Legislations
- Oviedo Convention on Human Rights and Biomedicine (2001)
- Approval of the Applicable Legal Standards for the Conduct of Clinical Trials of Medicines for Human Use, Law No. 46/2004
- Approval of the Composition, Operations, and Financing of the Ethics Commission for Clinical Research, Decree No. 57/2005 (Portuguese)
- Constitution, Article 35 (1997)
- Act on the Protection of Personal Data, No. 67/98 (1998)
Regulations
- Decree-Law No. 102/2007 of April 2
Guidelines
- Opinion 4/CNE/93 on Clinical Trials (1993)
- Opinion 9/CNE/94 on Ethics Commissions (1994)
- Doc. 13/CNECV/95 on Legislation on Clinical Trials and Ethics Committees (1995)
- Doc. 34/CNECV/2001 on the Helsinki Declaration (2001)
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