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Ethiopia - Apply for Advertising Drugs in a Mass Media

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Contents

Introduction

The information content of the drugs to be promoted on the mass media shall be strictly evaluated by the Authority and include the necessary precaution to be taken during application.

Eligibility

All Individuals or companies interested in Advertising Drug products in Ethiopia and other related products are eligible provided they have registered with DACA Board.

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Instructions

The labeling of all Drug products must comply with the labeling requirements as registered.

Required Information

  • information including composition,
  • indication information ,
  • information dosage/administration,
  • Information Adverse effects,
  • information on drug interactions and warnings/precautions.

Procedure

Step I Application Form.

make a formal application to DACA, planning and drug information Department. A medical representative shall apply to the planning, drug information department for drug promotion in mass media attaching the information to be promoted with the application form ( annex -2) prepared by the authority.

  • Only a medical representative who has been granted a certificate of competency from the authority is entitled to promote drugs the health professional.
  • Any medical representative should have a place to keep promotional materials and other documents used for his/her work
Step II

Wait for a few days for the reply from the department of Planning and drug information. The department, in reply to the application, shall give proper decision within five working days.

Step III

If the application is accepted, the authority shall write an approval letter to the concerned media on which the drug is to be promoted.

The information content of promotion in media for Analgesics, Anthilemntics shall include the right source of availability and shall state that the advice of health professional is required.

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Required Documents

  • Two copies of the receipt for the purchase of the form(s),
  • Evidence of the Drug product registration,
  • A letter of introduction of Advert Agent from the Applicant, (where applicable)
  • GSM telephone No. and email address of the Applicant/Advert Agent.
  • Radio (Script)
  • Outdoor (Script/Artwork)
  • Print (Script/Artwo
  • Online (Script/Artwork/Storyboard)
  • SMS (Script)
  • Drug Product sample in all pack sizes
  • Recorded Advert messages in CD/VCD/DVD on approval of the advertisement material.

Fees

Explain the fees structure which is required for obtaining the certificate/document.

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

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 takes only five days

Office Locations & Contacts

The Ethiopian Food, Medicine and Health Care Administration and Control Authority (FMHACA).

P.O.Box 5681

Addis Ababa Ethiopia

Telephone: 011-5-524122

Fax: 011-5-540477

E-mail: regulatory@fmhaca.gov.et

Website: http://www.daca.gov.et

Website: http://www.fmhaca.gov.et

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Video

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". 
	

Information which might help

Enter other informations which might help

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

http://arazygroup.com/blog/register-medical-devices-in-ethiopia/

http://www.moh.gov.et/fmhcaca

http://www.who.int/medicines/areas/quality_safety/regulation_legislation/icdra/WF-3-Dec.pdf

http://www.fmhaca.gov.et

Others

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