Information to marketing authorisation holders on submission of applications before the accession to the EU
12.11.2012
The Agency for Medicinal Products and Medical Devices is expecting a higher influx of new applications for granting marketing authorisations in the period before 1 December 2012, due to a suspension of reception of new applications until 1 July 2013, which means until the date of Croatia’s accession to the EU. We would therefore kindly ask our applicants to notify in advance and book a slot with the HALMED’s Registry at the Sky Office location at +385 1 4884 163, should they submit more than four applications.
The Agency announced the suspension of reception of new applications for granting marketing authorisations on HALMED’s webpages on 9 July 2012.
