News and Educations

Updated guidance on submission of scientific advice applications published


The Agency for Medicinal Products and Medical Devices (HALMED) has published updated guidance for submission of scientific advice applications.

Updated guidance also includes a new version of the application form for scientific advice in bilingual (Croatian/English) version. The guidance is available here.

The scientific advice is a procedure where HALMED advises pharmaceutical manufacturers or applicants/marketing authorisation holders on the appropriate pharmaceutical, non-clinical and clinical studies that need to be carried out for the purpose of granting or varying a marketing authorisation. Furthermore, the advice can be given on GMP and regulatory issues, pharmacovigilance activities, planned changes in labelling (mock-up) and package leaflet, changes to legal/dispensing status, proposals on medicinal product name and all other regulatory issues within the competence of HALMED.