CASubmissionFormat object

Format option(s)

Depends on type of MD (CE-marked, non-CE-marked, use within or outside label) and study (investigation of MD alone or Combination study with MP)

Standard application form available

Yes

Standard application form

(1) Submission to AEMPS/ Dept. Medical Devices- SGPS: (MDs non-CE marked and/or CE-marked used outside label): The protocol has to be submitted by use of the standard application form “Formulario de datos básicos de la solicitud de autorización de investigaciones clínicas con productos sanitarios”, available for download on the AEMPS website.

(2) Submission to AEMPS/ Dpt. for Medicinal Products for Human Use - SGMUH (MP+MD Combination studies): The protocol has to be submitted via the online portal “Sede Electrónica” (upload the xml file with the protocol).

Additional Information

1) Submission to AEMPS/ Dept. Medical Devices- SGPS:
• email to psinvclinic@aemps.es,
• CD-ROM with the information dissected into separate files and a paper version of the form B (by ordinary mail)

2) Submission to AEMPS/ Dpt. for Medicinal Products for Human Use - SGMUH:
Online submission via Portal ECM (Ensayos Clínicos con Medicamentos)
The AEMPS website (Section Clinical Trials) provides practical guidance and manuals on the use of the portal ECM and the application modality.
The submission portal is also accessible via "sede electrónica” to upload the xml file with the protocol.

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