The Law 46/2004 of 19 August 2004 which incorporates the principles of the Clinical Trials Directive 2001/20/EC and creates the “Comissão de Ética para a Investigação Clínica” (National Ethics Committee for Clinical Research – CEIC) was repealed by a new law (Law 21/2014 of April 16)
The Law 21/2014 of 16 April covers all clinical research with humans including not only clinical trials with medicinal products for human use but also studies with medical devices, cosmetics, food supplements and all kind of observational studies. This law also creates the National Ethics Committees Network, coordinated by CEIC, a National Portal for register all clinical research, and a clinical trials database.
Other research related laws in Portugal include:
- The ratified convention on biomedicine.
- The national laws on medicinal products.
- The national law and privacy of personal data.
- The law on medical devices (some topics were repealed by the Law 21/2014 of 16 April).
- The law of genetic information and health information.
All these documents can be found on the website of the National Authority of Medicines and Health Products (INFARMED I.P.) which is the Portuguese Regulatory Agency, at http://www.infarmed.pt and on the website of National Ethics Committee for Clinical Research, at http://www.ceic.pt.
For performing clinical trials in Portugal, sponsors have to get authorization from the Competent Authority and ethical approval from the Ethics Committee (CEIC) plus approval from the National Data Protection Authority (CNPD – “Comissão Nacional de Proteção de Dados”).
The application to the REC, to the competent authority and to CNPD may be submitted in parallel, or in any order.
There is no procedural interaction between the competent authority and the national or local research ethics committee during the approval process. Nevertheless, all of them can request for it.