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 Medical devices other than IVD Medical devices_EFDA Guideline for Application of Accessories and Spare parts_EFDA Guidance on criteria for bundling or grouping of medical devices Guideline for Medical device Post-approval Change Notification_EFDA Guideline for Marketing Authorization of Low risk Medical devices_EFDA Covid-19 vaccine AEFI Reporting Form word document Guidance for Emergency Use Authorization of COVID-19 Vaccine Supplementary guideline for Clinical trial Authorization 2020 Guideline for Registration of oral care skin care products with therapeutic claim Guideline for WHO Pre-qualified Medicines through Collaborative Registration Procedure Good Review Practices (GRevPs) Guideline Guidelines for WHO Pre-qualified Medicines through Collaborative Registration Procedure Guideline for Registration of Low-Risk Medicines Annexes to cosmetic product manufacturing Directive No. 49 2020 Temporary COVID-19 Medical Product Approval and Import Permit Authorization Directive Strategy for the Prevention and Containment of AMR in Ethiopia Oct 2015 Standard operating procedures for pharmaceuticals good distribution and storage practices National Medical Instruments List with minimum specification 2013 Health Professionals Registration and Licensing Directive 2014 GUIDELINES FOR SUBMISSION OF POST-APPROVAL VARIATION MEDICINE APPLICATIONS 2015 Guidelines for Registration of Biotherapeutic Proteint Products Food Manufacturing Factories Pre licensing Directive (Revised) Cosmotics Importers,Distributors and Exporters Self-Inspection Check list Aministrative Measure taking and compliant handling Directive 2012 Food Medicine and Healthcare Administration and Control Councils of Ministers Regulation No 299 2013Title Content Date Document Link doc_category_hfilter 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 Master Data Guideline_March 2021 Master Data Guideline_March 2021 April 19, 2021 traceability 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 This Donation Guideline is intended to provide guidance to applicants wishing to donate or receive Covid-19 vaccines. This will be a “living document” and will be updated on a regular … 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 Pharmaceutical Products Traceability Directive Pharmaceutical Products Traceability Directive January 13, 2021 medicine-directives Pharmacovigilance Directive English 2020 Pharmacovigilance Directive English 2020 December 30, 2020 medicine-directives pharmacovigilance-newsletter bulletin-and-newsletter Guideline for Conditional approval of medicines 2020 Guideline for Conditional approval of medicines 2020 December 16, 2020 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 medicine-guidelines Traditional Medicine Clinical Trial guidance 2020 Traditional Medicine Clinical Trial guidance 2020 November 9, 2020 medicine-guidelines Supplementary guideline for Clinical trial Authorization 2020 Supplementary guideline for Clinical trial Authorization 2020 November 9, 2020 medicine-guidelines Guideline for Registration of 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 RDU Directive RDU Directive September 23, 2020 medicine-directives Food Consignment Technical guideline Food Consignment Technical guideline September 22, 2020 food-guidelines Good Review Practices (GRevPs) Guideline Download Good Review Practices (GRevPs) Guideline File size: 206 KB Downloads: 739 August 25, 2020 medicine-directives Guidelines for WHO Pre-qualified Medicines through Collaborative Registration Procedure Download Guidelines for WHO Pre-qualified Medicines through Collaborative Registration Procedure File size: 159 KB Downloads: 827 August 25, 2020 medicine-directives Guideline for Registration of Low-Risk Medicines Download Guideline for Registration of Low-risk Medicines File size: 284 KB Downloads: 845 August 25, 2020 medicine-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 Cosmetic manufacturer Directive 2020 Cosmetic manufacturer Directive 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 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 cosmetic-directive Cosmetics Import, Export and Wholesale Control Directive Cosmetics Import, Export and Wholesale Control Directive 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 Download COVID directive File size: 1 MB Downloads: 1017 March 25, 2020 medicine-directives Rational Medicine Use Directive 2019 Rational Medicine Use Directive 2019 July 5, 2019 medicine-directives Food registration directive 2019 Food registration directive 2019 July 5, 2019 food-directives Alcohol Advertisement and Labeling Control Directive No 41/2019 Alcohol-Advertisement ald Labeling Control Directive No 41 2019 Download Alcohol-Advertisement ald Labeling Control Directive No 41 2019 http://www.fmhaca.gov.et/publication/alcohol-advertis…ctive-no-41-2019/ File size: 1 MB Downloads: 857 June 18, 2019 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 non-categorized 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 Small Scale Medicine Establishment Directive WHEREAS, it is necessary to protect public health through regulation of small scale medicine manufacturers to operate in accordance with the required safety, quality and efficacy requirements of medicine products; WHEREAS, regulatory provisions regarding the … 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: 457 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: 1342 March 6, 2019 Precursor Chemicals Directive 2013 Download Precursor Chemicals Directive 2013 File size: 95 KB Downloads: 422 March 6, 2019 non-categorized PORT DIRECTIVE Download PORT_DIRECTIVE File size: 502 KB Downloads: 587 March 6, 2019 non-categorized 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 Promotion Directive 2013 ከጊዜ ወደ ጊዜ እያደገ የመጣውን የመድኃኒትና የህክምና መሣሪያ አቅርቦትና የመረጃ ቴክኖሎጂ መራቀቅ ጋር ተያይዞ የሚካሄድ ማንኛውም የመድኃኒትና የህክምና መሣሪያ የማስተዋወቅ ተግባርን መቆጣጠር አግባባዊ የመድኃኒት አጠቃቀምን ለማረጋገጥ አይነተኛ መሣሪያ እንደሆነ በመታመኑ፤ የመድኃኒትና የህክምና መሣሪያ አምራቾች፣ አስመጪዎች … 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 One time purchase order directive Download One_time_purchase_order_directive File size: 87 KB Downloads: 807 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 Prescription paper Directive 2013 Download NPS Prescription paper Directive 2013 File size: 204 KB Downloads: 553 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 NPS Control Directive 2013 Download NPS Control Directive 2013 File size: 192 KB Downloads: 501 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: 1143 March 6, 2019 non-categorized Medicines Waste Management Disposal Directive Final print WHEREAS, it is found necessary to protect the public health and the environment from health risks emerging out of unsafe management and disposal of medicines waste. WHEREAS, it is found necessary to avert problems related … 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: 803 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 Medicine EIW control Directive Download Medicine_E_I_W_control_Directive File size: 240 KB Downloads: 557 March 6, 2019 non-categorized Medicine Donation Directive Download Medicine_Donation_Directive File size: 107 KB Downloads: 547 March 6, 2019 non-categorized Medical Equipment Donation Directive WHEREAS, medical equipment has significant contribution to the improvement of quality healthcare service; WHEREAS, it is found necessary to protect the community from unsafe, incompatible, non functional, substandard and outdated medical equipment by ensuring the … 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: 468 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 Medicine For Community Pharmacy 4th It is by far known that medicines are integral components of a healthcare system. Although there are immense active pharmaceutical entities in the global market, limiting medicines that shall be used within a given health … 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: 365 March 6, 2019 non-categorized IODIZED SALT DIRECTIVE ከዚህ ቀደም በሀገራችን ለምግብነት የሚቀርበው ጨው አዮዲን የሌለው በመሆኑ ይህም ህብረተሰቡን ለተለያዩ የጤና ችግሮች ስለሚያጋልጥ ጨው በአዮዲን እንዲበለፅግ በማስፈለጉ ! ማንኛውም በምግብ ጨው አምራች፣ ላኪ፣ አስመጪና ጅምላ አከፋፋይ ንግድ ሥራ ላይ የሚሰማራ ድርጅት የብቃት ማረጋገጫ … 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 INFANT AND FOLLOW UP FORMULA DIRECTIVE WHEREAS, considering the vulnerability of infants and the potential health risks including severe infections associated with unsafe or poor quality infant formula, special formula and follow-up formulas; WHEREAS, following the national attention afforded to the … March 6, 2019 non-categorized Health Professionals Registration and Licensing Directive 2014 የጤና ባለሙያዎች የሚሰጡት አገልግሎት ደረጃውን የጠበቀና ህብረተሰቡን ተጠቃሚ መሆኑን ማረጋገጥ አስፈላጊ በመሆኑ፤ የጤና ባለሙያዎችን ምዝገባና የሙያ ፈቃድ አሰጣጥና የቁጥጥር ስርዓትን ማጠናከር አስፈላጊ በመሆኑ፤ ባለስልጣኑም ከተሰጡት ስልጣንና ኃላፊነቶች መካከል በበቂ መጠን በገበያ ላይ የማይገኙ የጤና ባለሙያዎችንና … March 6, 2019 non-categorized Health Professionals Registration and Licensing Directive የጤና ባለሙያዎች የሚሰጡት አገልግሎት ደረጃውን የጠበቀና ህብረተሰቡን ተጠቃሚ መሆኑን ማረጋገጥ አስፈላጊ በመሆኑ፤ የጤና ባለሙያዎችን ምዝገባና የሙያ ፈቃድ አሰጣጥና የቁጥጥር ስርዓትን ማጠናከር አስፈላጊ በመሆኑ፤ ባለስልጣኑም ከተሰጡት ስልጣንና ኃላፊነቶች መካከል በበቂ መጠን በገበያ ላይ የማይገኙ የጤና ባለሙያዎችንና … 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 Healthcare Waste management Without prejudice to the definition provided under proclamation No. 661/2009, in this directive unless the context otherwise requires: 1) “hazardous wastes” means wastes generated in health facilities that poses substantial or potential threats to public … March 6, 2019 non-categorized Handbook on Substance Abuse For Trainers Download Handbook_on_Substance_Abuse_For_Trainers File size: 6 MB Downloads: 4784 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 Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. According to article 4, sub article 11 of proclamation … March 4, 2019 non-categorized FOOD SUPPLEMENT DIRECTIVE WHEREAS, it is necessary to ensure the safety, quality and presentation of food supplements; WHEREAS, the nutritional intake from a diet may be insufficient and it may be recommended by health professional, consumers may consider … March 4, 2019 non-categorized Food Manufacturing Factories Pre licensing Directive (Revised) Download Food Manufacturing Factories Pre licensing Directive (Revised) File size: 15 MB Downloads: 2083 March 4, 2019 non-categorized Food Importers, Whole sellers and Exporters Directive በምግብ ንግድ ሥራ ላይ የተሰማሩና የሚሰማሩ ድርጅቶች የሚልኩት፣ የሚያስመጡት ወይም የሚያከፋፍሉትን ምግብ ጥራትና ደህንነቱን በማረጋገጥ የህብረተሰቡን ጤና መጠበቅ አስፈላጊ በመሆኑ፤ ወደ ሀገር ውስጥ የሚገቡ ምግቦች ጥራታቸውንና ደህንነታቸው የተረጋገጠ እና አግባብ ያለውን መስፈርት ያሟሉ መሆናቸውን ማረጋገጥ … March 4, 2019 non-categorized Finalized_Promotion_Control_guideline_2nd_Edition Download Finalized_Promotion_Control_guideline_2nd_Edition File size: 286 KB Downloads: 668 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 EMERGENCY MEDICINE LIST It is by far known that medicines are the key 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 … March 4, 2019 non-categorized Directive for Medicine Manufacturing Establishment 2013 WHEREAS, it is necessary to protect public health through regulation of medicine manufacturer engaged in processing of active and inactive ingredient for further processing and distribution of medicines manufactured within their premises; WHEREAS, regulatory provisions … 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 CPD Directive FINAL March_2013 Whereas changing medical knowledge, evolving technology, rapid organizational changes, increasing public expectations and greater accountability necessitate the need for updating professional competence; Whereas continuing professional development will contribute to the competency of health professionals and … March 4, 2019 non-categorized CPD Accreditation Guide Final March 20131 Health professionals must maintain, update and enhance their knowledge, skills and attitude in order to adequately deliver quality health care. This is particularly important due to a changing disease pattern in which diseases that had … March 4, 2019 non-categorized Clinical Trial Authorization Guideline Clinical research is necessary to establish the relative safety and effectiveness of specific health and pharmaceutical products and healthcare practices. Much of what is known today about the risk and benefits of specific products and … 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 Administrative Measure taking and compliant handling Directive 2012 Download Aministrative Measure taking and compliant handling Directive 2012 File size: 225 KB Downloads: 431 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: 6268 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: 8567 February 26, 2019 regulations policies-legislation-and-regulation FCTC Ratification proclamation Download FCTC Ratification proclamation File size: 1 MB Downloads: 2193 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 Medicine and Medical Device Recall Directive 2018 ደህንነቱ፣ ጥራቱና ፈዋሽነቱ ወይም ውጤታማነቱ የተጠበቀ መድኃኒት እና የህክምና መሳሪያ እንዲቀርብ በማድረግ የህብረተሰቡን ጤና መጠበቅ በማስፈለጉ፤ ማንኛውም መድኃኒትና የህክምና መሳሪያ ደህንነት፣ ጥራትና ፈዋሽነት ወይም ውጤታማነት ጉድለት ሲኖረው፤ የተጭበረበረ፣ የተሳሰተ ወይም የሀሰት ገለጭ ፁሁፍ የተፃፈበት ወይም … February 26, 2019 medicine-directives GMP inspection directive WHEREAS, ensuring Compliance with the current Good manufacturing practice of pharmaceutical products is necessary condition for pre and post approval of Marketing Authorization; WHEREAS, it is necessary to ensure products are consistently produced and controlled … February 26, 2019 medicine-directives 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 Cosmetics and Sanitary Items Directive Without prejudice to the definitions provided under Proclamation No. 661/2009 and Regulation No.299/2014, in this directive, unless the context otherwise requires: 1) “Cosmetics” includes ordinary, medicated and functional cosmetic; 2) “Ordinary Cosmetic” means any substance … February 26, 2019 cosmetic-directive Food Advertising Directive 1. “ምግብ” ማለት በአዋጁ አንቀጽ 2 ንዑስ አንቀጽ 1 መሰረት የተሰጠው ትርጓሜ እንደተጠበቀ ሆኖ በምግብ አምራች ድርጅት ተመርቶ ከአንድ ክልል በላይ ወይም ለውጪ አገር ገበያ ሽያጭ የተዘጋጀ ምርት ነው፤ 2. “የጨቅላ ህፃናት ምግብ” ማለት ከእንስሳ … January 8, 2019 non-categorized Drug Administration And Control Proclamation No. 176/99 In this Proclamation, unless the context provides otherwise: 0. “Drug” means any substance or mixture of substances used in the diagnosis, treatment, mitigation or prevention of a disease in man or animal. This shall include … January 8, 2019 policies-legislation-and-regulation proclamations 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 … January 8, 2019 policies policies-legislation-and-regulation
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