Ethiopia - Register for quality of Medicine with (FMHACA)

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Procedure

Apply In-Person:

1. Registering for quality medicine in Ethiopia can be done by getting application from Food, Medicine and Health Care Administration and Control Authority of Ethiopia contact link
2. Applicants must fill-in all necessary details in the application form.
3. Individuals have to carry related documents that are mentioned under “Required Documents” section of this page (Both photocopies and originals).
4. Applicant has to attach photocopies of documents (whichever is necessary) along with the application form while submitting.
5. Applicant must provide drug protective evidence and other related evidences as requested by the authority.
6. Fee must be paid as per the authority’s request. Payments are done by bank draft to the Ethiopian Food, Medicine and Health Care Administration and Control Authority.
7. If all the procedures are followed properly, the registration will be completed within 3 months.
8. If the registration has not been done within 3 months, applicant can visit the office to know the status of the application.

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Required Documents

• Copy of permit
• Copy of Receipt
• Dossier formatted according to FMHACA
• Vetting Samples
• Current Certificate of Registration Retention
• Documents in respect of C1-3
• Evidence by competent Health Authority
• Agency Agreement
• Comprehensive Certificate of Analysis
• Certificate of Pharmaceutical products
• Chemical Documentation
• Pharmaceutical Documentation
• Quality of Raw Materials
• Active Pharmaceutical Ingredients

Office Locations & Contacts

Food, Medicine and Health Care Administration and Control Authority
Address: Food, Medicine and Health Care Administration and Control Authority of Ethiopia, Airport
Rd, Addis Ababa, Ethiopia
Contact: +251115524122
Contact link
Location link

Eligibility

• All medical supplies and instruments, sanitary items and other cosmetic, raw and packaging materials of health care which are from both local and international in Ethiopia are eligible to apply for this certificate.

Fees

• Fee for this procedure is payable only by bank draft and the fee must be paid as per the request of the authority.

Validity

• This registration is valid for 4 years.

Documents to Use

Please attach documents that can be used by people e.g. links.

Sample Documents

Please attach sample completed documents that would help other people.

Processing Time

• Processing time for this procedure is 3 months.

Related Videos

Videos explaining the procedure or to fill the applications.
Attach videos using the following tag <&video type='website'>video ID|width|height<&/video&> from external websites.
Please remove the '&' inside the tags during implementation.
Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe, myspace, revver,
sevenload, viddler, vimeo, youku, youtube
width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is displayed.
e.g In the following url 'http://www.youtube.com/watch?v=Y0US7oR_t3M' Video ID is 'Y0US7oR_t3M'.

Instructions

• Applicant must provide genuine information while applying for registration.

Required Information

• Name
• Address of the Premises of Business
• Details of medicines
• Information about all drugs and dosages used

Need for the Document

• This document is necessary for providing manufacturers of medical devices with information concerning documentation to be submitted by them in order to be registered with the Drug Administration and Control Authority.
• All medical and IVD devices should be registered with the authority before they can be imported, distributed and sold in the Ethiopian market.

Information which might help

• FMHACA holds the power for maintaining health services in Ethiopia.
• Determine the qualifications of professionals required for engaging in public health services at various levels.

Other uses of the Document/Certificate

Please explain what are other uses of obtaining this document/certificate.
e.g. Birth Certificate can be used as proof of identity.

External Links

Link

Others

• Coordination of Ethiopia pharmaceuticals is given in the following Link