Snapshot

The Expedited “fast-track” registration procedure pathway has been developed by the Namibia Medicines Regulatory Council (NMRC) of Namibia.

This pathway can be used where All products.

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

When relevant, the agency relies on prior decisions from Canada EU-EMA Japan South Africa Switzerland United Kingdom United States WHO Zazibona Zimbabwe

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 within 30 days of receipt. 2. Applications that pass screening will require payment of an 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. are then communicated to the applicant and a deadline to respond to queries is outlined (i.e. 90 days from the date of the letter for applicant to respond). 4. Completed evaluation reports and recommendations are forwarded to the Pharmaceutical and Analytical Committee of the NMRC. 5. The Council may fast track review of applications for products as contemplated under regulations 45. Evaluation of the application within 6 months of NMRC time is guaranteed with this pathway. More resources are outlaid towards processing applications submitted through the expedited review pathway thus higher fees are prescribed in the current fee schedule.