Reimbursement of costs of expert activities conducted upon request – waivers and refunds; provision of expert information to competent authorities
This guideline supersedes Guideline UST-24 version 9 with the effect from 12 January 2023.
The Guideline is published with regard to and in compliance with the provisions of Section 112 of Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts (Act on Pharmaceuticals), as amended (hereinafter referred to as the “Act on Pharmaceuticals”); Section 27 of Act No 296/2008 Coll., on Safeguarding the Quality and Safety of Human Tissues and Cells Intended for Use in Man and on Amendments to Related Acts (Act on Human Tissues and Cells), as amended (hereinafter referred to as the “Act on Human Tissues and Cells”); Act No 375/2022 Coll., on Medical Devices and In Vitro Diagnostic Devices, as amended (hereinafter referred to as the “Act on Devices”); Section 39f, paragraph 16 of Act No 48/1997 Coll., on Public Health Insurance, as amended (hereinafter referred to as the “Act on Public Health Insurance”); and Section 24g, paragraph 2 of Act No 167/1998 Coll., on Dependency-Producing Substances and on Amendments to some Acts, as amended.
The guideline is of the nature of a recommendation.
Annex 1: Application for waiver/refund of reimbursement of costs pursuant to the Act on Pharmaceuticals and the Act on Human Tissues and Cells
Annex 2: Application for refund of reimbursement of costs pursuant to the Act on Medical Devices an Act on In Vitro Diagnostic Medical Devices
Annex 3: Application for refund of cost reimbursement pursuant to the Act on Dependency-Producing Substances