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medscopeglobal.com · Léky · SÚKL

Léková novinka

Přípravek: UST

Novinka24. června 2026

This guideline supersedes guideline UST-29 version 26 with effect as of June 24, 2026.

The guideline is being issued on the basis and in compliance with the provisions of Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts, as amended (hereinafter referred to as the “Act on Pharmaceuticals“), of Act No 48/1997 Coll., on Public Health Insurance and on Amendments to Some Related Acts (hereinafter referred to as the “Act on Public Health Insurance”), of Act No 634/2004 Coll., on Administrative Fees, as amended (hereinafter referred to as the “Act on Administrative Fees“), of Act No 106/1999 Coll., on Free Access to Information, as amended (hereinafter referred to as the “Act on Free Access to Information“), of Act No 257/2001 Coll., on Libraries, as amended (hereinafter referred to as the “Act on Libraries”), of Act No 218/2000 Coll., on Budgetary Rules, as amended (hereinafter referred to as the “Act on Budgetary Rules“), of Act No 375/2022 Coll., on Medical Devices and In Vitro Diagnostic Medical Devices, as amended (hereinafter referred to as the “Act on Devices”), and Act No 167/1998 Coll., on Dependency-Producing Substances and on Amendments to Some Other Acts, as amended (hereinafter referred to as the “Act on Dependency-Producing Substances”).

The Guideline is for recommendation.

Annex 1: Pricelist of cost reimbursements

Annex 2: Substitute form for obtaining details associated with the payment of an administrative fee

Annex 3: Substitute form for obtaining details associated with the reimbursement of costs for expert activities conducted upon request

Annex 4: Substitute form for obtaining of data for application associated with the payment for reimbursement of costs of expert activities performed upon request – medical devices and in vitro diagnostic medical devices

Annex 5: Administrative Fee Refund Applications

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