Ethiopia - Apply for Advertising Drugs in a Mass Media

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Procedure

Apply In-Person:

1. To advertise drugs in mass media, medical representative has to approach Ethiopian food and drug authority contact link
2. Download the application form from the following application form Refer page number 22
3. Complete the application form with necessary details.
4. Make sure you have all the documents in hand that are listed under the “Required Documents” section of this page.
5. Submit the application form along with the documents to the concerned officer.
6. The address is mentioned in the office locations & contacts section below.
7. Now the authorities will verify your application and validate the submitted documents.
8. The department, in reply to the application, shall give proper decision within five working days.
9. If the application is accepted, the authority shall write an approval letter to the concerned media on which the drug is to be promoted.
   

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Required Documents

• Completed application form
• Promotional material
• Drug license
  

Office Locations & Contacts

Ethiopian food and drug authority
P.O box: 5681
Africa Avenue, near wolosefer,
Kirkos sub city, 02/03 kebelle, 02
Phone: +251-11-552-41-22
Email: [email protected]
Contact link

Eligibility

All Individuals or companies interested in Advertising Drug products in Ethiopia and other related products are eligible provided they have registered with Ethiopian food and drug authority.

Fees

Fee will be disclosed by the authority at the time of application submission.

Validity

All approved Drug adverts shall be valid for three months to one year from the date of approval except in cases where extended validity, up to a period of validity of registration license is required.

Documents to Use

application form Refer page number 22

Sample Documents

Please attach sample completed documents that would help other people.

Processing Time

The department, in reply to the application, shall give proper decision within five working days

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.gIn the following url 'http://www.youtube.com/watch?v=Y0US7oR_t3M' Video ID is 'Y0US7oR_t3M'.

Instructions

Advertisement to the general public should contain the following particulars:

• The name(s) of the active ingredient(s) using either international non proprietary names (INN) or the approved generic name of the drug;
  
• The brand name;
  
• Major indication(s) for use;
  
• Major Precautions, contra-indications and warnings;
  
• Name and address of manufacturer or distributor
  

Required Information

• Name of the medical representative
• Designation
• Drug details
• Promotion details
• Media details
• Brand name
• Manufacturer details
• Distributor details
  

Need for the Document

• Promoting drugs in social media will create awareness about the drug.
• According to the Medical Ethics medical practitioners are not allowed to advertise their Drugs or services, with a view in Mind that Direct-to-consumer advertisings are commonly misleading, inaccurate or loaded with unbalanced information which can mislead patients
  

Information which might help

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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

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Others

More information which might help people.