CATimelineAuthorisation object

General timespan (max nr days)

30

Mode of approval (General)

INFARMED usually sends an email confirmation and a letter.

ATMP/GMO trials (max nr days)

50

Mode of approval (ATMP/GMO trials)

Explicit

External expert advice required (max nr days)

100

Xenogeneic cell therapy (max nr days)

No time limit

Mode of approval (Xenogeneic cell therapy)

Explicit

Clock-stop possible if complementary information requested

Yes

Applicable national legal framework/ Reference

Art 26 & 77 of Law 21/2014 (pt)

Additional Information

Submission to INFARMED and CEIC are simultaneous at RNEC.
Submission to Health Units and respective Ethical Committee are done at the same time.
A DPO in each Health Unit is responsible for assuring the compliance of data protection procedures with GDPR.

NB! Hospital administrations may delay the approval even after receiving authorization from INFARMED/ CEIC/ CNPD because of several internal requirements.

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
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