11.04.2014
Due to ongoing works on the IT infrastructure of the Agency for Medicinal Products and Medical Devices, today from 5 to 6pm the HALMED staff will be temporary unavailable via phone and e-mail as well as the on-line application.
We thank you for your understanding.
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09.04.2014
The company Agmar d.o.o. has, in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent a letter to healthcare professionals on the new list of devices compatible for blood glucose determination in patients treated with Extraneal solution for peritoneal dialysis (icodextrin). The letter contains the new list of devices for blood glucose determination permitted to be used in those patients. The letter follows up to the previous letters addressed to doctors, that HALMED reported on its webpages in June 2008, July 2010 and August 2011.
Detailed information and the Dear Healthcare Professional Letter is accessible under the link below.
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01.04.2014
From 2 September 2013, the Agency for Medicinal Products and Medical Devices (HALMED) has been implementing a one year project “Preparation for eCTD and implementation of digital archive system” from the IPA 2009 TAIB project. The project has been funded by the European Union and co-financed by HALMED. The project is led by Mr Denis Matas from the Central Finance and Contracting Agency (CFCA) and Assisstant Professor Arian Rajh, PhD from HALMED.
Further information is accessible under the link below.
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01.04.2014
The government of the Republic of Croatia appointed on its meeting held on 27 March 2014 a new president and a new member of the Agency Board.
Professor Vlatka Bilas, PhD was appointed a new president of the Agency Board and Vesna Martek Radonić as a new member of the Agency Board.
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28.03.2014
Due to ongoing works on the IT infrastructure of the Agency for Medicinal Products and Medical Devices on Friday, 28 March 2014 from 17,00 to 19,00 h the HALMED staff will be temporary unavailable via phone and e-mail as well as the on-line application.
We thank you for your understanding.
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27.03.2014
The Head of the Agency for Medicinal Products and Medical Devices (HALMED), Viola Macoluić Šarinić, MD, PhD, Spec. participated today together with prominent representatives of relevant European medicines authorities at the round table discussion within the Conference “Different perspectives – one vision; better patient health protection”, organised by Drug Information Association (DIA) from 25 to 27 March 2014 in Vienna.
During the Conference HALMED as a competent regulatory authority of a Member State received
many compliments from prominent participants with regard to the successful integration to EU marketing authorisation procedures and undertaking responsibilities and obligations as a full member of the EU regulatory network for medicines. Also, the leading pharmacovigilance actors emphasised the amazing Croatian pharmacovigilance experience, as well as the HALMED’s proactive approach in surveillance of safe use of medicines.
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24.03.2014
Within the “Medicinal products” Section on the webpages of the Agency for Medicinal Products and Medical Devices (HALMED) a new subsection “Biological and biosimilar medicinal products” has been launched.
HALMED is providing questions and answers related to properties of biological and biosimilar medicines, their quality, safety and efficacy requirements, marketing authorisation procedure and special requirements for post-authorisation monitoring of these medicines. Also, answers are given with regard to the interchangeability of biological and biosimilar medicinal medicinal products during treatment.
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24.03.2014
The Co-ordination Group for Mutual Recognition and Decentralised Procedure - Human (CMDh) has endorsed recommendations to restrict the use of diacerein-containing medicines. The Committee for Human Medicinal Products (CHMP) has recommended granting a marketing authorisation for nine new medicines, recommended extensions of indications for Pegasys, Tresiba and Victoza and concluded its review of the safety of propylene glycol in intravenous formulations. Also, the CHMP adopted recommendations for the influenza virus strains that should be included in vaccines for the prevention of seasonal influenza in winter 2014/2015. Further information is accessible under the link below.
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21.03.2014
The Agency for Medicinal Products and Medical Devices (HALMED) has published the second Supplement, labelled 3.2. of the online Croatian Pharmacopoeia Edition 3.0. This supplement is based on the second Supplement of the eighth European Pharmacopoeia Edition published on the 1 January 2014 and coming into effect on the 1 July 2014.
Detailed information is accessible under the link below.
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19.03.2014
The Agency for Medicinal Products and Medical Devices (HALMED) is informing its clients that a detailed list of laboratory testing point values of the Official Medicines Control Laboratory Division – OMCL is available on the HALMED webpages, based on which the price for certain laboratory testing is determined.
Detailed information is accessible under th elink below.
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