Regulatory Services

Registration and follow up of medicines, medical equipment and supplies

Medicines & Medical Device Registration :- A Certificate of Registration ( Market Authorization ) is a document submitted by Ethiopian Food and Drugs Authority ( EFDA ) after the evaluation of the products technical documents.

Registration is required by Regulatory Authorities and it allows the bearer to import, market and distribute medicines and medical devices throughout the country. The registration has a validity period of four years.

Preparing and submitting your registration dossier for

    • Pharmaceutical Products (drugs, herbal, medicinal products, sugar substitutes, biologics, and nutritional products),
    • Medical Devices and Sanitary Products (cosmetics and personal care products)
    • Preparing, Prescreening and submitting your registration applications through EFDA e-RIS
    • Tracking and follow-up of registration applications(from SRA or non SRA region)
    • Re-registration and Variation (Major or Minor) applications and follow-up
    • Elaborating responses to notifications, observations and warning letters
    • Providing pharmacovigilance service to your products
    • Acting as a liaison between you and National Regulatory Authorities in instances where product recalls are necessary.
    • Follow up on Payment related to registration, annual retention fee and others
    • Follow up with EFDA regulatory related port clearance issues and other agencies to ensure seamless conduct of the commercial activities of the agents in Ethiopia.
    • Taking into custody documents relating to the products and technical dossiers.
    • Ensure confidentiality of client’s technical documents and communications.

    Business Consulting

      • Market Analysis, Market Share, Competitor Analysis
      • Feasibility Study and Business Planning
      • Compile industry, market, Regulatory, supply and consumption data
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      • Clinical pharmacy Practice(Short Courses),Good Dispensing Practice
      • Supply Chain: Good Distribution Practice& Good Storage Practice
      • Health promotion and disease Prevention (the pharmacists role)
      • Marketing and promotion training
      • Code of conduct
      • Promotion/ Selling skill
      • Territory Management
      • Customer database
      • Business Planning
      • Coaching