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 three hard-copies (one copy with the original documents for the CEC archive, and two copies with copies of the documents for the assessors).
  • 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.
  • The applicants may collect two hard-copies with copies of the documents at Ksaverska 4 within 30 days after the new application has been reviewed. Through CEC online database you will be informed about dates and time when you can collect copies of the documentation. Otherwise, the documentation shall be destroyed.

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 1), (.docx), (.pdf) (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 3.x version or Internet Explorer 8.

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:

  • User instructions for applicants - (.pdf) (available in Croatian language)
  • User instructions for local administrators - (.pdf) (available in Croatian language)

Any queries or application-related error reports should be sent to the IT Unit's e-mail address it.unit@halmed.hr or to the CEC's professional secretary at: andreja.duilo@halmed.hr.