Distribution, Manufacturing and Inspection

Approval for Import of Medicinal Products - Program Medicinal Products

Under the Article 64 of the Medicinal Products Act (Official Gazette No. 71/07, 45/09 and 124/11), the Agency for Medicinal Products and Medical Devices may authorise urgent import of a finished medicinal product that has not been approved for marketing in the Republic of Croatia, whereas the authorisation for the import of medical devices that have not been entered in the register of medical devices maintained by the Agency for Medicinal Products and Medical Devices, is governed by the Article 46 of the Medical Devices Act (Official Gazette No. 67/08 and 124/11).

In order to ensure a uniform format of all import applications, the Agency has designed two programmes to simplify the submission and processing of received applications, and the granting of approvals for the import of a finished medicinal products and/or medical devices, as well as the storing of the relevant data in the Agency database.

The Agency has been using the above programmes since 1 August 2005.
The Agency will not be in a position to process any applications sent in a format other than those supported by these programmes.

Here you can find the above programmes (Medicinal Products, Medical Devices) and instructions for their installation and use (Instructions - Medicinal Products, Instructions - Medical Devices), as well as the "Read Me First" document (available only in Croatian).

Additional explanations concerning installation and use of the above programmes may be requested by sending an e-mail to support@halmed.hr or through the "Enquiries" link on the Agency website.

If in the meantime any changes are made to the above programmes, more detailed instructions will be available from this website.

Notice on submission of applications, May 2010

We would hereby like to notify all applicants for approval for the import of medicinal products and/or medicinal devices that starting with 1 June 2010 all applications have to be submitted on CDs or DVDs only. We will no longer be able to accept applications on floppy discs.