News and Educations

Minor changes to the procedure of DSUR submission

04.07.2022

Agency for Medicinal Products and Medical Devices of Croatia (HALMED) hereby informs applicants that, regarding DSUR submission, all documentation (cover letter and the document itself) should be sent to the e-mail address: ispitivanja@halmed.hr.

The cover letter should contain the following data:

  • Period covered by the report
  • Clinical trials ongoing in Croatia
  • Data needed to issue an invoice for the DSUR assessment procedure (address and VAT number…)

Any questions or requests for additional information may be sent to HALMED via e-mail ispitivanja@halmed.hr.

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