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Medicine Registration Information System (MRIS)

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The Ethiopian Food, Medicines and Health care administration and Control Authority (EFMHACA) is the National Regulatory Body of Ethiopia which is under the Ministry of Health. The Authority is responsible to ensure the quality, safety and/or efficacy of medicines, food, cosmetics and medical devices, the standards of health and health related institutions, the healthcare practice, and competence and ethics of Health professionals.

EFMHACA was established under the Ethiopian Food, Medicines and Health care Administration and Control Authority establishment council of Ministers Regulation No. 189/2010. After repealing the drug administration and control proclamation 176/1999, FMHACA became operational as of July 17, 2010. Its budget is from the Ethiopian government. It is mandated by the Food, Medicines and Health care Administration and Control proclamation 661/2009.

The Authority is found at the Ethiopian capital, Addis Ababa, in Addis Ababa City Administration at a distance of 5km from Bole international airport. Its address is at
Africa Avenue, near wolosefer,
Kirkos sub city, 02/03 kebelle, 02 House number,
Tel: +251-115-524120/22,
fax: +251-115-52411392,
Website: fmhaca.gov.et,
E-mail: regulatory@fmhaca.gov.et.

Vision

Quality health services and products to all citizens

Mission

To promote and protect the public health by ensuring safety, efficacy and quality of health and health related products and services through product quality assessment and registration; licensing and inspection of health professionals, health institutions, pharmaceutical and food establishments, and provision of up-to-date regulatory information while promoting proper use of health and health related products and services including proper use of medicines.

Objectives

To protect the health of consumers by ensuring:-

  • Food safety and quality
  • Safety, efficacy, quality and proper use of medicines
  • Competence and ethics of health professionals
  • The standards of health institution and
  • The hygiene and environmental health protection suitability for individuals and community health