Small Scale Medicine Establishment Directive 2014 - FMHACA-2026

See details

4.9 out of 5

29 votes

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 regulatory measures.

Here's how it works

01. Edit your regulatory ethiopia online

Type text, add images, blackout confidential details, add comments, highlights and more.

02. Sign it in a few clicks

Draw your signature, type it, upload its image, or use your mobile device as a signature pad.

03. Share your form with others

Send it via email, link, or fax. You can also download it, export it or print it out.

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

Ease of Setup

DocHub User Ratings on G2

Ease of Use

DocHub User Ratings on G2

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.

Start using our platform today for free to streamline your document editing and submission process!

See more Small Scale Medicine Establishment Directive 2014 - FMHACA versions

We've got more versions of the Small Scale Medicine Establishment Directive 2014 - FMHACA form. Select the right Small Scale Medicine Establishment Directive 2014 - FMHACA version from the list and start editing it straight away!

Versions	Form popularity	Fillable & printable
2014	4.9 Satisfied (29 Votes)

be ready to get more

Complete this form in 5 minutes or less

Get form

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.

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

Upload your Small Scale Medicine Establishment Directive 2014 - FMHACA to DocHub (after you’ve set up an account for this). If you need to complete fields in it, use appropriate tools from the top pane. For example, add Signature Fields, assign each to a particular party, and click on Sign → Request signatures from others. Customize your message for your recipients and click Send Request. You can also send your document by fax or as a Signing link instead of using email (you’ll locate these options by navigating to the Menu → Send)

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

If you edit your Small Scale Medicine Establishment Directive 2014 - FMHACA with DocHub, you will not need to look for other software or solutions to eSign it. An electronic signature is a component of DocHub’s substantial editing toolset, which enables you to apply changes in your form without switching between websites. Simply complete your form, double-check the correctness of your data and place your electronic signature at the end to make it submission-ready quickly.

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.

Security and compliance

At DocHub, your data security is our priority. We follow HIPAA, SOC2, GDPR, and other standards, so you can work on your documents with confidence.

Learn more

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-2026

Here's how it works

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