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General guidelines

  Name En. v. Valid. since Replaces Amends
UST-38 Non-intervention post-marketing studies that are not security - assessing the advertising nature NO 04.01.2016 -  
UST-37 Application for a hospital exemption for advenced therapy medicinal products NO 10.05.2019 UST-37 version 0  
UST-36 version 6 Administrative fees, reimbursement of costs for expert activities conducted upon request in compliance with Act No 296/2008 Coll., on Safeguarding the Quality and Safety of Human Tissues  and Cells Intended for Use in Man YES 26.02.2019 UST-36 version 5  
UST-35 version 2 Non-intervention post-marketing studies YES 12.1.2015 UST-35 version 1  
UST-34 version 2 Project of the laboratory control and sample collection NO 01.06.2019 UST-34 version 1  
UST-30 version 3 Basic principles for distinguishing between medicinal products for human use and other products, including detailed specification of medicinal products subject to marketing authorization NO  03.12.2012 UST-30  version 1  
UST-29 version 24

Administrative fees, reimbursements of costs of expert activities, reimbursements of activities associated with the provision of information and reimbursements of other activities

YES 01.06.2023 UST-29 version 23  
UST-27 version 3 Basic provisions of the Act on Advertising Regulation concerning the advertising of human medicinal products NO 19.09.2011 UST-27 version 2  
UST-24 version 10 Reimbursement of costs of expert activities conducted upon request – waivers and refunds; provision of expert information to competent authorities  YES 12.01.2023 UST-24 version 9  
UST-23 version 3 Providing of free samples of human medicinal products for promotional purposes NO 10.11.2014       -  
UST-22 Standard terms of dosage forms, methods of administration, and containers - amendment NO 01.10.2003        - UST-17
UST-21 version 7 Reporting of Selected Medicinal Products and Batch Release onto the Market  YES 01.04.2021

UST-21 version 6

UST-20 version 1 Application for an opinion to the proposal of a specific therapeutic programme YES 01.11.2020 UST-20  
UST-19 version 4 Application for a decision whether a product should be classified as a pharmaceutical or a medicinal product subject to registration YES 01.11.2018 UST-19 version 3  
UST-16 version 2
Sponsorship and provision of gifts and other benefits to professionals under the Act on Advertising
NO 04.12.2020 UST-16 version 1  
UST-15 version 5 Procedure to be followed by health care professionals and vendors of selected pharmaceuticals in case of suspected quality defect of a medicinal product NO 09.11.2018 UST-15 version 4  
UST-11 version 4 Reporting form for use of a non-registered medicinal product NO 02.04.2013

UST-11 version 2