Distribution, Manufacturing and Inspection

Approval for Import of Medicinal Products - Program Medicinal Products

Under the Article 129 of the Medicinal Products Act (Official Gazette No. 76/13, 90/14 and 100/18), 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.

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

The Agency will not be in a position to process any applications sent in a format other than those supported by this programme.

Here you can find the above programme (Medicinal Products) and instructions for their installation and use (Instructions - Medicinal Products), 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 programme, 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.