Did you know that Croatian CEC and MOH have different timelines for approvals?

The Central Ethics Committee is obliged to give a written Opinion on the acceptability of proposed clinical trial within 30 days of  the date of receipt of complete documentation as is regulated by the Ordinance on Clinical Trials.

CEC timeline for approval per submission type, is as follows:

  • 30 days after the complete documentation has been submitted*
  • 90 days after the complete documentation has been submitted for gene therapies, somatic cells and genetically modified organisms therapies

*The deadline for the approval may be extended by an additional 90 days in the event of the need for consultation with experts or committees.

For xenogenic medicinal products, there is no deadline for giving the Opinion on the acceptability of conducting the clinical trial.

MOH timeline for approval per submission type, is as follows:

30 days for:

  • IPs which have the marketing authorization in other countries, but not in Croatia;
  • IPs that are authorised for marketing in the Republic of Croatia, but need to be tested for new indications, new methods of administration, newly proposed active substance combinations, and different dosage regimens compared with those previously approved, or for the purpose of gaining new clinical experience required;
  • IPs whose bioavailability will be tested either in comparison with the bioavailability of any product already authorised for marketing in the Republic of Croatia or in comparison with that of a product that has not been authorised for marketing in the Republic of Croatia.

60 days for:

  • IPs with no marketing authorization in any country;

90 days for:

  • a drug product intended for gene therapy, treatment with somatic cells, including xenogenic cells and treatment with medicinal products containing genetically modified organisms