General guidelines
| Guideline | Name | Eng.version | Valid since | Replaces | Amends |
|---|---|---|---|---|---|
| UST-46 | Reporting Supplies of Medicinal Products on the Market (REG-13) | 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 |