Welcome to FMHACA

Welcome to FMHACA's official website. It presents information on organizational structure of FMHACA, pharmaceutical guidlines and other resources. Contact address of each directorates is also made available. Please visit our website and find out much more.

3-5 Aug 2015, Hilton International Hotel, Addis Ababa, Ethiopia


የ2008 ዓ.ም ዕድሳት ለማከናወን የሚረዳ የውስጥ ቁጥጥር (Self Inspection Report) ማድረጊያ ቅጽ፡፡New

የመድኃኒትና የሕክምና መገልገያ መሣሪያዎች አስመጪና ጅምላ አከፋፋይ፣ የኮስሞቲክስ የሣኒተሪ ዝግጅቶች፣ የኮስሞቲክስ ጥሬ ዕቃዎች ላኪ፣ አስመጪና እና ጅምላ አከፋፋይ እና የምግብ አምራች አስመጪና አከፋፋይ የ2008 ዓ.ም ዕድሳት ለማከናወን የሚረዳ የውስጥ ቁጥጥር (Self Inspection Report) ማድረጊያ ቅጽ፡፡ 
Food Importers & Wholesalers Self Inspection Checklist
Food Manufacturers Self Inspection Checklist
Cosmetics Importers, Distributors and Exporters Self-Inspection Checklist
Medicine Self Inspection checklist

To All Market Authorization Holders pdf New

All applicants with previously registered medicines by the authority in which the long-term storage stability was conducted under storage condition 25°C ± 2°C/60% RH ± 5% RH are expected to initiate a stability study as recommended by the WHO (30ºC±2ºC/65%±5%RH and the more universal condition of 30ºC±2ºC/75%±5%RH)  ,submit the stability data on a schedule base as per their ongoing stability study protocol and revise their shelf life if there is a need to do so. In the mean time all are required to inform the authority if there is any out of specification while performing their study under the recommended storage condition. Click here to download the document.

Bio waiver and Variation draft Guide line for your CommentNew

Guidance for bio waiver V5
Variation Guidelines Draft V3

FMHACAS Laboratory Accreditation New Building

The Authority has been ensuring safety, efficacy and quality of medicines by quality control tests; in addition to other quality assessment mechanisms. After great efforts; The authority's laboratory has attained accreditation from internationally recognized ISO/IEC 17025:2005 accreditation body; for testing and calibration laboratories. Read more...

The Ethiopian Government ratified the WHO frame work convention on tobacco control

The WHO Framework Convention on Tobacco Control Adopted at Geneva on the 21st day of May, 2003. The FCTC, one of the most quickly ratified treaties in United Nations history. The treaty is legally binding in most ratifying countries.

Ethiopia was signed the convention in March 04, 2004.The House of Peoples Representative of the Federal Democratic Republic of Ethiopia has ratified the Convention at its session held on  January   21, 2014.

With regard to this; the Foods, Medicines and Health care Administration and Control  Authority of Ethiopia is hereby empowered to undertake all acts necessary for the implementation of the convention.

The objective of the convention is to protect present and future generations from the devastating health, social, environmental and economic consequences of tobacco consumption and exposure to tobacco smoke by enacting a set of universal standards stating the dangers of tobacco and limiting its use in all forms worldwide.  To this end, the treaty's provisions include rules that govern hazard, demand and supply reduction of tobacco use.

FMHACA in collaboration with Womens, Children and Youth, and Social Affairs...

The Ethiopian Food, Medicine and HealthCare Administration and Control Authority, in collaboration with Womens, Children and Youth, and Social Affairs standing committee of the parliament of Ethiopia has commemorated the 6th national sexual violence day with a theme of Substance abuse and sexual violence. A total of 520 members of the two Houses attended the session at the parliaments main venue on 23-11-2011. Read more...

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