National Legislation
The conduct of clinical trials of medicinal products for human use is regulated by the provisions of Regulation (EU) No. 536/2014 of the European Parliament and of the Council, of 16 April 2014 (the Regulation), and Law No. 9/2026, of 6 March, which ensures the implementation, within the domestic legal order, of the Regulation on clinical trials of medicinal products for human use and which repeals Directive 2001/20/EC.
Complementing the legislation referred to above, there is a set of guiding standards covering various areas related to clinical trials, which are available in Volume X of EudraLex.
In this regard, and as part of the harmonised European system, the conduct of clinical trials of medicinal products for human use at national research centres is subject to prior authorisation by INFARMED ¿ National Authority of Medicines and Health Products, IP (INFARMED, IP), following the technical-scientific and ethical assessment of the clinical trial application, in accordance with the terms set out in the Regulation and in Law No. 9/2026, of 6 March.
Documents:
- Regulation (EU) No. 536/2014 of the European Parliament and of the Council, of 16 April 2014 ¿ on clinical trials of medicinal products for human use and repealing Directive 2001/20/EC. Text with EEA relevance.
- Law No. 9/2026, of 6 March - Regulates clinical trials of medicinal products for human use and amends the clinical research law.
- Legislation related to Law No. 21/2014, of 16 April:
- Ministerial Order No. 135-A/2014, of 1 July - Approves the composition, funding and operating rules, as well as the coordination between the Ethics Committee for Clinical Research (CEIC) and the Health Ethics Committees (CES).
- Ministerial Order No. 63/2015, of 5 March - Sets the fees applicable to acts carried out under Law No. 21/2014, of 16 April.
- Ministerial Order No. 64/2015, of 5 March - Concerning the National Network of Health Ethics Committees (RNCES).
- Ministerial Order No. 65/2015, of 5 March - Concerning the National Registry of Clinical Studies (RNEC).
- Order No. 2291/2015, of 5 March - Concerning the coordinating committee of the RNEC.
- Decree-Law No. 176/2006, of 30 August - Medicinal Products Statute.
- Decree-Law No. 102/2007, of 2 April - Establishes the principles and guidelines of good clinical practice with regard to investigational medicinal products for human use, as well as the specific requirements applicable to manufacturing or import authorisations for such products, transposing into domestic law Commission Directive 2005/28/EC of 8 April.
- Law No. 67/98, of 26 October - Personal Data Protection Law (transposes into Portuguese law Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data).
- Law No. 12/2005, of 26 January - Personal genetic information and health information.
- Decree-Law No. 131/2014, of 29 August - Implements Law No. 12/2005, of 26 January, with regard to the protection and confidentiality of genetic information, human genetic databases for healthcare and health research purposes, the conditions for offering and conducting genetic tests, and the terms under which medical genetics consultation is ensured.
- Decree-Law No. 80/2018, of 15 October - Regulates the health ethics committees.
