07.11.2014
On its November 2014 meeting the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) endorsed recommendations regarding the safe use of Corlentor/Procoralan (ivabradine), Kogenate Bayer/Helixate Nexgen and Tecfidera.
More information is accessible under the link below.
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05.11.2014
The Agency for Medicinal Products and Medical Devices (HALMED) has published a third Supplement to the on-line edition of Croatian Pharmacopoeia labelled 3.3. This Supplement is based on the third Supplement of the eighth edition of European Pharmacopoeia published on 1st July 2014 coming into effect on 1st January 2015 and valid until 31st March 2015.
More information is accessible under the link below.
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03.11.2014
The Agency for Medicinal Products and Medical Devices (HALMED) is informing visitors on the new entry regulation in the Sky Office Business Building as of 3 November 2014.
Doors at the elevator pre-space, the door to the staircase to underground floors and the door to staircase to ground-floor will be under controlled system and the entry will be possible only with a pass control.
In accordance with the new entry control, Sky Office visitors will not be able to access to building floors directly from the garage by elevators, but they may walk to the ground-floor to the reception where they have to report their visit to the security. Visitors will be able to enter the protected area when a staff member at the Sky Office meets them on the agreed underground floor and lead them into the premises.
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30.10.2014
Agmar d.o.o., the marketing authorisation holder for Glucose 10% Viaflo solution for infusion (glucose hydrate), is carrying out, at the Agency’s request , the recall procedure of the batch 14C17E3M of this medicine.
More information is accessible under the link below.
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29.10.2014
Within the programme of Benchmarking of European Medicines Agencies (BEMA) in the EEA, the Agency for Medicinal Products and Medical Devices (HALMED) received the highest mark excellent (5) among all the benchmarked medicines agencies and many indicators of HALMED’s operations are marked as the best practice at the EU level. These outstanding results rank HALMED among the top agencies within the EU regulatory network. In accordance with the highest marks of certain indicators, HALMED was marked with an exceptional total mark – 4.14 out of the maximal 5.0
The programme Benchmarking of European Medicines Agencies (BEMA) is carried out by the Heads of Medicines Agencies (HMA). During their stay from 21 to 24 October 2014, BEMA’s assessors thoroughly checked HALMED’s business operations and documentation in order to carry out the final evaluation of HALMED’s operations. HALMED’s highest marks were in business aspects relating to education of stakeholders and promotion of reporting in the area of safety, quality and efficacy, HALMED’s quality system, continuous procedure improvement, conflict of interest management, deadline tracking system and pharmacovigilance system monitoring.
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29.10.2014
Four new Ordinances were published under Medicinal Products Act in the Official Gazette No 122 of 17 October 2014 (Official Gazette No 76/13, 90/14).
Ordinances are accessible on the HALMED webpages in the Legislation section, or under the link below.
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28.10.2014
The Agency for Medicinal Products and Medical Devices (HALMED) organises the international regulatory and pharmacovigilance conference entitled “Croatian Mark in the EU” which will be held from 11 to 12 November 2013 in Hotel Ivan, Solaris, in Šibenik.
All interested for participation may register via registration form, which is, along with detailed information, accessible at the HALMED's webpages in the Conferences and workshops/Regulatory and pharmacovigilance conference "Croatian Mark in the EU" section, or under the link below.
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28.10.2014
Following to enquiries from marketing authorisation holders, HALMED is publishing instructions regarding the inclusion of information as regard the medicinal product status under additional monitoring in promotional material intended to healthcare professionals and patients.
More information is accessible under the link below.
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27.10.2014
On Friday, 3rd October 2014 the Annual Election Assembly of the Croatian Society of Pharmacy took place, where also the Agency for Medicinal Products and Medical Devices (HALMED) awarded pharmacists for their contribution to spontaneous reporting of adverse reactions in 2013. The Head of HALMED, Viola Macolić Šarinić, MD, PhD, Clinical Pharmacologist and Toxicologist on that occasion held a lecture “40 years of spontaneous reporting in the Republic of Croatia”.
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27.10.2014
On Wednesday, 29 October 2014, a round table “Generic medicines – why are they an actual topic again” will be held in the Big Hall of the Croatian Medical Association, Šubićeva 9 at 5 p.m.
The round table will take place within the 120th meeting of the Croatian Society for Clinical Pharmacology and Therapeutics and it is intended to all interested healthcare professionals, representatives of competent authorities and associations.
The Head of HALMED, Viola Macolić Šarinić, MD, PhD, will have a lecture entitled “Generic medicines – positions of the regulatory authority”.
More information is accessible under the link below.
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