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Ethiopian Food and Drug Administration Guidelines

Here are Some EFDA guidelines

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0% found this document useful (0 votes)
569 views19 pages

Ethiopian Food and Drug Administration Guidelines

Here are Some EFDA guidelines

Uploaded by

aragawtesfa123
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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 Home  About Us  News and Events  Services  Publications  Directorates COVID19

Public Information  Announcement  Contact

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Title Date

 2024.03.01 Guideline for Registration of Medicine June 14, 2024

 2023.09.06 Guideline-for-WHO-Pre-qualified-Medicines-through- June 14, 2024


Collaborative-Registration-Procedure-

 2023.12.20 GUIDELINE FOR NON-ROUTINE REGISTRATION June 14, 2024

 2023.11.02 Guideline on Variation Application to Registered Medicines June 14, 2024

 2023.12.22 Guidelines on Reliance for Regulatory Decision Making June 14, 2024

 2023.12.21 Guideline on Medical Products Special import permit June 14, 2024

 2024.01.11 Guideline for control of advertising and promotion June 14, 2024

 2024.01.19 Guidance for Registration of Radiopharmaceuticals June 14, 2024

 2024.01.19 Guideline of Medicinal Gases Registration June 14, 2024

 2024.01.20 Guideline for Medicinal product information June 14, 2024

 2024.01.20 Guideline for preparation and publication of public June 12, 2024
assessment reports

 2024.01.20 Guideline for Renewal of MA June 12, 2024

 2024.01.29 Guideline on Variation Applications to Registered Vaccines June 12, 2024 ERROR fo

Invalid do

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Title Date

 2024.01.31 Guidelines for Conditional Approval June 12, 2024

 2024.01.31.Guideline-for-Registration-of-Antiseptics-and-Disinfectants June 12, 2024

 2024.01.31.Guideline-for-Registration-of-oral-care-skin-care-products- June 12, 2024


with-therapeutic-claim

 2024.02.27 Guidance-on-waiver-of-in-vivo-bioequivalence-requirements June 12, 2024

 2024.04.16 Good RevPractice Guideline June 12, 2024

 2024.01.13 Guideline for describing the role and responsibilities of MA June 12, 2024

 2024.01.30 Guidelines for Registration of Biotherapeutic Proteint June 12, 2024


Products

 2024.01.29 Guideline-for-Registration-of-Vaccine June 12, 2024

 2024.01.30 Guidelines on evaluation of similar biotherapeutics June 12, 2024

 1003- ማብራሪያ – የትንባሆ ምርት አወጋገድ መመሪያ ቁጥር 1003-2016 Description May 31, 2024
TOBACCO PRODUCTS DISPOSAL DIRECTIVE 1003-2016

 TOBACCO PRODUCTS DISPOSAL DIRECTIVE 1003-2016 May 31, 2024

 Pharmacovigilance newsletter Q 3 Issue 1_Final__2024 May 31, 2024

 Ethiopian National Tobacco Control Strategic Plan From 2023 – 2031 May 27, 2024

 Sinopharm Covid 19 vaccine active surveillance report April 16, 2024

 EFDA Voice Newsletter April 2024 April 11, 2024

 1000 – የመድኃኒት ማምረቻ ተቋማት የብቃት ማረጋገጫ አሰጣጥ እና ቁጥጥር መመሪያ ቁጥር April 3, 2024
1000-2016

 999 – የመድኃኒት የመልካም አመራረት ሥርዓት ቁጥጥር መመሪያ ቁጥር 999-2016 April 3, 2024

 Rational Drug Use of insulin April 3, 2024

 Rational Drug Use 2 April 3, 2024

 Product Registration April 3, 2024

 Jimma Branch April 3, 2024

 Counterfeit Drugs April 3, 2024



https://t.me/pharmacyh
Title Date

 Pharmacovigilance newsletter Q 2 Issue 1 March 29, 2024

 Guideline on Variation Applications to Registered Vaccines March 26, 2024

 Guideline of Medicinal Gases Registration March 26, 2024

 Guideline for Renewal of MA March 26, 2024

 Guideline for preparation and publication of public assessment reports March 26, 2024

 Guideline for Non-Routine registration March 26, 2024

 Guideline for Medicinal product information March 26, 2024

 Guideline for describing the role and responsibilities of MA March 26, 2024

 Guidance on waiver of in vivo bioequivalence requirements March 26, 2024

 Guidance for Registration of Radiopharmaceuticals March 26, 2024

 Good RevPractice Guideline March 26, 2024

 Guidelines for Conditional Approval March 26, 2024

 Guideline for Registration of oral care skin care products with therapeutic March 26, 2024
claim

 Guideline-for-Registration-of-Antiseptics-and-Disinfectants March 26, 2024

 Guideline Variation Application to Registered Medicines March 26, 2024

 EFDA Voice Newsletter December 2023 January 16, 2024

 Traditional medicine January 15, 2024

 Tobacco January 15, 2024

 Tobacco control Addis Ababa 3 January 15, 2024

 Tobacco control Addis Ababa 2 January 15, 2024

 Tobacco control Addis Ababa 1 January 15, 2024

 Self medication January 15, 2024

 Seeding trees January 15, 2024

 Press conference January 15, 2024 


https://t.me/pharmacyh
Title Date

 Prescription and non- prescription drug January 15, 2024

 Pharmacovigilance January 15, 2024

 Milk safety January 15, 2024

 Iodized salt January 15, 2024

 Good Dispensing practice January 15, 2024

 Food Adulteration January 15, 2024

 ERIS January 15, 2024

 Anti-microbial resistance January 15, 2024

 Clinical Trial Application Form November 30,


2023

 Routine Clinical Trial Application screening form November 30,


2023

 Non routine clinical trial application screening form November 30,


2023

 Clinical Trial Authorization Guideline (4th edition) October 31, 2023

 EFDA Voice Newsletter September 2023 October 3, 2023

 Overview of barcode use for pharmaceutical products in Ethiopia July 25, 2023

 Identification and Labeling of Pharmaceutical Products with barcode July 25, 2023

 Tenofovir alafenamide fumarate 25 mg _Vemlidy_Gilead Sciences, Inc July 12, 2023

 Sofosbuvir 400 mg and Velpatasvir 100 mg_Epclusa_Gilead Sciences, Inc July 12, 2023

 Emtricitabine and Tenofovir alafenamide fumarate_Descovy 200 mg-25 July 12, 2023
mg _Gilead Sciences, Inc

 Emtricitabine and Tenofovir alafenamide fumarate_Descovy 200 mg-10 July 12, 2023
mg _Gilead Sciences, Inc

 Artemether injection 80 mg_KPC Pharmaceuticals, Inc_SmPC July 12, 2023

 Artemether injection 40 mg_KPC Pharmaceuticals, Inc_SmPC July 12, 2023



https://t.me/pharmacyh
Title Date

 Artemether 20 mg and Lumefantrine 120 mg tablet_Comether_KPC July 12, 2023


Pharmaceuticals, Inc

 Amphotericin B 50mg _AmBisome_Gilead Sciences, Inc. July 12, 2023

 List of Medicines for Community Pharmacy June 9, 2023

 List of Medicines for Drug Shop June 9, 2023

 CEM-ART drugs-2016-2021 June 8, 2023

 A blueprint for strengthening pharmacovigilance systems in resource June 8, 2023


limited countries

 Prevalence, Intensity, and Correlates of Schistosomiasis and Soil- June 8, 2023


Transmitted Helminth Infections after Five Rounds of Preventive
Chemotherapy among School Children in Southern Ethiopia

 Clinical Trial Authorization Guideline June 8, 2023

 Guideline on Medical Products Special import permit June 8, 2023

 Health Policy June 7, 2023

 Guidelines for Registration of Similar Biotherapeutic Products (SBPs) June 7, 2023

 Guidelines for Registration of Biotherapeutic Protein Products June 7, 2023

 Clinical Trial application processing flow diagram June 7, 2023

 List of recalled medicines and medical devices June 7, 2023

 Medicines Waste Management Disposal Directive June 7, 2023

 Report of Pfizer vaccine AEFI in July 2022 June 6, 2023

 Janssen AEFI Active surveillance June 6, 2023

 Efficacy and safety of praziquantel preventive chemotherapy in June 6, 2023


Schistosoma mansoni infected school children in Southern Ethiopia A
prospective cohort study

 COVISHIELD vaccine report June 6, 2023

 Comparative Assessment of the National Pharmacovigilance Systems June 6, 2023

 Baseline assessment of pharmacovigilance June 6, 2023



Title Date

 Adverse Drug Events Reported on DTG June 6, 2023

 ADE-aDSM-Preliminary EFDA June 6, 2023

 MQCD ISO/IEC 17025:2017 June 6, 2023

 Definition of Powers and Duties of the Executive Organs Proclamation June 5, 2023
No. 1263-2021

 Medicine and Medical Device Import, Export and Wholesale Control June 5, 2023
Directive 872-2022

 SUMMARY OF PRODUCT CHARACTERISTICS TEMPLATE FOR Applicants June 5, 2023

 PATIENT INFORMATION LEAFLET (PIL)TEMPLATE FOR Applicants June 5, 2023

 AEFI SURVEILLANCE COURSE FOR HEALTH PROFESSIONALS June 5, 2023

 PV Trainer Guide May 2022 June 5, 2023

 AEFI Training Manual for HCP-EFDA June 5, 2023

 PV Training for Healthcare Professionals Participant’s Manual 2022 June 5, 2023

 list of GCP Inspectors June 4, 2023

 List of GMP inspectors June 4, 2023

 List of pharmaceutical Importer and Wholesaler inspector June 4, 2023

 Guidelines for Consumer Reporting of Side effects of medicines June 4, 2023

 National Pharmacovigilance Guideline June 4, 2023

 TB PV guideline June 2, 2023

 HIV PV guideline June 2, 2023

 Antimalarial PV guideline June 2, 2023

 NTD PV guideline June 2, 2023

 NCD PV guideline June 2, 2023

 EFDA Vaccine Safety Risk and Crisis Communication Guideline June 2, 2023

 EFDA GMP Guideline for pharmaceutical products second edition June 2, 2023

Title Date

 EFDA Voice Newsletter May 2023 May 24, 2023

 EFDA Voice Newsletter December 2022 May 24, 2023

 EFDA Voice Newsletter August 2022 May 24, 2023

 EFDA Voice Newsletter April 2022 May 24, 2023

 GUIDELINE FOR PREPARATION AND PUBLICATION OF PUBLIC May 23, 2023


ASSESSMENT REPORTS FOR APPROVED MEDICINES

 Brochure Results on ADR Reports on DTG containing ARV regimens May 23, 2023

 Magnesium sulfate-Kalceks 500 mg per ml solution for injection_ Public May 17, 2023
assessment summary report_Package label

 OCTANATE 500 and OCTANATE 1000 _SUMMARY OF PRODUCT May 17, 2023
CHARACTERISTICS

 OCTANATE 500 and OCTANATE 1000 _ Public assessment summary May 17, 2023
report

 Utrogestan Vaginal 100 mg and 200 mg Soft capsules _ Public assessment May 17, 2023
summary report_Package label

 Utrogestan Vaginal 100 mg and 200 mg Soft capsules_SUMMARY OF May 17, 2023
PRODUCT CHARACTERISTICS

 Minox 5, 50 mg ml, cutaneous solution_SUMMARY OF PRODUCT May 16, 2023


CHARACTERISTICS

 Minox 5, 50 mg ml, cutaneous solution_ Public assessment summary May 16, 2023
report_Package label

 Delstrigo 100 mg 300 mg 245 mg film-coated tablets_ Public assessment May 16, 2023
summary report_Package label-1

 CELMANTIN 10 mg and 20 mg film-coated tablets_public assessment May 16, 2023


summary report_Package label

 Delstrigo100 mg 300 mg 245 mg film-coated tablets_SUMMARY OF May 16, 2023


PRODUCT CHARACTERISTICS

 CELMANTIN 10 mg and 20 mg film-coated tablets_SUMMARY OF May 16, 2023


PRODUCT CHARACTERISTICS

Title Date

 Verquvo 2.5 mg, 5 mg 10 mg film-coated tablets Summary of product May 15, 2023
Characteristics

 Verquvo 2.5 mg, 5 mg 10 mg film-coated tablets_Public assessment May 15, 2023


summary report and packaging material

 Guideline for Renewal of Medicines Marketing Authorization May 15, 2023

 J&J Vaccine Brochure May 9, 2023

 Medicine Marketing Authorization Directive No. 963-2023 የመድኃኒት የገበያ May 4, 2023
ፈቃድ አሰጣጥ መመሪያ ቁጥር 963-2015

 CLINICAL TRIAL DIRECTIVE No. 964 2023 የህክምና ሙከራ መመሪያ ቁጥር 964- May 4, 2023
2015

 Brochure-MDR medicines aDSM-TICs analysis report April 27, 2023

 Brochure-COVID-19 (Covishield-astrazeneca) vaccine active safety April 27, 2023


monitoring report

 Brochure-Medsafety mobile app for ADR reporting user guide April 27, 2023

 Pfizer Vaccine Brochure April 27, 2023

 Guidelines on Reliance for Regulatory Decision Making April 25, 2023

 Pharmacovigilance newsletter 2015 Q3 March April 24, 2023

 Pharmacovigilance newsletter 2015 Q2 December April 24, 2023

 Pharmacovigilance newsletter 2015 1st quarter April 24, 2023

 Guideline for Emergency use Authorization of Medicines for Public April 3, 2023
Emergency Situations

 Guideline for control of medicine advertising and promotion April 3, 2023

 List of Authorized Clinical Trial Applications V1, 2015 E.C March 10, 2023

 Definition of Organization, Powers and Duties of the Ethiopian Food and March 8, 2023
Drug Authority Council of Ministers Regulation No. 531/2023

 957 Traditional medicinal products Manufacturing Certificate of February 1, 2023


Competence and Market Authorization Directive

 Medicine Donation Control Directive No. 958/2023 February 1, 2023 


Title Date

 Summary of product Characteristics of Sildenafil Citrate 50 January 3, 2023

 Public assessment summary report of sildenafil January 3, 2023

 Pharmacovigilance newsletter Quarter 1 ,Issue 1 Sep, 2022 December 21,


2022

 Pharmacovigilance newsletter Volume 1, Issue 1, 2022 December 21,


2022

 Droxiderm SmPC November 24,


2022

 Droxiderm PAsRv1 November 24,


2022

 Diclofenac Sodium Injection 75 mg/2 ml Public assessment summary November 2,


report 2022

 SUMMARY OF PRODUCT CHARACTERISTICS DICLOFENAC SODIUM November 2,


INJECTION 75MG/2ML 2022

 AEFI standard reporting form Ethiopia October 21, 2022

 Addendum to AEFI Surveillance Guideline 2022 October 21, 2022

 ADE-ADR-ME-reporting form-EFDA October 21, 2022

 AEFI-Surviellance & response of AEFI guideline-3rd edition October 21, 2022

 AEFI-Surviellance & response of AEFI guideline-3rd edition October 19, 2022

 ADE-ADR-ME-reporting form-EFDA October 19, 2022

 Addendum to AEFI Surveillance Guideline 2022 October 19, 2022

 AEFI standard reporting form Ethiopia October 19, 2022

 Pharmacovigilance Directive No. 932/2022 932 የመድኃኒት ጎጂ ባህሪያት ክትትል October 17, 2022
ሥርዓት መመሪያ ቁጥር 932-2015

 Summary of product characteristics for Ritonavir Tablets USP 100 mg October 17, 2022

 Summary of product characteristics for Pyrazinamide 150mg Tablets October 14, 2022

 Summary of product characteristics for DOVPRELA (Pretomanid Tablets October 14, 2022
200 mg) 
Title Date

 Public assessment summary report for DOVPRELA (Pretomanid Tablets October 14, 2022
200 mg)

 Summary of product characteristics for Isoniazid 100mg and 300mg October 10, 2022
tablets

 Public assessment summary report for Isoniazid 100 and 300 mg tablets October 10, 2022

 PRIVACY POLICY October 8, 2022

 Guidelines for Software as Medical Devices September 28,


2022

 Guidelines for Medical Device Refurbishment September 28,


2022

 Guidelines for Medical Device Donations September 16,


2022

 Emergency medicines list September 2,


2022

 OTC medicines list September 2,


2022

 Guidelines for Medical devices Clinical Investigation Authorization July 26, 2022

 Medical devices Decommissioning and Disposal Guideline July 18, 2022

 Medical Devices Recall Guideline July 18, 2022

 Medical devices Post Marketing Surveillance Guideline July 18, 2022

 Guidelines for Medical Devices GMP Inspection May 18, 2022

 Ethiopia’s Medicine and Medicine Facility Inspection Process Achieved May 10, 2022
ISO/IEC 17020:2012 Accreditation

 Pharmaceutical Products Barcoding Guideline May 6, 2022

 Guidelines for Medical device Labeling April 28, 2022

 Hemlibra_Emicizumab_ Summary of product characteristics v1 April 6, 2022

 Hemlibra_Emicizumab_ Public assessment summary reportv1 April 6, 2022


Title Date

 Lumerax DT 20120_ Artemether 20 mg & Lumefantrine 120 mg March 21, 2022


Dispersible_public assessment summary report

 Lumerax DT 20120_ Artemether 20 mg & Lumefantrine 120 mg March 21, 2022


Dispersible_Summary of product characteristics

 የኮቪድ 19 ወረርሽኝ ለመከላከልና ለመቆጣጣር ስለሚወሰዱ ክልከላዎች እና ስለሚጣሉ March 10, 2022
ግዴታዎች ለመወሰን የወጣ መመሪያ ቁጥር 803

 ፕሪከርሰር ኬሚካሎችን ለመቆጣጠር እና በአግባቡ ጥቅም ላይ ለማዋል የወጣ መመሪያ ቁጥር March 10, 2022
393_2012

 ጉድለት የተገኘበት መድኃኒት እና የህክምና መሳሪያ አሰባሰብ መመሪያ ቁጥር_392_2013 March 10, 2022

 በባለስልጣኑ ስር ለሚገኙ የቴክኒክ ኮሚቴዎች የአበል ክፍያ አፈጻጸም መመሪያ 377/2013 March 10, 2022

 የምግብ መድሀኒትና የጤና ክብካቤ አስተዳደርና ቁጥጥር ባለስልጣን የአንድ ጊዜ የመድኃኒት March 10, 2022
ግዢ መመሪያ 374

 የአልኮል ማስታወቂያና ሽያጭ መመሪያ_372_2013 March 10, 2022

 የናርኮቲክ መድኃኒቶችንና የሣይኮትሮፒክ ንጥረ ነገር ማዘዣ ወረቀት ለመቆጣጠር የወጣ መመሪያ March 10, 2022
ቁጥር 369

 የምግብ ጨው ቁጥጥር መመሪያ 361-2013 March 10, 2022

 የምግብ ላኪ፣ አስመጪና አከፋፋይ ቁጥጥር መመሪያ ቁጥር 357_2013 March 10, 2022

 የመድኃኒትና የህክምና መሣሪያ ማስተዋወቅ መመሪያ ቁጥር 353_2013 March 10, 2022

 የመድኃኒት ችርቻሮ ድርጅቶች ቁጥጥር መመሪያ ቁጥር 349_2013 March 10, 2022

 ከጨርቅ የተሰራ የፊት መሸፈኛ ጭንብል አምራች የብቃት ማረጋገጫ የምስክር ወረቀት እና የገበያ March 10, 2022
ፍቃድ 347

 አግባባዊ የመድኃኒት አጠቃቀም ቁጥጥር መመሪያ ቁጥር 346 2013 March 10, 2022

 Administrative Measure Taking and Complaint Handling Directive March 10, 2022
No_345_2013

 Pharmaceutical Manufacturer GMP Inspection Directive No 338 March 10, 2022

 Medical Equipment Donation Directive No. 336-2020 March 10, 2022

 Infant Formula and Follow up Formula Directive No 335 2020 March 10, 2022

 Graphic_Health_Warning_directive_No 334_2013 March 10, 2022 


Title Date

 Food Supplement Directive No. 333-2020 March 10, 2022

 Guidelines for Medical Devices Good Clinical Practices March 8, 2022

 Master data Guideline _2nd Edition 2022 February 7, 2022

 Ethiopian AMR PC_Strategic Plan 2021_2025 February 2, 2022

 Risk Management Plan Guideline for COVID-19 Vaccines January 27, 2022

 General Guidelines for Medical devices Marketing Authorization January 25, 2022

 Guideline on requirements of Medical Devices Clearance at ports of entry January 24, 2022

 Guidelines for Medical Device GDP and GSP January 20, 2022

 Global Trade Item Number (GTIN) Allocation Guideline January 17, 2022

 Global Location Number (GLN) Allocation Guideline January 17, 2022

 GMP Application form December 30,


2021

 INIGAST 40 Public assessment summary report v1 December 15,


2021

 INIGAST 40 Summary of product characteristics v1 December 15,


2021

 ALLTERA 50 Summary of product characteristics v1 December 15,


2021

 ALLTERA 50 Public assessment summary report v1 December 15,


2021

 ALLTERA 50 Public assessment summary report v1 December 14,


2021

 Baby food control directive 840-2021 November 25,


2021

 Guideline for Medical Devices Good Manufacturing Practice November 1,


2021

 Regulatory Preparedness and Mitigation Strategy for Emergency Health October 11, 2021
Threats

Title Date

 Guidelines for Borderline Medical devices_EFDA October 8, 2021

 Guideline for Registration of Medicines 2020 September 13,


2021

 የመድኃኒት የመልካም አመራረት ስርዓት ቁጥጥር አሰራር መመሪያ 830 2013 September 13,
2021

 Medicine Good Manufacturing Practice (GMP) Inspection Procedure September 13,


Directive 830 2021 2021

 Guideline for Registration of Insecticide Treated Net 2021 August 4, 2021

 Guideline for Classification of In Vitro Diagnostic Medical Devices_EFDA July 21, 2021

 Guideline for Classification of Medical devices other than IVD Medical July 21, 2021
devices_EFDA

 Guideline for Application of Accessories and Spare parts_EFDA July 12, 2021

 Guideline for Medical Devices Bundling for Marketing authorization May 6, 2021
application

 Tobacco Control Directive Number 771/2021 April 20, 2021

 Tobacco Control Directive Number 771/2021 April 20, 2021

 National-pharmacovigilance-Roadmap-2020 April 13, 2021

 Guideline for Medical device Post-approval Change Notification EFDA April 5, 2021

 Guideline for Marketing Authorization of Low risk Medical devices_EFDA April 5, 2021

 Covid-19 vaccine AEFI Reporting Form March 12, 2021

 Covid-19 vaccine AEFI Reporting Form March 12, 2021

 EFDA_Guidelines for IVD Registration Requirements February 19,


2021

 EFDA_Guidelines for Non-IVD Registration Requirements February 19,


2021

 Guideline for COVID-19 Vaccine donation February 15,


2021

 Guidance for Emergency Use Authorization of COVID-19 Vaccine January 29, 2021 
Title Date

 Traditional Medicine Clinical Trial guidance 2020 November 9,


2020

 Supplementary guideline for Clinical trial Authorization 2020 November 9,


2020

 Guideline for WHO Pre-qualified Medicines through Collaborative October 1, 2020


Registration Procedure

 Guideline for Registration of Low-risk Medicines October 1, 2020

 Risk-based Guideline for Post-Marketing Quality Surveillance September 25,


2020

 Food Consignment Technical guideline September 22,


2020

 PV Newsletter V7 ISSUE 2 Feb 2020 July 8, 2020

 PV Newsletter V7 Issue 1 Oct 2019 July 8, 2020

 Annexes to cosmetic product manufacturing Directive No. 49/2020 June 17, 2020

 Food and Medicine Administration Proclamation No.1112/2019 June 10, 2020

 Internal quality Food import export June 5, 2020

 Traditional Medicine Guidance May 26, 2020

 የኮሮና ቫይረስ ግብአት አምራች፣ አስመጪና አከፋፋይ ድርጅት የብቃት ማረጋገጫ የምስክር April 13, 2020
ወረቀት አሰጣጥ ጊዜያዊ መመርያ

 Temporary COVID-19 Medical Product Approval and Import Permit April 10, 2020
Authorization Directive

 Annexes to Cosmetics Import, Export and Wholesale Control Directive April 1, 2020
No. 48/2020

 Cosmetics Import, Export and Wholesale Control Directive No 331-2020 April 1, 2020

 የኮሮና ቫይረስ ወረርሺኝን ለመከላከል ኅብረተሰቡ የሚጠቀምባቸው የመከላከያ ምርቶች አምራች፣ March 25, 2020
አስመጪ እና አከፋፋይ የብቃት ማረጋገጫ የምስክር አሰጣጥ ጊዜያዊ የአሠራር መመሪያ፡፡ 2012

 Strategy for the Prevention and Containment of AMR in Ethiopia Oct 2015 March 7, 2019

 Strategic plan For Traceability Implementation March 7, 2019



Title Date

 STG -Primary Hospital March 7, 2019

 STG -Health Center March 7, 2019

 STG-General Hospital. March 7, 2019

 Standard operating procedures for pharmaceuticals good distribution March 7, 2019


and storage practices

 RDV Formulary March 6, 2019

 PV NL 8 March 6, 2019

 PV Newsletter VI ISSUE I Nov 2010 March 6, 2019

 PV_Newsletter_V5_ISSUE 3_Dec_2015 March 6, 2019

 PV Newsletter V2 ISSUE 1 Sept 2012 March 6, 2019

 PV Newsletter V2 issue 2 March 6, 2019

 PV Newsletter V1 ISSUE 3 Nov 2011 March 6, 2019

 PV Newsletter V1 ISSUE 2 June 2011 March 6, 2019

 PV Newsletter V5 ISSUE 2 Sep 2015 March 6, 2019

 PV newsletter V3 Issue 4 March 6, 2019

 PV newsletter V3 Issue 1 March 6, 2019

 Proclamation 661 March 6, 2019

 Pharmacovigilance newsletter No 15 March 6, 2019

 Pharmacovigilance newsletter No 10 March 6, 2019

 pharmacovigilance newsletter No 11 March 6, 2019

 pharmacovigilance newsletter no 7 March 6, 2019

 Pharmacovigilance newsletter 16 March 6, 2019

 Pharmacovigilance newsletter 14 March 6, 2019

 Pharmaceutical Assessment 2016 March 6, 2019

 OVER THE COUNTER MEDICINES LIST FOR ETHIOPIA 2nd edition March 6, 2019 
Title Date

 NPS List and report format March 6, 2019

 NPS FORMULARY March 6, 2019

 National Medical Instruments List with minimum specification 2013 March 6, 2019

 Narcotic Manual final March 6, 2019

 Medicines Market Authorization Strategy 2017 March 6, 2019

 Medicines Good Dispensing Manual second edition 2012 March 6, 2019

 Medicine Retail outlet model 2013 March 6, 2019

 Medicine For Ethiopia NDL March 6, 2019

 Medicines Good Prescribing Manual second edition 2012 March 6, 2019

 LIST OF ORPHAN MEDICINES FOR ETHIOPIA 2014 March 6, 2019

 LIST OF MEDICINES FOR RURAL DRUG VENDOR 2011 March 6, 2019

 List of Medicine for Health Centers March 6, 2019

 LIST OF ESSENTIAL MEDICINES FOR ETHIOPIA March 6, 2019

 LDHC March 6, 2019

 Inspection Manual for Inspectors March 6, 2019

 Health Institution Promotion March 6, 2019

 Handbook on Substance Abuse For Trainers March 6, 2019

 Guidelines on evaluation of similar bio-therapeutics March 6, 2019

 Guidelines For Registration Of Medical Devices or Supplies March 6, 2019

 Guidelines for Registration of Bio-therapeutic Protein Products March 6, 2019

 Guideline For Drug Information Center March 6, 2019

 Good prescribing manual for Ethiopia new 2 March 6, 2019

 Good Dispensing manual new 2 March 4, 2019

 GMP Guideliens March 4, 2019



Title Date

 GCP Guideline March 4, 2019

 Finalized_Promotion_Control_guideline_2nd_Edition March 4, 2019

 EXECUTIVE SUMMARY GATS Ethiopia Oct 20 2017 March 4, 2019

 Ethiopia Tobacco Control Strategic Plan March 4, 2019

 Ethiopian Pharma co-vigilance Guideline 2014 March 4, 2019

 Ethiopia_National Drug Control Master Plan 2017 March 4, 2019

 Ethiopia GATS FactSheet Aug 2017 March 4, 2019

 DIB_V5_issue2_new March 4, 2019

 Citizen Charter March 4, 2019

 Bulletin_2007_Issue_1 March 4, 2019

 Bulletin_2006_Issue_3 March 4, 2019

 Bulletin_2006_Issue_2 March 4, 2019

 ART Study March 4, 2019

 AMR Baseline Survey March 4, 2019

 Allergy_card_scan March 4, 2019

 Adverse Drug Event Reporting Form March 4, 2019

 ADR_Study March 4, 2019

 4th_LMDS_List_for_Drug_Shop March 4, 2019

 Medicines Market Authorization Strategy 2017 February 26,


2019

 Rate of service fees regulation no 370 2015 February 26,


2019

 Food Medicine and Healthcare Administration and Control Councils of February 26,
Ministers Regulation No 299 2013 2019

 FCTC Ratification proclamation February 26,


2019

Title Date

 Guideline for Registration of Vaccine February 26,


2019

 Guideline for Registration of Medical devices 2014 February 26,


2019

 Ethiopian Medicines Formulary 2013 February 26,


2019

 Drug Administration And Control Proclamation No. 176/99 January 8, 2019

 National Drug Policy January 8, 2019

Showing 1 to 353 of 353 entries


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