Drug database
Clinical Trials
| Guideline | Name | Eng.version | Valid since | Replaces | Amends |
|---|---|---|---|---|---|
| KLH-22 version 5 | Requirements Governing the Text of Patient Information Leaflet Trial Subject Information Sheet/Informed Consent Form | YES | 1.6.2022 | KLH-22 version 4 | |
| Reporting Adverse Reactions to Medicinal Products for Human Use in a Clinical Trial and to Medicinal Products without Marketing Authorisation | YES | 20.7.2018 | KLH-21 version 6 | ||
| KLH-19 version 3 | Requirements on authorisation of clinical trials on medicinal products – data required for the pharmaceutical part of the documentation | YES | 11.09.2024 | KLH-19 version 2 | |
| KLH-12 version 4 | Requirements for Documentation Relating to Compliance with Good Manufacturing Practice in the Submission of Applications for Clinical Trial Authorisation | YES | 11.09.2024 | KLH-12 version 3 | |
| SKP-1 version 2 | Certificate of good clinical practice issuing | NO | 31.01.2022 | SKP-1 version 1 |