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Read a Patient Information Leaflet Report Side Effects to Medicines

Inspections in Institute of Immunology started

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.


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

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.


Newly approved medicinal products

The list of newly approved medicinal products for the period between 1st May 2015 and 31st May 2015 is available in the continuation of this notice.


Recommendations for variation application based on the signal safety assessment from the PRAC May 2015 meeting

The Agency for Medicinal Products and Medical Devices (HALMED) has made publically available on its webpages recommendations for variation application based on the safety signal assessment adopted at the European Medicines Agency’s (EMA) Pharmacovigilance and Risk Assessment Committee (PRAC) May 2015 meeting, as well as Croatian translations of these recommendations. The concerned active substances are fingolimod, latanoprost (Xalatan), leflunomid and natalizumab. The recommendations are available here.

From May 2015 the EMA has started with a simultaneous publication of recommendations in English and their translations in all official languages of the EU member states. Recommendations and translations are published by the EMA approximately three weeks after the PRAC meeting. The Croatian translation, beginning from the PRAC May 2015 meeting will be published on the HALMED webpages simultaneously with recommendations in English and Newsletter will also be sent to users.


PRAC News – June 2015

The European Medicines Agency’s (EMA) Pharmacovigilance and Risk Assessment Committee (PRAC) has started a review of the following medicines from the SGLT2 inhibitor group: kanagliflozin, dapagliflozin and empagliflozin.

Further information ias accessible under the link below.


EMA started review of diabetes medicines called SGLT2 inhibitors

The European Medicines Agency (EMA) has started a review of canaglifozin, dapagliflozin and empagliflozin, which are medicines known as SGLT2 inhibitors used to treat type 2 diabetes. The aim of the review is to evaluate the risk of diabetic ketoacidosis, a serious condition that usually develops in people with type 1 diabetes when insulin levels are too low.

Further information is accessible under the link below.


MRP i DCP postupci
Croatian Pharmacopoeia
Events - HALMED

Workshop: “Regulatory framework in medicines distribution”

A workshop “Regulatory framework in medicines distribution” will be held in Zagreb and organised by the Agency for Medicinal Products and Medical Devices (HALMED). The workshop will be held in May 2015 at HALMED’s premises, Ksaverska cesta 4. The exact dates of the workshop will be announced later, depending on the number of registered participants.


Rovinj, 21-24 May 2015
5th Croatian Congress on Pharmacy with International Participation

The Croatian Pharmaceutical Society organises in collaboration with the Faculty of Pharmacy and Biochemistry and the Agency for Medicinal Products and Medical Devices (HALMED) the 5th Croatian Congress on Pharmacy with International Participation that will be held from 21 to 24 May 2015 in Rovinj.

More information is accessible under the link below.


Educational course “Distribution of medical devices”

The Agency for Medicinal Products and Medical Devices (HALMED) is organising in Zagreb an educational course “Distribution and good practice in medical device distribution”. The course will be held at the HALMED’s premises, Ksaverska cesta 4, and the exact date of the course will be determined when enough interested participants has gathered (the foreseen duration 6 school hours). The course is intended to wholesalers of medical devices and authorised manufacturer’s representatives from the third countries.


Educational course “Introduction to medical devices vigilance”

The educational course “Introduction to medical devices vigilance”, organised by the Agency for Medicinal Products and Medical Devices (HALMED), will take place at the HALMED’s premises at Ksaverska cesta 4. The exact date will be announced when enough interested participants have been gathered (the approximate duration is 6 school hrs).
More information is available in the continuation of this information.