Ethiopia - Obtain a Certificate for Pharmaceutical Products

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Procedure

Apply In-Person:

1. Certificate for Pharmaceutical Products in Ethiopia can be obtained from the Food, Medicine and Health Care Administration and Control Authority of Ethiopia contact link
2. Applicant must provide all necessary information in the application form.
3. Applicant should prepare all documents that are needed for completing this procedure.
4. Applicant must carry both photocopies and originals of all documents that are mentioned under “Required Documents” section of this page.
5. Applicant must attach photocopies of documents (whichever is necessary) along with the application form while applying for this procedure.
6. Fee for this procedure has to be paid as per authority’s instructions.
7. If all above-mentioned procedures were followed properly by the applicant, certificate of Incorporation will be provided to the applicant within 3 months.
8. Applicant can get their certificate by visiting the office or via post.
9. If there is no update regarding the application is provided within 3 months, applicant can visit the office to know details of their application.

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Required Documents

• Manufacturing License
• Free Sale Certificate
• Trademark Registration
• Certificate of Incorporation
• Business Name Registration
• CPP Legalization
• Contract Manufacturing Agreement
• Documents regarding formulas, dosage and other active ingredients in the product

Office Locations & Contacts

Location Addis Ababa
Address:
Food, Medicine and Health Care Administration and Control Authority of Ethiopia,
Addis Ababa, Ethiopia
Contact No:(+251)-11-551-8025
contact link
location link

Eligibility

• Any Individuals or citizens of Ethiopia who own a drug manufacturing business in Ethiopia are eligible.

Fees

• Fee for this procedure has to be paid as per the instruction of concerned authorities.

Validity

• Certificate is valid forever.

Documents to Use

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

Sample Documents

Please attach sample completed documents that can be used by 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 be aware of rules and regulations before dissolution of an organization.
• Applicant should follow all instructions provided by concerned authorities properly.

Required Information

• Name of the Product
• Dosage of the Product
• Name and amount of active ingredient in the product per unit dose
• Name of the Product License Holder
• Address of the Product License Holder
• Name and Address of the Manufacturing facility
• Completed formula name and details
• Product information for health professionals

Need for the Document

• Certificate is necessary for manufacturing and selling pharmaceutical products in Ethiopia legally.

Information which might help

• If the applicant wishes to change their product name, they can reach out to the FMHCA, Ethiopia.

Other uses of the Document/Certificate

Please provide other uses of the document / certificate.
e.g. Birth Certificate can be used as a proof of identity.

External Links

external link

Others

More information which might help people.