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Fmhaca license renewal requirements

Fmhaca 2026

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The document is the 'Guideline for Registration of Medicines' issued by the Food, Medicine and Health Care Administration and Control Authority of Ethiopia (FMHACA). It outlines the procedures and requirements for the registration of pharmaceutical products in Ethiopia, including detailed instructions on documentation needed for various modules such as administrative information, quality control, clinical studies, and non-clinical reports. The guideline emphasizes compliance with international standards and provides specific criteria for bioequivalence studies, product specifications, and stability testing. It aims to ensure the safety, efficacy, and quality of medicines available in the Ethiopian market.

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Click ‘Get Form’ to open the fmhaca document in the editor.
Begin by filling out the 'Applicant' section, providing your name, business address, and contact information.
In the 'Product Details' section, enter the proprietary name, approved generic names, strength per dosage unit, and dosage form.
Complete the qualitative and quantitative composition table by listing all components along with their functions.
Review and ensure that all required documents are attached as indicated in the 'Details on dossiers submitted with the application' section.
Once all sections are filled out accurately, save your changes and submit the form for review.

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Got questions?

We have answers to the most popular questions from our customers. If you can't find an answer to your question, please contact us.

What is Fmhaca, Ethiopia?

Food, Medicine and Health Care Administration and Control Authority (Ethiopia) Acronym. FMHACA.

What is DACA in Ethiopia?

The Drug Administration and Control Authority (DACA) of Ethiopia is a pivotal institution located in Addis Ababa, dedicated to ensuring the safety and efficacy of pharmaceuticals and healthcare products within the country.

Does Ethiopia have its own essential drug list?

For nearly four decades, Ethiopia has continuously updated its Essential Medicines List to reflect scientific advancements and national health priorities, said Mr Seyoum Wolde, Deputy Director General, Medicines sector, EFDA.

What is the difference between an EFDA and a dental assistant?

Efda Salary Annual SalaryMonthly Pay Top Earners $59,500 $4,958 75th Percentile $51,500 $4,291 Average $48,099 $4,008 25th Percentile $40,500 $3,375

What is the full form of EFDA?

Expanded Function Dental Auxiliary (EFDA)

efda license renewal online

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