NLClinicalTrialsIMP object

Applicable national regulations

General Act(s) on Medical/Clinical Research in Humans
National Act on Medicinal Products

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

(1) Act XCV of 2005 on the Medicinal Products for Human Use and on the Amendment of Other Regulations Related to Medicinal Products (as amended) – the 'Medicine Act'

(2) Decree 35/2005 (VIII.26) on the Clinical Trials of Investigational Substances for Human Use and the Good Clinical Practice - the ‘Clinical Trial Decree'

ATMP/ GMO trials: Applicable regulations (if separate legal text)

Decree No 4/2009 (of 17 March 2009) of the Ministry of Health – on Medical Devices (available in Hungarian only). It also applies to Advanced Therapy Medicinal Products, taking into account Regulation (EC) No 1394/2007 of the European Parliament and the Council of 13 November 2007 on ATMP and amending Directive 2001/83/EC and Regulation (EC) 726/2004/EC .

Transposition of (GCP) Directive 2005/28/EC

Incorporated in transposition act(s) of Directive 2001/20/EC

General legislation on Medical/ Clinical Research in Humans

Act CLIV of 1997 on Health Care (as amended)- the "Health Care Act"
Articles 157 – 164 cover biomedical research involving human subjects

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

(1) Biomedical Research/ Non-interventional clinical trials:
- Decree 23/2002 (of 9th May 2002) of the Minister of Health on biomedical research on human individuals (as amended):
Applicable to non-interventional clinical trials and biomedical research and clinical investigations on Medical Devices and In-vitro Diagnostics
- Decree 1/2007 (I. 24.) EüM on the amendment of Decree No. 23/2002 (V. 9) EüM of the Minister of Health on medical research in humans

(2) Authorisation Procedures:
Executive Decree No 235/2009 (of 20 October 2009) on rules governing authorisation procedures of biomedical research, clinical trials with investigational medicinal products for human use as well as clinical investigations on medical devices intended for human use.

Additional Information

NB: The legislation on clinical trials on investigational medicinal products (CTIMPs) has been almost completely separated from those of other biomedical research.