e1%8b%a8%e1%8d%8b%e1%88%ad%e1%88%9b%e1%8a%ae%e1%89%aa%e1%8c%82%e1%88%8b%e1%8a%95%e1%88%b5-%e1%88%98%e1%8d%85%e1%88%84%e1%89%b5 %e1%88%98%e1%8c%bd%e1%88%94%e1%89%b6%e1%89%bd%e1%8a%93-%e1%8a%a5%e1%8a%93-%e1%89%a0%e1%88%ab%e1%88%a8-%e1%8c%bd%e1%88%91%e1%8d%8e%e1%89%bd Guideline for Registration of Antiseptics and Disinfectants Guideline for Registration of Antiseptics and Disinfectants March 6, 2021 %e1%8b%a8%e1%88%98%e1%8b%b5%e1%8a%83%e1%8a%92%e1%89%b5-%e1%8c%8b%e1%8b%ad%e1%8b%b5%e1%88%8b%e1%8b%ad%e1%8a%95 EFDA_Guidelines for IVD Registration Requirements EFDA_Guidelines for IVD Registration Requirements February 19, 2021 %e1%8b%a8%e1%88%85%e1%8a%ad%e1%88%9d%e1%8a%93-%e1%88%98%e1%88%a3%e1%88%aa%e1%8b%ab%e1%8b%8e%e1%89%bd-%e1%88%98%e1%88%98%e1%88%aa%e1%8b%ab EFDA_Guidelines for Non-IVD Registration Requirements EFDA_Guidelines for Non-IVD Registration Requirements February 19, 2021 %e1%8b%a8%e1%88%85%e1%8a%ad%e1%88%9d%e1%8a%93-%e1%88%98%e1%88%a3%e1%88%aa%e1%8b%ab%e1%8b%8e%e1%89%bd-%e1%88%98%e1%88%98%e1%88%aa%e1%8b%ab Guideline for COVID-19 Vaccine donation Guideline for COVID-19 Vaccine donation February 15, 2021 %e1%8b%a8%e1%88%98%e1%8b%b5%e1%8a%83%e1%8a%92%e1%89%b5-%e1%8c%8b%e1%8b%ad%e1%8b%b5%e1%88%8b%e1%8b%ad%e1%8a%95 Guidance for Emergency Use Authorization of COVID-19 Vaccine Guidance for Emergency Use Authorization of COVID-19 Vaccine January 29, 2021 %e1%8b%a8%e1%88%98%e1%8b%b5%e1%8a%83%e1%8a%92%e1%89%b5-%e1%8c%8b%e1%8b%ad%e1%8b%b5%e1%88%8b%e1%8b%ad%e1%8a%95 Guideline for Conditional Approval of Medicines Guideline for Conditional Approval of Medicines January 29, 2021 %e1%8b%a8%e1%88%98%e1%8b%b5%e1%8a%83%e1%8a%92%e1%89%b5-%e1%8c%8b%e1%8b%ad%e1%8b%b5%e1%88%8b%e1%8b%ad%e1%8a%95 Pharmaceutical Products Traceability Directive Pharmaceutical Products Traceability Directive January 13, 2021 traceability-amh Pharmacovigilance Directive Amharic 2020 Pharmacovigilance Directive Amharic 2020 December 30, 2020 %e1%8b%a8%e1%88%98%e1%8b%b5%e1%8a%83%e1%8a%92%e1%89%b5-%e1%88%98%e1%88%98%e1%88%aa%e1%8b%ab%e1%8b%8e%e1%89%bd %e1%8b%a8%e1%8d%8b%e1%88%ad%e1%88%9b%e1%8a%ae%e1%89%aa%e1%8c%82%e1%88%8b%e1%8a%95%e1%88%b5-%e1%88%98%e1%8d%85%e1%88%84%e1%89%b5 %e1%88%98%e1%8c%bd%e1%88%94%e1%89%b6%e1%89%bd%e1%8a%93-%e1%8a%a5%e1%8a%93-%e1%89%a0%e1%88%ab%e1%88%a8-%e1%8c%bd%e1%88%91%e1%8d%8e%e1%89%bd Guideline for Conditional approval of medicines 2020 Guideline for Conditional approval of medicines 2020 December 16, 2020 %e1%8b%a8%e1%88%98%e1%8b%b5%e1%8a%83%e1%8a%92%e1%89%b5-%e1%8c%8b%e1%8b%ad%e1%8b%b5%e1%88%8b%e1%8b%ad%e1%8a%95 ETHIOPIAN ESSENTIAL MEDICINES LIST SIXTH EDITION 2020 EML sixth edition December 9, 2020 Supplementary guideline for Clinical trial Authorization 2020 Supplementary guideline for Clinical trial Authorization 2020 November 9, 2020 %e1%8b%a8%e1%88%98%e1%8b%b5%e1%8a%83%e1%8a%92%e1%89%b5-%e1%8c%8b%e1%8b%ad%e1%8b%b5%e1%88%8b%e1%8b%ad%e1%8a%95 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 %e1%8b%a8%e1%88%98%e1%8b%b5%e1%8a%83%e1%8a%92%e1%89%b5-%e1%8c%8b%e1%8b%ad%e1%8b%b5%e1%88%8b%e1%8b%ad%e1%8a%95 Good Review Practices (GRevPs) Guideline Good Review Practices (GRevPs) Guideline October 1, 2020 %e1%8b%a8%e1%88%98%e1%8b%b5%e1%8a%83%e1%8a%92%e1%89%b5-%e1%8c%8b%e1%8b%ad%e1%8b%b5%e1%88%8b%e1%8b%ad%e1%8a%95 Guideline for Registration of Low-risk Medicines Guideline for Registration of Low-risk Medicines October 1, 2020 %e1%8b%a8%e1%88%98%e1%8b%b5%e1%8a%83%e1%8a%92%e1%89%b5-%e1%8c%8b%e1%8b%ad%e1%8b%b5%e1%88%8b%e1%8b%ad%e1%8a%95 Risk-based Guideline for Post-Marketing Quality Surveillance PMS Guideline 2020 September 25, 2020 %e1%8b%a8%e1%88%98%e1%8b%b5%e1%8a%83%e1%8a%92%e1%89%b5-%e1%8c%8b%e1%8b%ad%e1%8b%b5%e1%88%8b%e1%8b%ad%e1%8a%95 RDU Directive RDU Directive September 23, 2020 %e1%8b%a8%e1%88%98%e1%8b%b5%e1%8a%83%e1%8a%92%e1%89%b5-%e1%88%98%e1%88%98%e1%88%aa%e1%8b%ab%e1%8b%8e%e1%89%bd Food Consignment Technical guideline Food Consignment Technical guideline September 22, 2020 food-guidelines-amh Good Review Practices (GRevPs) Guideline August 25, 2020 %e1%8b%a8%e1%88%98%e1%8b%b5%e1%8a%83%e1%8a%92%e1%89%b5-%e1%88%98%e1%88%98%e1%88%aa%e1%8b%ab%e1%8b%8e%e1%89%bd Guideline for Registration of Low-Risk Medicines August 25, 2020 %e1%8b%a8%e1%88%98%e1%8b%b5%e1%8a%83%e1%8a%92%e1%89%b5-%e1%8c%8b%e1%8b%ad%e1%8b%b5%e1%88%8b%e1%8b%ad%e1%8a%95 PV Newsletter V7 ISSUE 2 Feb 2020 Pharmacovigilance newsletter No 2 2012 July 8, 2020 %e1%8b%a8%e1%8d%8b%e1%88%ad%e1%88%9b%e1%8a%ae%e1%89%aa%e1%8c%82%e1%88%8b%e1%8a%95%e1%88%b5-%e1%88%98%e1%8d%85%e1%88%84%e1%89%b5 %e1%88%98%e1%8c%bd%e1%88%94%e1%89%b6%e1%89%bd%e1%8a%93-%e1%8a%a5%e1%8a%93-%e1%89%a0%e1%88%ab%e1%88%a8-%e1%8c%bd%e1%88%91%e1%8d%8e%e1%89%bd PV Newsletter V7 Issue 1 Oct 2019 Pharmacovigilance newsletter No 2 2012 July 8, 2020 %e1%8b%a8%e1%8d%8b%e1%88%ad%e1%88%9b%e1%8a%ae%e1%89%aa%e1%8c%82%e1%88%8b%e1%8a%95%e1%88%b5-%e1%88%98%e1%8d%85%e1%88%84%e1%89%b5 %e1%88%98%e1%8c%bd%e1%88%94%e1%89%b6%e1%89%bd%e1%8a%93-%e1%8a%a5%e1%8a%93-%e1%89%a0%e1%88%ab%e1%88%a8-%e1%8c%bd%e1%88%91%e1%8d%8e%e1%89%bd Annexes to cosmetic product manufacturing Directive No. 49/2020 Annexes to cosmetic product manufacturing Directive No. 49 2020 June 17, 2020 %e1%8b%a8%e1%8a%ae%e1%88%b5%e1%88%9e%e1%89%b2%e1%8a%ad%e1%88%b5-%e1%88%98%e1%88%98%e1%88%aa%e1%8b%ab%e1%8b%8e%e1%89%bd Cosmetic manufacturer Directive 2020 Cosmetic manufacturer Directive 2020 June 17, 2020 %e1%8b%a8%e1%8a%ae%e1%88%b5%e1%88%9e%e1%89%b2%e1%8a%ad%e1%88%b5-%e1%88%98%e1%88%98%e1%88%aa%e1%8b%ab%e1%8b%8e%e1%89%bd Food and Medicine Administration Proclamation No.1112/2019 Food and Medicine Administration Proclamation 1112 June 10, 2020 %e1%8a%a0%e1%8b%8b%e1%8c%85 %e1%8d%96%e1%88%8a%e1%88%b2%e1%8b%8e%e1%89%bd%e1%8d%a3-%e1%88%95%e1%8c%8e%e1%89%bd-%e1%8a%a5%e1%8a%93-%e1%8b%b0%e1%8a%95%e1%89%a6%e1%89%bd Internal quality Food import export Internal quality Food import export June 5, 2020 %e1%8b%a8%e1%88%9d%e1%8c%8d%e1%89%a5-%e1%88%98%e1%88%98%e1%88%aa%e1%8b%ab%e1%8b%8e%e1%89%bd Traditional Medicine Guidance Traditional Medicine Guidance May 26, 2020 %e1%8b%a8%e1%88%98%e1%8b%b5%e1%8a%83%e1%8a%92%e1%89%b5-%e1%8c%8b%e1%8b%ad%e1%8b%b5%e1%88%8b%e1%8b%ad%e1%8a%95 Cloth Mask Directive Cloth Mask Directive May 14, 2020 የኮሮና ቫይረስ ግብአት አምራች፣ አስመጪና አከፋፋይ ድርጅት የብቃት ማረጋገጫ የምስክር ወረቀት አሰጣጥ ጊዜያዊ መመርያ Temporary Licensing Procedures April 13, 2020 ለኮሮና ቫይረስ ወረርሽኝ የሚውሉ ግብዓቶችን ወደ ሀገር ውስጥ ስለማስገባት የወጣ ጊዜያዊ የአሰራር መመርያ Import Covid Directive 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 %e1%8b%a8%e1%8a%ae%e1%88%b5%e1%88%9e%e1%89%b2%e1%8a%ad%e1%88%b5-%e1%88%98%e1%88%98%e1%88%aa%e1%8b%ab%e1%8b%8e%e1%89%bd 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 %e1%8b%a8%e1%8a%ae%e1%88%b5%e1%88%9e%e1%89%b2%e1%8a%ad%e1%88%b5-%e1%88%98%e1%88%98%e1%88%aa%e1%8b%ab%e1%8b%8e%e1%89%bd 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 %e1%8b%a8%e1%88%98%e1%8b%b5%e1%8a%83%e1%8a%92%e1%89%b5-%e1%88%98%e1%88%98%e1%88%aa%e1%8b%ab%e1%8b%8e%e1%89%bd Rational Medicine Use Directive 2019 Rational Medicine Use Directive 2019 July 5, 2019 %e1%8b%a8%e1%88%98%e1%8b%b5%e1%8a%83%e1%8a%92%e1%89%b5-%e1%88%98%e1%88%98%e1%88%aa%e1%8b%ab%e1%8b%8e%e1%89%bd Food registration directive 2019 Food registration directive 2019 July 5, 2019 %e1%8b%a8%e1%88%9d%e1%8c%8d%e1%89%a5-%e1%88%98%e1%88%98%e1%88%aa%e1%8b%ab%e1%8b%8e%e1%89%bd Alcohol Advertisement and Labeling Control Directive No 41/2019 Alcohol-Advertisement ald Labeling Control Directive No 41 2019 June 18, 2019 Tobacco Control Directive English version March 2015 WHEREAS, tobacco products have serious health, social, economic and environmental consequences; WHEREAS, tobacco consumption has been scientifically confirmed to cause serious ailments including cancer, respiratory disease, cardiac and blood vessel diseases; disability as well as … April 19, 2019 National Drug Policy …….Based on economic development and the living standard of its people Ethiopia is considered to be one of the least developed countries. Although the fundamental cause for this is the backward socio-economic system which prevailed … April 8, 2019 %e1%8d%96%e1%88%8a%e1%88%b2%e1%8b%8e%e1%89%bd %e1%8d%96%e1%88%8a%e1%88%b2%e1%8b%8e%e1%89%bd%e1%8d%a3-%e1%88%95%e1%8c%8e%e1%89%bd-%e1%8a%a5%e1%8a%93-%e1%8b%b0%e1%8a%95%e1%89%a6%e1%89%bd 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 traceability-amh GCP Guideline March 4, 2019 clinical-trials-amh Clinical Trial Authorization Guideline March 4, 2019 clinical-trials-amh Drug Administration And Control Proclamation No. 176/99 January 8, 2019 non-categorized-amh
EFDA
Ethiopian Food and Drug Administration
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