| UST-47 | Calculating the usual quantity of medicinal products marked with the “limited availability” flag. | NO | 1. 7. 2025 | – | |
| UST-46 | Reporting Supplies of Medicinal Products on the Market (REG-13) | YES | 5. 6. 2024 | – | |
| UST-45 version 1 | Reporting Launch, Interruption, Renewal or Cessation of a Medicine on the Market with Focus upon Obligations Associated with the Notification of Supply Interruption and Quantities of Goods Available to the MAH | YES | 11. 7. 2025 | UST-45 | |
| UST-44 version 1 | 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 | YES | 3. 2. 2025 | UST-44 | |
| UST-43 version 1 | 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 | 5. 12. 2024 | UST-43 | |
| 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 | 1. 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
| 4. 1. 2016 |
–
|
|
| UST-37 version 1 |
Application for a hospital exemption for advenced therapy medicinal products
|
NO
| 10. 5. 2019 | UST-37 |
|
| UST-36 version 7 |
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
| 27. 1. 2025 | UST-36 version 6 |
|
| 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
| 1. 6. 2019 |
UST-34 version 1
|
|
| UST-30 version 4 |
Basic principles for distinguishing between medicinal products for human use and other products, including detailed specification of medicinal products subject to marketing authorization
|
NO
| 20. 12. 2013 | UST-30 version 3 |
|
| UST-29 version 25 | Administrative fees, reimbursements of costs of expert activities, reimbursements of activities associated with the provision of information and reimbursements of other activities |
YES
| 27. 1. 2025 | UST-29 version 24 |
|
| UST-27 version 4 | Basic provisions of the Act on Advertising Regulation concerning the advertising of human medicinal products |
NO
| 1. 1. 2025 | UST-27 version 3 |
|
| UST-24 version 12 | Reimbursement of costs of expert activities conducted upon request – waivers and refunds; provision of expert information to competent authorities |
YES
| 3. 3. 2025 | UST-24 version 11 |
|
|
UST-23 version 3
| Providing of free samples of human medicinal products for promotional purposes |
NO
| 10. 11. 2014 |
–
|
|
|
UST-21 version 7
| Reporting of Selected Medicinal Products and Batch Release onto the Market |
YES
| 1. 4. 2021 | UST-21 version 6 |
|
| UST-20 version 2 | Application for an opinion to the proposal of a specific therapeutic programme |
YES
| 19. 12. 2024 | UST-20 version 1 |
|
|
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
| 1. 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
| 4. 12. 2020 |
UST-16 version 1
|
|
| UST-15 version 7 |
Procedure to be followed by health care professionals and vendors of selected pharmaceuticals in case of suspected quality defect of a medicinal product
| YES | 1. 2. 2025 | UST-15 version 6 |
|
Drug database