Snapshot

The Verification Procedure pathway has been developed by the of Tunisia.

This pathway can be used where Medicinal products for human use, including in particular biological products and vaccines already authorized and marketed by a reference regulatory authority. .

This pathway accelerates the regulatory review process.

It is a verification review (a recognition pathway).

Target time assessment is Admissibility (screening) = 10 working days. Applicant response = 30 working days. Marketing authorisation decision = 60 working days. Variations = 30 working days. NB: It should be noted that the clock-stop begins as soon as the ANMPS issues a request for clarification or additional information and ends upon receipt of a complete and satisfactory response from the applicant. .