CASubmissionFormat object

Format option(s)

Online portal
Mandatory On-line Submission through RNEC: https://www.rnec.pt/

Preferred format

Online portal

Standard application form

Annex 1: Clinical trial Application Form https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/application-form2009_en.pdf

Standard application form - Additional information

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

Guidance on submission format available

Yes

Guidance on submission format

Yes, but only in Portuguese

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)
Links:
http://www.infarmed.pt/web/infarmed/entidades/medicamentos-uso-humano/ensaios-clinicos/submissao_infarmed
and at https://www.rnec.pt/pt/submissao-nacional

National legal framework in place

Yes

Applicable national legal framework/ Reference

Art 26 (1) Law 21/2014 (pt)

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395