The State Institute for Drug Control (SÚKL) has published an updated, already 3rd version of Guideline CAU-08 – Requirements for the structure of expert documentation supplementing an application and for the structure of statements of other participants when submitting evidence in proceedings on the determination or change of the amount and conditions of reimbursement of medicinal products / partially reimbursed medicinal products, effective as of 2 January 2026.
The main change is the introduction of a new Annex No. 5 – Structured Submission A for marketing authorisation holders – immunisation.