Snapshot

The Verification Review pathway has been developed by the Namibia Medicines Regulatory Council (NMRC) of Namibia.

This pathway can be used where All therapeutic products..

This pathway accelerates the regulatory review process.

It is a verification review (a recognition pathway).

When relevant, the agency relies on prior decisions from Australia Brazil China EU-EMA Japan Mexico Saudi Arabia Singapore South Africa South Korea Switzerland Taiwan (Chinese Taipei) Turkey United Kingdom United States WHO Zazibona Zimbabwe

Target time assessment is 1. Medicine application dossiers are received and screened for completeness using the appropriate screening checklist and a response of the outcome of the screening will be communicated to the applicant. 2. Applications that pass screening will require payment of application fee to be allocated an application number and progress to the evaluation stage. In the event that an application is incomplete and fails the screening stage, the applicant can re-submit a complete application at a later date. This re-submission will incur another screening fee. 3. A detailed review of the dossier is done and a report is generated. Deficiencies, missing information etc. is communicated to the applicant and a deadline to respond to queries outlined 4. Completed evaluation reports and recommendations are forwarded to the Pharmaceutical and Analytical Committee of the NMRC or in case of Veterinary medicines to the Veterinary Medicines Committee of the NMRC. 5. Products approved by NMRC based on the recommendations of the Pharmaceutical and Analytical Committee or the Veterinary Medicines Committee are allocated a registration number and gazetted. The product is then entered into the Medicines Register and notification of registration communicated to the applicants. Recommendations from these committees to Council may define whether a product is to be registered or not. The total target NRA time for assessment is 90 calendar days.