CASubmissionFormat object

Standard application form available


Standard application form

INFARMED - Portuguese Authority of Medicines and Health Products, created The National Platform for Clinical Trials (PNEC), the portal contains the most important information relating to Clinical Trials in Portugal (from applicable legislation to data on approved trials). This portal is open to all interested persons who may register on it to gain access to all the data introduced by all the other registered individuals and organisations. Soon, the portal will provide access to an electronic submission tool for clinical trials authorisation applications and their amendments, for requests relating to the approval procedures for clinical trials being reviewed by the regulatory authorities, and for the selection and appropriateness of clinical trial-related information, thus avoiding duplication.