Clinical Research

Approves the Clinical Investigation Law that revokes Law no. 46/2004, of 19 of August.

First amendment to Law no. 21/2014, of 16 April, which approves the law on clinical research, in order to set the conditions under which monitors, auditors and inspectors may access the registration of participants in clinical trials.

Diplomas relating to Law no. 21/2014, of 16 April:

Approves the composition, funding and operating rules, as well as the articulation between the Ethics Committee for Clinical Research (CEIC) and the Ethics Committees for Health (CES).

Establishes the fees that are due for the acts provided within the scope of Law 21/2014, of 16 April

On the National Network of Ethics Committees for Health (RNCES);

On the National Clinical Trials Register (RNEC);

Concerning the RNEC Coordinating Committee

Status of Medicinal Products

Establishes the principles and guidelines of good clinical practice as regards investigational medicinal products for human use, as well as the special requirements applicable to authorisations for the manufacture or importation of such products, transposing into the national legal system Commission Directive 2005/28/EC of 8 April.

Repeals Directive 2001/20/EC and concerns clinical trials on medicinal products for human use

Personal Data Protection Act (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.

Personal genetic information and health information

Regulates Law no. 12/2005, of 26 January, regarding the protection and confidentiality of genetic information, human genetic databases for the purposes of health care and health research, the conditions for offering and carrying out genetic tests and the terms under which medical genetic consultation is ensured.