The legislative framework

The NIHO Act

Act No. 358/2021 Coll. on the National Institute for Value and Technologies in Health Care and on amendments to certain acts is a law that entrusts the institute with specific tasks, time limits and basic framework for its functioning.

Other relevant legislation

Methodological manual of MoH SR

The methodological manual of the Ministry of Health of the Slovak Republic for Decree No. 422/2011 defines requirements for pharmacoeconomic analyses in submitted dossiers. It also includes a template for analysis as an attachment.

The aim of the methodological manual is to assist applicants in preparing submissions through clear guidelines, to increase transparency and to standardize the quality of submitted documentation. Higher quality of the dossiers can reduce the duration of reimbursement application process in Slovakia (by adhering to the guidelines, the need for additional communication and evidence may be reduced).

The manual was prepared in close collaboration between NIHO and the Ministry of Health of the Slovak Republic. The first version of the manual was issued in April 2024, and its use is mandatory for applications submitted from August 1, 2024.

Documents (in Slovak) can be downloaded here:

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