Piloting of a Centralised Zazibona Joint Assessment Pathway for medicinal products

ZAZIBONA is transitioning into a centralised process for the provision of either a positive or a negative scientific recommendation to the participating Member States. The recommendation relates to the quality and safety of the product under consideration. A request for Expressions of Interest in the piloting of this centralised ZAZIBONA joint assessment pathway for medicinal products was published in December 2024.

The ZAZIBONA centralised process will be implemented from January 2024, starting with the registration of applicants to use the online submission portal. Stakeholder engagement sessions for review and progress updates on the pilot will be scheduled for June and November 2024.

 Overview of the process

Under the centralised procedure,

• The pilot will accept up to 30 product applications. The window for submissions of EOIs opened on the 12^th February 2024. The window shall remain open until 30 applications have been received. ZAZIBONA has over the years received approximately 30-40 applications per year, and this informed the number of applications for inclusion in the pilot phase.
• Dossiers will be submitted centrally, and not to individual Member States. Therefore, applicants are no longer required to submit applications to Member States to qualify to use the procedure.
• A cost recovery fee shall be paid This fee shall be independent of application fees levied by the Member States should an applicant choose to use a positive recommendation to seek registration (Marketing Authorisation).
• Applications will be tabled at the quarterly joint assessment sessions whose tentative dates for 2024 are:
  • 26 February – 1 March
  • 27 – 31 May. Cut-off date for submission responses: 1 April.
  • 26 – 30 August. Cut-off date for submission of responses: 1 July.
  • 11 – 15 November. Cut-off date for submission of responses: 1 September.
• Queries will be deliberated on in the joint assessment session and the agreed list of queries communicated centrally.
• The final decision remains a recommendation, which shall be valid for 12 months.
• The written positive recommendation can be used by the applicant to support expedited review and finalisation of the application by any of the member states that have product registration processes.