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 4 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 01.07.2012 UST-36 version 3  
UST-35 version 2 Non-intervention post-marketing studies YES 12.1.2015 UST-35 version 1  
UST-34 Project of the laboratory control and sample collection NO 01.04.2008  -  
UST-33 Application of Act No 477/2001 Coll., on Packages, as amended, in relation to pharmaceuticals NO 01.04.2007 UST-13  
UST-32 version 2 EAN-Codes notification and registration YES 17.09.2009 UST-32 version 1  
UST-31 version 2 Principles for identification of human medicinal products in the CR YED 24.07.2013 UST-31 version1  
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 16

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

YES 1.6.2016 UST-29  version 15  
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 5 Reimbursement of costs of expert activities conducted upon request – waivers and refunds YES 07.11.2014 UST-24  version 4  
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 3 Notification of selected medicinal products to SUKL NO 3.1.2014

UST-21 version 2

 
UST-20 Application for an opinion to the proposal of a specific therapeutic programme NO 05.06.2003    
UST-19 version 3 Application for a decision whether a product should be classified as a pharmaceutical or a medicinal product subject to registration YES 03.12.2012 UST-19 version 2  
UST-16 version 1 Sponsorship according to the Act on Advertising NO 01.07.2007 UST-16  
UST-15 version 4 Procedure to be followed by health care professionals and vendors of selected pharmaceuticals in case of suspected quality defect of a medicinal product NO 30.10.2015 UST-15 version 3  
UST-11 version 4 Reporting form for use of a non-registered medicinal product NO 02.04.2013

UST-11 version 2