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 YES 1.9.2013 -  
UST-36 version 5 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 01.01.2017 UST-36 version 4  
UST-35 version 2 Non-intervention post-marketing studies YES 12.1.2015 UST-35 version 1  
UST-34 version 1 Project of the laboratory control and sample collection NO 15.3.2014  UST-34  
UST-31 version 3 Principles of Identification of Medicinal Products for Human Use in the Czech Republic YES 14.03.2017 UST-31 version 2  
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 18

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

YES 01.01.2018 UST-29 version 17  
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 7 Reimbursement of costs of expert activities conducted upon request – waivers and refunds YES  01.01.2018 UST-24 version 6  
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 4 Notification of selected medicinal products to SUKL NO 01.11.2018

UST-21 version 3

 
UST-20 Application for an opinion to the proposal of a specific therapeutic programme NO 05.06.2003    
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 1 Sponsorship according to the Act on Advertising NO 01.07.2007 UST-16  
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