The conduct of clinical trials on medicines for human use is governed by Law no. 21/2014 of 16 April that implements Directive 2001/20/EC of the European Parliament and of the Council of 4 April in Portuguese legislation.
In addition to the above legislation there are a series of guidelines covering various matters related to clinical trials which can be found in Volume X of Eudralex.
To that end, and as part of the harmonised European system, the conduct of clinical trials in Portugal requires authorisation from INFARMED, I.P. and a prior favorable opinion from CEIC (Ethics Committee for Clinical Research).
- Law no. 21/2014, of 16 April - Establishes specific provisions regarding the conduct of clinical trials, clinical studies with and without intervention and those using medical devices and repeals Law 46/2014, of 24 August.
- Legal documents related to the Law no. 21/2014, of 16 April:
- Ordinance no. 135-A/2014, of 1 July - Approves the composition, funding and operating rules, as well as the relationship between the National Ethics Committee for Clinical Research (CEIC) and the Health Ethics Committees (CES);
- Ordinance no. 63/2015, of 5 March - Establishes the fees to be paid for the services provided within the scope of The Law No. 21/2014
- Ordinance no. 64/2015, of 5 March - concerning the National Network of Health Ethics Committees (RNCES);
- Ordinance no. 65/2015, of 5 March - concerning the National Clinical Studies Register (RNEC);
- Order no. 2291/2015, of 5 March - regarding the RNEC steering committee.
- Decree-Law no. 176/2006, of 30 August - Establishes the legal system of the medicinal products for human use and is usually referred as Medicinal Products Statute.
- Decree-Law no. 102/2007 of 2 April - Establishes the principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as requirements for authorization of the manufacturing and importation of such products.
- Law no. 67/98 of 26 October - Act on the Protection of Personal Data (transposing into the Portuguese legal system 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 - regulates the treatment of personal genetic information and health information
- Decree-Law no. 131/2014 of 29 August - Regulates Law 12/2005, of 26 January, regarding the protection and confidentiality of genetic information, the databases of human genetics with the purpose of providing health care and health research, the conditions of supply and realization of genetic tests and the conditions under which consults of medical genetics are assured.