Ethiopia - Renew License to Manufacture of Drugs for Sale

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Procedure

Apply In-Person:

1. To Renew License to Manufacture of Drugs for Sale the applicant has to approach in Ethiopian Food and Drug Administration contact link
2. Applicant has to get the application form for renewing from the respective office.
3. Applicant must provide all necessary information in the application form.
4. Make sure you have all the documents mentioned in “Required Documents” section of this page.
5. Applicant should attach photocopies of documents (whichever is necessary) along with the application form while submitting the application form.
6. Fee for this procedure is given the “Fees” section of this procedure.
7. If all above-mentioned procedures were followed properly by the applicant, the board will issue the license within one month.
   

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Required Documents

• Current copy of license
• Articles of Association
• Copy of Pharmacists I.D
• Attorney General Certificate
• Personal identification Number
• Memorandum of understanding
• Copy of previous License to manufacture drugs for sale, Wholesaler Dealers License and Premise License
• A copy of previous annual practice license for the pharmacist plus clearance from PSK
• List of drugs to be manufactured for year the license applies
• Non-Ethiopians to attach current work permit
  

Office Locations & Contacts

Ethiopian Food and Drug Administration
Africa Avenue, near Wolosefer,
Kirkos sub city, 02/03 kebelle, 02
Tel: +25111-5-524122
Fax: +251115521392 & +25111552411
Contact details link

Eligibility

Licensed manufacturers of drugs for sale are eligible for renewing.

Fees

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

Validity

Validity for the renewed license is one year.

Documents to Use

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Sample Documents

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Processing Time

The processing time for this procedure is within one month.

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

Any person who intends to renew license to manufacture drugs should make an application in the prescribed form for the licensing of the premises; and the application shall be accompanied by the prescribed fee.

Required Information

• Applicant name
• Reg. No
• Email address
• Cell phone No
• ID/passport/alien ID No
• Nationality
• Premise name & address
• Premise location, county, town, road and building
• Signature of the applicant
• Other professionals working in this premise
  

Need for the Document

A person intending to carry out the business as a manufacturer of drug and sale in pharmaceuticals is required to apply for and obtain license form Ethiopian Food and Drug Authority.

Information which might help

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Other uses of the Document/Certificate

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e.g. Birth Certificate can be used as proof of identity.

External Links

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Others

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