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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
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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
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date regulatory have been imported
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November 7, 2023
The Ethiopian Food
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interested parties to
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May 24, 2023
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