This guideline supersedes guideline CAU-08 version 0 as of 01 January 2022.
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 for a straightforward key documentation for decision-making, for the Institute and parties to the procedure to better navigate in the documentation, as well as for a straightforward course of the procedures conducted by the Institute.
The guideline is issued on the basis of and in compliance with the provisions of Sections 39b to 39f of 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.
Annex No 1: Structured submission template A for marketing authorisation holders