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 |
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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 |