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Ethiopia - Apply for Food Products Advertising Permit

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Contents

Introduction

Drug Administration and Control Authority (DACA) of Ethiopia has the mandate to regulate and control the manufacture, importation, exportation, advertisement, distribution, sale and use of foods, drugs, cosmetics, medical devices, bottled water and chemicals. Only a medical representative who has been granted a certificate of competency from the authority is entitled to promote drugs the health professional. The responsibility for the regulation and control of advertisement of these products is vested on the Advertisement Control Division in the Directorate of Registration and Regulatory Affairs.

DACA must approve all advertisement/promotional materials prior to utilization.Advertised food products must demonstrate to the Government of Ethiopia that the products are legally registered with DACA.

An application for advertisement must be submitted to DACA for its approval. This approval process is in addition to the Certificate of Registration issued by DACA, which authorizes importation and sale in Ethiopia.

Eligibility

All Individuals or companies interested in Advertising food 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 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

The applicant should address a letter for advertisement and/or product launch on its company’s letter headed paper to the Director (Registration & Regulatory Affairs) with a copy of the letter to the Deputy Director (Advertisement Control Division).

  • Applicant shall submit duly filled Application Form and should attach the following documents
The following documents shall accompany the application

i)Two copies of the receipt for the purchase of the form(s),

  • Evidence of 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)
  • Product sample in all pack sizes
  • Recorded Advert messages in CD/VCD/DVD on approval of the advertisement material.
  • Materials to be submitted are: TV (Script/Storyboard),

ii)Upon approval a food product advertising permit will be issues for 1 year.

The following drugs can be promoted on Massmedia, Newspapers, and billboards.
  • By Electronic and Print Media-TV, Radio, Newspaper
  • Oral contraceptives
  • ORS
  • Condoms
  • Vitamins,
  • food additives
  • Analgesics, Anthilemntics,
  • Medical Equipments
  • Medical supplies including self test for pregnancy and Hypertension but not self test for HIV
  • Medicated & Non medicated Cosmetics
Guideline for the regulation of Promotion & Advertisement of drugs
  • Sanitary and Beutifying agents eg. Tooth paste, diapers, Modes,
  • Industrial & Household Insecticides, pesticides
  • Disinfectants

This is done by issuing advertisement permits after careful evaluation of the claims made and monitoring of the advertisement to ensure that exposed materials correspond to the approvals given.

  • A medical representative must fulfill the following requirement to be engaged in promotional activities.
  • A Degree graduate from a recognized university in bachelor of pharmacy or above
  • A registered pharmacist with at least five years experience
  • Ethiopian by Nationality.
  • One who can present a contractual agreement from the employing company.(manufacturer or distributor)
  • One who is not denied by law not to serve in his profession anywhere for violating the law.
  • One who can present a medical evidence proving that he/she is free from psychiatric problem, hearing & sight problem, speech impairment, addiction of alcohol; narcotic and psychotropic drugs so that he/she is capable of discharging his/her professional responsibilities.
  • Medical Equipments shall be promoted by medical equipment maintenance man, by one specialized in Biomedical Engineering or by one who took a short term courses in Equipment maintenance
  • If a product is used for a wrong indication because its advertisement says so, the ailment will not be cured. It is therefore important that all stakeholders in advertisement must resonate at the same frequency in this renewed fight against unauthorized advertisements in Ethiopia especially of herbal products.

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Required Documents

  • Two copies of the receipt for the purchase of the form(s),
  • Evidence of 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)
  • 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 adverts shall be valid for 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

  • Time line for advert processing shall be 20 work days (Normal).
  • Time line for advert processing shall be 7 work days (Fast Track).

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

All Drugs except as indicated under shall not be advertised by 
  • radio, television, press, or in films;
  • means of aircraft, ship, boats, cars, vans and all other transport vehicles.
  • means of posters and billboards in places accessible to the public except as otherwise indicated under section 14 (2) of this regulation.
  • illuminated signs.
  • telephone, SMS
  • organizing competitions or sponsorship
  • the provision of leaflets of detachable inserts in non health or pharmaceutical publications.
  • the display in theatre or role play
  • door to door advertising.

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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