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General guidelines

  Name En. v. Valid. since Replaces Amends
UST-46 Reporting Supplies of Medicinal Products on the Market YES 05.06.2024 -  
UST-45 Reporting Launch, Suspension, Renewal and Termination of Medicinal Product Placement on the Market with Focus upon Obligations Associated with the Notification of Supply Suspension and Quantities of Goods Available to the MAH YES 01.06.2024 -  
UST-44 Requirements of the State Institute for Drug Control on the drafting, content and distribution of the letter to operators related to quality defects in medicinal products NO 11.04.2022 -  
UST-43 Requirements of the State Institute for Drug Control on the drafting, content and distribution of the letter for healthcare professionals related to the availability of a medicinal product NO 01.02.2022 -  
UST-42 version 1 Sponsoring and Provision of Gifts and Other Benefits to Experts and Employees of Healthcare Providers in Advertising for Medical Devices and in Vitro Diagnostic Medical Devices YES 31.10.2023 UST-42  
UST-41 version 1 Provision of Promotional Samples of Medical Devices and in Vitro Diagnostic Medical Devices YES 31.10.2023 UST-41  
UST-40 version 1 Recommending Guideline on the Term “Expert” YES 01.11.2023 UST-40  
UST-39 version 1 Regulation of Advertising for Medical Devices and in Vitro Diagnostic Medical Devices YES 31.10.2023 UST-39  
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