CASubmissionFormat object

Format option(s)

Paper form (or electronically + in writing); in the script in official use in the RS.

Standard application form available

Yes

Standard application form

The standard application form (Form 1) to be used for notification/ request for authorization is available (in Serbian and cyrillic script only) on the ALIMS website in section Regulativa » Medicinska sredstva» Obrasci (Obrazac za odobrenje / prijavu kliničkog ispitivanja medicinskog sredstva).

Guidance on submission format

Art 7 of the Rulebook Application 2011

Applicable national legal framework/ Reference

Art 7 of the Rulebook Application 2011

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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