News and Educations

Instructions for application of variations resulting from the referral procedurefor bromocriptine containing medicines

18.11.2014

The European Commission endorsed on 30 October 2014 Decision on marketing authorisations for bromocriptine-containing medicines, under Article 31 of Directive 2001/83/EC of the European Parliament and Council (procedure number EMEA/H/A-31/1379). Details are available on the European Commission’s webpages, or here.

More information is accessible under the link below.

Notice on cases of illegal distribution of medicinal products in the EU

18.11.2014

The Agency for Medicinal Products and Medical devices (HALMED) has received a notice from Spanish competent authorities concerning discovered illegal medicines distribution in Spain that may affect also other EU Member States and third countries. For illegally distributed medicinal products quality, safety and efficacy cannot be granted and therefore these medicines are considered counterfeits.

More information is accessible under the link below.

European Antibiotic Awareness Day

17.11.2014

The European Antibiotic Awareness Day (EAAD) is manifested on 18 November every year. This manifestation is organised by the European Centre for Diesease Control and Prevention (ECDC) aimed at raising awareness on microorganism resistance to antibiotics and importance of their rational use.

HALMED is monitoring from the close the antibiotic use in Croatia and appeals on their rational and correct use. The correct use of antibiotics will preserve their activity, enforce their clinical efficacy and reduce the potential for antibiotic resistance, thus in the end resulting in reuction in morbidity and mortality due to infections caused by resistant bacteria.

Meeting of HALMED’s representatives and competent authorities in the region

14.11.2014

The Agency for Medicinal Product and Medical Devices (HALMED) organised on 12 November in Šibenik a meeting of competent authorities for medicines on the topic “Inter-regulatory regional co-operation on medicines – possibilities and practice”.

Representatives from competent authorities from Croatia, Bosnia and Herzegovina, Montenegro, Kosovo, Macedonia and Serbia gathered after the International regulatory and pharmacovigilance conference “Croatian mark in the EU” to discuss possibilities for co-operation on medicines.

HALMED held a round table "Counterfeit medicines and safety features"

14.11.2014

The Agency for Medicinal Products and Medical Devices (HALMED) organised a round table "Counterfeit medicines and safety features" which was held on 11 November 2014 in Šibenik within the International regulatory and pharmacovigilance conference "Croatian Mark in the EU". Round table gathered stakeholders in the field of fighting counterfeit medicines; representatives from healthcare professionals, pharmaceutical industry, medicines retailers and wholesalers, patients, journalists, Ministry of Health, Customs Office of the Ministry of Finance, Croatian Health Insurance Fund and HALMED. Participants presented their positions and discussed the counterfeit medicines problem, as well as the prevention of the counterfeit medicines, and implementation of safety features.

Overview on International regulatory and pharmacovigilance conference “Croatian mark in the EU”

14.11.2014

The international regulatory and pharmacovigilance conference “Croatian mark in the EU”, was organised from 11 to 12 November in Šibenik by the Agency for Medicinal Products and Medical Devices (HALMED), under the auspices of the Croatian Ministry of Health. The conference was aimed at informing all stakeholders on medicines regulations that came into effect after Croatia’s accession to the EU with the aim to better harmonise with these requirements. A round table on counterfeit medicines and introduction of safety features was also held within the conference.

HALMED inspectors attended the Annual PIC/S seminar in Paris

14.11.2014

The Annual PIC/S seminar was organised from 22 to 24 October 2014 in Paris by the French Agency for Security of Health Products (ANSM).

HALMED’s inspectors attended this meeting. Here you may find a short summary of the seminar and an overview on other news and PIC/S activities.

Newly approved medicinal products

14.11.2014

The list of newly approved medicinal products for the period between 1st October 2014 and 31st October 2014 is available in the continuation of this notice.

Notice on temporary supply and use discontinuation of the batch 15HG229F1 of Ciprofloxacin Kabi 400 mg/200 ml solution for infusion

14.11.2014

Fresenius Kabi d.o.o., the marketing authorisation holder for medicinal product Ciprofloxacin Kabi 400 mg/200 ml solution for infusion has upon request of the Agency for Medicinal Products and Medical devices (HALMED) initiated a procedure of temporary supply and use discontinuation of the batch 15HG229F1 of this medicinal product from the Croatian market.
The procedure of temporary supply and use discontinuation of this batch has been initiated due to a suspected quality defect.

More information is accessible under the link below.

HALMED published a comparative overview of medicinal products utilisation in Croatia from 2007 to 2012

13.11.2014

The Agency for Medicinal Products and Medical Devices has published The medicinal products utilisation in Croatia from 2007 to 2012 in the Publication and Reports Section of the HALMED webpages. This pilot project is HALMED’s first publication in Croatia containing a comparative report on medicinal products utilisation over several years, that may serve as a base for planning of medicines utilisation and rational pharmacotherapy at all healthcare levels. In order to meet the needs of our users in our future publications, we are inviting you to send us your comments, suggestions and eventual proposals for improvement by using the e-mail address under the link below.

For Patients and Public

For Health Care Professionals

For Industry Representatives