News and Educations

The Head of HALMED held a lecture on the Lareb conference on reporting suspected adverse reactions from patients

30.04.2015

The Head of the Agency for Medicinal Products and Medical Devices (HALMED), Viola Macolić Šarinić, MD, PhD, held a lecture on the conference “Current perspectives and future possibilities”, dedicated to reporting suspected adverse reactions from patients, organised by Lareb in Leiden in the Netherlands from 23 to 24 April 2015.

The Head presented positive results, achieved by HALMED in the field of reporting adverse reactions, when it was first in the world to use the UMC’s on-line application for patient reporting. She also presented the exceptionally successful HALMED’s public educational campaign for promoting the importance of package leaflet reading and reporting adverse reactions and emphasised that this campaign had resulted in a three-fold increase in number of received reports from patients. The innovative co-operation started by HALMED with the theatre “Small Scene” with the aim to promote the importance of rational use of medicines and reporting of suspected adverse reactions among children, adolescents and adults was specially highlighted.

Further information is accessible under the link below.

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Marketing authorisation procedure in the Republic of Kosovo accelerated for medicines authorised by HALMED

29.04.2015

The Kosovo Medicines and Medical Devices Agency (AKPPM) has notified HALMED on the provisional change of Ordinance on granting marketing authorisation. This change will facilitate and accelerate authorisation of all medicines authorised by HALMED and thus pave the way for easier placing of products of Croatian manufacturers to the Kosovo market.

Under provision of this Ordinance, for medicinal products authorised by HALMED, applicants are required to submit only CTD Module 1 and the marketing authorisation procedure will last up to 70 days.

This regulatory change is a result of a successful cooperation between HALMED and AKPPM, based on which HALMED is recognised as a reliable and responsible partner in the regional regulatory environment that ensures efficacious, quality and safe medicines top all patients and users.

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Dear Healthcare Professional Letter on reminder on importance of correct preparation and use of Periolimel N4E, Olimel N7E and Olimel N9E emulsion for infusion due to risks of medication errors

24.04.2015

Agmar d.o.o. is, in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) sending a letter to healthcare professionals to inform them on the risk of a medication error when preparing and using Periolimel N4E, Olimel N7E and Olimel N9E emulsion for infusion. This notice concerns all Olimel/periolimel emulsions for infusion authorised in the Republic of Croatia – Periolimel N4E, Olimel N5E, Olimel N7E, Olimel N9 and Olimel N9E. However, as of April 2015, only Periolimel N4E, Olimel N7E and Olimel N9E emulsion for infusion will be placed on the market.

Further information and the Dear Healthcare professional Letter are accessible under the link below.

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Dear Healthcare Professional Letter on the first reported case of progressive multifocal leukoencephalopathy (PML) in a multiple sclerosis patient taking ingolimod (Gilenya) without previous treatment by natalizumab or other immunosuppressive medicines

24.04.2015

In agreement with European Medicines Agency (EMA) and Agency for Medicinal Products and Medical Devices (HALMED), Novartis Croatia d.o.o. would like to inform healthcare professionals of a first case report of PML in a patient taking fingolimod for multiple sclerosis without previous treatment by natalizumab or other immunossupressive medicines.

Further information and the Dear Healthcare Professional Letter are accessible under the link below.

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Notice on the beginning of dispensation of ellaOne without prescription

22.04.2015

Following to the Commission’s Decision on the reclassification status of ellaOne, we inform users of the medicine and healthcare professionals on the beginning of dispensation of ellaOne 30 mg tablets (ulipristal acetate) without prescription. This Commission’s Decision on the OTC status of ellaOne is legally binding to all EU Member States, including Croatia, and it was adopted based on the recommendation of the European Medicines Agency (EMA) in a release published by HALMED on 21 November 2014.

The marketing authorisation holder for ellaOne in the EU, Laboratoire HRA Pharma, has prepared an and produced and an OTC adapted version of the labelling, summary of product characteristics and package leaflet in Croatian. By doing this, the marketing authorisation holder has fulfilled its obligations imposed by the European Commission as a prerequisite for starting the dispensation of ellaOne without a prescription.

Since the conditions for implementation of the Commission’s decision in Croatia are fulfilled, the marketing authorisation holder’s representative for Croatia, Arenda d.o.o. has notified HALMED that OTC adapted ellaOne packaging will be available in Croatian pharmacies as of 22 April 2015. The remaining packaging intended for dispensation with medical prescription that may be still found in some Croatian pharmacies, will be dispensed solely upon prescription.

The marketing authorisation holder’s representative in Croatia has, in agreement with HALMED prepared a notice to pharmacists on the beginning of dispensation of ellaOne without a prescription that will be disseminated to pharmacies today or at delivery of new ellaOne packs.

HALMED would like to remind users that the emergency contraception by using the ellaOne method is to be used only occasionally and may not in any case replace the regular contraception methods.

The information for pharmacists, further information and linked news are accessible under the link below.

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Dear Healthcare Professional Letter on the new list of compatible appliances for blood glucose determination in patients treated with Extraneal solution for peritoneal dialysis (icodextrin)

14.04.2015

Agmar d.o.o. has in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) sent a Dear Healthcare Professional Letter on the new list of compatible appliances for blood glucose determination in patients treated with Extraneal solution for peritoneal dialysis (icodextrin).

Further information is accessible under the link below.

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The Head of HALMED held a lecture at the DIA conference “Development, innovation affordability and patient safety”

13.04.2015

The Head of the Agency for Medicinal Products and Medical Devices (HALMED), Dr Viola Macolić Šarinić, MD, PhD participated today, together with representatives from the relevant European bodies in the field of medicines, at the roundtable organised within the conference entitled “Development, innovation, affordability and patient safety”. The conference is organised by Drug Information Association (DIA) in Paris from 13 to 15 April 2015. At the roundtable discussion dedicated to the fiftieth anniversary of the EU pharmaceutical legislation, the HALMED Head held, together with Xavier De Cuyper, CEO of the Belgian Federal Agency for Medicines (AFMPS) a lecture on the scientific contribution of the EMA committees and network of national experts for medicines.

Further information is accessible under the link below.

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