Registration and regulatory follow up of medicines, medical equipment and supplies. Registration is required by Regulatory Authorities and allows the bearer to import, market and distribute medicines and medical devices throughout the country-the registration has a validity period of four years.
Medicines and Medical Device registration – A certificate of Registration (Market Authorization)- which is a document submitted by Ethiopian Food and Drug Authority (EFDA) after the valuation of the products technical documents.
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, pre-screening 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 waning 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.
Market Analysis, Market Share, Competitor Analysis
Feasibility Study and Business Planning
Compile industry, Market, Regulatory, Supply and Consumption data
Perform research and analysis to develop strategies for optimal supply chain service, promoting sustainable access to affordable and quality health products both in the public and private sector.
- Perform performance reviews of the supply chain service and regulation of the pharmaceutical sector at all levels of the health systems.
- Conducting market feasibility studies in the pharmaceutical and medical devices local manufacturing for the government and investors (local and foreign).
- Promote public private partnership.
Clinical pharmacy Practice (CPD 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
- Conducted the Comprehensive Assessment of PMED’s Organizational Capacity and it’s role in the Pharmaceutical and Medical Devices Sector.
- Conducted market feasibility study to establish cGMP compliant vaccines manufacturing facility in Ethiopia for MOH in collaboration with WHO.
- Conducted Pharmaceutical market feasibility studies for companies to invest in local manufacturing.
- Completed more than hundred new product registration, registration and variation applications.
- Provided support for about ten New GMP and renewal GMP Applications.