Ethiopia - Apply for Advertising Drugs in a Mass Media
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.
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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The labeling of all Drug products must comply with the labeling requirements as registered.
- information including composition,
- indication information ,
- information dosage/administration,
- Information Adverse effects,
- information on drug interactions and warnings/precautions.
- 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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- 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.
Explain the fees structure which is required for obtaining the certificate/document.
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
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processing takes only five days
- The Ethiopian Food, Medicine and Health Care Administration and Control Authority (FMHACA).
Addis Ababa Ethiopia
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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".
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Please explain what are other uses of obtaining this document/certificate. e.g. Birth Certificate can be used as proof of identity.
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