CASubmissionFormat object
Electronically
Mandatory online submission through RNEC: https://www.rnec.pt/
Online portal
Yes
Annex 1- Clinical Trial Application Form
https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/application-form2009_en.pdf
At Infarmed website there is a Zip File with all the files that must include documents to be submitted to CA through RNEC (on-line) as described above.
http://www.infarmed.pt/web/infarmed/entidades/medicamentos-uso-humano/ensaios-clinicos/submissao_infarmed
Yes
There is a Flowchart and Support slides describing the process and the needed documents to be submitted (Apresentação de Apoio - Ensaios Clínicos: Documentação e Boas Práticas Regulamentares - setembro 2017)
Link:
http://www.infarmed.pt/web/infarmed/entidades/medicamentos-uso-humano/ensaios-clinicos/submissao_infarmed
and at
https://www.rnec.pt/pt/submissao-nacional