Small Scale Medicine Establishment Directive 2014 - FMHACA-2025

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The document outlines the Small Scale Medicine Establishment Directive issued by the Ethiopian Food, Medicine and Healthcare Administration and Control Authority in June 2014. It establishes regulations for small scale medicine manufacturers to ensure compliance with safety, quality, and efficacy standards. The directive includes provisions for obtaining a Certificate of Competence, pre-approval inspections, requirements for premises and equipment, personnel qualifications, quality control practices, and procedures for handling violations. It aims to protect public health through stringent administrative measures and compliance checks.

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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 section. Complete all required fields, including your name, business details, and type of application. Ensure that all information is accurate and up-to-date.
Refer to Annex I for specific requirements regarding your premises. Make sure to attach any necessary documents, such as proof of qualifications and identification.
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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.

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.

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.

Small Scale Medicine Establishment Directive 2014 - FMHACA-2025

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See more Small Scale Medicine Establishment Directive 2014 - FMHACA versions

Complete this form in 5 minutes or less

Got questions?

How can I send my Small Scale Medicine Establishment Directive 2014 - FMHACA for eSignature?

Can I sign my Small Scale Medicine Establishment Directive 2014 - FMHACA while I edit it?

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

What is a first in class drug?

What is DACA Ethiopia?

People also ask

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

What are the drugs that are mostly used in Ethiopia?

How can I import medicine to Ethiopia?

What is the pharmaceutical regulation system in Ethiopia?

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

Related links

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Small Scale Medicine Establishment Directive 2014 - FMHACA-2025

Here's how it works

How to use or fill out Small Scale Medicine Establishment Directive 2014 - FMHACA with our platform

See more Small Scale Medicine Establishment Directive 2014 - FMHACA versions

Complete this form in 5 minutes or less

Got questions?

How can I send my Small Scale Medicine Establishment Directive 2014 - FMHACA for eSignature?

Can I sign my Small Scale Medicine Establishment Directive 2014 - FMHACA while I edit it?

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

What is a first in class drug?

What is DACA Ethiopia?

Related Searches

People also ask

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

What are the drugs that are mostly used in Ethiopia?

How can I import medicine to Ethiopia?

What is the pharmaceutical regulation system in Ethiopia?

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

Related links

Try more PDF tools