General guidelines

  Name En. v. Valid. since Replaces Amends
UST-36 version 3 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 3.6.2011 UST-36 version 2  
UST-35 version 1 Non-intervention post-marketing studies YES 1.9.2008 UST-35  
UST-34 Project of the laboratory control and sample collection NO 1.4.2008    
UST-33 Application of Act No 477/2001 Coll., on Packages, as amended, in relation to pharmaceuticals NO 1.4.2007 UST-13 -
UST-32 version 2 EAN-Codes notification and registration YES 17.9.2009 UST-32, version 1 -
UST-31 v.1 Principles for identification of human medicinal products in the CR
(version 1)
NO 1.7.2007 UST-31 -
UST-30 version 2 Basic principles for distinguishing between medicinal products for human use and other products, including detailed specification of medicinal products subject to marketing authorization NO  12.5.2010 UST-30  version 1 -
UST-29 version 10

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

NO 1.4.2012 UST-29  version 9  
UST-28 version 1 Authorisation of parallel import of medicinal products YES 4.7.2008 UST-28 -
UST-27 version 2 Basic provisions of the Act on Advertising Regulation concerning the advertising of human medicinal products NO 3.11.2008 UST-27 version 1 -
UST-24 version 3 Reimbursement of costs of expert activities conducted upon request - waivers and refunds YES 3.11.2009 UST-24  version 2  
UST-23 version 2 Providing of free samples of human medicinal products for promotional purposes NO 1.8.2008 UST-23 version 1  
UST-22 Standard terms of dosage forms, methods of administration, and containers - amendment NO 1.10.2003 - UST-17
UST-21 version 1 Notification of selected medicinal products to SUKL NO 1.9.2008 UST-21 -
UST-20 Application for an opinion to the proposal of a specific therapeutic programme NO 5.6.2003 - -

doc.pngUST-19_version 2, soubor typu doc, (80 kB)

Application for a decision whether a product should be classified as a pharmaceutical or a medicinal product subject to registration YES 1.8.2008 UST-19 verze 1 -
UST-17 Standard terms of dosage forms, methods of administration, and containers NO 1.5.2003 UST-4 -
UST-16 v.1 Sponsorship according to the Act on Advertising
(version 1)
NO 1.7.2007 UST-16 -
UST-15 version 1 Procedure to be followed by health care professionals and vendors of selected pharmaceuticals in case of suspected quality defect of a medicinal product NO 1.6.2009 UST-15 -
UST-11 version 3 Reporting form for use of a non-registered medicinal product NO 13.7.2009

UST-11 version 2

-
UST-9 Provision to minimise the risk of transmission of animal spongiform encephalopathies directed to pharmacies, manufacturers and wholesalers of active pharmaceutical ingredients and excipients for preparation of medicinal products in pharmacies NO 1.6.2001 - -
UST-5 Permanent service of the State Institute for Drug Control for cases requiring urgent measures for safety reasons for pharmaceuticals and medical devices NO 1.10.2000 - -