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Click ‘Get Form’ to open the Small Scale Medicine Establishment Directive in the editor.
Begin by reviewing the 'Definitions' section to understand key terms such as 'manufacturer' and 'active ingredient'. This will help you accurately fill out the application form.
Navigate to the 'Application to get certificate of competence' section. Complete the application form as outlined in Annex I, ensuring all required fields are filled accurately.
Incorporate necessary documentation, including proof of premises inspection and qualifications of personnel, as specified in the directive.
Utilize our platform's features to sign and submit your completed application form electronically, ensuring a smooth submission process.
After submission, keep track of your application status through our platform for any updates or requests for additional information from the Authority.

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What class of drug is most likely given fast track registration in Ethiopia?

Fast Track Registration: Antimalarial, antiretroviral, anti-tuberculosis medicines, maternal, neonatal and child health (MNCH) products, anti-cancer drugs, vaccines, Hepatitis, New drug, drugs for orphan diseases and drugs for emergent humanitarian aid shall have priority for evaluation and registration.

What is a first in class drug?

First-in-class drugs are those with novel mechanisms of action that offer a new therapeutic approach to treating a disease. In contrast, next-in-class drugs are those with a similar mechanism of action to existing drugs.

What is DACA Ethiopia?

Drug Administration and Control Authority (DACA) of Ethiopia.

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What is the period product submission for registration to the drug quality control?

(h) The period of registration process is Three (3) months after submission of samples and a complete drug dossier for each pharmaceutical product to be registered.

What are the drugs that are mostly used in Ethiopia?

It is also an important issue in Ethiopian Higher institutions. Shisha, Cannabis, Cocaine, and Marijuana have commonly used substances among university students in different parts of Ethiopia. The frequency of use also ranges between 2.5% and 4.5% and 7.4% from Debre Berhan and Haromaya Universities respectively.

How can I import medicine to Ethiopia?

Medicines, medical supplies, and medical equipment must be registered with the Ethiopian Food and Drag Authority (EFDA). A Certificate of Analysis (COA) is also required for processed food and pharmaceuticals.

What is the pharmaceutical regulation system in Ethiopia?

EFDA 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.