Medicinal Products

Transfer of Marketing Authorisation

The marketing authorisation holder initiates the procedure for transfer of marketing authorisation by a written application submitted to the Agency for Medicinal Products and Medical Devices (HALMED) in original, in Croatian.

The written application for transfer of marketing authorisation is to be submitted separately, for every pharmaceutical form and strength of the medicinal product on the current Application form for transfer of marketing authorisation. After completing the current Application form for transfer of marketing authorisation, the application should be printed on a memorandum, signed and sealed (no cover letter is needed).

Alongside the application for transfer of marketing authorisation, the applicant should submit:

  • Original statement of consent of the marketing authorisation holder’s responsible person for the transfer of the marketing authorisation to other natural or legal person, as well as the transfer of all rights and responsibilities to that other natural or legal person as well as the transfer of the entire product documentation, based on which the marketing authorisation was granted, as well as all approved variations after granting the marketing authorisations (please indicate which medicinal product, other natural or legal person and other data),
  • Original statement of the natural person or legal persons responsible person to which the marketing authorisation is to be submitted, about the acceptance of the marketing authorisation transfer, rights and responsibilities of the marketing authorisation holder and the acceptance of the complete product documentation based on which the marketing authorisation was granted, as well as all approved variations (please indicate the name of the medicinal product, current marketing authorisation and the date of taking the rights and responsibilities of the future marketing authorisation holder over),
  • Proof that the seat in the EU of the natural or legal person to which the marketing authorisation is to be transferred is not older than 6 months from the submission date,
  • Written authorisation/s of the future marketing authorisation holder's responsible person authorising a person for submission, signing of the application form and communication on behalf and for the account of the future marketing authorisation holder, after the transfer of the marketing authorisation, in original or certified copy,
  • Statement of consent of the applicant in the mutual recognition or decentralised procedure for submission of the application for transfer of the marketing authorisation in the Republic of Croatia to other marketing authorisation holder,
  • Written statement of the future marketing authorisation holder without a seat in the Republic of Croatia about the appointment of a local representative with the seat in the Republic of Croatia and his contacts,
  • Agreement between the manufacturer/s responsible for batch release and future marketing authorisation holder, if the manufacturer and future marketing authorisation are not the same person and if the agreement with the manufacturer that was submitted in the marketing authorisation procedure is not applicable any more,
  • Proof that the marketing authorisation holder has a local qualified person for pharmacovigilance residing in the Republic of Croatia, approved by the Agency (certified copy of the Agency's approval), or the proof of a submitted application for approval of local qualified person for pharmacovigilance with residence in the Republic of Croatia*,
  • Proposal of the summary of product characteristics, package leaflet and labelling (with details about the natural or legal person to which the marketing authorisation is to be transferred),
  • Proof of paid fee of the marketing authorisation procedure,
  • Proof of paid administrative fee.

The decision about the marketing authorisation transfer is issued to the new marketing authorisation holder for the period no longer than the current marketing authorisation.

The medicinal product released on the market according to the previous marketing authorisation may be on the market after the marketing authorisation transfer no longer than 18 months, if not expired before and the new marketing authorisation holder becomes responsible for the medicine.

The marketing authorisation transfer procedure is set out in the:

  • Medicinal Products Act (Official Gazette, No. 76/13),
  • Ordinance on granting the marketing authorisation (Official Gazette, No. 83/13).

*The application for approval of a local qualified person for pharmacovigilance is to be submitted to the Agency as a separate application. The criteria that the local qualified person for pharmacovigilance must fulfil and documentation that should be submitted alongside the application are set out in the Ordinance on pharmacovigilance (Official Gazette, No. 83/13).

Top