Press releases | News and Educations .: HALMED

Start of a new HALMED’s campaign on promoting the importance of package leaflet reading and reporting of ADRs

11.09.2013

The Agency for Medicinal Products and Medical Devices (HALMED) has started a public education campaign aimed at promoting the importance of package leaflet reading and ADR reporting among patients and end consumers. The aim of the campaign is to inform citizens that, alongside the information provided by a qualified healthcare professional, additional information may be obtained through package leaflet reading and to motivate them to get actively involved in the medication and monitoring of safe use of medicines by reporting ADRs. This approach will further contribute to the improvement of the safe use of medicines and more efficient health care for patients and overall public health.
The campaign will intensively be carried out at the national level from the beginning of September to the end of October this year through billboard, press ads, radio spots, on-line banners, posters in doctors’ waiting rooms and information leaflets on ADRs reporting that will be available in pharmacies throughout the country.

The international conference on medicinal products regulation “EU28:science, medicines, health – a regulatory system fit for the future” started today in Dubrovnik

06.05.2013

The two-days international conference “EU28: science, medicines, health – a regulatory system fit for the future” was solemnly opened today. This conference has been jointly organised by the European Medicines Agency (EMA), the Agency for Medicinal Products and Medical Devices of the Republic of Croatia (HALMED), under the auspices of the President of the Republic of Croatia, Prof. Ivo Josipović, PhD, and the Ministry of Health of the Republic of Croatia.
The conference has been supported by the IPA programme of the European Commission (Instrument for Pre-Accession Assistance programme), supporting, among others, the participation of candidate and potential candidate countries in the activities of European Institutions.
The conference was attended by about 250 participants – representatives from the civil service, public sector and pharmaceutical industry from EU Member States, Croatia, Albania, Bosnia & Herzegovina, Montenegro, Macedonia, Serbia and Kosovo under unscr 1244/99.

Volontary recall of the medical device OneTouch Verio®Pro – glycaemic self-management system intended for home and ambulatory care, manufactured by LifeScanEurope

19.03.2013

The Agency for Medicinal Products and Medical Devices has been informed by the company Johnson & Johnson S.E. d.o.o. Zagber about the voluntary recall of the medical device OneTouch®Pro – glycaemic self-management system intended for home and ambulatory use, manufactured by LifeScanEurope – Division of Cilag GmbH International, Switzerland.
The manufacturer of the product OneTouch®Pro has discovered that the analyser yields incorrect results of the glucose level above 56.8 mmol/l. Certain measurements in described cases will be reduced for exactly 56.8 mmol/l, and such an incorrect result may be fatal for the patient. The glucose level above 56.8 mmol/l is an exceptionally rare occasion.
Hereby we inform all users to stop using the product OneTouch®Pro – glycaemic self-management system, manufactured by LifeScan Europe. We wound kindly ask our users to use other analysers not afflicted by this problem or to ask their doctor, as long as the analyser has not been replaced by an accurate one. In order to replace the defective OneTouch®Pro – glycaemic self-management system, users may contact Johnson & Johnson S.E. d.o.o./LifeScan Croatia’s customer service at 0800 5433.
This recall does not refer to OneTouch® Ultra® and OneTouch® Vita® meters of glucose blood level and OneTouch® Vita® test strips. The aforementioned products may be used safely.
Further information is available in the continuation of this information.