News and Educations

Dear Healthcare Professional Letter on complaints on the product due to particles of a solid material to be present on the needle surface of Kineret 100 mg solution for injection in pre-filled syringe (anakinra)

10.06.2015

Swedish Orphan Biovitrum (Sobi) has in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and European Medicines Agency (EMA) sent a letter to healthcare professionals on complaints on the product due to particles of a solid material to be present on the needle surface of Kineret 100 mg solution for injection in pre-filled syringe (anakinra).

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

more

Inspections in Institute of Immunology started

08.06.2015

HALMED will conduct audits from 8th to 12 June 2015 in Institute of Immunology d.d., due to establish whether the manufacturer complies with Good Manufacturing Practice. This audit upon Institute of Immunology’s application for granting a manufacturing license for bacterial vaccines and manufacture of medicinal products derived from human blood or plasma and sera of animal origin.

Decisions on granting or rejecting the two manufacturing licenses to Institute of Immunology d.d., will be taken following the entire procedure of granting/rejecting manufacturing licenses, where audits make only a part of the procedure. HALMED will complete these procedures as a priority, but when the decision will be taken depends on the applicant and how fast he will respond to eventual deficiencies. Namely, under Medicinal Products Act, the deadline for granting or rejecting manufacturing licenses is 90 following submission of a valid application, where the deadline may be prolonged for a clock-stop period needed by the applicant to prepare written justifications during the procedure.

All relevant information is accessible under the link below.

more

HALMED is running a survey in June 2015 on healthcare professionals’ view on the communication in safe use of medicines and communication efficiency

08.06.2015

The Agency for Medicinal Products and Medical Devices (HALMED) has initiated in collaboration with the Croatian Association of General Practitioners (HDOD), Croatian Pharmaceutical Society (HFD) and Croatian Society of Cardiology (HKD) a survey on views of healthcare professionals how competent authorities, like HALMED in Croatia, communicate towards healthcare professionals new safety issues related to use of medicines.

The survey is part of a broader pharmacovigilance EU project entitled SCOPE (Strengthening Collaboration for Operating Pharmacovigilance in Europe) aimed at improving the health safety of patients in the EU, by promoting co-operation among member states and providing support to competent authorities for medicines to meet the requirements of the EU pharmacovigilance legislation.

As a result of HALMED’s efforts, the Republic of Croatia has been chosen with other Member States to participate in running this survey within the SCOPE project with the aim to provide a possibility to health care professionals to express their opinions and views on safety communication in medicines use. Other participating countries are Spain, United Kingdom, Ireland, Italy, Sweden, The Netherlands, Norway and Denmark.

The aim of this survey is to search through experiences of healthcare professionals in communicating the competent authority’s safety information, research their views on the efficacy of such a communication and find out what are health care professionals’ preferred communication channels.

According to settings of the SCOPE project, HALMED invites all general practitioners, pharmacists and cardiologists to participate in the survey as a target group.

The survey is running in June 2015 and the deadline for completing the survey is June 2015.

Further information on the survey is accessible under the link below.

more

CMDh News – May 2015

28.05.2015

At its meeting in May 2015, the Co-ordination Group for Mutual Recognition and Decentralised Procedure, agreed by consensus the following:
- the PRAC recommendation that the marketing authorisations for ibuprofen and dexibuprofen-containing medicines should be updated to minimise the small increased risk of cardiovascular problems, such as heart attacks and strokes
- the PRAC recommendation following PSUSA assessment for nationally authorised medicines containing the combination atenolol/chlortalidone.

At the same meeting, concerning the implementation of Art. 31 referral on polymyxin-containing medicines, the CMDh emphasised that addition of intrathecal & intraventricular routes of administration is expected to be suitable for the currently approved products for parentheral administration, provided that the pharmaceutical characteristics of the product are appropriate for these routes of administration.

Further information is accessible under the link below.

more

Information on brokering medicinal products in the Republic of Croatia, minimal rules for brokers, wholesaler’s responsibility in the case of purchasing medicinal products from brokers and public accessibility of brokers’ register

27.05.2015

Under Article 85b(1) of Directive 2001/83/EC of the European Parliament and Council and Article 116 of Medicinal Products Act (Official Gazette No 76/13, 90/14) medicinal products brokering may be performed by natural and legal persons with the seat in the Republic of Croatia and an EU Member State, having a permanent address and contact in the Republic of Croatia and EU Member State to ensure identification, location and supervision of their activities.

Further information on medicinal products brokering in the Republic of Croatia, minimal requirements for brokers, wholesaler’s responsibility in the case of purchasing medicinal products from brokers and making publically accessible data on medicinal product brokers are accessible under the link below.

more

Notice on temporary discontinuation of supply chain and use of batches 15HK11F2 and 15HL218F1 of Ciprofloxacin Kabi 400 mg/200 ml solution for infusion and batches 15IB15P2 of Ciprofloxacin Kabi 200 mg/100 ml solution for infusion.

26.05.2015

Fresenius Kabi d.o.o., the marketing authorisation holder for Ciprofloxacin Kabi 400 mg/200 ml solution for infusion, Fresenius Kabi d.o.o., has initiated upon request of the Agency for Medicinal Products and Medical Devices (HALMED) a procedure of temporary disruption of distribution and use of the batches: 15IB515P2 of Ciprofoxacin Kabi 400 mg/200 ml solution for infusion and batches 15IB15P2 of Ciprofoxacin Kabi 200 mg/100 ml solution for infusion in the Republic of Croatia.

The procedure of discontinuation of distribution and use of these batches has been initiated over concern on a suspected quality defect based on an increased number of suspected adverse reactions to these medicines reported to HALMED in the last several weeks.

More information is accessible under the link below.

more

5th Croatian Congress on Pharmacy in Rovinj

22.05.2015

The 5th Croatian Congress on Pharmacy with international participation was opened on 21st May at the hotel Lone in Rovinj. This Conference is being held from 21st to 24th May 2015 and it is organised by the Croatian Pharmaceutical Society in collaboration with the Agency for Medicinal Products and Medical Devices and the Faculty of Pharmacy and Biochemistry of the University of Zagreb. The Congress is being held under the auspices of the Ministry of Health and the Ministry of Science, Education and Sports.

HALMED staff members also participate at the Congress and they will give lectures and present posters on the novelties in medicines regulation and pharmacovigilance. The Head of HALMED , Viola Macolić Šarinić, MD, PhD, held the following lectures: “Challenges in granting a marketing authorisation to biosimilars in the EU” and “Adverse Drug Reactions in the Republic of Croatia”.

More than 800 participants are taking part at the Congress – representatives of state institutions, international organisations of pharmacists, pharmaceutical faculties and related study programmes, pharmaceutical industry and a number of experts from pharmacy and related disciplines from 12 countries.

More information is accessible under the link below.

more

CMDh updated advice on use of high-dose ibuprofen

22.05.2015

The CMDh has endorsed by consensus updated advice on the use of high-dose ibuprofen. This follows a review carried out by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), which confirmed a small increased risk of cardiovascular problems, such as heart attacks and strokes, in patients taking high doses of ibuprofen (at or above 2,400 mg per day). The review clarifies that the risk with high-dose ibuprofen is similar to the risk seen with some other non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors and diclofenac.

Further information is accessible under the link below.

more

For Patients and Public

For Health Care Professionals

For Industry Representatives