The review process is as follows;

  • One country acts as the rapporteur and conducts the primary review of the dossier (modules 2 – 5), whilst a second country acts as the co-rapporteur and conducts a peer review.
  • The product and report are then considered by a team of assessors from all ZAZIBONA participating countries during an assessment session.
  • The outcome of the assessment session is a consolidated assessment report (CAR) and a consolidated list of questions (CLOQ) and a recommendation for approval or rejection which are then tabled by the individual countries before their expert Committees.
  • The CLOQ and any other national questions are communicated to the applicant by each country to which the dossirer would have been submitted.
  • Registration after a ZAZIBONA recommendation remains the responsibility of each participating country however, a target of NMT 90 days has been set.
  • Applicants will also benefit from faster approvals when submitting the product reviewed by ZAZIBONA to other participating countries that initially did not receive the application or dossier.