CAU-08 version 2

Requirements on the structure of technical documentation to be submitted along with applications and on the structure of opinions of other parties in the submission of evidence in procedures concerning determination of or change to the amount and conditions of reimbursement of medicinal products and foods for special medical purposes

This guideline supersedes guideline CAU-08 version 1 as of 29 November 2024.

The guideline has been drafted by the State Institute for Drug Control (hereinafter referred to as the “Institute”) in order to:

• establish uniform standards for typical situations, in the effort to reduce the number of shortcomings and missing data, facilitating the assessment process;
• facilitate communication between parties to the procedure and the Institute;
• simplify the process of the preparation of documentation on the part of the applicant;
• provide straightforward key documentation for the Institute’s decision-making,

The guideline is issued in compliance with the provisions of Sections 39b to 39f of the Act No 48/1997 Coll., on Public Health Insurance, as amended, and Decree No 376/2011 Coll., implementing some provisions of the Act on Public Health Insurance, as amended.
The Guideline is of the nature of a recommendation.

• CAU-08_version2 (pdf, 140 kB)
• CAU-08_Annex1_version2_MAH (docx, 93 kB)