Apply In Person

1. To Get Medicine Registration Certificate, the applicant has to approach the Get Medicine Registration Certificate link
2. Applicant has get the form from the respective office.
3. Applicants must fill-in all necessary details in the application form.
4. Individuals have to carry related documents that are mentioned under “Required Documents” section of this page (Both photocopies and originals).
5. Applicant has to attach photocopies of documents (whichever is necessary) along with the application form while submitting.
6. Applicant must provide drug protective evidence and other related evidences as requested by the authority.
7. 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.
8. If all the procedures are followed properly, the registration will be completed within 3 months.
9. If the registration has not been done within 3 months, applicant can visit the office to know the status of the application.

• 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
• Requirements for Abbreviated New Drug
• Analytic report

Food, Medicine and Health Care Administration and Control Authority
Address: Food, Medicine and Health Care Administration and Control Authority of Ethiopia,
Africa Avenue,
near wolosefer,
Kirkos sub city,
02/03 kebelle, 02
Airport Road,
Addis Ababa, Ethiopia
P.O.BOX : 5681
Contact: +251115524122
Email - contactefda@efda.gov.et
Website link
Contact link
Location link

• A qualified person who intends to Get Medicine Registration Certificate are eligible for application.

• Fee for this procedure has to paid as per the authority request.

• This registration is valid for 4 years.

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

Please attach sample completed documents that would help other people.

• Processing time for this procedure is 3 months.

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'.

• Applicant must complete the application form before submitting. Incomplete applications will not be accepted.
• Applicant must provide genuine information while applying for this procedure.

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

• 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.

• 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.

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

link
link

More information which might help people.