03.02.2015
This year marks the 50th anniversary of the introduction of the first EU legislation on human medicines and the adoption of Council Directive 65/65. This Directive that was adopted on 26th January 1965 introduced clear rules and some founding principles that are valid until today and that are considered to be the beginning of the EU pharmaceutical legislation.
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03.02.2015
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 on Congress, registration, conference fees and preliminary programme is accessible under the link below.
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30.01.2015
The Agency for Medicinal Products and Medicla Devices (HALMED) starts to use Standard Terms exclusively directly via database of the European Directorate for the Quality of Medicines & Healthcare (EDQM & Healthcare). Namely, in the beginning of 2015 the EDQM decided to make publically accessible for free its Standard Terms data base. This notice was published on 12 January 2015 on the HALMED webpages.
More information and links to access the EDQM's database are available under the link below.
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29.01.2015
The Agency for Medicinal Products and Medical Devices (HALMED) would like to inform its users that as of 1 January 2015 new point values of certain OMCL's laboratory tests apply.
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27.01.2015
The Council of Europe's European Directorate for the Quality of Medicines and Healthcare (EDQM) has publishedon its website presentations held at the workshop „OTC Medicines: The role of good classification practices in promoting medication safety and accessibility in Europe“.
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27.01.2015
The Croatian Institute for Transfusion Medicine, the marketing authorisation holder for Soludeks 40, 100 mg/ml solution for infusion has notified the Agency for Medicinal Products and Medical Devices (HALMED) on the quality defect of batches 1280064, 1281064, 1282064, 1283064 of this medicine.
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26.01.2015
The Agency for Medicinal Products and Medical Devices (HALMED) has published on its webpages the results of the annual survey on customers satisfaction. Once a year HALMED carries out this investigation with the aim of continuous improvement of services and follow up of users needs. In the survey carried out in October 2014, the majority of participants evaluated HALMED with high grades (excellent and very good).
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23.01.2015
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended seven new medicines for granting a marketing authorisation, seven medicines for extensions of therapeutic indications and concluded the review of the GVK Biosciences investigation site.
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23.01.2015
Based on recommendations of the European Medicines Agency (EMA), the Agency for Medicinal Products and Medical Devices (HALMED) temporarily suspended the placing on the market of nine medicinal products in Croatia due to non-compliance with the good clinical practice. The clinical trials based on which the concerned medicinal products are authorised were carried out by GVK Biosciences at the investigational site in Hyderabad in India. Based on the fact that an inspection at the site discovered non-compliances with the good clinical practice rules, this temporary decision will be in effect until marketing authorisation holders have submitted new data, or carried out new trials on other sites.
In addition to the temporary suspension of placing on the market of these medicines, those medicines already on the market are being recalled to the pharmacy level.
This temporary suspension of placing on the market and recalls are being carried out as a precaution measures and are not initiated by safety reasons.
The list of medicines affected by the temporary suspension in Croatia is accessible here.
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21.01.2015
We inform all users of our services that as of 22 January 2015, it is possible to submit no more than 8 applications without previous appointment. The number of applications that may be submitted without appointment to the HALMED's Registry Office is increased from four to eight based on the proposal of our users from the survey on HALMED's customers satisfaction.
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