CASubmissionOfApplication object

Responsible for study submission

Sponsor
Other
Sponsor or other organization designated by sponsor

Guidance on submission of application

Detailed guidance for the applicant on trial submission and the definite structure of documentation is provided at INFARMED website (1). There is a File to be uploaded with all documents that must be submitted “ Estrutura de organização de pastas conforme Instruções ao requerente”.

At RNEC website, after sponsor is registered in the platform, there is also a tutorial for on-line submission. RNEC (National Registry of Clinical Studies) http://www.rnec.pt/pt. RNEC has a private area with registered users to submit studies and manage the process approval and also a public area where it is possible to search for registered studies in Portugal since January 2017

All the information is available only in Portuguese. For further guidance an email is available: daps@infarmed.pt
Link
(1) http://www.infarmed.pt/web/infarmed/entidades/medicamentos-uso-humano/ensaios-clinicos/submissao_infarmed

National legal framework in place

Yes

Applicable national legal framework/ Reference

Art 25-27 Law 21/2014 (pt)
Annex VIII and Annex XV, DL 145/2009 (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