ECGeneralEthicalReview object
Submission for Ethical review mandatory for
Clinical IMP trials
Clinical ATMP trials
Submission to CA and EC to be performed in the following order
In parallel
Sequentially (in any order)
Procedural interaction - Additional information
National Ethics Committee (CEIC) - Same as the one described above for Infarmed, but more details about the documents evaluated by CEIC experts are provided at CEIC website
Additional Information
NB! 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”) according Art 16 & 25 Law 21/2014 (pt).
Regulatory and ethics bodies involved in approval process
Competent Authority/-ies (CA)
Ethics committee(s)
• Recruiting sites: Administration Board and Local Ethical Committee
