Instructions for Applicants
- Online submission through CEC Online database of a new application for obtaining an opinion on acceptability of a clinical trial or a non-interventional trial should be announced approximately a month before the announced deadline for submission of documentation in order to make sure that the trial will be assessed at a wanted meeting. On the basis of submitted data, Agency will send invoice for CEC opinion to the applicant. Confirmation of the payment must be submitted as a part of documentation for clinical trial application.
- The documentation for the opinion on acceptability of a new trial must be submitted in one paper copy and one electronic copy (e-mail, CD, USB).
- Applicants must in the CEC Online database enter the requested data in order to generate appropriate forms for submission of the application before the announced deadline for submission of documentation. The forms must be signed by the applicant and submitted in hard copy together with the application and required documentation to the Agency. The data entered into the SEP Online database and the data submitted to the Agency in hard copy must be identical.
Example of CV of principal investigator and monitor:
- CV of the investigator, (.doc), (.pdf) (available in Croatian)
- CV of the monitor, (.doc), (.pdf) (available in Croatian)
Detailed instructions to applicants:
- Detailed instructions to applicants (Version 2), (.docx), (.pdf) (available in Croatian)
- National specifics related to the Clinical Trials Information System - CTIS (Version 1), (.docx), (.pdf) (available in Croatian)
- Instructions to applicants on new services related to the clinical trials approval - June 2022 (available in Croatian)
Using SEP Online database
SEP Online database is available at the following address http://sep.halmed.hr
In order to be able to use the application, you should use Mozilla Firefox or Google Chrome.
To register as a user of the SEP Online database, please fill in the form and send it, signed and stamped by the responsible person of the applicant to IT Unit or to CEC per post to: Agency for Medicinal Products and Medical Devices of Croatia, Ksaverska cesta 4, 10 000 Zagreb, Republic of Croatia or personally to HALMED's Registry Office.
- User instructions for applicants - (.pdf) (available in Croatian language)
- User instructions for local administrators - (.pdf) (available in Croatian language)