News and Educations

New application forms for transfer and revocation of marketing authorisation now available


The Agency for Medicinal Products and Medical Devices (HALMED) has, in accordance with the Ordinance on granting the marketing authorisation, No 83/13) prepared the Application forms for transfer of marketing authorisation and Application form for revocation of marketing authorisation, that you may find here.

The prepared forms serve as a standard template for preparing applications and after they have been populated, only need to be printed on a memorandum, signed and sealed (it is not necessary to attach a cover letter).

Applications for transfer of marketing authorisations, revocation of marketing authorisations are submitted in original, in Croatian for every pharmaceutical form and strength separately.