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 new applications for marketing authorisation.

Full electronic dossier should be submitted via CESP or sent by post/courier on CD or DVD to the following address:
Agency for Medicinal Products and Medical Devices
Ksaverska cesta 4
10 000 Zagreb
Croatia

In parallel to the electronic dossier submission, Cover letter, Application form and Letters of authorisation must be submitted in original paper copies with wet signature(s).

Detailed list of national requirements:

Documents to be submitted in paper (originally signed documents or certified copies):

  1. A separate Cover letter in Croatian language for each strength and/or pharmaceutical form,
  2. A separate Application form for each strength and/or pharmaceutical form,
  3. Letters of Authorisation
    a) Letter of Authorisation by the responsible person of the applicant by which he or she authorises a person responsible for submission of application, signing the Application form and communication on behalf of the applicant during the procedure,
    b) Letter of Authorisation by the responsible person of the future MAH (in case future MAH is different from the applicant, i.e. they are different legal entities) by which he or she authorises the applicant for submission of the application on his behalf,
    c) Letter of Authorisation by the responsible person of the applicant by which he or she authorises a responsible person for submission of application, signing the Application form and communication on behalf of the applicant after issuing marketing authorisation.

In case the person authorised for submission of application, signing the Application form and communication on behalf of the applicant during or after the procedure is not an employee of the applicant, the following Letter of Authorisation should be submitted in addition:

  • Letter of Authorisation by the responsible person of the legal entity in which the person authorised for submission of application is employed (i.e. an authorisation by his/her employer).

Documents to be submitted electronically (paper copies not required):

  1. Proof of establishment of the applicant in the EEA, not older than 6 months from the day of submission of the application (in case future MAH is different from the applicant, the aforementioned document is required also for the future MAH),
  2. Written statement by the future MAH (if not seated in Croatia) naming its local representative seated in Croatia with the contact details,
  3. 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),
  4. Proof that fee for the procedure has been paid,
  5. 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 done in Croatian kuna (HRK).

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