Licensing an advertisement for a medical product

Service Description

This service allows customers to obtain an advertisement license for a medical product through various advertising platforms (printed, audio, video, social media, website).

Service Process

• 1. Log in using UAE PASS to start the service
• 2. Fill out the application form
• 3. Attach the required documents
• 4. Pay the application fees
• 5. Submit the application
• 6. Upon advertisement approval: pay the advertisement licence fees
• 7. The applicant prints or writes the licence number on the advertisement design based on the approval and the licence expiry date

Conditions & Requirements

• The approval for the advertisement, promotion, or marketing of medical products is issued by EDE in accordance with the following conditions:
• 1. A valid Marketing Authorisation from EDE must exist for the medical product to be advertised. Products exempted from the Marketing Authorisation requirement under the provisions of Clause (3) of Article (5) of Federal Decree-Law No. (38) are excluded from this condition
• 2. The applicant must be a licensed pharmaceutical establishment or a licensed healthcare establishment
• 3. The advertising material must be truthful, non-misleading, and supported by evidence reflecting the approved information and approved indications of the medical product
• 4. The advertising material must clearly disclose any risks or side effects associated with the medical product
• 5. All other conditions and controls for promotional advertisements must be met in accordance with the target audience (whether healthcare professionals or the general public) as set out in the Executive Regulations of Federal Decree-Law No. (38)

Required Documents

• • Product registration certificate from the Emirates Drug Establishment (EDE)
• • Supporting document(s) according to the advertisement type and the medical product being advertised
• • Advertisement design according to the type of advertisement submitted (image of the printed advertisement, storyboard for video, audio advertisement script, etc.)

FAQ’s

• Q: Which products are prohibited from being advertised or promoted?
• The advertisement, promotion, or marketing of the following is prohibited:
  • Chemical precursors
  • Controlled and semi-controlled products or substances
  • Hazardous or toxic substances
  This applies to products intended for both human and veterinary use.