Medicinal Products

DCP Marketing Authorisation Procedures

Specific national requirements

  1. A written statement from the future MAH (if not seated in Croatia) naming its local representative seated in Croatia with the contact details,
  2. Proof that the future MAH has a responsible person for pharmacovigilance seated in Croatia, approved by the Agency, or proof that application for his/her approval has been submitted to the Agency (this submission should be separate from the submission for marketing authorisation),
  3. Proof that the fee for the procedure has been paid.

For Patients and Public

For Health Care Professionals

For Industry Representatives