Medicinal Products

Information to Marketing Authorisation Holders on the Application Submission before the Accession to the EU

Agency for Medicinal Products and Medical Devices herewith informs marketing authorisation holders that the submission of new applications for granting marketing authorisations will be temporarily suspended from 1 December 2012 to 1 July 2013, which means by the Croatian accession to the EU.

The suspension of new application submissions is necessary in order to ensure the Agency's prompt conclusion of the status of procedures of applications submitted according to the current legislation and to facilitate the beginning of implementation of new procedures when Croatia becomes member of the EU.

The period of temporary suspension of application submissions approximately equals the legal deadline of 210 days, in which, according to the current Medicinal Products Act, HALMED is required to either grant or reject the marketing authorisation for a medicinal product upon receipt of a valid application. Given that the Croatian accession to the EU will bring certain changes to the procedures for granting the marketing authorisation, for all the applications that would not be completed prior to accession, it would be necessary to repeat the validation, regardless of the phase of the procedure they are in, in that moment.

During the aforementioned temporary period of suspension of application submission from 1 December 2012 to 1 July 2013, the submission of applications for renewals and variations will not be suspended.