Law of March 9, 2023, on clinical trials of medicinal products for human use

Texts

The consolidated text (tekst ujednolicony) is unofficial; only the signed PDFs from Dziennik Ustaw / Monitor Polski are legally authentic.

Keywords

Related acts

Acts referring to this act

• Amending Acts: Law of July 26, 1991 on Personal Income Tax.
• Amending Acts: Law of 21 February 2019 on the Medical Research Agency
• Amending Acts: Law of 18 March 2011 on the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Amending Acts: Law of 6 November 2008 on Health Care Consultants
• Amending Acts: Law of November 6, 2008, on Patient Rights and the Patient Ombudsman
• Amending Acts: Law of December 5, 2008, on the prevention and combating of infections and infectious diseases in humans
• Amending Acts: Law of 27 August 2004 on healthcare benefits financed from public funds
• Amending Acts: Law of September 6, 2001, Pharmaceutical Law.
• Amending Acts: Law of 5 December 1996 on the professions of physician and dentist.
• Amended Acts: Law of June 4, 2025, on the National Cardiology Network
• Legal Basis: Regulation of the Minister of Health of 26 January 2024 amending the regulation on the rules of the Supreme Bioethics Committee for Clinical Trials
• Legal Basis: Regulation of the Minister of Health of October 18, 2023, on the method of determining the amount of compensation benefit for damage related to participation in a clinical trial
• Legal Basis: Regulation of the Minister of Health of August 18, 2023, on the rules of the National Bioethics Committee for Clinical Trials
• Legal Basis: Regulation of the Minister of Health of 22 September 2023 on the Team for Benefits from the Clinical Trials Compensation Fund
• Legal Basis: Regulation of the Minister of Health of 19 October 2023 on the determination of the regulations of the Appeal Committee for Benefits from the Clinical Trials Compensation Fund and the remuneration of the members of this Committee
• Legal Basis: Regulation of the Minister of Health of July 24, 2023, on the design of a declaration of no conflict of interest in connection with the preparation of an ethical assessment of a clinical trial
• Legal Basis from Art.: Regulation of the Minister of Health of 22 September 2023 on the Team for Benefits from the Clinical Trials Compensation Fund
• Legal Basis from Art.: Regulation of the Minister of Health of August 18, 2023, on the rules of the National Bioethics Committee for Clinical Trials
• Legal Basis from Art.: Regulation of the Minister of Health of July 24, 2023, on the design of a declaration of no conflict of interest in connection with the preparation of an ethical assessment of a clinical trial
• Legal Basis from Art.: Regulation of the Minister of Health of 26 January 2024 amending the regulation on the rules of the Supreme Bioethics Committee for Clinical Trials
• Legal Basis from Art.: Regulation of the Minister of Health of October 18, 2023, on the method of determining the amount of compensation benefit for damage related to participation in a clinical trial
• Legal Basis from Art.: Regulation of the Minister of Health of 19 October 2023 on the determination of the regulations of the Appeal Committee for Benefits from the Clinical Trials Compensation Fund and the remuneration of the members of this Committee
• Consolidated Text for an Act: Announcement of the Marshal of the Sejm of the Republic of Poland of December 4, 2025, on the announcement of the consolidated text of the law on clinical trials of medicinal products for human use
• Repeals Resulting From: Regulation of the Minister of Health of October 12, 2018, on the forms of documents submitted in connection with a clinical trial of a medicinal product and on fees for submitting an application to commence a clinical trial
• Repeals Resulting From: Regulation of the Minister of Health of May 2, 2012, on Good Clinical Practice
• Repeals Resulting From: Regulation of the Minister of Health of April 26, 2012, on clinical trial inspections
• Repeals Resulting From: Regulation of the Minister of Health of April 30, 2004 on the method of conducting clinical trials involving minors
• Repeals Resulting From: Regulation of the Minister of Health of April 30, 2004 on reporting unexpected serious adverse drug reactions
• Repeals Resulting From: Regulation of the Minister of Finance of April 30, 2004, on compulsory civil liability insurance for researchers and sponsors