Legislations
- Law 336/2002
- Oviedo Convention on Human Rights and Biomedicine (2001)
- Law No. 667/2001 on the Protection of Individuals with Regard to the Processing of Personal Data and on the Free Movement of Such Data
Regulations
- Ordinance No. 57/16.08.2002 (2002)
MOH:
- Emergency Ordinance 152/1999 on Medicinal Products for Human Use
- Order of MOH No. 1300/2004: Detailed Guidance on the Application Format and Documentation to be submitted in an Application for an Ethics Committee Opinion on the Clinical Trial on Medicinal Products for Human Use (2004)
- Order of MOH No. 1117/2004: Detailed Guidance for the Request for Authorization of a Clinical Trial on a Medicinal Product for Human Use to the Competent Authorities, Approval of Substantial Amendments and Declaration of the End of the Trial (2004)
- Order of MOH No. 904/25.07.2006 Transposing Directive 2001/20/EC of the European Parliament and of the Council (2006)
Guidelines
- MOH: Guideline for Clinical Trials in Pediatric Populations (CPMP/ICH/2711/99) (1999)
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