Medicinal Products

MRP and DCP Procedures - Specific National Requirements

Specific national requirements

New applications in MRP/DCP

The electronic format (eCTD) is the format for the submission of all applications for marketing authorisation.

Full electronic dossier should be submitted via CESP to HALMED.

Detailed list of national requirements:

  1. Written statement by 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 responsible person for Pharmacovigilance seated in Croatia authorised 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 fee for the procedure has been paid,
  4. Proof that the administrative fee has been paid directly to the State treasury in the amount of 225 HRK. This fee should be paid for each strength/pharmaceutical form to:
    Recipient:
    Ministarstvo financija
    Katančićeva 5
    10000 Zagreb
    Hrvatska (Croatia)
    IBAN CODE: HR12 1001 0051 8630 00160
    SWIFT CODE: NBHRHR2XXXX
    Reference: 64 5002-47107-MAH's VAT number
    The payment should be made in Croatian kuna (HRK).