NLClinicalTrialsIMP object

Applicable national regulations

General Act(s) on Medical/Clinical Research in Humans
Transposition of (CT) Directive 2001/20/EC
Transposition of (GCP) Directive 2005/28/EC
Other

Transposition of (CT) Directive 2001/20/EC (or comparable national legal framework)

• Act of 6 September 2001 Pharmaceutical Law, published in Journal of Laws from 2008, No. 45, item 271 (Dz.U. 2008 nr 45 poz. 271), hereinafter referred to as "Pharmaceutical Law 2001 (en)".

Act transposing (GCP) Directive 2005/28/EC

• Order of the Minister of Health of 2 May 2012 (Dz.U. 2012 poz. 489) concerning special requirements of Good Clinical Practice
• Order of the Minister of Health of 11 Mar 2005 (Dz.U. 2005 nr 57 poz. 500) concerning special requirements of Good Clinical Practice

General legislation on Medical/ Clinical Research in Humans

• Act of 5 December 1996 on the professions of a physician and a dentist, hereinafter referred to as "Physician’s Profession Act 1996" (Dz.U. 1997 nr 28 poz. 152, Dz.U. 2005 nr 226, poz. 1943 with amendments), covers medical experiments on humans and basic regulations concerning Bioethics Committees.

Other applicable regulations/ implementing provisions (Acts, laws, decrees, ordinances, circulars, etc)

Pharmaceutical Law 2001 (en) & Physician's Profession Act 1996 are specified by several ordinances and regulations issued by the Minister of Health (or Finance). Some of the most relevant regulations published in the Journal of Laws (Dziennik Ustaw, Dz.U):

(1) Clinical trial application to the CA/ EC:
• Order of the Minister of Health 2 May 2012 (Dz.U. 2012 poz.491) regulates the documentation and fees for submitting an application to the CA and the Bioethics Committee (includes templates for trial application, submission of amendments and trial termination).
• Order of the Minister of Health 15 Nov 2010 (Dz.U. 2010 nr 222 poz. 1453) on clinical trial application, the submission fees for authorization and the final report on the conduct of a clinical trial
• Order of the Minister of Health 11 Feb 2011 (Dz.U. 2011 nr 40 poz. 210) concerning detailed requirements for the basic documentation of clinical trials (drafting, monitoring, preparing and storing)

(2) Adverse Event Reporting
• Order of the Minister of Health 30 Apr 2004 (Dz.U. 2004 nr 104 poz. 1107) on reporting of unexpected serious
adverse reaction to a medicinal product

(3) Central Record of Clinical Trials
• Order of the Minister of Health 29 November 2002 Dz.U. 2002 nr 209 poz. 1783 in matter of the Central Register of Clinical Trials

(4) Inspection
• Order of the Minister of Health 7 Apr 2005 (Dz.U. 2005 nr 69 poz. 623) regulates the nature and extent of inspection of clinical trials

(5) Patients’ Rights
• The Act on Patients’ Rights of 6 Nov 2008 (Dz.U. 2012 poz. 159)

(6) Clinical trials on Minors
• Order of the Minister of Health 30 April 2004 (Dz.U. 2004 nr 104 poz. 1108) on the conduct of clinical trials in minors

Additional Information

There has been an ongoing process of adjusting the legal framework to the European Union directives (European Directive 2001/20/EC and European Directive 2005/28/EC).

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395
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