Egyptian Drug Authority

 
Services > General Directorate of Pharmaceutical Research > Marketing Materials and Media Monitoring

Marketing Materials and Media Monitoring:

Vision


  Monitor & co-operate with all parties to encourage the rational use of drugs.
  Ensure correct, scientific and ethical content of the each different forms of the printed items used in the medical field.
  Keep eye open on the market to take appropriate actions for humiliated legislation.
  Omit misleading claims within the Egyptian market.

Mission


  It is concerned with reviewing any promotional material before it's publishing to ensure its integrity.

Strategic Objective


1.Collect process and analyze Individual Case Safety Reports (ICSRs).
2.Collect process and analyze Periodic Safety Update Reports (PSURs) submitted regularly by the companies.
3.Prepare reports on serious, unexpected or rare drug adverse reactions and recommend reporting to WHO or any recall.
4.Provide and analyze safety information for medicines submitted to the Technical Committee (TC) for registration.
5.Provide and analyze safety information for medicines at the renewal stage.
6.Prevent preventable ADRs.
7.Communicate and disseminate with international institutions working in pharmaco-vigilance.
8.Contribute to the assessment of the risk-benefit profile of medicines, thus encouraging safer and more effective use of medicines and a resolution of the sometimes apparently conflicting interests of public health and individual patient welfare.
9.Prepare a bi-annual report on the post-marketing surveillance survey conducted, focusing on misuse and abuse of medicines, trends of self -medication, poly-pharmacy and product defaults. This report should include a root-cause analysis and recommend protective and proactive actions.
10.Influence the content of course materials delivered to medical and pharmaceutical students to include issues related to the practice of pharmaco-vigilance.

Scope


The scope shall cover:
Any and all marketing and promotion activities(advertising) undertaken by pharmaceutical Manufacturing and distributor companies operating in the territory of Egypt in pharmaceutical products that :
1. Intended for human use
2. Have been officially registered
3. Promotional activities targeting
A) Physicians, pharmacists, and other healthcare professionals qualified to recommend prescribe, supply, sell or administer pharmaceutical products and involved in patient care.
B) Public/patients

Logistics


  Minister decree (76-2000)
  Pharmacy law (127-1955)
  Technical committee decree dated 20/11/2008
  Cover Letter
  General Guidelines
  Workflow Chart
  Information must be mentioned in case of advertisement to the public
  Application Form
  Information must be mentioned in case of advertisement to physicians & health care professionals
  Attachments that are to be provided with each promotional material for each product
  Check List Form
  Declaration
  Approved non-prescription medicines by minister decree 442/2014
  Guidelines of non-prescription medicines advertising and promotion
  Final effective prescription medicine promotion guidelines

Complaints


  How to complain
  Complaint application form
 
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